FDA approves J&J’s prostate cancer drug Zytiga

Johnson & Johnson's billion-dollar buyout of Cougar Biotech has paid off. The FDA has approved Zytiga (abiraterone acetate) in combination with prednisone for patients with late-stage castration-resistant prostate cancer who have previously received chemotherapy. In clinical trials, those who received Zytiga and prednisone had a median overall survival of 14.8 months compared to 10.9 months for patients receiving the placebo and prednisone, according to a statement. The decision...

Study: Can Gastric Bypass Surgery Help Treat Diabetes?

There has recently been a little controversy surrounding gastric bypass surgery, if it is better than dieting alone or it has negative long term effects. However a report this week announces more understanding how gastric bypass affects metabolism and can potentially influence treatments for type 2 diabetes, a global epidemic strongly linked with obesity and lack of...

Sanofi offers Genzyme execs retention bonuses, green light for R&D

Sanofi-Aventis CEO Chris Viehbacher is leaving no doubts about his ambitious R&D plans for Genzyme. Anxious to avoid a flight of top scientists, Viehbacher tells the Wall Street Journal that he's offering retention bonuses to keep top hands on board. And he's making a weekly trip to Cambridge, MA to emphasize his sincerity. "If you're in a company that has been independent for years, one of the original biotech companies, and you've just been acquired by a big multinational, you're going to...

InterMune pours cold water on red-hot takeover rumor

Shares of Brisbane, CA-based InterMune ($ITMN) surged more than five percent yesterday after Bloomberg treated the market to a story that Goldman Sachs had been brought in to scout buyout offers for the biotech. But the stock quickly calmed back down after the company put out a release stating that it had no plans for an M&A deal, adding that the developer is still plenty excited about its prospects for a newly-approved treatment for idiopathic pulmonary fibrosis. InterMune shares had...

The Link Between Diabetes And Oral Health: Practitioners Share New Data And Treatment Protocols

The links between oral disease and other systemic health issues are now well known. While some 65 percent of people in the US have periodontal disease, the rate is 90 percent among individuals with diabetes. Yet there continues to be little to no connection between the medical and dental care that patients...

OncoMed pockets $20M as it takes lead cancer antibody into trial

Redwood City, CA-based OncoMed hit an important milestone in its ambitious collaboration deal with Bayer Schering, earning a $20 million payday after the developer gained FDA acceptance for an IND needed to launch a Phase I dose-escalation study of an experimental antibody for cancer. Last summer Bayer agreed to pay OncoMed up to $387.5 million for each new cancer stem cell and protein therapeutic program targeting the Wnt signaling pathway. And the biotech company is right on schedule...

Vertex offers a blockbuster case for telaprevir

Vertex execs spent a good deal of this morning's FDA panel review on the hepatitis C drug telaprevir addressing one of the key safety concerns that regulators have with the drug. Tackling the rash triggered in some patients head on, the developer emphasized that only a relative handful of cases were discovered during the trial process and the patients could be quickly switched to the standard of care. Telaprevir "produces substantial clinical benefit compared to the current treatment,"...

Pfizer lays out slate of Ph3 successes for its crucial RA program

Pfizer ($PFE) outlined a slate of late-stage successes for tofacitinib, a crucial drug designed to treat rheumatoid arthritis. Tapped as a likely blockbuster in the event that Pfizer can successfully wrap its Phase III work, investigators announced that the drug hit all primary endpoints in two late-stage clinical trials. Patients taking the oral RA drug at both five and ten milligrams in both studies demonstrated reduced signs and symptoms of RA, according to Pfizer. But only top-line results...

Merck wins unanimous FDA panel support for blockbuster boceprevir

Merck ($MRK) walked away from yesterday's FDA panel review of the new hepatitis C drug boceprevir with a unanimous recommendation for marketing approval and a laundry list of suggested post-marketing studies to add to its to-do list. Next up is today's review of Vertex's telaprevir, which had an even better cure rate than boceprevir in clinical trials and which a top agency staffer suggested is already a favorite for approval as regulators close in on a pair of new therapies that can offer...

Molecular Partners Reports Positive Results From Its First Clinical Studies

Molecular Partners AG, a leader in the development of next generation therapeutics, announced today that it has completed two phase I/IIa clinical trials with MP0112, its lead molecule targeting VEGF-A. The DARPin molecule was shown to be safe and well tolerated in two separate Phase I/IIa trials in wet age-related macular degeneration (wet AMD) and diabetic macular edema...