The latest news sliced only 3% off the biotech's share price.
Medtronic is headed to the European market with what it says is the first implantable defibrillator cleared for full-body MRI scans, following a widespread trend toward imaging-safe implants.
After Massachusetts Gov. Deval Patrick banned Zogenix's powerful new FDA-approved painkiller, Zohydro, the company filed a lawsuit arguing the ban was unconstitutional. On Tuesday, federal district court judge Rya Zobel said she was inclined to agree with Zogenix and was leaning towards granting a preliminary injunction that would allow Zohydro to be sold in Massachusetts.
A Louisiana jury pummeled Takeda Pharmaceutical and Eli Lilly & Co. with $9 billion in punitive damages in a liability suit over their blockbuster diabetes drug Actos. It's one for the record books, an amount so far beyond normal that even the victorious lawyers discounted it.
Boehringer Ingelheim, determined not to let clot-fighter Pradaxa be outdone by Bayer and Johnson & Johnson's Xarelto, has added a couple of new uses to the drug's label, snagging the FDA's okay to treat deep vein thrombrosis (DVT) and pulmonary embolism (PE) in some patients. But it still has a long way to go--and some safety concerns to dispel--before it can retake the anticoagulant throne.
In late March, Massachusetts Governor Deval Patrick banned the newly approved purely hydrocodone pain pill Zohydro--and now the maker of that drug is fighting back. Zogenix filed a lawsuit in a Boston federal court seeking a restraining order against the governor's Zohydro ban.
The FDA has been trying for several years to expand its inspection staff in China, a country that accounts for many of the active pharmaceutical ingredients used in U.S. drugs. But according to testimony in a hearing last week, the agency currently has only two drug inspectors stationed in the country.
GlaxoSmithKline says it's rolling out sales and marketing reforms around the world. Apparently, the changes come none too soon. The British drugmaker opened another bribery investigation, this time in Iraq, to check out allegations that it paid government-employed physicians to promote its products.
Edwards Lifesciences won a CE mark for its innovative aortic valve system. European approval for the device comes at a critical moment for the company, as it attempts to strengthen its hold on foreign markets and stay a step ahead of its competition.
A couple of weeks ago, the FDA handed Pfizer's meningitis B candidate its breakthrough therapy designation, setting it up for a race to market with Novartis' Bexsero. Now, the Swiss company's jab has one to match, meaning it may not be long before it can start contributing some much-needed sales to Novartis' vaccines unit.