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Regulatory

Latest Headlines

Latest Headlines

Pfizer, Novartis race to market with 'breakthrough' meningitis B vaccines

Both Pfizer and Novartis have picked up the FDA's much-coveted breakthrough-therapy designation for their meningitis B vaccines, and now the rivals have chosen the same day to submit their injections for approval, leaving it up to regulators which will hit the market first.

FDA says Apotex India plant has faked data for years

In April, the FDA banned a plant in Bangalore, India, owned by Canadian generic drugmaker Apotex. A warning letter sent last week and posted today by the FDA says that among other issues, it found that the company had deleted data of failed test results and then reported that the batches had passed.

Merck seeks sanctions against Brown U doc over Vioxx comments

David Egilman, a professor of family medicine at Brown University, was once a federal witness in a lawsuit filed against Merck over the now-long-withdrawn Vioxx. Merck finally closed the books on all the Vioxx suits last summer, but the company is now asking a federal judge to sanction Egilman for leaking info to the Wall Street Journal.

FDA approves Novartis U.S. vaccine plant it is trying to sell

Novartis' $1 billion influenza vaccine manufacturing plant in Holly Springs, NC, has just become the first pandemic-ready site FDA-approved to make cell-culture influenza vaccines. Now it needs to find a buyer for the facility.

Obesity device before FDA panel despite not meeting primary endpoints

An implantable device to treat morbid obesity with vagal nerve blocking therapy will be considered by the FDA's Gastroenterology-Urology Devices panel on June 17. Its chances going into the meeting don't look great: The panel documents point out that it didn't meet either of its primary efficacy endpoints and the panel date was already delayed once in March. Still, while the 12-month data aren't good, at 18 months the device looks a bit more promising.

Sources: Bayer, J&J's Xarelto faces first U.S. lawsuits

The inevitable has happened for Bayer's fast-selling anticoagulant blockbuster, Xarelto. Someone in the U.S. has filed a lawsuit over its safety concerns. In fact, a number of lawsuits have been filed, according to reports in a German newspaper.

U.K. gatekeepers nix hep C drug Sovaldi till Gilead ponies up more evidence

Should the British health service pay for the expensive-yet-effective hepatitis C treatment Sovaldi? The U.K.'s cost-effectiveness gatekeepers say they're not convinced.

Pharma execs weigh leaving China in wake of widening corruption crackdown

China's yearlong crackdown on allegedly corrupt practices by pharmaceutical companies has left foreign executives there spooked--so much so that some are asking their lawyers if they should leave the country altogether.

Bard wins unanimous FDA panel vote for first drug-eluting balloon

C.R. Bard won a unanimous vote from an FDA advisory panel for its drug-eluting balloon catheter, setting the stage for the device's full regulatory approval.

U.K. price watchdog changes its tune on BMS melanoma blockbuster Yervoy

Three months after Britain's National Institute for Health and Care Excellence said it would not recommend Bristol-Myers Squibb's Yervoy as a first-line treatment for melanoma, the much-feared cost-effectiveness agency has changed its mind. A new draft guidance from NICE now says Yervoy should be available as the first choice for treating patients with advanced melanoma.