CPhI South Korea
25-Aug-2016 - Stem cells and biosimilars are driving the Korean pharma market, according to the country’s Biomedicine Industry Association KoBIA.
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
update - Hospira regrets non-compliance
24-Aug-2016 - Pfizer’s Hospira unit and Napp Pharmaceuticals broke ABPI rules covering the promotion of biosimilar medicines according to the UK industry group.
23-Aug-2016 - Sagent Pharmaceuticals has recalled another lot of its injectable penicillin in the US after a customer found rust in a vial of the drug.
22-Aug-2016 - An Indian facility owned by Pfizer’s Hospira unit has been banned from supplying some drugs to the EU after MHRA inspectors found breaches of manufacturing regulations.
22-Aug-2016 - Actavis has recalled five lots of a diabetes drug glipizide made by Patheon after tests revealed that the tablets did not meet specifications.
Fast-tracked Factor Xa inhibitor is being made for Portola by CMC Biologics and Lonza
22-Aug-2016 - Portola Pharmaceuticals says it was "caught off guard" after the US FDA raised manufacturing concerns in a complete response letter for its Factor Xa inhibitor, AndexXa.
19-Aug-2016 - Biologics developers need to be more vigilant about immunogenicity and manufacturing changes than small molecule drug manufacturers according to the EMA.
18-Aug-2016 - Roche is updating instructions for its Accu-Chek insulin pump after patients who failed to load the device correctly experienced hyperglycemic symptoms.
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.