Counterfeit Avastin hits U.S. shores, Genentech warns

Counterfeit Avastin — the world’s best-selling cancer drug — is being distributed in the United States, Genentech Inc. and parent company Roche warned Tuesday.
Officials from South San Francisco-based Genentech could not say if patients had been directly harmed by counterfeit Avastin, which has been sold at least since December, or how much revenue the company had lost. But a Roche evaluation of the counterfeit vials showed that they did not contain the active ingredient in Avastin.

FDA ready for onslaught Thursday at medical device 'town hall'

Let’s just say that Jeff Shuren isn’t expecting an easy Thursday.
Given that federal regulators are a consistent target of Bay Area medical device company CEOs and their venture capital backers, the director of the Food and Drug Administration’s Center for Devices and Radiological Health expects an earful at a “town hall” meeting in South San Francisco.

Mr. Hastings goes to Washington, fights for drug approvals

OncoMed Pharmaceuticals ’ Paul Hastings threw down some interesting facts and ideas to a House Energy and Commerce health subcommittee hearing Thursday. Whether committee chair Fred Upton and his counterparts will pick them up is another thing.
The hearing comes as Congress looks at reauthorizing the Prescription Drug User Fee Act, or PDUFA, which is designed to allow the Food and Drug Administration to decide in a timely manner whether a drug is safe and effective. The program is funded by drug company fees.

FDA liaison in Bay Area? Why not, BayBio says

BayBio wants the FDA to base an agency employee in the Bay Area as a liaison to the region’s life sciences community.
That may be easier said than done at a time when government budgets are under intensive scrutiny, but BayBio President Gail Maderis said biotech, diagnostics and device companies and the Food and Drug Administration need to work more closely at a time when the industry-FDA relationship has soured.
Maderis, who hopes to make a case to legislators during a Biotechnology Industry Organization-sponsored meetup with Capitol Hill legislators next week, said there is precedent for federal agencies getting out of the Beltway: The Patent and Trademark Office recently opened a branch in Chicago.

Avastin gets FDA hearing in June

Genentech Inc. will get its day — actually two — in front of the Food and Drug Administration to plead its case for keeping Avastin as a treatment for women with metastatic breast cancer.

The hearing, scheduled for June 28-29, comes after the FDA in December said it would yank its conditional approval of Avastin for use by women with breast cancer that has spread to other parts of the body.

Alexza shares plummet after FDA setback

Genentech fires back at FDA over Avastin breast cancer rejection

Genentech asks for Avastin hearing