Topic:

Regulatory

Latest Headlines

Latest Headlines

CryoLife gains PMA nod for angina treatment tool

CryoLife achieved premarket approval for a new disposable device that aids a transmyocardial revascularization procedure.

Risperdal plaintiff's lawyer demands sealed J&J docs from FDA

If you don't succeed in court, try the FDA. That's the approach of a Philadelphia lawyer who wants to make some Risperdal data public, but is barred from doing so by a federal judge's order.

J&J files FDA app for fast-moving cancer candidate ibrutinib

The closely watched cancer treatment ibrutinib, winner of three "breakthrough" designations from the FDA, is now ready for the agency's review. 

Abbott rides next-gen Xience stent into Japan

Abbott Laboratories won Japanese approval for its Xience Xpedition drug-eluting stent, plotting to launch the device in one of the world's largest markets and pad sales in its flagging vascular business.

Pharma, FDA still lagging in post-marketing safety research

The good news: Drugmakers are wrapping up more post-marketing safety studies, now that the FDA can crack the whip. More good news: Companies got to work on a bigger proportion of the studies required. The bad news: More than 40% of required studies still haven't begun, and the percentage of completions is still quite low.

'Breakthrough' ibrutinib NDA makes rapid arrival at FDA

Ibrutinib notched another milestone in a fast trip toward FDA approval. Johnson & Johnson's Janssen has delivered the NDA for the closely watched cancer drug to U.S. regulators, setting the stage for a potential approval on the early side of the time line from the company and partner Pharmacyclics.

UPDATED: Myriad sues Ambry over cancer Dx patents

When the Supreme Court invalidated some of Myriad Genetics' gene patent claims last month, a bevy of competitors rolled out similar cancer diagnostics of their own, but now Myriad summoned its legal dogs once more, suing Ambry Genetics on claims that it violated patents not covered by the ruling.

Data fraud allegedly delayed FDA nod for Pfizer-BMS drug Eliquis

The allegations could raise more questions about the integrity of drug research in China.

AdvaMed now wants device tax repeal as part of broader tax code revamp

A major medical device-lobbying group is now pushing for a repeal of a 2.3% industry tax as part of a broader revamp of the U.S. tax code.

Amgen commits $50M-plus in 3-way deal to expand cardiovascular drug pipeline

Amgen continued its deal spree today with a three-way collaboration, in-licensing U.S. rights to Servier's heart drug Procoralan (ivabradine)--approved in Europe but not in the U.S.--along with a second, mid-stage cardiovascular drug while dealing out the European rights to Servier on a heart-failure drug now on the threshold of Phase III studies.