23-Jan-2017 - Ocular Therapeutix Inc. has resubmitted its eye pain drug Dextenza to the US FDA claiming it has solved manufacturing problems that saw the agency reject the drug in July.
News in brief
- US FDA OKs Akorn plant after re-inspection
- Mappel doesn't want to supply US after warning letter
- 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
23-Jan-2017 - The EDQM has set out how it will integrate risk-based elemental impurities testing into the European Pharmacopoeia.
23-Jan-2017 - ICH is currently seeking public comment on proposed "modernizations" to the clinical trial design, planning, management, and conduct guidelines ICH E8 and E6.
19-Jan-2017 - Czech authorities have ordered B. Braun Medical s.r.o to stop supplying medicines from a warehouse in Rudná after identifying breaches of GDP guidelines.
18-Jan-2017 - The US FDA is inspecting more foreign plants but has not shown if its efforts have improved the quality of API and drug imports according to a GAO report.
18-Jan-2017 - The US FDA has criticised Sato Yakuhin Kogyo Co responses to data integrity concerns an inspection team raised after visiting its drug plan last June.
17-Jan-2017 - Problems at a CMO have forced Janssen-Cilag to ship Haldol made in Austria to patients in Switzerland to maintain supplies.
17-Jan-2017 - The US FDA expects biosimilar developers to provide data from switching studies to demonstrate interchangeability with a reference biologic in draft guidance published today.
Regulatory & Safety: Featured news
Welcome to in-PharmaTechnologist's monthly round up of who's been moving where in the small-molecule manufacturing world. The CEO of BMS is moving internally, Axim Biotechnologies and Pharmalink have new board members, whilst Vium and Dova Pharmaceuticals have new Chief executives.
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.