People aware of the matter said the Aayog has instead moved a draft Bill proposing that medical devices be governed by a separate regulator. NEW DELHI: Government think tank Niti Aayog has rejected the health ministry’s proposal to bring medical…
Biocon’s biologics portfolio comes into its own
Five years ago, Biocon’s biologics business largely consisted of insulin clones and was worth about ₹400 crore. At the time, Biocon was valued at just under $1 billion. Announcing its second-quarter results on Wednesday, MD and chairperson Kiran Mazumdar-Shaw said…
Warning Letters: FDA Cites Chinese API Maker
Jiangsu NHWA FDA’s warning letter to Jiangsu comes after a five-day inspection of the company’s Jiawang facility last April that uncovered issues with the company’s product testing procedures and investigations into out-of-specification (OOS) test results for active pharmaceutical ingredients…
Zealand takes on Takeda’s IBD drug with tiny buyout
After years developing a peptide to treat short bowel syndrome (SBS), Zealand Pharma is joining the hunt for the white whale of the gastrointestinal track: inflammatory bowel disease. The Danish biotech is buying out Toronto-based Encycle Therapeutics for up to…
South Korea warns of ‘serious risk’ from vaping, considers sales ban
SEOUL (Reuters) – South Korea on Wednesday advised people to stop using liquid e-cigarettes due to growing health concerns and vowed to speed up an investigation into whether to ban sales, a move likely to hit major producers such as…
NeuroRx secures $95M to fund PhIII for NMDA depression drug
After kicking off a Phase III trial testing its NMDA drug in suicidal bipolar depression, NeuroRx has secured access to around $95 million (HKD$750 million) to complete the program and fund the manufacturing activities. New York-based GEM Global Yield has…
Alkermes to lay off 160 in cost-cutting restructure
Dive Brief: Alkermes on Wednesday said it will lay off about 160 employees, curtail future hiring and cut spending as it starts a corporate restructuring designed to stem losses. The Irish biopharma expects to complete most of the job cuts…
FDA to Withdraw Generic Drug After Cipla subsidiary InvaGen Pharmaceuticals Company Repeatedly Fails to Resubmit Bioequivalence Data
After the US Food and Drug Administration (FDA) discovered an abbreviated new drug application (ANDA) relied on data from a disreputable contract researcher, and after repeated attempts over five years to get the company to resubmit new data, the agency…
Alexion Pharma to acquire clinical-stage biopharmaceutical firm Achillion
BOSTON & BLUE BELL, Pa.–(BUSINESS WIRE)–Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN) today announced that they have entered into a definitive agreement for Alexion to acquire Achillion, a clinical-stage biopharmaceutical company focused on the development of oral small…
Allergan gets FDA okay for paediatric Botox use
The FDA has approved Allergan’s Botox to treat lower-limb spasticity in children, further extending the use of the drug – widely used as a wrinkle treatment – in therapeutic indications. The US regulator has given the botulinum toxin-based drug a…
