26-Sep-2016 - Amid ongoing patent litigation, the FDA has approved Amgen’s Amjevita: the first US biosimilar version of AbbVie’s top selling rheumatoid arthritis biologic Humira.
News in brief
- US FDA warns Concept Products for failing to fix cGMP violations at Tianjin plant
- Bangladesh Court orders 34 drug firms to halt production, again
- CDSCO imposes 45 day limit on provision of supplemental data
- Bayer increases Monsanto offer
- Cheryl Laboratories added to US FDA "Red List" after refusing to allow inspection
22-Sep-2016 - The US FDA has warned people not to use a $30 DIY epinephrine delivery device developed after Mylan increased the price of the Epipen.
21-Sep-2016 - Brexit will not stifle interest in the UK’s cell and gene therapy space, says the CGT Catapult which has reported a tenfold growth in investment since 2012
20-Sep-2016 - Sarepta Therapeutics says it is considering selling its FDA priority review voucher to support manufacturing scale-up for Exondys 51, its approved Duchenne Muscular Dystrophy drug.
20-Sep-2016 - Shire has abandoned its partnership on CTI BioPharma’s oral kinase inhibitor pacritinib seven months after deaths in a Phase III trial halted its clinical development.
19-Sep-2016 - The EMA has recommended a European ban of all non-critical drugs made by US CMO Pharmaceutics International Inc (Pii).
15-Sep-2016 - Bayer has said it will not cut drug R&D or manufacturing investment as a result of its planned acquisition of Monsanto.
15-Sep-2016 - Teva expects to restart drug manufacturing at the Hungarian plant under US import alert in the next few months.
Regulatory & Safety: Featured news
Valeant, Rentschler, Celgene, MannKind, and Syngene are among those welcoming new leaders for 2016. Oh, and Turing waves goodbye to Martin Shkreli… welcome to a New Year’s CEO special.