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license applications in India for Sprycel from Bristol-Myers Squibb and Onglyza from AstraZeneca have been quietly withdrawn as firms in the space suggest at least a higher bar has been set.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