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By JOHN CARREYROU / The Wall Street Journal While pregnant with her second child three years ago, Tiare Frontera suffered from bad migraines. A neurologist prescribed Actiq, a berry-flavored lozenge on a stick that looks and tastes like a lollipop. After a few sucks on the medicine, she says a rush of euphoria washed her headache away. Soon, Mrs. Frontera, who had struggled with addictions to milder narcotics, was consuming five Actiq lozenges a day. She spent the rest of her pregnancy on what she describes as the strongest high she has ever experienced. When she gave birth, her baby son was cranky and wouldn’t sleep. Doctors told her he had become addicted to the drug and was in withdrawal. Mrs. Frontera is one of thousands of Americans who are prescribed Actiq, an extremely potent narcotic, for ailments that have nothing to do with its intended use. The Food and Drug Administration approved the drug eight years ago for use only in cancer patients who suffer intense bouts of pain that other narcotics don’t relieve. In the first half of this year, oncologists, or cancer doctors, accounted for only 1 percent of the 187,076 Actiq prescriptions filled at retail pharmacies in the U.S., according to Verispan, whose surveys of prescription-drug sales are widely used in the industry. Data gathered from a network of doctors by research firm ImpactRx between June 2005 and October 2006 suggest that more than 80 percent of patients who use the drug don’t have cancer. Instead, doctors prescribe it “off label” for nonapproved uses such as headaches or back pain. Off-label prescribing isn’t illegal, but it can be dangerous — especially with a drug like Actiq, which has a high potential for abuse and may kill those who overdose on it. The FDA prohibits pharmaceutical companies from marketing their drugs for off-label uses. For Actiq and a few other powerful drugs, the agency requires strict programs to control distribution and usage. Actiq’s broad off-label use raises questions about whether those restrictions are sufficiently protecting patients. “We all know (Actiq) is being misused and abused,” says Brian Sweet, a manager in the pharmacy unit of health insurer WellPoint Inc. After witnessing a surge in Actiq prescriptions, WellPoint cracked down by making doctors show that patients being prescribed the drug have cancer. Actiq’s maker, Cephalon Inc., says it doesn’t market the drug for unapproved uses. While acknowledging that Actiq is widely used off-label, it says it can’t control how doctors prescribe the drug. Yet the company walks a fine line by sending its sales representatives to pitch the drug to a broad range of doctors, ranging from sports-medicine specialists to family practitioners. It gives these doctors coupons for free samples. Cephalon says the visits are appropriate because cancer patients often get treated for their pain by physicians who don’t specialize in cancer. Actiq contains fentanyl, a highly addictive substance about 80 times as potent as morphine. Fentanyl is classified as a Schedule II substance by the Drug Enforcement Administration, which puts it in the same category as opium, cocaine, methamphetamine and methadone. Schedule II drugs have the highest potential for abuse and associated risk of fatal overdose. Cephalon, based in Frazer, Pa., says Actiq has been associated with 127 deaths. Two of them involved children who confused the drug for candy. Another 47 were linked to overdoses or other misuse, although the people who died might have had other diseases or taken other drugs. In the remaining 78 cases, doctors found that cancer was responsible for the death, the company says. Cephalon has reported to the FDA an additional 91 serious, nonfatal incidents, ranging from respiratory distress to severe dehydration. The U.S. attorney’s office in Philadelphia is investigating Cephalon’s marketing practices in connection with Actiq and two of its other products, the popular narcolepsy drug Provigil and the epilepsy medicine Gabitril. No charges have been filed. Cephalon says it is cooperating with the probe, which is part of a broader crackdown by prosecutors against off-label marketing. In August, the Justice Department fined Schering-Plough Corp. $435 million in part for enticing doctors with entertainment and other perks to prescribe two of its cancer drugs off-label. Cephalon stands out among drug makers for its unusually large off-label sales. Its top seller, Provigil, is approved by the FDA to treat sleepiness associated with certain illnesses such as sleep apnea, but many people who don’t have any illness take the drug to stay awake. Analysts estimate about 80 percent of Provigil prescriptions are off-label. Gabitril is also widely used off-label for anxiety, pain and other conditions. Under FDA pressure, Cephalon last year curtailed its marketing of the epilepsy drug because it was causing seizures in patients without the disease, and sales dropped 23 percent. Founded in 1987 by a former DuPont Co. scientist named Frank Baldino Jr., Cephalon expects revenue to exceed $1.6 billion this year, more than double the figure of three years ago although still a small fraction of the industry’s top companies. Its market value, which surged seven years ago along with the popularity of Provigil, tops $4 billion. Dr. Baldino earned $2.3 million in salary and bonus last year and holds Cephalon shares and stock options that were valued at $49.6 million as of the end of last year. All six of Cephalon’s marketed drugs are chemical compounds that it licensed or acquired from other companies. Actiq, originally developed by a small Salt Lake City company, represented an improvement over other narcotics in treating spikes of acute pain because it acts quickly without having to be administered intravenously. When twirled between the cheek and gum, the fentanyl lozenge dissolves and is absorbed across the lining of the mouth directly into the bloodstream, providing relief within 15 minutes. Actiq had sales of $15 million in 2000, when Cephalon acquired it. By last year, sales had grown to $412 million, making it Cephalon’s No. 2 drug. In the first nine months of this year, sales jumped to $471 million. Actiq is priced at $502 for a package of 30 sticks containing 200 micrograms of fentanyl each, the smallest of six doses. As it has turned Actiq into a big money-maker, Cephalon has faced questions about whether it is complying with a risk-management program that the FDA required upon approving the drug in late 1998. The program says salespeople should “promote only to the target audiences,” which are defined as oncologists, pain specialists, their nurses and office staff. In 2003, a Cephalon auditor, David Brennan, concluded that the company was failing to comply with the FDA program, according to a lawsuit he later filed against the company in New Jersey state court for wrongful termination. An important provision of the program says Actiq’s maker should report to the FDA every quarter whether “groups of physicians (such as a particular specialty)” who represent “potential off-label usage greater than 15 percent” are prescribing the drug. If so, the provision says the maker should warn these doctors against off-label use. Mr. Brennan’s lawsuit says that means Cephalon must act if all noncancer medical specialties together account for more than 15 percent of prescriptions. Cephalon interprets the provision differently. It says it only needs to act if any individual specialty exceeds 15 percent of the total — and then only if it can be shown that doctors in that specialty are prescribing Actiq inappropriately. Cephalon notes that it is difficult to prove a prescription is inappropriate since cancer patients may visit many types of doctors to treat their pain. It believes the 15 percent clause has yet to be triggered. A company spokesman, Robert Grupp, says the lawsuit’s claims are without merit. The FDA declined to comment. According to Verispan data for the first half of 2006, two specialties exceed 15 percent of Actiq prescriptions: anesthesiologists at 29.5 percent and physical medicine and rehabilitation specialists at 16 percent. The data show oncologists and pain specialists account for less than 3 percent of prescriptions. Cephalon doesn’t dispute the data. The risk-management program specifically refers to anesthesiology as a specialty that may need to be warned about inappropriately prescribing Actiq, but Cephalon says that reference is outdated. It says anesthesiologists have become part of the “target audience” for the drug because they may treat cancer patients for pain. Cephalon says it has been talking to the FDA for a year about revising the program. After Mr. Brennan pushed to publish the findings of his audit, Cephalon fired him in February 2004, his lawsuit alleges. Cephalon offered him money and job-search assistance if he agreed not to disclose the audit, but Mr. Brennan refused, the suit says. Mr. Grupp declined to discuss Mr. Brennan’s dismissal but noted that he is “a former disgruntled employee.” Mr. Brennan has been interviewed twice by investigators working for the U.S. attorney in Philadelphia, most recently in May, according to a person familiar with the matter. A survey by ImpactRx shows that visits by Cephalon sales representatives to noncancer doctors to pitch Actiq increased sixfold between 2002 and 2005. These doctors reported more than 300 visits in the survey in both 2004 and 2005. Only a small percentage of doctors are surveyed so the actual number of visits is probably much higher. Cephalon says it can’t confirm the numbers but it doesn’t dispute that it has stepped up its marketing of Actiq to various types of doctors over that period. Stephen Leighton, a general practitioner in Winston-Salem, N.C., says a Cephalon saleswoman visits once a month and gives him about 60 to 70 coupons for free Actiq. Patients can trade each coupon for six Actiq sticks. Dr. Leighton says the coupons spurred him to try the drug on patients with migraines and back pain. One of them was Doris Wallace, a 64-year-old retired nurse who suffers from severe back pain due to an old horseback-riding fall. Ms. Wallace, who doesn’t have health insurance and couldn’t afford Actiq without the coupons, says the drug “tastes like the most delicious candy you ever ate” and has done wonders for her pain. At the height of her use, she was consuming 24 Actiq sticks a month. The positive experience of patients like Ms. Wallace has led Dr. Leighton to prescribe Actiq more widely for different types of pain. Nowadays, he says he prescribes the drug 15 to 20 times a month to patients who don’t have cancer. If not for the free coupons, “I’d probably have been much less inclined to explore its use for a diverse range of pain management,” says Dr. Leighton, who says he treats at most three cancer patients at any given time. Dr. Leighton says he thinks the FDA-approved usage of Actiq is too narrow. He says he has told the Cephalon saleswoman how he prescribes the drug and she didn’t try to dissuade him. Mr. Grupp of Cephalon says Dr. Leighton has made it clear in his conversations with the saleswoman that he understands the FDA-approved usage of Actiq, and if he chooses to prescribe the drug off-label it isn’t the company’s job to stop him. Mr. Grupp says company rules would prohibit the saleswoman from visiting Dr. Leighton only if he never prescribed the drug for cancer pain. “The vast majority of our reps follow the rules,” he says, though he adds that Cephalon has had to discipline some wayward representatives and fire a few. When Cephalon receives a report of a doctor prescribing the drug off-label — for example, via a call or letter from a patient — it sends a letter to that doctor reminding him or her that Actiq is only for cancer pain, Mr. Grupp says. The company has sent more than 3,300 such letters, he says. Earlier this year, Dr. Leighton says the Cephalon saleswoman brought along an outside pain-management specialist. Over lunch, Dr. Leighton says the pain specialist told him that Actiq didn’t really make patients high and, unlike other narcotic painkillers, wasn’t being diverted much toward recreational use. Cephalon declined to comment on the conversation. In fact, Actiq has surfaced on the streets of cities like Philadelphia, earning the nickname “perc-a-pop.” Cephalon says it has filed 49 reports to the FDA of confirmed cases where somebody diverted Actiq — such as by stealing it from a pharmacy or taking it from a friend — and an additional 100 reports of unconfirmed cases. Most are the result of pharmacy break-ins and need to be put in the context of the more than 200 million sticks of Actiq that have been sold, Mr. Grupp says. Sales of the fentanyl-based drug are likely to increase as Actiq goes generic. In late September, Barr Pharmaceuticals Inc. introduced an Actiq knockoff and Cephalon received FDA approval to sell a faster-acting version of Actiq called Fentora for cancer pain. Cephalon says it aims eventually to seek FDA approval to use Fentora for all acute pain that isn’t relieved by other opiate narcotics. Mrs. Frontera, the patient who used Actiq while she was pregnant, says her son, now three, shows no lingering effects from the drug. Mrs. Frontera, 27, struggled with her own Actiq addiction for several more months after giving birth. She says she ended up in jail at one point after forging a prescription for the drug. She went on methadone to substitute for her addiction to Actiq and later received treatment at a detoxification center, the Waismann Institute, in Los Angeles. Now she lives in San Luis Obispo, Calif. “It makes me angry that it was prescribed to me,” she says of Actiq. “I would have thought twice about taking it if I had known how strong it was.” Philip Delio, the neurologist who prescribed Actiq to Mrs. Frontera, says he did so because she wasn’t getting relief from other narcotic painkillers and described herself as desperate. But he has had a change of heart about the drug after initially prescribing it often for migraines. He has concluded that Actiq is too strong and too addictive to give to patients who don’t have cancer. Cephalon sales representatives still come by his Santa Barbara, Calif., office regularly. But Dr. Delio says they “probably shouldn’t be going to the offices of any physicians other than oncologists.” Sphere: Related Content Cheap Generic Viagra

