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The Most Interesting FDA Review for 2008 2008-03-04 05:10:00 t's time for large-cap pharma investors to mark their investing calendars. Last week Eli Lilly (NYSE: LLY) announced that the FDA had granted its top pipeline compound a priority review that could give it marketing approval in 2008.The FDA priority review for Lilly's blood thinner, prasugrel, means that the agency should make a decision on whether to grant approval to the acute coronary syndrome treatment around June 26 (assuming a six-month review date from Lilly's Dec. 26 marketing application). This PDUFA date is the FDA's goal for making a decision on marketing approval, but the review date is not set in stone and might come before or after that date.
Campbell gets OK to resume practice 2008-02-28 05:08:00 He didn't learn until after extensive testing that he'd actually suffered a heart attack last winter. Since then, his life was focused on his recovery and on how soon he could safely stop taking Plavix — a blood-thinning, anti-clotting drug — and return to the field.What he thought was going to be just another routine visit to his doctor in early February turned out to be the breakthrough for which he's waited. He was told he could stop taking the medication immediately, much sooner than he thought."I thought it was just a checkup," Campbell
said. "They decided I was going to come off the Plavix."
Thailand heart patients caught in drug dilemma 2008-02-23 08:52:00 Saree said that 34,000 patients
who had been set to receive the drug were now caught in a lurch, unable to afford to buy the drug at full price."Plavix is expensive. Hospitals charge between 80 to 120 baht (2.47 to 3.70 dollars) for one tablet," she said.The removal of patent protections has angered Western drug giants, who say it is an infringement of their intellectual property rights. Activists have hailed copycat drugs, saying it helps developing nations seeking cheaper medicines for the poor.
Read more:Thailand
, dilemma
Heart attacks, deaths rise after Plavix stopped 2008-02-19 04:28:00 Heart attacks
and deaths
nearly doubled after patients stopped taking the anti-clotting drug Plavix, according to the first national study documenting the risk to heart patients who end their drug therapy.The study of more than 3,000 U.S. military veterans who had heart attacks or chest pain found their risk of another heart attack or death spiked in the 90 days after they stopped taking the medication, made by Bristol-Myers Squibb Co. and Sanofi- Aventis SA. The U.S.-funded study appears in the Feb. 6 Journal of the American Medical Association.
Read more:Heart
Sanofi Fourth-Quarter Net Jumps 6.2% on Plavix Sales 2008-02-15 15:53:00 Sanofi expects 2008 earnings per share, excluding some items, to increase 7 percent. GlaxoSmithKline Plc, Europe's largest drugmaker, forecast a profit decline this year, while Novartis AG said growth may pick up in the second half. Sanofi benefited from a recovery in Plavix after a U.S. judge ruled that Apotex Inc. couldn't continue to market cheaper imitations of the product, Sanofi's second-best seller.
Read more:Sales
, Quarter Net
Increased Rate of Heart Attack, 2008-02-10 03:08:00 Doctors from the federal Department of Veterans Affairs and elsewhere suggested that one possible solution for the "rebound effect" with Plavix might be to take patients off the drug more gradually or to add aspirin therapy as it is reduced.The study, published in this week's Journal of the American Medical Association, focused on 3,137 patients discharged from 127 Veterans Affairs hospitals from 2003 to 2005. Plavix is generically known as clopidogrel.
Read more:Heart
Plavix Sales Nearly Triple 2008-02-03 17:56:00 Bristol-Myers Squibb Co. (BMY) announced that its fourth quarter loss narrowed from the year-ago quarter as sales of its blood thinner drug Plavix increased nearly three-fold. The company also lowered its full year 2008 earnings outlook, reflecting the impact of the Medical Imaging divestiture.On a GAAP basis, Bristol-Myers' net loss from continuing operations for the quarter ended Dec.31, 2007, narrowed to $133 million or $0.07 per share from $170 million or $0.09 per share for the same period in 2006.
Read more:Sales
, Nearly
, Triple
Bristol-Myers Squibb 2008-01-28 00:50:00 As a result, James Kelly upgraded shares to 'Neutral' from 'Sell,' and took the stock off the Americas Sell List, a portfolio of negatively viewed stocks. He lowered his price target to $28 per share from $30.'Valuation now better reflects the company's growth challenges beyond Plavix, Avapro, and Abilify,' Kelly wrote in a client note.
Read more:Bristol
, Myers
Dr Reddy’s gets FDA nod for Plavix 2008-01-22 03:50:00 Dr Reddy
’s Laboratories has got approval from the US Food and Drug Administration (FDA) to sell a generic version of blood-thinning drug Plavix sold by Bristol-Meyers Squibb and Sanofi-Aventis.One of the top-selling drugs in the world, Plavix is the biggest grosser for Sanofi-Aventis, logging global sales of nearly $6 billion in 2006 and $3.77 billion in the US alone, as per figures from pharma market intelligence firm IMS Health.
