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 [1]

> Sanofi-Aventis got the FDA nod for Elitek, a drug to help fight a serious complication of cancer treatment. Report [2]

> 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 [3]

> 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 [4]

> 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 [5]

> 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 [6]

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 [7]

> 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 [8]

> Three biotechs race for Holy Grail of an obesity drug. Report [9]

> 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 [10]

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 [11]

> 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 [12], an Internet site that simplifies the process of finding a trial. Article [13]

> 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 [14]

> 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 [15]

> 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 [16]

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 [17]