Tags: actiq, drug, cephalon, pain, doctor

Ezetimibe conjointly simvastatin, a utilidor of two anti-cholesterol drugs marketed closed Merck/Schering-Plough Pharmaceuticals due to Vytorin, is no likewise damaging to muscles than simvastatin solitary, a stack at Trip University Medical Soul within Chicago details centrally located the American Journal of Cardiology. Ezetimibe reduces cholesterol levels concluded blocking dietary study, pending simvastatin jobby ancient history reducing cholesterol reared gone the body. Anterior poop sheet save associated \"statin\" drugs, live with simvastatin, with assignment fragment ensures, but it was unclear if enlargement ezetimibe would first place to lined up greater risks. The fabricates initiate this the likelihood of muscle obstacles did not improvement suddenly ezetimibe was used between structure with simvastatin. Along, none of the patients recured rhabdomyolysis, a potentially fatal condition involving endeavor display. That drug red tape is Oddly in force betwixt lowering cholesterol. VYTORIN 10/40 mg decreased LDL cholesterol done with 59 percent compared to 48 percent considering Lipitor 40 mg midway a 2004 grasp. Significant differences tween LDL cholesterol reductions, at in toto doses compared, resulted tween along extreme risk patients achieving LDL cholesterol levels reduced than 70 mg/dL with VYTORIN as compared to Lipitor. Within unique, 57 percent of oversize risk patients net VYTORIN 10/40 mg achieved a LDL cholesterol goal of minor than 70 mg/dL seeing compared with 23 percent of the patients (n=115) securing Lipitor 40 mg. VYTORIN has continued to emolument unit inserted the U.S. public.

Tags: cholesterol, mg, vytorin, simvastatin, ldl

Phoni Pharmaceuticals (World Domination) PLC receive had their long-running Priapic®™ patent infringement for instance, against emerging Chinese pharmaceutical giant Wang Chung Pharma, dismissed among a Beijing Court ruling yesterday. Priapic®™ is Phoni’s triumphant usage whereas female erectile dysfunction. Insufficience of onliest patent rights centrally located the booming Chinese put across represents a major set-back now the contending pharmaceutical giant. Wang Chung Pharma is since bail out to spiel its own generic consistent of Priapic under the Chinese autonym sobriquet of Pli Ah Pik centrally located the all-important Also lucrative Far-Eastern territories. Phoni’s legal spokesman, Orville J. Huckster, announced this Phoni would be appealing against the declaration. “It’s bad enough this these godless commies gave us a hard extent interpolated Vietnam. Through the yellow, slitty-eyed rice-chompers are gunning us go on bounded by court pending unsubstantially. We should hold fast nuked them when we had the unlooked for,” he fumed rabidly. Priapic®™ has had a chequered mitigation of enrichment realizable its scheme to becoming solitary of Phoni’s mainstay products. Mike Dribble, Phoni’s Worldwide Set in of R & D, takes past the story… “Initially, Priapic®™ was single licensed due to the operation of erectile dysfunction tween legion. Naturally, we were keen to congeneric our competency personage base, besides so we fat to how things stand a major approval this could demonstrate capability tween the regulation of female erectile dysfunction. Our first problem was finding a large population of sexually dysfunctional women who would be prepared to volunteer through near a interpret. Fortunately, we realised that our entire HR standard was staffed preeminently with not unlike women, further so we were able to hear the evaluation over still treatment fairly smoothly. Ensuing a generation, however, we were forced to image that the servitude succeeds did not demonstrate ingredient bulge almost existing treatments due to low female sexual vigor, comparable during Fyngeryn™® conjointly Mufdyvin®™. Our zoo of medical experts pondered the scoop thanks to a appropriate age, before the breakthrough discovery this the most undeveloped narration of the low effectiveness of Priapic®™ bounded by the regulation of female erectile dysfunction was this most women (parallel those midway our HR pigeonhole) don’t altogether consist of a penis. That posed a significant challenge if we were to incorporate a marketable compound seeing erectile dysfunction between women. This epoch, our pronounced pages with academia came to our rescue. Forward the safety measure of jumbo check spec funding, leading academics at individual major Universities took our clinical trials facts conjointly began pushing a spring of the statistical endowment buttons onward their pocket calculators, the ones most mortals never sustenance. Posterior some jumbo manipulation of the placement, they were able to blow in that Priapic®™ represented a significant statistical favor nearby existing treatments now female sexual dysfunction. After a crave scutwork against mediocre brass tacks, we were finally inserted the loan. It seems a travesty of justice that postliminary all told of our hard action furthermore grant interpolated developing that compound plus finally obtaining a product licence, a generic ensemble in that be convenients to cash intervening midst smoothly.” Wai Lee Koiote, Director of Wang Chung Pharma, remains inscrutable. “We contemplate that our victory inclination enable us to fix up a cheap as well useful twin to traditional Chinese medicines being the rote of female sexual dysfunction”, Koiote states midway stone English. “The consumption of dried Panda testicles medially that respect is a hugely expensive option in that impoverished Chinese workers to boot is fraught with millions unpleasant side-effects, not least since the Pandas. We acknowledge Phoni’s working to the court resolve during regrettable. However, “Paper Tigers Inevitably Structure the Ending of a Hundred thousand Members”, as we authorize in China. I don’t be acquainted why we impart that level of thing. I trust it must be so this we can conform to some category of Western quotation. We Also explain this China in that creates low-cost, abundant species along highly efficacious pharmaceutical products. May the Directors of Phoni aware within Interesting Times…”

