Topic:

Regulatory

Latest Headlines

Latest Headlines

Switzerland, U.S. ready to end WTO truce on some IP complaints with India in focus

A two-decade truce that has seen members of the World Trade Organization avoid filing "non-violation complaints and situations" for intellectual property rights may not last another year as the U.S. and Switzerland increasingly want to fight denials of patents and compulsory licensing of some key drugs, The Hindu reported.

UPDATED: Medtronic strikes back with FDA approval of its third-gen TAVR

Analysts said Edwards Lifesciences widened the lead over Medtronic with the FDA approval its Sapien 3 TAVR, but Minnesota's industry bigwig struck back just days later, receiving approval of a third-generation version of its own TAVR, the CoreValve Evolut R.

Medicines Co. gets leg up on Angiomax generics with FDA approval for cangrelor

The Medicines Co. has suffered a series of setbacks since it kicked off late-stage studies for its blood-thinning injection cangrelor almost a decade ago. But now, the company is enjoying a bright point as the FDA signed off on the drug for a smaller subset of patients, giving Medicines Co. a boost as it braces for generic competition for one of its bestsellers.

Acorda's inhaled levodopa shows promise in Phase II trials

Acorda Therapeutics moved a step closer to collecting the payoff from its $525 million acquisition of Civitas, maker of an inhaled levodopa, in the scramble to deliver an improved formulation of the standard Parkinson's med. The conventional oral formulation suffers from unpredictable absorption in the bloodstream and a wearing-off effect after about 5 years.

J&J, Stryker, Zimmer in line as India eyes price caps on orthopedic implants

India may soon make scuttlebutt on medical device price controls a reality, starting with orthopedic implants, the Times of India reports, as the National Pharmaceutical Pricing Authority asks Johnson & Johnson, Zimmer and Stryker to submit details of production and pricing of their products, including those for knee and hip.

Vietnam gets official WHO nod as global vaccine supplier

The World Health Organization has officially named Vietnam as the fifth country in the Western Pacific region to meet requirements to produce vaccines for the global market, with reports in April suggesting the government expects to have a 6-in-1 vaccine ready for the market next year.

Foreign investors allowed up to 44% of India's Syngene IPO shares

India's Foreign Investment Promotion Board sharply hiked the foreign investment limit allowed for an upcoming initial public offering of shares in Syngene International, the CRO unit of Bangalore-based Biocon, setting the stage for a capital market entry expected in July.

Package inserts on endoscopes revised in Japan

Japan's Pharmaceutical and Medical Devices Agency has issued the English-language version of revised package inserts for endoscopes, citing "malfunctions and adverse events reported in Japan and overseas."

India's Kumar eyes a one-stop shop on pharmaceuticals

India's alphabet soup of ministries and agencies that have a role in national pharmaceutical policies will have to get to know each other better under the latest big idea to streamline decision-making and set policies.

Medicines Co. finally wins an FDA nod for the clot-busting cangrelor

A year after enduring a stinging FDA rejection, the Medicines Company convinced regulators to change their minds on the blood-thinning cangrelor, winning approval to treat a smaller group of patients after years of development.