Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

Europe bans some APIs from Chinese drugmaker Zhuhai United

China's Zhuhai United Laboratories bills itself as the world's largest manufacturer of the API for the antibiotic amoxicillin. But the sterile manufacturing for some of its amoxicillin products has been called into question by inspectors in Europe, which is banning the sterile drugs for now, except in limited cases.

Siemens snags FDA approval for HIV combo test

Siemens scored FDA approval for its HIV combo test, a win for the company as it looks to its diagnostics unit to chart some growth amid lagging fortunes.

Australia's moves on biosimilar substitution draw flak from U.S. biologic medicines group

A move by Australia to be the first country to allow pharmacies in some cases to substitute biosimilars for originator drugs has drawn a rebuke by the U.S.-based Alliance for Safe Biologic Medicines, which includes members such as Amgen and the Biotechnology Industry Organization.

Natco eyes U.S. FDA green light for Copaxone generic sales

India's Natco Pharma said all it needs is the approval from the U.S. FDA to launch a generic version of Teva's Copaxone and put it on track to compete with versions from Sandoz, Momenta Pharmaceuticals and Mylan.

China's BeiGene gets U.S. FDA IND nod on oncology candidate BGB-3111

China's BeiGene has received U.S. FDA approval on an IND application for clinical development of BGB-3111, a proprietary Bruton tyrosine kinase inhibitor for the treatment of B-cell malignancies, putting a fresh round of funds to use as it works on three main oncology candidates.