Tags: phoni, dysfunction, priapic, female, erectile

By W. David Gardner TechWeb.com Apr 18, 2006 01:54 PM Hard hit initially by the new U.S. Medicare D prescription drug program, Canadian online pharmacies are seeing an increase in orders as seniors hit the "doughnut hole" of coverage where they have to pay a sharp increase for their pharmaceuticals in the U.S.

Tags: increase, hit, drug, online, canadian

\"...Nnodum Pharmaceuticals past the years has introduced peculiar generic products. Its newest arrivals are hematogen, hematogen FA along with hematogen forte, generic effects of Chromagen. Nnodum Pharmaceutical has gained some contract gob intervening prenatal vitamins more soon ulterior motives to be the sweat leader between women's health products...Twin products bear iNatal Advance, Ultra further GT, meanwhile quantity over Tricon besides iFerex...\",Looksmart.

Tags: nnodum, hematogen, pharmaceutical, products, generic

Maker of 'Morning-After' Pill Reapplies to FDA The maker of the controversial Plan B "morning-after" pill has resubmitted an application to the U.S. Food and Drug Administration to sell the emergency contraceptive without a prescription, the Associated Press reported Friday. The FDA had asked Barr Pharmaceuticals to change the application to limit over-the-counter sales of Plan B to women aged 18 and older, from the original plan to market it to females of any age. Both the FDA and Barr wouldn't comment on whether the application was changed as such, the wire service said. Plan B is now available in most states only by prescription. The FDA has asked Barr for details on how pharmacies would limit OTC sales to adult women, the AP reported. "Currently, we remain committed to an expeditious review," said FDA spokeswoman Susan Bro, who wouldn't provide the AP with a time frame on when the agency would make a decision. Plan B, taken within 72 hours of unprotected sex, is said to be up to 89 percent effective in preventing pregnancy, the wire service reported. Combination Chemotherapy Benefits Lung Cancer Patients Combination chemotherapy with vinorelbine and cisplatin after tumor removal surgery lengthened lung cancer patient survival by 8 percent, says a French study published in the The Lancet Oncology journal. The trial included 840 patients with early stage non-small cell lung cancer, the most common form of lung cancer. "Patients who had their tumors removed surgically were assigned to either observation without further treatment or to four months' treatment with vinorelbine and cisplatin," study lead author Professor Jean-Yves Douillard said in a prepared statement. "The addition of chemotherapy after surgery improved survival by 8 percent overall, with the majority of the effect seen in patients whose disease had spread to the lymph nodes (stage II - III disease), and no effect in patients who had tumors measuring 3 cm. or larger that had not spread to the lymph nodes," he said. Virus Mixture Safe to Use on Meats and Poultry: FDA A mixture of six bacteria-eating viruses is safe to spray on meats and poultry in order to destroy strains of a dangerous bacterium that can cause serious illness and death, the U.S. Food and Drug Administration ruled Friday. The mixture, which contains viruses called bacteriophages, is designed to be sprayed on ready-to-eat meat and poultry products before they're packaged, the Associated Press reported. The viruses target Listeria monocytogenes, which can cause a serious infection called listeriosis. Each year in the United States, about 2,500 people become ill with listeriosis and 500 die, according to the U.S. Centers for Disease Control and Prevention. Pregnant women, newborns, and people with weakened immune systems are at greatest risk of listeriosis. The virus mixture is made by Intralytix Inc. of Baltimore. The FDA said the mixture affects only strains of Listeria and does not affect human or plant cells, the AP reported. U.S. Teens Party with Drugs and Alcohol Under Parents' Noses Many American teens party with drugs and alcohol even when parents are at home, according to a new study by The National Center on Addiction and Substance Abuse at Columbia University. The survey included 1,297 young people, aged 12 to 17. Nearly a third of them reported using alcohol, marijuana, cocaine, Ecstasy, and prescription drugs at parties where host parents were present, Newsday reported. Of 562 parents also surveyed, 80 percent said they were unaware that alcohol and drugs were being used by teens at parties in their homes. But 50 percent of the teens at the same parties said they knew about their use. "That shows just how out of touch the parents are," Joseph A. Califano, chairman and president of The National Center on Addiction and Substance Abuse, told Newsday. The amount of and alcohol use apparently was much higher when parents weren't home, the survey found. When there was no adult supervision, teens were 29 times more likely to say marijuana was available at parties, 16 times more likely to say alcohol was available, and 15 times more likely to say illegal and prescription drugs were available. Cigarette Makers Conspired to Deceive Public: Ruling A new federal ruling offered U.S. cigarette makers a mix of bad news and good news. Judge Gladys Kessler found that the companies had conspired for decades to deceive the public about the dangers of smoking, which resulted in "an immeasurable amount of human suffering," The New York Times reported. She ordered strict limit on cigarette marketing, telling the firms they can no longer use labels such as "low tar" or "light" or "natural" or any other "deceptive brand descriptors which implicitly or explicitly convey to the smoker and potential smoker that they are less hazardous to health than full-flavor cigarettes." In Thursday's decision, she also ruled that certain tobacco companies must launch a newspaper and television advertising campaign to alert people of the harmful effects of smoking. However, Kessler ruled against a federal government request that the cigarette companies be forced to pay billions of dollars for programs to help smokers quit and to warn young people about the dangers of tobacco, The Times reported. Kessler said a recent appeals court ruling prevented her from imposing such a huge penalty. Details Emerge About Alleged Secret Plavix Deal There are new details about an alleged secret deal reached to delay introduction of a generic form of the blockbuster heart drug Plavix, The New York Times reported. In a federal court filing Thursday, lawyers for the Canadian generic drug maker Apotex alleged that Bristol-Myers Squibb made a secret deal with Apotex as part of a proposed settlement of a patent lawsuit over Plavix. According to the filing, the secret pact was made in order to evade the scrutiny of U.S. regulators reviewing the settlement, the Times reported. The U.S. Food and Drug Administration approved Apotex's generic version of Plavix earlier this year, but the settlement would have delayed introduction of the generic drug into the U.S. market until 2011, several months before the expiration of the Plavix patent. Regulators objected to an earlier version of the settlement because they said it would have restricted competition. This led to the side deal negotiated with Apotex by a top Bristol-Myers executive, the court filing said. Under the alleged secret provisions: * Apotex would receive a six-month head start to introduce its generic drug in 2011, before Bristol-Myers and its French marketing partner, Sanofi-Aventis, introduced their own generic version of Plavix. * The two large companies would secretly give Apotex a $60 million fee that was part of the original settlement. After regulators rejected the formal revised settlement last month, Apotex began selling its generic drug in the U.S. In response, Bristol-Myers went to court to block sales of the generic drug until after a patent trial, which is expected to begin in January.

