TOP 100 MEDICAL SITES
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| Hope Grows for FDA Approval of Adventrix's Chemo Drug Prohost Biotech submits:Despite the emergence of new biological treatments for cancer, chemotherapy is still essential, and indispensable as a major treatment for malignancies. The adverse events caused by these chemicals were found to be acceptable as a risk versus the great reward of using chemotherapy. Due to the technological evolution that took place in the past decade and the surfacing of state-of-the-art technologies such as nanotechnology, scientists believed possibilities exist now for improving the adverse effect profiles of these therapeutic molecules. Reformulating the existing products has become an increasingly common product lifecycle-management technique. We read that a 2004 report on the U.S. drug market from BCC, Inc. projected that reformulations would grow from 62% of the market in 2003 to 79% in 2008. Finding ways to modify and improve existing products’ side effect profiles has become feasible after being an essential but unreachable goal. Among Wednesday’s news, Adventrix (ANX) announced that, based on information received from the FDA, it decided to resubmit its New Drug Application (NDA) for ANX-530 (vinorelbine injectable emulsion), or Exelbine, a novel emulsion formulation of the approved cancer chemotherapy drug vinorelbine for approval for the sake of improving its side effects of the marketed drug. From the same press release we understood that the firm has met with the FDA and clarified certain matters regarding stability data necessary to file the Exelbine NDA and that the studies are ongoing and the emerging data will enable the firm to resubmit the NDA in the fourth quarter of this year. Background: Adventrix had submitted an NDA for ANX-530 to the FDA in December 2009. On March 1, 2010 it announced that it had received a refusal-to-file letter from the FDA regarding that submission. In the letter, the FDA indicated that the data included in the December 2009 NDA submission from the intended commercial manufacturing site was insufficient to support a commercially-viable expiration dating period. The FDA identified only this one chemistry, manufacturing and controls (CMC) reason for the refusal to file. No clinical or nonclinical issues were otherwise identified.Complete Story » seekingalpha.com |
Soccer Injuries: Boys Versus Girls Soccer may be safer than football, but after age 12 the game heats up and so does the risk of getting sidelined. online.wsj.com |
Arena Weight Loss Drug Looks Promising Wealth Daily submits:By Ian CooperWeight loss may not be the most exciting topic right now... But a lot of money is going to be made in the coming years on obesity drug stocks.Complete Story » seekingalpha.com |
Appeals Court Upholds Pay-to-Delay Deals, Again Pharmalot submits: In yet another blow to the US Federal Trade Commission, a federal appeals court has refused to reconsider its ruling last April that upheld the legality of so-called pay-for-delay deals that thwart the introduction of generic rivals (here is the order). However, in a dissenting opinion, Justice Rosemary Pooler writes that the issue must ultimately be decided by the US Supreme Court, given the conflicting outcomes in various cases. The initial ruling by the US Second Circuit Court of Appeals was made after reviewing a deal in which Bayer (BAYRY.PK) paid Barr Pharmaceuticals (BRL), which is now owned by Teva Pharmaceuticals (TEVA), to drop its patent challenge to the Cipro antibiotic. Barr challenged the Cipro patent in October 1991 and struck a deal with Bayer in January 1997, about two weeks before the case was set to go to trial.Complete Story » seekingalpha.com |
The Cancer-Drug Fast Track Clinical trials are notoriously inefficient. Can an experiment in personalized testing revolutionize treatment? online.wsj.com |