Topic:

Regulatory

Latest Headlines

Latest Headlines

Four months later, 23andMe's clash with the FDA remains unresolved

In the four months since 23andMe agreed to stop selling all health-related genetic tests in the U.S. while it submits them for a formal FDA review, the California company's future has become cloudier, not clearer.  A recent blog post on its web site informed customers that executives continue to meet with regulators, but a resolution to the matter doesn't appear to be anywhere close to happening.

Industry predicts dire consequences from FDA's generic labeling proposal

The FDA says it wants to level the playing field by having generic drugmakers independently update drug labels when there are known risks to the products. The industry feels as if it is being nudged off a cliff.

Stallergenes beats Merck to market as FDA OKs its allergy pill

France's Stallergenes won FDA approval to market the U.S.'s first oral immunotherapy for grass allergies, giving it a head start on rival Merck, which expects to launch a similar product this year.

MannKind soars after Afrezza scores a big win, but commercial questions linger

A group of FDA advisers voted resoundingly in favor of MannKind's inhaled insulin, lending momentum to the long-delayed drug as it makes its third run at an approval.

FDA lambastes GSK plant for releasing contaminated products

Much has been made as of late of the manufacturing problems found at some of India's biggest drugmakers. But a warning letter sent in March to a GlaxoSmithKline active pharmaceutical ingredient plant in Cork, Ireland, illustrates that Big Pharma is not immune to quality issues.

It's a big win for Eli Lilly in multibillion-dollar Alimta patent fight

Eli Lilly just scored billions in additional sales. A federal judge decreed that an unusual patent on Lilly's cancer drug Alimta is valid. And that means the company keeps its Alimta exclusivity till 2022.

GE Healthcare unit recalls infant warmer systems in China

A GE Healthcare unit recalled hundreds of infant resuscitation devices in China after uncovering potential safety issues. The recall coincides with China's latest regulatory action, which calls for more stringent oversight of medical device makers.

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.