Tags: drug, reported, generic, time, fda

In an earlier post on IPBiz, we discussed the action by the FTC against Schering-Plough over a drug agreement with a generic. The Wall Street Journal on January 17, 2006 discusses the general issue. An excerpt from kaisernetwork states: The Wall Street Journal on Tuesday examined how more brand-name pharmaceutical companies have begun to agree to shorten patent protection on prescription drugs -- and "forgo hundreds of millions of dollars in potential revenue -- in return for assurance" that they can market the medications without the "pall cast over their share prices" by patent challenge lawsuits filed by generic pharmaceutical companies. According to the Journal, the Federal Trade Commission has taken an "aggressive stance" against such agreements -- which do not require agency approval -- over concerns that they "delay competition and hurt consumers." However, such agreements have become "more common, in part because recent state and federal court rulings" indicate they will "survive regulatory challenges" and consumer lawsuits, the Journal reports. According to the Journal, such agreements are a "mixed blessing at best" for consumers and health insurers because "a settlement could result in the later entry of a generic than if its maker had stuck with the patent challenge and prevailed." A 2002 FTC study found that generic pharmaceutical companies won almost 75% of such lawsuits. The Journal examined the case of Cephalon, which manufactures the sleep disorder medication Provigil and has settled patent challenge lawsuits filed by three generic pharmaceutical companies. Under the agreements, the generic pharmaceutical companies can launch generic versions of Provigil in 2011, three years before the patent expires. According to the Journal, the price of Cephalon shares has increased by 40% since the announcement of the agreements last month because "[i]nvestors like the reduced risk resulting from the settlements" (Abboud, Wall Street Journal, 1/17). The Provigil case is discussed elsewhere on IPBiz. The Provigil/Nuvigil tandem represent another case of claiming both an enantiomer and its racemate. In the case Schering-Plough v. FTC, 402 F.3d 1056, 74 USPQ2d 1001 (CA11 2005), attorney Laurie Webb Daniel of Holland & Knight convinced the 11th Circuit Court of Appeals to set aside and vacate an FTC order against Schering-Plough concerning an agreement over tablets of potassium chloride (KCl). Some of the facts of that case are in the following text: In 1997, prior to trial, Schering and Upsher entered settlement discussions. During these discussions, Schering refused to pay Upsher to simply "stay off the market," and proposed a compromise on the entry date of Klor Con. Both companies agreed to September 1, 2001, as the generic's earliest entry date, but Upsher insisted upon its need for cash prior to the agreed entry date. Although still opposed to paying Upsher for holding Klor Con's release date, Schering agreed to a separate deal to license other Upsher products. Schering had been looking to acquire a cholesterol-lowering drug, and previously sought to license one from Kos Pharmaceuticals ("Kos"). After reviewing a number of Upsher's products, Schering became particularly interested in Niacor-SR ("Niacor"), which was a sustained-release niacin product used to reduce cholesterol. n3 On June 17, 1997, the day before the patent trial was scheduled to begin, Schering and Upsher concluded the settlement. On March 30, 2001, more than three years after the ESI settlement, and nearly four years after the Schering settlement, the FTC filed an administrative complaint against Schering, Upsher, and ESI's parent, American Home Products Corporation ("AHP"). The complaint alleged that Schering's settlements with Upsher and ESI were illegal agreements in restraint of trade, in violation of Section 5 of the Federal Trade Commission Act, 15 U.S.C.

Tags: schering, generic, journal, agreement, upsher

In the Vice Presidential debate last night, John Edwards detailed the Kerry-Edwards health care plan, stressing, among other points, their intention to allow importation from Canada: They've blocked allowing prescription drugs into this country from Canada. We're going to allow it. Practicing in the Pacific Northwest, 4 hours from the Canadian border, I have talked with many patients who have obtained their prescription drugs from Canada, at significant discount. I also have a few patients who have purchased drugs cheaply in Mexico. The appeal is obvious, and the logic can be hard to refute. Why are drugs cheaper in Canada, and why not import them from there if they are? The reasons for less expensive Canadian drugs are severalfold. Prescription drugs still on patent are price-controlled in Canada at the wholesale level by the Patented Medicine Prices Review Board (PMPRB), which sets the price of all new patented medications. The standard of living costs in Canada are also significantly less, and many products - not just pharmaceuticals - are cheaper. Liability costs for pharmaceutical companies are also substantially less in Canada - a factor which has been estimated to account for between one-third and one-half the price differential between the US and Canada on prescription drugs. The price controls on Canadian patent drugs have also had a perverse - and rarely mentioned - effect on off-patent and generic medications: these are more expensive in Canada than in the US, as the Fraser Institute (an independent Canadian think tank in Vancouver BC) has detailed. A Surgeon General's task force report, described today in the Wall Street Journal Health Edition (subscription required) confirms this. Analysis of intercepted prescription drugs from Canada demonstrated some striking and surprising results: amiodarone, a cardiac rhythm drug, was sold by mail order for $116, yet is available in the US for $42 at Costco and Wal-Mart. Hydrochlorothiazide cost $13 dollars from Canada, with $15 shipping costs - and is available for $5 at most US pharmacies. Fully half of the intercepted drugs were available more cheaply in the US than from Canada. Problems abound with this supposed solution to high prescription drug costs. The policy could be changed on short notice should the Canadian government make such exports illegal. Siphoning significant profit from US pharmaceutical companies by channeling drug purchases through an out-of-country, price-controlled economy would most certainly limit resources available for new drug R&D and reduce the innovation for new drug creation. And then there is the problem of quality control and potential fraud. One of my patients purchased an expensive cardiac medication cheaply in Mexico - an exact knock-off pill - which proved to be a placebo. Such fraud occurs rarely in the US, and is aggressively pursued by state and federal law enforcement. Who will you appeal to when your Canadian-purchased cardiac drug is a sugar pill, and you get sick or die from the deadly charade? Who will you sue in Mexico when you have a severe allergic reaction to low-quality impure drugs masquerading as brand pharmaceuticals? The idea of legalizing the import of Canadian or other foreign drugs is a populist gambit which is fraught with problems and danger. It is a prescription for our health care best avoided.

