Topic:

Regulatory

Latest Headlines

Latest Headlines

The FDA OKs 5 blockbusters in slow start to 2013 drug approvals

Few productivity metrics in biopharma measure up to the annual rate of new drug approvals. So now that the FDA has come through with only 13 novel approvals in the first half of the year, well off the pace of 39 new approvals in 2012, there's some handwringing going on.

Gore beats back St. Jude's patent suit

After a three-year legal spat, Gore has prevailed over St. Jude Medical and can keep its heart plug on the market, the company said.

GlaxoSmithKline's new diabetes drug faces delay at the FDA

Glaxo says that the FDA asked for more time to review the information the big pharma company had submitted in response to the agency's queries and pushed back the deadline to April 15, 2014.

FDA staffers back approval of Bayer hypertension drug

Bayer garnered support from FDA staff for its submission for approval of riociguat for two forms of pulmonary hypertension, though reviewers recommended clearing the experimental drug at a lower dose than the company sought.

Senate joins effort to save FDA user fees from sequester

Echoing their counterparts in the House, 5 senators from both parties have introduced a bill that would spare millions of FDA dollars from mandatory budget cuts, allowing the agency to use industry-provided money to speed up approvals.

Pressure mounts on House leaders to allow device tax repeal vote

House Republican leaders face pressure from their sizeable freshman class to allow action on a bill that would repeal the 2.3% medical device tax.

Sunshine Act in today's pharma forecast as mandate takes effect

The earnings picture may be cloudy today in the drug business, but sun is shining in from another quarter. Today is the first day of data-gathering for the newly implemented Physician Payments Sunshine Act.

Tension rises in China as officials fine J&J, visit Sanofi

Amid Chinese government probes of potential graft, corruption and opportunistic pricing, even drugmakers that say they're confident about their compliance expect fallout from the investigations.

Strides Arcolab says Form 483 issues under control, will continue supplying U.S.

Strides Arcolab recently joined a few of its fellow Indian drugmakers in a club no manufacturer wants to be part of. In June, the company became the latest in a series of Indian pharmas this year to draw critical observations from the FDA for production shortfalls.

Fresenius cans managers tied to data manipulation

Fresenius Kabi is taking seriously the FDA's allegations that staff at an Indian API plant lied to investigators and concealed data, and the generic drug unit of the German healthcare giant said it has fired the workers responsible.