Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
Ranbaxy Sues FDA for Revoking Tentative Approvals for Nexium, Valcyte Generics
Indian generic maker Ranbaxy Laboratories said on November 19 that it has sued the US FDA for rescinding tentative approvals for its generic versions of AstraZeneca PLC’s proton pump inhibitor Nexium (esomeprazole) and Roche’s antiviral medicine Valcyte (valganciclovir). The company’s…
To read the full story
Related Article
- US FDA Withdraws Tentative Approvals for 2 Generic Drugs of Ranbaxy
November 11, 2014
BUSINESS
- Takeda CEO Says Orzeyful Could Redefine NT1 Standard of Care
July 31, 2026
- Pfizer Seeks Pediatric Expansion for Hympavzi in Japan
July 31, 2026
- Nippon Shinyaku Exercises Option for AB2 Bio’s Tadekinig Alfa in US
July 31, 2026
- Alfresa Takes Stake in Ember to Bolster Pharma Cold Chain in Japan
July 31, 2026
- Sanwa Kagaku Says Kumamoto Plant Remains Shut, Drug Supplies Stable
July 31, 2026
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
Adeno-associated virus (AAV) gene therapies have long been viewed as carrying only a minimal risk of insertional mutagenesis — a…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…