Topic:

Regulatory

Latest Headlines

Latest Headlines

Medtronic snags EU approval for an MRI-safe ICD

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.

Judge likely to boot Massachusetts ban of new opiate Zohydro

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.

Jury slaps Takeda, Lilly with massive $9B in damages in Actos cancer case

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.

UPDATED: Boehringer's Pradaxa fights to regain ground with new clot-fighting approval

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.

Zogenix sues Massachusetts over ban on controversial painkiller Zohydro

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.

FDA is adding inspectors in China but for now it has only 2

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.

If GSK's chief wants to be Mr. Clean, he needs to get out the broom

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 wins CE mark for aortic valve system

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.

Novartis' Bexsero wins FDA 'breakthrough' status

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.

Sanofi misled investors with rosy Lemtrada predictions, lawsuit alleges

Sanofi investors are fed up with disappointing news on the multiple sclerosis drug Lemtrada. Vaunted as a potential blockbuster, the drug hasn't even made it to market in the U.S. Now, some investment funds are suing the French drugmaker, saying executives talked up Lemtrada in public--and kept bad news from the FDA private.