26-Jul-2016 - The European Medicines Agency (EMA) has released a concept paper proposing changes to its current guidance on first-in-human clinical trials.
News in brief
26-Jul-2016 - The US FDA says it identified “significant deviations” from manufacturing standards a facility in Denmark operated by allergy immunotherapy developer ALK-Abello (ALK).
26-Jul-2016 - The US FDA will not approve the candidate eye pain eye treatment Dextenza until developer Ocular Therapeutix addresses concerns about how the product is made.
Micro Labs completes repeat studies and predicts drugs will be back on the market in autumn
Sandoz repeats tests and Teva pulls malaria pill as EMA calls for suspension of Semler trialled drugs
25-Jul-2016 - Sandoz is repeating bioequivalence studies and Teva is withdrawing an antimalarial after the EMA recommended that drugs trialled by Semler should be suspended.
21-Jul-2016 - European authorities want to revise the guidelines covering first-in-human studies in light of the French trial in which one man died and others were hospitalised earlier this year.
21-Jul-2016 - GSK will recall more antibiotics made at a UK API unit that has been offline since the US FDA raised contamination concerns last year.
Update: Sandoz remains committed to launching 5 biosims by 2020
19-Jul-2016 - The US FDA has issued Sandoz with a complete response letter for its Neulasta biosimilar.
19-Jul-2016 - Ethical principles for conducting research involving humans were originally detailed in 1978 – today, a new report is urging Congress to make updates to the decades old document.
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.