Topic:

Regulatory

Latest Headlines

Latest Headlines

Cubist's superbug drug clears FDA panel, lines up for Pfizer showdown

Cubist's latest antibiotic won praise from a panel of FDA advisers, setting the stage for a likely approval and head-to-head competition with Pfizer's blockbuster Zyvox.

Hospira settles investor suit tied to its manufacturing mess-ups

Costs mount quickly when manufacturing issues are bad enough to attract the FDA's attention. There can be a substantial hit to value if investors get freaked out, and sometimes that can lead to litigation that makes the proposition even more expensive. That is what happened to Hospira, which has agreed to pay $60 million to settle an investor lawsuit.

Sorin scores expanded CE mark for its Perceval sutureless aortic valve

Sorin knows that it needs to reach the widest patient population possible to succeed in the cardiac marketplace. With that in mind, the Italian cardiac medical device company can celebrate its new CE mark allowing its Perceval sutureless aortic valve to be used for all adults with aortic stenosis and related problems.

FDA lets Fresenius import saline to help with shortage

The FDA has been scrambling for months to help relieve shortages of some common products used in U.S. hospitals, including saline solution and nitroglycerin. To do that it has been looking for some overseas suppliers that can kick in extra capacity, and it now says it has found one to get more saline into the U.S.

FDA lifts a partial hold on Curis cancer drug

Lexington, MA-based Curis says the FDA has lifted the partial clinical hold on CUDC-427, which was instituted after the death of a patient in a Phase I study of solid tumors and lymphoma.

In a regulatory overhaul, Chinese authorities pass new rules governing medical devices

Medical device makers will soon face stricter regulation in China, as lawmakers passed new rules governing sales and manufacturing of medical equipment. The rules provide a major overhaul to decade-old legislation and increase punishment for the most serious corporate malpractice violations, Reuters reported.

Glaxo scraps the ovarian cancer app for Votrient

The drug giant is pulling its application in Europe after concluding that the data didn't paint a sufficiently positive portrait of overall survival benefits for patients--despite an improvement seen in progress-free survival.

FTC aiming for $1B pay-for-delay patent settlement this year

The Federal Trade Commission is so fed up with "pay-for-delay" pharma deals, that it's hoping to reach a $1 billion settlement in at least one pharma antitrust case this year. That's the word from Deborah Feinstein, director of the FTC's Bureau of Competition, who revealed the agency's aims at a recent meeting of the American Bar Association's Section of Antitrust Law in Washington, D.C.

Massachusetts bans Zogenix's controversial new painkiller Zohydro

While congressional reps and activists flog the FDA for approving the powerful new painkiller Zohydro, Massachusetts Gov. Deval Patrick is taking a more direct approach. Patrick says he's banning Zohydro from his state until Zogenix develops an abuse-deterrent version.

Abbott has won U.S. approval for the peripheral-artery-disease stent it bought last year

Abbott announced on Friday that its Supera Peripheral Stent System has got the FDA's approval to treat blocked blood vessels in the upper leg caused by peripheral artery disease.