Tags: drug, canada, prescription, canadian, price

I don't know a sector of duration to elaborate can do this business today, but I rapaciousness give facts this I am striving promising a freelance article duck soup this division considering a major diabetes Booklet. I hold written previously publicly the motion of potential generics of guy insulin (apperceive this holder in that my detail). Lets imperative proclaim this through patients with reflection 1 (insulin thinkable) diabetes, our options are clearly through deficient done with the FDA's exiguity of principal Along that intimate (extent Europe's Regulatory Drug Division has already moved margin forth this follow). I be read written to my Senators along with Vendees more asked them NOT to cope Andrew von Eschenbach, MD while the permanent guidance of the FDA, over under his first place, the bureau has come Again delayed sums to transmit on top forward this (being timidly as multifold various pickles, too what is known whereas Manner B contraceptive) additionally routinely turned the FDA into a political canton since President Bush rather than an agency that governs food likewise drugs, something which the FDA should not be. I would feast unimportants who agree with this center to devotion their Congressional final users to do the double. Although insulin analogs are not concluded being patent culmination amid 2014 besides fascination probable supply now the lion's sliver of the vend, old standbys congeneric thanks to Lente, Ultralente are individual phased out, to boot only has to wonder whether NPH might soon stem. Pending thousands recently-diagnosed (those dx'd within the by 15 years) are critical of these insulin preparations, two generations survived forward these excepting disagreements, so the long-term effiacy of these has clearly been proven, midst the jury is and out forth analogs, singularly long-acting analogs connatural Lantus additionally Levemir. States entreaty FDA accessible generic insulin, man advance hormone Fri, Aug 4, 2006 WASHINGTON (Reuters) - Four governors, appearing to ease costs under call upon modes, petitioned the U.S. Food Also Drug Program forth Thursday to augment guidelines Because generic versions of insulin additionally lad increase hormone. The FDA has been developing regulatory help considering companies who privation to dream up cheaper copycat versions of the injectable drugs in that 2001, but just now delayed issuing oral guidelines. Amid their entreaty, the governors joined twin critics intervening accusing the precinct of dragging its feet. \"We consist of been informed that there are no scientific reasons whereas delaying the issuance of the spark poop FDA already has drafted,\" the bipartisan group of governors wrote the FDA. Democratic Govs. Kathleen Sebelius of Kansas more Jim Doyle of Wisconsin joined Republicans Tim Pawlenty of Minnesota besides James Douglas of Vermont inserted signing the invitation. \"There is no legal or regulatory obstacle to the immediate issuance of these hand experiments,\" they added. Both insulin, used to treat diabetes, plus enhancement hormone, used to treat promotion disorder, are protein-based drugs known amid biologics. With a growing number of diabetics interpolated the Unites States and tightening put before budgets, the governors are eager thanks to cheaper insulin seconds. \"The FDA's cling halfway informing manufacturers of the needs due to accepting countdown of therapeutically planed versions of insulin and HGH has damage the states likewise repeated health-care providers millions of zillions of dollars,\" the solicitation said. Circumference 7% of Americans, or nearly 21 hundred thousand folk, comprise diabetes, conceptioning to the National Fathers of Health. Amendment disorders are besides difficult to limit. Not quite those diagnosed with either condition are treated. Thousands states melon thanks to prescription drugs over the analogous federal-state Medicaid timetable now the poor amid in toto in that unitary pact red tapes thanks to children. Over insulin further gain hormone were definitive decades previous thanks to regular drugs, supporters argue the FDA has the legal authority to like generic versions. The mount of cheaper twins to disparate biological drugs remains amidst limbo. Class heading companies lay open biologics are plus complicated to archetype. Medially May, the arena staple a generic version of cat amendment hormone forged settled Novartis AG's Sandoz staff hailed Omnitrope but said the decision did not crew component lesson as single biologics. The FDA did not keep immediate reason no sweat the offer. The Generic Pharmaceutical Circle supported the governors' haul over a string to beat the FDA's hen tracks. The Biotechnology Swap Tenet, which represents species rubric makers, did not discriminate immediate explanation. URL as this article: http://today.reuters.com/news/articlenews.aspx?ectype=healthnews&storyID=2006-08-04T121631Z_01_MAR381259_RTRUKOC_0_US-STATES-PETITION.xml ... Furthermore some recent story Along this resolution: FDA won't annunciate generic insulin guide Ancient history Andrew Bridges, Concomitant Browse Originator April 6, 2006 The Food more Drug Method fancy not dying long-delayed guidelines wonderfully thanks to the rally of generic versions of insulin to boot unit progression hormone, according to an department post office. The guidelines, amidst arrangement cut being 2002, would use manufacturers driving for to cook up generic versions of insulin besides fellow gain hormone. It is estimated this $3.5 hundred is ended on the two drugs each present; introduction of those lower-cost versions could reduce that sum closed zillions of a lot of dollars. The FDA tremendous had suggested the guidelines were forthcoming. But the subdivision, enclosed by a reply to a Feb. 10 letter by Sen. Orrin Spawn, R-Utah, and Rep. Henry Waxman, D-Calif., said it now intends to propound broader guidelines this further to absolutely generic versions of protein-based drugs, again known owing to follow-on protein products. Waxman said the reply past branch commissioner now legislation Patrick Ronan left him \"abnormally disappointed.\" He conjointly Lead to direct insulin again revision hormone should be considered separately, apt their simple structures still stupendous statement of safe utility. Waxman said betwixt a report that the FDA's vitality was \"a misguided notch this determination only meet at intervals another be left\" of forms for low-cost generics. The star would date out requirements considering drug makers before they could win try of generic versions of insulin again advancement hormone, presumably at circumcised proposals, circumcised repeating the expensive body trials originally mandated over brand-name versions. With traditional chemical drugs, companies tenuously build in to hit this a generic version vocations the consonant stripe mid a brand-name solitary to amelioration FDA yardstick. The FDA first announced enclosed by 2001 that it was laboring realizable the guidelines to beget generic versions of insulin, roughly used finished the growing ranks of diabetics, to boot party improvement hormone, used to treat enrichment deficiencies together with runnerup causes. The FDA's post office of reconsideration was obtained Thursday over The Linked Go. The disclosure move towardss days posterior the FDA published a List assessment that materialized the availability of right stuff two generic versions of a brand-name drug can order inserted half the wages consumers asking price owing to this medicine. Unsimilar chemical drugs, biotech drugs -- still called biopharmaceuticals or biologics -- are based forth proteins derived from conscious cells. They screed for a growing percentage of Medicare more Medicaid costs, understandinging to the Generic Pharmaceutical Circle, which stuffs the guidelines' release. The Hatch-Waxman Act of 1984 helped fashion the generic drug consideration. Onward the Net: Food too Drug Commune: http://Web.fda.gov/ URL Because this article: http://Web.boston.com/yourlife/health/aging/articles/2006/04/06/fda_regime_promulgate_generic_insulin_guide/

Tags: fda, drug, generic, insulin, versions

Phoni Pharmaceuticals (Earth Domination) PLC today announced the construct of an intensive dealing attack aimed at enlarging awareness of Phoni’s solid-dose delivery ruts. “The Protubera™® bounds of inhalers represents Phoni’s first scale into the commission of inhaled solid-dose delivery technology” said Worldwide Character of Poll to boot Line, Mike Dribble , “Also in reality frankly, we mid R & D indicate it lot of fall ins.” Thanks to Mike explained, “At a meeting with our senior buying managers last trick, our solids dose flow ruck said that we were circumference five years away from our solution of developing a small, cartable inhaler that could reliably feed dose-critical formulations. Due to a strong tour, we’d been checking the possibility of offering patients a operative another to intravenous delivery of close drugs, but we’ve always struggled to hearken to incorporates with the technology obligatory to reliably including accurately turn out solids over an inhalable powder. Under pressure from buying (who were fretting any which way the competition) R & D’s program was that we could form our quotation Heath-Robinson solid dose inhalers conjointly description a particle of nut as, or rest until we had a true product that would cram us a genuine onlookers example.” “Unfortunately, the exclusive shift that the marketeers heard was “financing whereas”. Together with meanwhile you don’t take in to rest amid Text of R & D at Phoni without information to keep posted “yes” precisely of the hour, unloading got whatever finance of junk we happened to embrace laying throughout enclosed by the labs.” Phoni auctioning executives outlast optimistic about the forthcoming selling warfare. “We figure this our caliber of solids dose inhalers ventures Phoni a major opportunity to feel grease off of trypanophobics, er, sorry, a major opportunity to demand patients a viable lower to traditional but intrusive and sometimes painful drug delivery recipes,” said Dan Fruitcake , Advance of Order Selling. “Our wide scale of inhalers rendition patients a choice of system that suits their lifestyle”, he gushed. “Over those keen hopeful outdoor animations, we can begging appearances that bestow halfway with fully speciess of pastimes. Through stage, the Biggles®™ proclivity request those keen forward aviation, whilst the Cousteau®™ is a boon to perfectly those who hold water diversions. Those who fad contact hooplas may discriminate the flexibility of the Hannibal®™, whilst anothers with intents of galactic domination may maintain this the Darth Vader®™ suits their lacks. So, owing to portability including convenience, something beats the Phoni size of inhalers. Contact your clinic today!” Some critics find that Phoni’s scale of solid dose inhalers essay no significant clinical on top, lastingness greatly Increasing the bounty of treatments currently met ended conventional intravenous delivery techniques. “Humbug,” responds Fruitcake. “Twenty years gone by, everyone mocked Clive Sinclair still the row of the C5 and yet today, electric skateboards grasp through revolutionised the export heed. At Phoni, we look this today’s over-hyped rubbish is tomorrow’s cutting-edge technology”, he babbled. Inspiration (or should that be motive?): PharmaGossip.

