Topic:

Regulatory

Latest Headlines

Latest Headlines

Japan's MHLW slated to review Nippon Boehringer high blood pressure combo

Japan's Ministry of Health, Labor and Welfare will hold an advisory committee approval review on April 20 for several drugs, a spokesman said, including Nippon Boehringer Ingelheim's triple combination to treat high blood pressure

AZ, BMS get a breather in India as compulsory license application appeals yanked

Compulsory license applications in India for Sprycel from Bristol-Myers Squibb and Onglyza from AstraZeneca have been quietly withdrawn as firms in the space suggest at least a higher bar has been set.

Quality issues not behind sight loss in off-label Avastin use in India

Roche has checked a batch of Avastin (bevacizumab) in India linked to partial loss of sight for 15 patients and did not find any quality-related issues, though it repeated that the off-label use of the drug to treat age-related macular degeneration is not approved.

Merck KGaA loses FDA approval for fertility drug after abandoning postmarketing studies

It's been more than 10 years since the FDA signed off on Merck KGaA's fertility drug Luveris. But now, after the company failed to conduct a postmarketing trial, the FDA has yanked the drug's approval at the German pharma's request.

FDA bans products from 3 more Chinese drugmakers

Three Chinese drugmakers that have received Form 483s after FDA inspections found quality manufacturing problems have been added to the FDA import alert list, indicating products have been banned from the U.S.

Belgian startup raises €10M to back CE mark trial for micro-invasive glaucoma implant

iStar Medical raised a €10 million ($11.4 million) Series B round to fund a study to support a CE mark for its latest product. Its MiniJect is an injected implant that is designed to reduce intraocular pressure in glaucoma patients by improving aqueous humor outflow from the anterior chamber to the suprachoroidal space.

Obama aides focus on overall pharma benefits in TPP, not biologics data period

Getting key lawmakers to pass the Trans-Pacific Partnership (TPP) trade pact by the end of President Barack Obama's final term may hinge on whether they buy a pitch that the deal is overall good for the drug industry.

J&J gets FDA approval for continuous manufacturing of Prezista

It may not be anything like a meme or a juggernaut, but some definite momentum is building in pharma for continuous manufacturing. Janssen, Johnson & Johnson's generic drug unit, has won FDA approval for a continuous manufacturing line at a plant in Puerto Rico. That came just days after Eli Lilly said it would build a continuous manufacturing facility in Ireland.

Full-speed ahead in China's online drug sales push?

Apparently more and more e-commerce firms are looking to sell prescription drugs online in China, state-run Xinhua news agency said, convinced that regulators will fully open that now mostly closed avenue.

Cheaper drug prices the destination in China healthcare reform map

China's Premier Li Keqiang said the State Council has mapped out medical system reforms for this year with plans to buy drugs for public hospitals via a central system and then compare prices to pharmacies and other outlets for transparency.