QLT, Novartis restructure Visudyne deal; Teva launches Copaxone patent battle with Mylan;

> Canadian eye-care company QLT said it restructured its pact with Novartis, giving it exclusive rights to sell anti-blindness treatment Visudyne in the United States. Report

> Sanofi-Aventis got the FDA nod for Elitek, a drug to help fight a serious complication of cancer treatment. Report

> Generic drugmaker Teva Pharmaceutical Industries sued rival Mylan, alleging that Mylan's application to market a copycat version of Teva's multiple sclerosis drug Copaxone was infringing certain patents. Report

> The drug industry stands to gain in a health-care overhaul by getting tens of millions of newly insured customers, while insurance companies--especially those that cater to the individual market--look like they are in for a tougher time. Report

> Health officials predicted a shortfall in the supply of swine flu vaccine, as the numbers of cases, hospitalizations and deaths grow to levels unprecedented for this time of year. Report

> Some treatments for inflammatory bowel disease increase the risk of infection-related cancers, French scientists said on Monday, but the benefits of the drugs still outweigh the risks. Report

Biotech News

> The FDA has thrown up a roadblock for Amgen's bone drug denosumab, delaying its decision as the agency requests a new clinical program to support approval of the drug, along with more information on its post-marketing surveillance plan. Denosumab report

> Human Genome Sciences (HGSI) has laid claim to a rich prize for its success getting albinterferon alfa-2b ready for regulatory review as a new hepatitis C therapy: a $75 million from its development partner Novartis. Report

> Three biotechs race for Holy Grail of an obesity drug. Report

> Novartis is facing what could be a serious setback on one of its most promising drug candidates. The FDA said today that it will need to see more information on dosing before it can approve indacaterol, a COPD drug which is viewed as one of Novartis' most important late-stage prospects. Article

Biotech IT

> Phase Forward's work to develop a faster and more accurate data loader for Merck has garnered recognition form the Society for Clinical Data Management. The effort yielded a data loading increase to 100,000 records per hour, up from 1,000, and an 80% drop in errors. Report

> With a paucity of participants in clinical trials among the factors in lengthening the development timeline for new drugs, contract research giant Quintiles has opened ClinicalResearch.com, an Internet site that simplifies the process of finding a trial. Article

> Symyx has unveiled a hosted informatics service that combines the company's software with data archiving capabilities in a secure data hosting and communications facility. Report

> Drug absorption and pharmacokinetics simulation company Simulations Plus has released version 4.7 of its ClassPharmer software for the analysis of chemical libraries and design of molecular structures. Article

> Fall must be the season of clinical trial software--Akaza Research has unveiled version 3.0 of OpenClinica, its open-source electronic data capture (EDC) software. Report

And Finally... Forest Laboratories' antidepressant Lexapro combined with an intensive treadmill training program helped people with partial spinal cord injuries walk better and faster, U.S. researchers said. Report

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