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 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.
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.
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.
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.
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.
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.
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 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.
Two diagnostics companies hoping to improve the rate of early-stage colon cancer detection made it past an FDA panel of experts in late March with mixed results.