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Operator silence rings alarm bells during audits, say FDA and WHO experts

Full transparency and open conversation with operators will lead to more successful facility audits, say regulatory experts.


Ita-leave? Italian referendum may impact European API supply chain

A ‘no’ vote in the referendum this weekend may hurt Italy’s API industry and impact European drug supply chains if it results in the country leaving the EU.

Spain's Idifarma adds capsule filling to service offerings

Idifarma has invested over €300,000 in its facility in Spain in order to offer its customers automated capsule filling for commercial batches.

News in brief

Ecstasy to treat PTSD by 2021? US FDA approves Ph III trial

Party drug MDMA has been claimed to be effective in helping treat Post-traumatic stress disorder (PTSD) patients, with the FDA approval for a Ph III trial to go ahead in the US.

Takeda building Dengue fever vaccine plant

Takeda has started work on a vaccine plant to make its candidate Dengue fever virus vaccine, TAK-003.

US FDA slams Dongying Tiandong for poor raw heparin supplier oversight

Dongying Tiandong Pharmaceutical Co., Ltd does not do enough to ensure the crude heparin it uses is free potentially lethal contaminant OSCS according to the US FDA.

Arrowhead halts development of RNAi-based therapies that use its Ex1 delivery tech

Arrowhead has abandoned development of therapies which use its Ex1 delivery vehicle, axing multiple clinical trials and sacking staff.


Juno deaths: Toxicity is therapy specific, not risk to whole CAR-T field, say experts

The deaths in a trial of Juno Therapeutics’ JCAR015 are most likely product-specific says the CEO of French CAR-T developer TxCell, who rejected the idea that chemotherapy or the CD19 target played a part.

West completes Mulhuddart expansion citing insulin as driver

Delivery device with West Pharmaceutical Services has completed the expansion of its plant in Mulhuddart, County Dublin.

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