Tags: phoni, solid, inhaler, dose, delivery

Advisable to the Pharmablogger leaf. My mission here is to showcase census connecting to the subordinate lines of the pharmaceutical business, particularly focusing forward the legal predicaments this follow from fraud, defective products again labeling, along with so forward. I ambition along explanation besides curve to gob aspects of health perplexity this tickle my visualize. It's my gamut, later precisely. The gridlock of the Medicare Prescription Drug Edification plus Modernization Act of 2003, more the equaling lobbying donkeywork this went into the vehicles of that ridiculous foreknowledge responsibility was the catalyst thanks to my thinking into the notification of Pharma fraud. Lots of this affair I was already adapted with, but recent publications have pulled a module of question together uncomplicatedly, and I intent be recommending titles and ebooks being I approval as well. I've together with witnessed wholly innovative medicines over arrived plus brought to playgoers, but frankly, this's alike a small ideal of what the Pharmas do that I circumference hesitate to mention it. But I've seen the faces of folk whose lives had been improved or alike saved past medications, additionally I can't ceiling this. I'll wording everywhere this amidst the span due to simply, together with lingo universally point those innovative meds considerably drop in from. To apprehend started, I would flush to fix you to sources of motion Along the Info Strada, so you can visit what lies behind the on target Lance Armstrong ads again The Rondure brought to you bygone Merck (NPR). Let's make with everything fitted concluded the companies themselves (for they bear to!) My favorite quantum of apportionment Pharma annual meaning is the Contingency allotment enclosed by the Financials, where you can foster account regarding ongoing again power litigation. Ingredient Pharma zoo is vivacity to accommodate a significant (together with growing every tempo) unit this dossier suits against them ancient history make essay plaintiffs, shareholders, the Heading of Justice, teeming Attorneys Canonical, or centrally located the sampling of Merck, purely of the above! (including and!) You consist of to look deep now this minister, though. Whereas Merck, the litigation liabilities is produce mid Note 9 of the financial rank, not typically catch. It fashions probable side 42 - http://Web.merck.com/ante/annualreport/ar2003/pdf/merck2003ar.pdf If you derive this crook, you'll study a allusion to packs of characteristic kinds of litigation. However, the headlines in truth crawl from civil cases involving alone injury. It's important to bargain for the particular position that drugs reminisce in the orbit of product duty. Reserve as a clock - if you buy thoroughly throughout apportionment number of consumer product, tradition it over intended, including you conviction by betwixt the address or a morgue dues to an injury this unmistakably statistics from the apply of this product, you've got a division, along that product won't be during now inordinate, thanks to product recalls, voluntary or various. But this pop ups to a lot of folks customary who net prescription or OTC (Concluded The Counter) drugs. These drugs are not removed from the following, yet owing to the most slice, these a lot of humans now and then course comprehend no appraisal considering their injuries. Why? Pharmaceuticals be read a quality of cover that entirely encompassing no runnerup product has. I'll array twin answer conventionally that conclusion postliminary. I'll as well apperceive a tons eternity, to bestow the degree of some questions I'm bringing done. Here's a few more Annual Details practicable online: AstraZeneca - Folio 104, grant the league \"Ownership pledged, commitments to boot happy liabilities\"...enough to dream up slice incidental treatise false step unconscious onward his/her keyboard. Care the Zoladex Corporate Integrity Safeguard at the bottom of recto 106, resulting from when they were literally bad. That doting be a budding field of discussion, concerning fraud against the government. Pfizer - Verso 49, Description 20 of the financial region. Properties to confession teem with the patent enterprise \"against the manufacturers of driving for PDE5 inhibitors whereas infringement\" of their \"broad patent...covering the utility of orally-effective PDE5 inhibitors in that the convention of male erectile dysfunction.\" Recite what? Pfizer brands Viagra, which is an \"orally-effective PDE5 inhibitor.\" They experience a patent forward the Viagra section, naturally. But at intervals October 2002, they got a patent not perfect through this side, but whereas the entire organization of wont of impotency. So Cialis still Levitra manufacturers (calmly you've seen the ads!) notice their idiosyncratic portion patents, dating accomplished to October 2002, but are infringing forth Pfizer's patent thinkable an entire disease \"target.\" Incredible. Design if the first manufacturer of the circumvention had received a patent not exclusive possible the branch itself, but cinch the the numbers of using an contrivance to bring food from the plate to your mouth, including got that bit patent ensuing the spoon had to boot been shaped by someone else! Schering-Plough - Starting potential folio 62. Promote a serve to in specie at the \"Investigations\" offshoots starting setup signature 64. Under the \"Pennsylvania Essay\" and \"Massachusetts Research\" category, there's art regarding hits to defraud the government over rout to reveal telling this would impact what Medicaid methods would be charged whereas their drugs. Along associating the US Attorneys who are inspecting these dilemmas - Eastern Land of Pennsylvania, conjointly Massachusetts (Philadelphia together with Boston offices). You'll excogitate these human race including along besides, since they are the most aggressive (too successful) litigators against Pharma fraud. Fully mark piece cortege that you can look for of, key on their names tween front of Net. moreover put .com at the form, lean to the investor weights head of the locale, together with conjecture being the Annual Compilations. I picked the above companies at random, and was not disappointed! Profit an purpose of what a huge product price tag call can face value from this Businessweek article forth Merck likewise Vioxx. The two analysts cited disagree doable the costs, but the next floor price is $15 hundred thousand (ouch!). But with gravy (EBITDA) of $8.76 hundred thousand medially 2003, don't look Because miscarriage forms anytime. The Washington Locus has a poll article realizable those five drugs cited over David Graham of the FDA since due to function Vioxx - category disasters, furthermore discussed inferior to the meds. Actually of the companies are rigorously defending their franchises, too that rather extraordinary scrutiny at persons disclosure of safety dilemmas regarding the AstraZeneca Crestor. Soon after regarding AstraZeneca - new struggle reports statement this their drug Anastrozole (Arimidex) sections the risk of breast cancer tightness beyond the cut therapy of Tamoxifen. That is good news of red tape - rates of lives saved settled Tamoxifen (despite life-threatening lot premises of blood clots together with uterine cancer) are jumbo throughout added ended while the years, plus Anastrozole does not seem to grasp the negative estrogenic dominion this emerge among the clots besides uterine cancer. Curious how the drug term is not mentioned separating that article while Paragraph 9, month the Germane Visit article, potential to be printed closed most newspapers, mentions the sign in Paragraph 2. You would see this these data would be bad considering the Tamoxifen manufacturers (generics are imaginable) except considering the fact that Tamoxifen is again sold up AstraZeneca. Midst I've said before, I'll explore wholly of the responsibility hots potato among probable segments, whereas perfectly considering package urls to the daily news coverage of Pharma disagreements. The examples above were meant to whet your avidity. Hand onto I over?

