Latest Headlines

Latest Headlines

India considers drug testing labs in each state

India may house drug testing laboratories in each state under an INR17.5 billion ($270 million) plan to shore up quality.

Something's got to give in India's pharma policy contradictions

India wants to cap drug prices at home while ramping up sales of generics to Western markets targeting the U.S.--all while dozens of manufacturing plants are under regulatory scanners on quality and testing.

Japanese flu vaccine makers pump up prices 50%, drawing flak as peak season hits

In an unusual and possibly coordinated move, four Japanese flu vaccine makers hiked retail prices by 50% just ahead of the season when most Japanese start receiving their jabs, officials told the Japan Times.

UPDATED: 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.