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

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

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. 

QuVa buys New Jersey manufacturing plant citing access to regional markets

QuVa Pharma has agreed to buy a manufacturing facility in New Jersey, US at which it plans to compound sterile pharmaceutical products for hospitals.

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

Sandoz is repeating bioequivalence studies and Teva is withdrawing an antimalarial after the EMA recommended that drugs trialled by Semler should be suspended.

Teewinot gets US patent for bioreactor used to make synthetic cannabinoid APIs

Teewinot Life Sciences has been granted a US patent for a bioreactor it uses to produce synthetic cannabinoids.

Recipharm: Q2 rev up on M&As, higher demand and anti-radiation med

Acquisitions, higher demand for sterile liquid processing and a surge in Thyrosafe orders helped Recipharm offset pricing pressure in Portugal and lower UK sales in Q2.

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