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Regulatory & Safety: Top Headlines

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US drug reimportation 'Trump proposal' risky and inefficient, AmerisourceBergen

08-Dec-2016 - AmerisourceBergan has warned of the dangers of reimportation a day after the Senate rejected Bernie Sanders’ “Trump proposal” to overturn the ban.

Troubled Halol plant earns Sun a US FDA Form 483

07-Dec-2016 - The US FDA has issued Sun Pharmaceutical Industries with a Form 483 citing problems identified at its plant in Halol.

Mylan says cost cutting plan will impact up to 10% of its staff

07-Dec-2016 - Mylan NV has announced a restructuring plan that it says will impact less than 10% of its workforce.

Indian-made fake erectile dysfunction meds seized in Switzerland en route from Serbia

06-Dec-2016 - Fake erectile dysfunction drugs found in Serbian coaches entering Switzerland were made in India according to regulator Swissmedic.

MULTIPLE MYELOMA

Takeda overturns negative EU CHMP opinion for oral drug Ninlaro in ‘face-to-face’ appeal

06-Dec-2016 - Takeda was awarded conditional EU marketing authorisation of the small molecule drug Ninlaro, overturning the EMA’s negative opinion on its efficacy against Multiple Myeloma (MM).

Bluebird Bio reports positive early safety data from Ph I CAR-T trial

02-Dec-2016 - Bluebird Bio has reported encouraging efficacy and safety data from a Phase I trial of its CAR-T multiple myeloma therapy, bb2121.

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

01-Dec-2016 - Full transparency and open conversation with operators will lead to more successful facility audits, say regulatory experts.

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