All news articles for October 2017

US FDA bans APIs made by Fleming Labs

news in brief

US FDA bans APIs made by Fleming Labs

By Gareth Macdonald

Fleming Laboratories has been banned from shipping APIs to the US by the FDA which says its manufacturing plant in Nawabpet, Telangana in India is not up to code.

GettyImages/urfinguss

Daiichi Sankyo inks Glycotope ADC deal

By Flora Southey

Daiichi Sankyo Company has signed an option agreement to develop Glycotope’s antibody drug conjugate (ADC) to target various cancers including ovarian, lung and breast tumours.

Novartis HQ in Basel, Switzerland (source Novartis)

Novartis to pay $3.9 bn for radiopharma drug & biz

By Flora Southey

Novartis has announced plans to buy radiopharmaceutical firm Advanced Accelerator Applications (AAA), which will add neuroendocrine tumour treatment Lutathera to its portfolio.

GettyImages/Waldemarus

BIOPRODUCTION CONGRESS DUBLIN 2017

HPRA tells drug makers how to get ‘GMP inspection-ready’

By Flora Southey

Firms should identify risks prior to inspection, make staff available during regulator visits, and respond promptly post-inspection when undergoing GMP site checks, says Ireland’s Health Products Regulatory Authority (HPRA).

Gettyimages/Ruskpp

MHRA pulls Evertogen's GMP certificate after inspection

By Gareth Macdonald

Evertogen Life Sciences Limited should recall drugs made at its facility in Mahabubnagar, India according to the MHRA, which identified critical quality and data integrity problems during an audit in August.

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