Latest Headlines

Latest Headlines

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.

Mylan bags rights to distribute Gilead's Sovaldi in India

Gilead has named Mylan as the exclusive distributor of branded forms of its hepatitis C blockbusters Sovaldi and Harvoni in India.

Gilead plows ahead in India with Mylan deal on hep C, but will it work?

Mylan Pharmaceuticals Private has signed an agreement with Gilead Sciences for exclusive rights in India to distribute the best-selling Sovaldi (sofosbuvir) and Harvoni combination with ledipasvir for treating hepatitis C.

India's Sun Pharma recalls epilepsy treatment levetiracetam batch over failed dissolution tests

Sun Pharma issued a recall of 3,363 bottles of its levetiracetam extended-release drug for treating epilepsy in the United States after the tablets failed dissolution tests.

FDA hands Lupin plant 6 black marks, along with ANDA approval

Lupin expected to introduce 15 to 20 new products to the U.S. market this year, but that was before the announcement today that the FDA had found shortcomings at one of its key plants in India.