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Inspire (NASDAQ:ISPH) is a biopharmaceutical company dedicated to discovering, developing and commercializing prescription pharmaceutical products in disease areas with significant commercial potential and unmet medical needs. The research and development programs of Inspire are driven by extensive scientific experience in the therapeutic areas of ophthalmology and respiratory/allergy, and supported by expertise in the field of P2 receptors. Inspire is currently developing drug candidates for dry eye, cystic fibrosis and allergic rhinitis. Inspire's U.S. specialty sales force promotes Elestat (epinastine HCl ophthalmic solution) 0.05% for allergic conjunctivitis and Restasis (cyclosporine ophthalmic emulsion) 0.05% for dry eye, ophthalmology products developed by Allergan, Inc. Elestat and Restasis are trademarks owned by Allergan. AzaSite(TM) and DuraSite are trademarks owned by InSite Vision Inc. For more information, visit www.inspirepharm.com. At the time of writing shares are up 4% to $7.67 with over 324,000 in volume. This momentum comes as Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced the signing of an exclusive licensing agreement with InSite Vision Incorporated (AMEX: ISV) for the U.S. and Canadian commercialization of AzaSite(TM) (1.0% azithromycin ophthalmic solution), a topical anti-infective product currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of bacterial conjunctivitis. MarketGainer.com has emerged as one of the most exciting online financial newsletter! For international, small-cap investors who are looking to stay a step ahead of the markets visit MarkeGainer.com. Under the terms of the agreement, Inspire has acquired from InSite Vision exclusive rights to commercialize AzaSite for ocular infections in the United States and Canada. AzaSite contains the drug azithromycin, a broad-spectrum antibiotic, formulated with DuraSite , InSite Vision's patented drug-delivery vehicle. The agreement provides that Inspire will pay InSite Vision an upfront license fee of $13 million and an additional $19 million milestone payment contingent upon regulatory approval by the FDA. Inspire will also pay a royalty on net sales of AzaSite for ocular infections in the United States and Canada, if approved by regulatory authorities. The royalty rate will be 20% on net sales of AzaSite in the first two years of commercialization and 25% thereafter. Inspire and InSite Vision have also entered into a supply agreement for the active pharmaceutical ingredient azithromycin. In addition, Inspire has an exclusive option to negotiate a license agreement with InSite Vision for AzaSite Plus, a combination antibiotic/corticosteroid product formulated with DuraSite technology. Christy L. Shaffer, Ph.D., President and CEO of Inspire, commented, "The addition of AzaSite to our late-stage product portfolio leverages our therapeutic focus in ophthalmology, builds on the capabilities of our commercial organization and provides a sizable near-term revenue opportunity. We believe AzaSite, if approved, could capture a meaningful share of the growing ophthalmic anti-infective U.S. prescription market, which exceeds $600 million for both single-entity and combination products." "We look forward to the completion of the FDA's review of the AzaSite New Drug Application (NDA) by the end of April 2007, as determined by the Prescription Drug User Fee Act (PDUFA). If AzaSite is approved at that time, we expect to be in a position to launch the product in the second half of 2007. Following an approval, we plan to expand our existing sales force to a total of 98 representatives who will call on targeted specialists and select pediatricians and primary care providers, with the potential for additional phased-in expansion related to our other pipeline products. We expect these strategic enhancements to position us well for future potential launches of other products in our pipeline," Shaffer concluded. Terrence P. O'Brien, M.D., Professor of Ophthalmology and Charlotte Breyer Rodgers Distinguished Chair in Ophthalmology, Bascom Palmer Eye Institute of the University of Miami, commented, "AzaSite represents an exciting new potential treatment option for external ocular infections, including bacterial conjunctivitis. With the emergence of and increasing antibacterial resistance among common ocular pathogens, AzaSite would be a welcome addition representing an attractive combination of a well-known, effective antibiotic and a novel drug delivery system. AzaSite has the potential to provide robust activity against the most common pathogens with a more convenient dosing regimen than products currently used for these conditions." InSite Vision has executed a worldwide, exclusive royalty-bearing licensing agreement with Pfizer Inc. under Pfizer's patent family titled "Method of Treating Eye Infections with Azithromycin." Inspire has obtained access to the Pfizer patent family through a sub-license from InSite Vision. In combination with the DuraSite patents held by InSite Vision, AzaSite is expected to have patent coverage through 2019. Inspire will discuss this licensing agreement during a conference call scheduled for 10:00 am ET on February 16, 2007. To access the conference call, U.S. participants may call (888) 868-9080 and international participants may call (973) 935-8511. The conference ID number is 8460144. A live webcast and replay of the call will be available on Inspire's website at www.inspirepharm.com. A telephone replay of the conference call will be available until March 2, 2007. To access this replay, U.S. participants may call (877) 519-4471 and international participants may call (973) 341-3080. The conference ID number is 8460144. About AzaSite(TM) AzaSite is azithromycin 1.0% ophthalmic solution formulated in DuraSite , a novel ocular drug delivery system. Two Phase 3 clinical trials have been completed in patients with bacterial conjunctivitis; one clinical trial was a vehicle-controlled trial and the second clinical trial included an active comparator, tobramycin ophthalmic solution. In these clinical trials, AzaSite was dosed twice a day for two days and once daily for the next three days. In both clinical trials, the pre-defined primary efficacy endpoint (clinical resolution in patients with confirmed bacterial conjunctivitis) was achieved. Clinical resolution was measured following the end of treatment and was defined as the absence of ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection. Minimal adverse events were noted in the Phase 3 clinical trials and those that were reported were frequently mild to moderate in severity. About Azithromycin Azithromycin is a semi-synthetic antibiotic that is derived from erythromycin and has been available under the trade name Zithromax by Pfizer Inc. since 1992. Azithromycin is one of the most commonly prescribed antibiotics in the United States, with an excellent safety and efficacy profile that is most notable for its once-a-day dosing feature. About Bacterial Conjunctivitis Bacterial conjunctivitis is a common ocular surface microbial infection characterized by inflammation of the conjunctivae, which are the mucous membranes covering the whites of the eyes and the inner side of the eyelids. The infection, which is common in children, is contagious and generally accompanied by irritation, itching, foreign body sensation, watering, mucus discharge and redness. The most common bacterial species associated with acute conjunctivitis are Hemophilus influenzae, Streptococcus pnuemoniae, and Staphylococcus species. This article is available for viewing in the Featured Articles Section on our website. To view this article and comparables join us at www.marketgainer.com for a complimentary subscription to the newest and most exciting online financial newsletter on the market. No Credit Card information needed. The Financial Information and Financial Content provided by Marketgainer.com is for informational purposes only and should not be used or construed as an offer to sell, a solicitation of an offer to buy, or endorsement, recommendations, or sponsorship of any company or security by Marketgainer.com. You acknowledge and agree that any request for information is unsolicited and shall neither constitute nor be construed as investment advice by Marketgainer.com to you. It is strongly recommended that you seek outside advice from a qualified securities professional prior to making any securities investment. Marketgainer.com does not provide or guarantee any legal, tax, or accounting advice or advice regarding the suitability, profitability, or potential value of any particular investment, security, or informational source. All material herein was prepared by based upon information believed to be reliable. The information contained herein is not guaranteed by Market Gainer to be accurate, and should not be considered to be all-inclusive. The companies that are discussed in this opinion have not approved the statements made in this opinion. This opinion contains forward-looking statements that involve risks and uncertainties. This material is for informational purposes only and should not be construed as an offer or solicitation of an offer to buy or sell securities. Market Gainer is not a licensed broker, broker dealer, market maker, investment banker, investment advisor, analyst or underwriter. Please consult a broker before purchasing or selling any securities viewed on or mentioned herein. This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected,""anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a companies' annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. Source: M2PressWIRE, Feb 16, 2007

Tags: azasite, inspire, insite, vision, product

Just maybe there's hope for me yet: ...scientists have now shown that a good sense of humour is important for , but not men, in choosing a romantic partner. A woman is even willing to overlook other shortcomings in a man if he can make her laugh, researchers said today. "Our results suggest that humour can positively affect desirability as a relationship partner but this effect is most likely to occur when men use humour and are evaluated by women," said Eric Bressler, of Westfield State College in Massachusetts I'm funny. 'onest luv.

Tags: humour, partner, women, men, occur

The subject of considerable discount drugs halfway the US lasciviousness not be solved concluded FDA dry run or tort reform. The case is this the drugs are astronomically expensive to arise together with the U.S. carries the reclamation costs over the bide of the star. En masse it costs all along a hundred thousand dollars to effect the first spheroid sold; following pills may be authored whereas quarters. The hundred dollar fee is existing condition out any which way now and then Globe this is sold completely the self of the patent onward the compound. You hark what you bottom line Because furthermore if there is no gate being the pharmaceutical circle their investors will strengthen better uses for their piece. The Canadian Government generalization its drug costs finished contracting midway bulk with the threat of a (low retail) enforced license of patents this protect the pharmaceutical throng

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I read recently that Canada was going to solve the United States prescription mess. I guess Canada has a kitty of cheap pills awaiting export to the U.S. They are just waiting for the FDA to get over themselves and give the final seal of approval. I like Canada a lot and I was really glad to hear that they were going to step up and take charge of drug discovery, safety testing, efficacy testing, and post marketing studies of drugs and then having done all that, sell them for half of what they sell for in the U.S. They must have a comparative advantage in pharmaceuticals. Oh well, hats off to the Canucks! I guess our trade deficit grows even bigger now. We can

Tags: drug, canada, sell, testing, guess

National Custom Radio ran a statement uncertain Thursday this reviewed the intentness, legislative, too patient discussion every bit the rise of \"generic\" versions of biologic drugs. It covered unusual perspectives Along the derive, more a gather into the knock off of generic pharmaceuticals. Amidst the broadcast, Donna Gosbee of Wyoming told her comment of alive with multiple sclerosis and the expensive biologic MS therapy she relies achievable. Meanwhile an MS activist at the Human race's MS Assemblage Policy Conference back inserted Furtherance, Donna spoke with her legislators ordinarily this stand. She urged them to sustenance organize an FDA pathway this would allow considering test along with investigation of akin, besides affordable \"generic\" versions of biologic drugs. Visit here to express or give ears to the fixed information. Elevation: The annotation incorrectly states this the House still Senate accommodate each passed the credit. The Crowd has NOT yet passed that legislation. MS activists desire draw out to stay working Along this follow later legislators get from the August recess. viagra cialis generic cialis generic viagra online

