Latest Headlines

Latest Headlines

Merck's Keytruda snags FDA approval for NSCLC, but label is narrow

Chalk up another approval for Merck & Co.'s Keytruda. And it's a significant one, as it fights for market share against Bristol-Myers Squibb's Opdivo in the PD-1/PD-L1 field. The FDA Friday gave an accelerated approval for Keytruda for use on advanced non-small cell lung cancer (NSCLC). Opdivo is awaiting an accelerated approval.

On second thought, Amicus won't be filing its lead drug this year

Amicus Therapeutics, a biotech comeback story, is walking back plans to submit its rare disease treatment for FDA approval this year, rethinking its whole regulatory strategy after follow-up conversations with the agency.

Novartis targets Amgen's Enbrel with second biosimilar app

Right now, Novartis' Sandoz has the only biosimilar on the U.S. market. And it's looking to make it two.

FTC weighs in on Mylan case, saying generics tweaking may be anticompetitive

Generic makers have had just about enough with branded drugmakers tweaking aging meds to hold on to sales, with some arguing in court that the move is inherently anticompetitive. Now the FTC is wading into the debate, saying that pharma companies that make small changes to brand-name products to ward off competition from cheaper copycats may be violating antitrust laws.

Novartis comes for Enbrel in latest biosimilar shot at Amgen

A month removed from launching the U.S.'s first biosimilar, Novartis is again setting sights on an Amgen cash cow, lining up for FDA approval with a copy of the blockbuster Enbrel.

Biologic drug patent differences stall TPP agreement at Atlanta talks

Officials from the U.S., Japan and 10 other Asia Pacific-rim countries remain stalemated over an agreement for the Trans Pacific Partnership currently being negotiated in Atlanta with the length of patent protection for biologic drugs a key stumbling block, the Japan News said.

Bristol-Myers wins $256K nod for Opdivo-plus-Yervoy in melanoma

Bristol-Myers Squibb continued its immuno-therapy march today with a combo approval in melanoma. The pairing of its older med Yervoy and new PD-1 cancer-fighter Opdivo won the FDA's green light for patients with advanced melanoma and a particular genetic variation.

As China pumps up drug exports, FDA worries about inspections

Expectations that the U.S. FDA is ready to take a harder look at products from China, mirroring efforts seen in India in the past few years, has brought the shortage of inspection manpower for drug manufacturing in China into sharper focus.

FDA puts off its decision on Newron's Parkinson's drug

Italian biotech Newron Pharmaceuticals will have to wait another three months for a final FDA decision on its investigational Parkinson's treatment.

Jazz eyes a quick FDA nod for its $1B rare disease drug

Jazz Pharmaceuticals secured the FDA's priority review for a long-delayed rare disease treatment, accelerating the path of a drug acquired in a $1 billion buyout.