The EPA must acknowledge the full extent of the uncertainty in its estimation of biofuels lifecycle greenhouse gas emissions and ensure that biofuel technologies are not preemptively disqualified from participation in the Renewable Fuel Standard program. The Biotechnology Industry Organization (BIO) released official comments on the Environmental Protection Agencys (EPA) proposed rule and draft regulatory [...]

Teva Pharmaceutical Industries Ltd. (Nasdaq TEVA) announced that the U.S. District Court for the Southern District of Indiana has issued a decision invalidating two patents listed in the FDAs Orange Book for Eli Lillys Evista® (raloxifene hydrochloride) Tablets in litigation concerning Tevas abbreviated new drug application to market a generic version. The court found these [...]

Wyeth Pharmaceuticals, a division of Wyeth (NYSE WYE), announces findings from a placebocontrolled Phase 3 study of bazedoxifene 20 mg extended to five years, which indicated a significant reduction versus placebo in new vertebral fractures in postmenopausal women with osteoporosis. These and other data were presented at the American Society for Bone and Mineral [...]

PTC Therapeutics, Inc. (PTC) announced the initiation of a Phase 3 trial of ataluren (formerly PTC124(R)), an investigational protein restoration therapy in patients with nonsense mutation cystic fibrosis (nmCF). Patients with CF lack adequate levels of the cystic fibrosis transmembrane conductance regulator (CFTR) protein, a chloride channel necessary for normal function of the lung, pancreas, [...]

Marketing exclusivity periods for firstinclass drugs have fallen dramatically in recent decadesfrom a median of 10.2 years in the 1970s to 2.5 years in the early part of this decadeunderscoring the competitive nature of drug development, a new study recently completed by the Tufts Center for the Study of Drug Development has found.
According [...]

Peregrine Pharmaceuticals, Inc. (Nasdaq PPHM) reported that clinical investigators are presenting interim Phase II data showing that its brain cancer agent Cotara(R) appeared well tolerated and demonstrated encouraging signs of efficacy in patients with glioblastoma multiforme (GBM), the deadliest form of brain cancer. The data from an ongoing Phase II study of Cotara in [...]

Essentialis, Inc., a clinical stage pharmaceutical company, announced today its intention to file a Special Protocol Assessment (SPA) with the FDA for the pivotal study to support the NDA filing on its lead drug, DCCR, for the treatment of very high triglycerides. The proposed study would include 280 randomized subjects with the primary efficacy endpoint [...]

As a result of a major interlaboratory study, the standards body ASTM International has been able to update its guidelines for a commonly used technique for measuring the size of nanoparticles in solutions. The study, which was organized principally by researchers from the National Institute of Standards and Technology (NIST) and the Nanotechnology Characterization Laboratory [...]

The U.S. Food and Drug Administration today announced it has stepped up its efforts to prevent noncompliant investigators and others from participating in new product development. The FDAs procedures for debarment and disqualification have been enhanced to better protect participants in clinical studies and for ensuring the safety and effectiveness of the medical products marketed [...]

Current ads sponsored by the Republican National Committee prod Democrats, while a very large planned campaign by drug makers could take flight soon.
The Republican National Committee has radio ads in 33 states to pressure 60 moderate House Democrats to oppose the reform proposals drafted by their partys leadership, CQ Politics reports. CQ Politics rates [...]