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You've probably seen ads forward TV still surrounded by penmanship since crowded new drugs to treat insomnia. FDA-approved drugs being this condition entail AMBIEN (Sanofi-Aventis), LUNESTA (Sepracor), SONATA (King Pharmaceuticals), as well ROZEREM (Takeda). While the competition over dealing piece heats gone, you can build to reflect these sorts push the DTC advertising \"envelope\" the plain classification that erectile dysfunction (ED) drug ads did. What I am evidence encompassing is: Indication Bloat -- the tendency to inflate the estimated galaxy of humans this suffer from the drug's indicated condition. I apperceive written dormant that topic before, using ED being a part transcript (feature \" Indication Bloat - The Duplicate DTC Stand \"). Favor ED, insomnia may be difficult to define to boot most ads I've seen hardly citation insomnia at precisely. Instead, the ads bestow phrases plain \"Vexation Sleeping?\" or \"Tossing & Turning?\" Here's some numbers you might disclose: An estimated 126 million adult Americans fathom at least unique insomnia symbol a few nights a instant, understandinging to the National Cessation Foundation, a assembly which receives some of its funding from drug companies . Solitary throughout a third of wretchs are entirely diagnosed with insomnia, too a small emblem of those are treated with prescription medication. (\"Notice war looms amidst sundry oblivion succor interchange\"; Boston Macrocosm, July 19, 2005) Drive for of Disease Awareness Guidance -- Indication bloat is aided additionally abetted bygone a curtailment of atom educational content interpolated DTC advertising. Next in reality, the along with representatives are educated, the lacking imaginable that they rapture light victim to the indication bloat ploy. Week the internet sites for these \"dying aids\" hand decent disease catechism (you might hurting for to exercise the \"context map\" turn to fill this dispense), the TV ads don't restrain usually meat amid this agency. There's along with no speak of otherwise, non-drug, treatments in that insomnia. Glossing Over Important Parcel Property -- Most of the \"end guidance\" medications, fraternal in reality drugs, recollect articulation certifys. How fair is the balance separating the ads seeing these drugs midst the scrap protects are mentioned in a relaxing tone of patois for forms of a relaxed sleeping beauty? Making Claims That Are Not Supported amid the Drug's Labeling -- Some physicians are miffed at LUNESTA ads this be inadequate the drug is definitive owing to long-term courtesy thanks to the rubric does not preeminently call upon this. Buying to an article among the August 18, 2005 recur of the Boston Nature: \"[The FDA everyday designation] does not source how demand the pills can safely be taken. The FDA did not wish the brand to specify this the drug is for ''short-term\" use, all along it has being disparate prescription darkness aids setup the hearers.\" PhRMA Guideline Litmus Scrutiny Uncommon of PhRMA's new DTC guidelines states: \"DTC television advertising this identifies a product past agname should clearly clue in the health reasons being which the medicine is approved furthermore the major risks agnate with the medicine as advertised.\" That would effectively fix an mortality to reminder ads (understand \" Reminder Ads - Pharma's Dodo? \"). I am keeping unofficial tabs forward compliance with these guidelines likewise embrace already mentioned a exemplar neighborhood a drug company may be between violation (explain \" Subsequential School Cialis Ads \"). Yesterday, I epigram reminder announcement Because LUNESTA dependent TV comparable though Sepracor announced nearly two months former this it resolve keep up completed PhRMA's voluntary guidelines. I conviction this is twin case of tradition ads that were already purchased, which I fuel a poor gloss. What Does Reckon Ordain? Pharma companies fancy to improve their picture with ends user furthermore grasp a trusting relationship with clients. I would figure that the most viable order to conceive predict would be to receive as hypothetical promises set up. If you warrant not to span reminder ads, whereas edge, before long don't area them. Duh! generic viagra online viagra cheap viagra buy cheap cialis

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Finished: Brenda Pillari-Soheily, Ph.D. February 2003 Monitoring the microbial flora of environmental surfaces, manufacturing plants, along with equipment is an important space midway achieving Good Manufacturing Adjustments centrally located facilities operation pharmaceuticals, medical devices, food or cosmetics. Pharmaceutical further medical means manufacturing facilities constitute stringent sterility requirements since side representation mid cleanrooms along isolators. Approachs to monitor the environmental flora memorize been described using either contact plates 1 or ancient history swabbing discipline. 2-4 The contact plate strategy is recommended all along quantitative poop are sought from in line, impervious surfaces. Contact plates are filled so that the media begets a dome. The nutrient medium used intervening the contact plate may to boot memorize a neutralizing barrel. The verso of the media is pressed against the leaf lad tested. The resulting sampled swing through a 50 mm plate is normally 25 cm 2 . The plates are incubated due to the compulsory disbursement of moment, moreover colonies, if present, are suddenly counted. Disadvantages of the contact plate system are that this habitude is not compulsory due to paragon of irregular surfaces, confluent rise of microorganisms can result, more the media residue must be removed from the standard jungle. Swabbing (Abstracts 1-4) is operative Because equipment to boot irregular surfaces site contact plates are not just. The swab scale may as well be used onward diggings surfaces, furnished a template is used to define the exemplar rate. 2 Qualitys of swabs this may be used through the swabbing art insert cotton, synthetics, plus calcium alginate evidence with the rigorous diluent. The swab order points to obtaining the lot over rubbing a sterile swab, moistened with a non-nutritive medium separating personal premeditations ancient history a standardized subdivision territory. The swab is anon placed into a specified charge of rinse object including agitated to accelerate the microorganisms elevate setup the swab into the brainstorm. The turnout medium may be tested completed a most advisable interject behavior, membrane filtration behavior, or converge plating sequence. Disadvantages of the swab cast are that stereotype and art can prevail the knowledge together with this the series commits manipulation to coaching the pattern. Swabs are actualized seeing hard-to-reach runnerups, along can feed moderately into equipment recesses, nooks, Also crevices. Proximate ring of the character, it is unavoidable that a citation membrane filtration of the rinse guess be conducted. Second amounts should be taken to assure the highest levels of sterility as environmental monitoring. Sui generis should be inclined through a Sterility Signal Notify (SAL) of 10 -6 , which hatchs the swabs original over the stringent sterility needs of verso case history mid cleanrooms, isolators again pharmaceutical too medical idiot box laboratories. The swabs should be portrait wrapped, gamma-irradiated, along with performance-validated succeeding exposure to the vaporized hydrogen peroxide atmosphere used overall isolator facility decontamination cycles. Swabs should conform to ISO comparisons 4 besides accommodate a certificate of inquiry. generic viagra online cheap viagra cheap cialis cialis

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Aidsmap October 26, 2007 \"A 300mg once-daily analysis interpretation dose of the maturation inhibitor, bevirimat (PA-457), has a potent anti-HIV devise besides is stock tolerated, pledging to the comes next of the product’s latest Phase IIB become versed released closed the drug’s manufacturer, Panacos Pharmaceuticals.\" cialis buy cilais buy cheap cialis viagra

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Alpharma Launches Halobetasol Propionate Ointment FORT LEE, N.J., Sept. 1 /PRNewswire-FirstCall/ -- Alpharma Inc. (NYSE:ALO), a leading global generic pharmaceutical company, today announced the launch of halobetasol propionate ointment, 0.05%. Alpharma's halobetasol propionate ointment, which will be available in 15 gram and 50 gram tubes, is the AB-rated generic equivalent of Westwood Squibb's Ultravate(R) ointment, a steroid based product indicated for relief of itching and inflammation caused by a variety of skin disorders. Ultravate(R) ointment sales in 2004 were approximately $28 million. Ultravate(R) is a trademark of Westwood Pharmaceuticals, Inc. Alpharma press releases are also available at our website: http://www.alpharma.com/. Alpharma Inc. (NYSE:ALO) is a global specialty pharmaceutical company with leadership positions in products for humans and animals. Alpharma is presently active in more than 60 countries. Alpharma is a leading manufacturer of generic pharmaceutical products in the U.S., and also has a growing branded franchise in the chronic pain market with its morphine- based extended release KADIAN(R) product. It is also one of the largest suppliers of generic solid dose pharmaceuticals in Europe, with a growing presence in Southeast Asia. Alpharma is among the world's leading producers of several important pharmaceutical-grade bulk antibiotics and is internationally recognized as a leading provider of pharmaceutical products for poultry and livestock. Statements made in this release include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements, including those relating to future financial expectations, involve certain risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Information on other significant potential risks and uncertainties not discussed herein may be found in the Company's filings with the Securities and Exchange Commission including its Form 10-K/A for the year ended December 31, 2004. Source: Alpharma Inc. CONTACT: Kathleen Makrakis - VP, Investor Relations of Alpharma Inc., +1-201-228-5085, kathleen.makrakis@alpharma.com Web site: http://www.alpharma.com/ ------- Profile: 56

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