Latest Headlines

Latest Headlines

Cima Labs wins a round in India on Fentora patent

Cima Labs, U.S.-based maker of Fentora (fentanyl), a painkiller for cancer patients, will get to keep its India patent for the oral version of the drug, at least for now.

Hospira's new India plant again faulted by the FDA

The opening of Hospira's new plant in India that it is counting on to lower its manufacturing costs will be delayed again after it racked up another set of observations during a reinspection by the FDA last month. Unless quickly resolved, it will be an issue that Pfizer will inherit given its $15 billion buyout of Hospira announced last month.

Gilead moves from Japan to India lining up hep C, HIV licensing deals

Gilead Sciences has been busy in India and Japan signing licensing agreements for at least four of its drugs.

Takeda confirms eyeing opportunities in India, elsewhere, in vaccine space

Japan's Takeda Pharmaceutical has looked at Indian companies in the vaccine space as it moves to tighten focus on that aspect of its business ahead of a Phase III trial for a dengue candidate and more broadly emerging markets as seen by a recent M&A deal in Turkey.

India's CDSCO board recommends Phase III drug trial waivers for 'well-regulated' therapies

India's Central Drugs Standard Control Organization has recommended new guidelines for Phase III trial drug trial waivers.

Indian diagnostics company Thyrocare aims for $100M IPO

Indian diagnostics company Thyrocare, which touts itself as "the world's largest thyroid testing laboratory," is planning an IPO on the Indian stock market by the end of June with hopes of raising $85 to $100 million.

Bharat, Serum Institute ramp up production of their swine flu vaccines

Two Indian vaccinemakers are ramping up production of their swine flu vaccines, to replace stocks that were destroyed recently after they expired.

Showdown looms as PhRMA pushes for stronger compulsory license framework in trade pacts

In advance of this year's version of the U.S. list of problem countries in terms of intellectual property protection for patented drugs and other products, the pharma industry made what could be considered a last-ditch effort to limit the use of compulsory licenses.

India's CDSCO issues flurry of fixed-dose application bans

India's Central Drugs Standard Control Organisation has named and shamed several companies for submitting falsified data on fixed-dose combination and new drug applications.

India's NPPA targets international cardiac stent makers for meeting on product price data

India's National Pharmaceutical Pricing Authority ordered international makers of cardiac stents to meet with the agency Feb. 25 after several companies failed to submit data about the price of their products.