Topic:

Regulatory

Latest Headlines

Latest Headlines

Industry coughs up $97M in first medical device tax payment

Medical device coffers are $97 million lighter this week, as the industry just paid its first semi-monthly tax bill, trade groups said.

France yanking Bayer's Diane-35 off the market

France's drug regulators last year faced scathing criticism for dragging their feet when it came to the dangers of off-label use of diabetes drug Mediator. Now faced with consumer fears over deaths tied to off-label use of Bayer acne drug, Diane-35, they are acting with dispatch.

In India, a call to halt financial incentives for stent use

The global stent industry might have to brace for problems in India, where observers see surgeons increasingly overusing stents when cheaper drug treatments would work just fine. Some governmental pushback could be in the cards, as The Times of India says kickbacks and gifts are promoting the practice and the medical community is starting to clamor for changes.

FDA staffers frown over Pharmaxis data for inhaled CF treatment

Australia's Pharmaxis is scheduled to make its case for a new cystic fibrosis therapy in front of an FDA advisory committee. But based on the agency staff review out earlier this week, investigators will likely get grilled about a high dropout rate in two key studies and the mixed efficacy data they delivered.

UPDATED: FDA hands Sanofi, Isis an approval for HoFH drug Kynamro

Late Tuesday the FDA came through with an approval for mipomersen (Kynamro), an antisense drug advanced by Isis and partnered with Sanofi's Genzyme. It's the second new drug approved recently for homozygous familial hypercholesterolemia, a rare and dangerous form of high cholesterol.

Boehringer gets FDA panel's thumbs up on 'modest' new COPD treatment

Last week FDA staffers came up with a lukewarm review of the efficacy seen in Boehringer Ingelheim's prospective COPD drug olodaterol, but couldn't fault its safety profile. And that seemed to satisfy the panel of outside experts who met to review the drug today, giving it a pass with a lopsided 15-to-1 vote in favor of approval.

FDA expands use of Pfizer's Prevnar 13

The FDA will now allow use of Prevnar 13 in children and adolescents ages 6 to 17, a recent expansion that could allow Pfizer to hit lofty sales goals.

Witness: J&J lowered own standards to deem metal hips 'safe'

When Johnson & Johnson's metal-on-metal hip implants failed an internal safety test, the company opted against fixing the issue and instead just changed its protocols, a witness testified in one of thousands of lawsuits the drug and device giant now faces.

Bowing to French demands, EMA to review new contraceptive safety

The European Medicines Agency is launching its own review of contraceptive safety. At the request of France, which zeroed in on the risk of blood clots with third- and fourth-generation birth control pills, EMA says it will also sift the data.

U.K. physicians join up with pharma in doc-payment pledge

Will U.K. drugmakers be the next to shine a light on payments to doctors? A leading physicians group and the Association of the British Pharmaceutical Industry are promising new disclosures. What form those disclosures will take remains to be seen.