News in brief
25-Oct-2016 - The US FDA has told Aduro Biotech not to enrol subjects in trials of its listeria-based immunotherapies after one study subject tested positive for the bacteria.
24-Oct-2016 - Biotrial has accused French newspaper Le Figaro of leading a “smear campaign” through its coverage of the Phase I trial in which one man died and five others were hospitalised in January.
24-Oct-2016 - APIs made by Laxachem Organics pvt ltd were not the source of bacteria in Pharmatech laxatives linked to a spate of Burkholderia cepacia infections according to the US FDA.
20-Oct-2016 - The US FDA has warned Teva Pharmaceutical Industries about its facility in Godollo, Hungary over ongoing concerns about manufacturing operations.
19-Oct-2016 - US FDA inspectors found vermin in drug production areas at a manufacturing facility operated by Montana Compounding Pharmacy.
19-Oct-2016 - The US FDA has identified quality control problems at a sterile drug manufacturing facility operated by Akorn Pharmaceuticals.
18-Oct-2016 - Advanced osteoarthritis patients will be barred from taking part in fasinumab trials after a sufferer enrolled in a Phase IIb study developed joint disease.
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.