FDAnews Drug Daily Bulletin

A provision in the 2007 FDA Amendments Act (FDAAA) intended to limit the use of citizen petitions to block approvals of generic drugs has failed to change the behavior of brand companies, whose use of the petitions continues to rise, according to a new study.

Drugmakers now need to get government approval in France before advertising their products to health professionals and the general public, thanks to a decree that took effect May 9.

Novo Nordisk will have to wait until late October to get word on the fate of two ultra-long-acting insulin treatments because the FDA needs additional time to review data clarifications and analyses it requested after the initial NDA submissions.

Merck Serono has confirmed that it will be closing its Geneva headquarters next year, despite strong opposition from its staff.

Pfizer has paid $896 million to resolve about 60 percent of the cases alleging its menopause drugs caused cancer in women, the drugmaker said in a securities filing.

Pharmaceutical companies including GlaxoSmithKline and Novartis AG will get federal money to help develop medicines against pandemics and bioterrorist threats, the U.S. government said.

The U.S. Supreme Court ruled that pharmaceutical companies do not have to pay overtime to their representatives who visit doctors’ offices to promote their products, a dispute that had threatened the industry with billions of dollars in potential liability.

The cost of medicines to the State will be reduced as a result of a new agreement between the Department of Health and the pharmaceutical industry body, the Irish Pharmaceutical Healthcare Association.

Lawmakers in the House and Senate are debating versions of a bill that would allow prescription drug coupons to be used in Massachusetts.