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| Tuesday 10 November 2009 |
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News In Brief
First OTC statin launched Merck has launched the first over-the-counter statin. The new 10-milligram dose simvastatin will be marketed by Johnson & Johnson in the United Kingdom under the brand name Zocor Heart-Pro at a cost of £12.99 (US $23.59) per 28-day pack. The UK announced in May that it had approved the switch to OTC status for people at moderate risk of heart disease, arguing that easier access would allow more people to protect themselves from the risk. The decision comes 4 years after similar attempts in the United States failed to achieve OTC status for low-dose statins. But now it is reported that the FDA has reversed course and is now willing to reconsider this. FDA accepts Antegren BLA Biogen Idec and Elan said the FDA has accepted their BLA for natalizumab (Antegren) to treat multiple sclerosis, a treatment that many analysts predict will be a blockbuster. Antegren is a first-in-class selective adhesion molecule inhibitor, a class that targets various inflammatory conditions. In the case of multiple sclerosis, natalizumab acts by preventing inflammatory T-cells from crossing the blood–brain barrier and attacking the myelin sheath that insulates axons. Antegren was granted Priority Review and accelerated approval designations, and is on track for gaining approval before the end of November. Measures aim to respond to animal rights protestors Pharmaceutical companies and the UK government have announced initiatives in response to heightened activity from animal rights protestors. GlaxoSmithKline, AstraZeneca and Pfizer said they are donating £4million (US $7.2 million) to animal research and training at universities. In addition, the UK Home Office announced plans for a crackdown on animal rights campaigners who use terror tactics against scientists. Protesting outside a person’s house in an intimidating manner will be a specific criminal offence. Harassment laws will also be tightened up and special prosecutors appointed for each police area. The announcements come at a time when attacks by animal rights extremists have raised questions about the future of medical research in the UK, following the decision by contractors to pull out of building animal research laboratories at Oxford and Cambridge Universities. FDA issues guidance for “available therapy” In two guidance documents, FDA said that a product that was granted accelerated approval will not prevent the agency from granting accelerated approval or Fast Track designation to a competing product for the same indication. The guidances state that products that were granted accelerated approval based on surrogates will not be considered “available” or “existing” therapies until efficacy is confirmed under conventional approval conditions. The agency said it is preferable to have more than one treatment approved under the accelerated approval provision, because “the availability of the therapy is less certain than it is with a conventional approval.” For example, approval may be withdrawn if post-approval studies fail to verify clinical benefit, and such a withdrawal would leave no treatment available. http://www.fda.gov/cber/gdlns/availther.pdf http://www.fda.gov/cber/gdlns/fsttrk.pdf Generic manufacturer buys rival Mylan Laboratories, the largest generics drugs manufacturer in the United States, has agreed to acquire King Pharmaceuticals. The deal, worth around US $4 billion in stock, is the latest move among generic drug makers to strengthen and diversify their businesses in the face of increasing numbers of patent extensions from big pharmaceutical companies. King has built an extensive sales and marketing infrastructure as well as a business development arm devoted to acquiring branded products and companies. Race is key to rapid approval of heart drug A clinical trial of BiDil, developed by NitroMed, was stopped on 19 July because of its effectiveness when used in addition to normal therapy in African Americans with heart failure. The drug, a combination of the nitric oxide donor isosorbide dinitrate and the vasodilator hydralazine, is on course to become the first medicine approved for use in a specific ethnic group, with a predicted launch date of 2005. FTC approves Sanofi’s takeover bid The US Federal Trade Commission said that it had approved Sanofi-Synthélabo's bid to take over Aventis after the companies agreed to divest some assets and royalty rights. Sanofi will divest the anticoagulant fondaparinux sodium (Arixtra) to GlaxoSmithKline, as well as studies involving the colorectal cancer treatment irinotecan (Campto) that Aventis is carrying out. Sanofi must also divest Aventis’s rights to the insomnia drug eszopiclone (Estorra), either to Sepracor or to another agency-approved buyer. Agencies accused of delaying medicinal marijuana research Researchers have launched lawsuits accusing US government agencies of obstructing attempts to obtain supplies of medicinal marijuana. In one lawsuit, the Florida-based campaign group Multidisciplinary Association for Psychedelic Studies is demanding a decision on an application filed in 2003 to buy 10 grams of marijuana from a small farm at the University of Mississippi, under contract from the National Institute on Drug Abuse, to test a vaporizer delivery method. The second lawsuit states that the Drug Enforcement Administration has stalled an application to set up a separate farm to grow marijuana for research, filed in 2001 by botanist Lyle Craker of the University of Massachusetts at Amherst. | | ||||||||||||||||||||||||||
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