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Regulatory & Safety: Top Headlines

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US FDA finds cGMP deviations at ALK-Abello facility in Denmark

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).

US FDA won't OK eye pain candidate until Ocular Therapeutix addresses production concerns

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.

EMA proposes changes to Ph I guidelines after fatal BIA 10-2474 trial

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.

GSK to expand recall of antibiotics made at Worthing API unit

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

US FDA rejects Sandoz’s Neulasta biosimilar

19-Jul-2016 - The US FDA has issued Sandoz with a complete response letter for its Neulasta biosimilar.

Report: Congress needs to update human research regulations

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.

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