Sanofi Aventis sees no Plavix copy despite FDA 2008-01-17 13:55:00 A Sanofi spokesman said that as a court injunction was in force against a generic version of Plavix launched by Apotex the launch of another copy was "highly improbable". The U.S. Food and Drug Administration said on Wednesday it had approved pills containing clopidogrel bisulfate, the active ingredient in Plavix, made by Dr Reddy's. (Reporting by Noelle Mennella; Editing by Paul Bolding)
Read more:despite
Healthy skepticism 2008-01-16 02:05:00 Consider the drug Plavix, which helps keep blood from clotting. It has been labeled effective, but what are the numbers? In an experiment published in the New England Journal of Medicine on more than 15,000 patients with chronic heart disease, the risk of heart attack, stroke, or death in the next two years for patients who took aspirin and Plavix was 7 percent. The risk for those who took aspirin alone was 8 percent. Also, patients who take Plavix face a higher risk of serious bleeding. In fact, the number of people who experienced the benefit equaled the number who experienced the harm.
Lilly asks FDA to approve blood thinner 2008-01-12 11:14:00 Indianapolis drug company Eli Lilly
and Co. and its development partner met their year-end deadline to submit blood thinner prasugrel for regulatory approval. Lilly and Daiichi Sankyo Co. Ltd. filed for U.S. Food and Drug Administration approval on Dec. 26, they announced today.Prasugrel could be a blockbuster if it successfully supplants the current best-selling blood thinner, Plavix, which racked up $6 billion in sales in 2006.
Read more:approve
Lilly and Daiichi Sankyo file Plavix rival prasugrel with FDA 2008-01-11 19:37:00 Eli Lilly
and Daiichi Sankyo have filed their much-touted oral antiplatelet prasugrel with US regulators and will be hoping it can challenge Plavix, Sanofi-Aventis and Bristol-Myers Squibb’s blockbuster.Lilly and its Japanese partner said they have submitted a New Drug Application for prasugrel to the US Food and Drug Administration for the treatment of patients with acute coronary syndrome (ACS) who are managed with percutaneous coronary intervention (PCI), including coronary stenting. The treatment will be marketed as Effient and the companies added that a filing in Europe will follow later this quarter.
Read more:rival
Sanofi gets EU okay on Plavix loading dose tablet 2008-03-11 11:26:00 "This positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) needs to be ratified by the European Commission in the coming months before final approval," Sanofi said in a statement.Recommendations for marketing approval by the CHMP are normally endorsed by the EU Commission within a couple of months.
Sanofi-Aventis KK recently obtained approval to produce Plavix in Japan 2008-03-18 16:27:00 The firm's only plant in Japan
is used to make both pills and ampuls of drugs. Sanofi-Aventis will install more tablet-coating machinery at the facility this year. More packaging machinery will be added in 2009, and in 2010 the company will expand the equipment that forms ingredients into the shapes of pills.Within the year, the factory will have the annual capacity to make 2.9 billion tablets. And once all the planned equipment is installed, the capacity will reach 3 billion tablets a year.
Read more:recently
, produce
Prasugrel better on stent-related clots than Plavix 2008-04-05 17:22:00 CHICAGO (AFP) — A cocktail of new anti-blood clot drug Prasugrel and aspirin reduces the risk of stent-related
clots more than the standard treatment, according to a clinical trial review presented Saturday.Prasugrel cut the risk of platelet formation around where a stent -- a small metal device -- was inserted to keep an artery open, by an average of 58 percent compared to Copidogrel (Plavix), according to analysis presented to the 57th annual American College of Cardiology conference in Chicago.Researchers found that, during clinical trials, the anti-blood clot drug developed by US firm Elli Lilly and Japan's Daiichi Sankyo lab offered greater protection against the risk of stroke and death than Plavix, the standard treatment from American lab Bristol-Meyers Squibb and France's Sanofi. Read more:better
Drug-Eluting Stents - How Long on Plavix? 2008-04-20 06:08:00 he importance of taking Plavix (clopidogrel - a drug that helps prevent blood clotting) after receiving drug-eluting stents (DES) has received a lot of attention over the past few years. Not long after DES came into common usage, reports surfaced indicating that there is a long-term risk of sudden occlusion of the coronary artery with these stents, produced by the sudden formation of blood clots at the site of the stent. Sudden blockage of a coronary artery, of course, can have catastrophic results including heart attack and sudden death. The long-term use of Plavix is thought to substantially decrease this risk.Unfortunately, long-term Plavix therapy is not benign. Indeed, trauma or surgery while on Plavix can have devastating consequences. Some cardiologists refuse to allow their DES pat
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