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Regulatory & Safety: Top Headlines

FDA warning for Sandoz after data and training issues at Indian plants

25-Nov-2015 - Manipulated employee records and English-only training materials were among violations cited by the US FDA at two Indian plants, but Sandoz is confident these will be resolved.

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News in brief

Seaweed shortage prompts Thermo to suspend sale of two lab agars

25-Nov-2015 - Thermofisher Scientific has stopped selling two agars used in pharmaceutical industry control labs, citing a worldwide shortage of the seaweed used to make them.

EC mulls changes to Orphan Drug rules

24-Nov-2015 - Tweaks to EU orphan drug rules (OD) may be needed to accommodate Ebola treatment development and block industry attempts to delay generic entry says the European Commission.

Pfizer gets OK for $160bn Allergan acquisition

23-Nov-2015 - The boards of Pfizer and Allergan yesterday signed a $160bn merger that will create the world’s biggest pharmaceutical company.


Turing head Martin Shkreli buys out failing biotech

23-Nov-2015 - Martin Shkreli, the CEO who recently hiked the price of Turing's HIV drug, has taken over KaloBios.

Dispatches from PCT Europe

Future epidemic trials must cut through red tape, says Ebola researcher

19-Nov-2015 - A professor who conducted fast-track trials during last year’s Ebola outbreak says next time such trials must be part of humanitarian response… because there will be a next time.


CEO who ‘only employs beautiful women’ guilty of sex discrimination

18-Nov-2015 - The CEO of Immuno Biotech who said he only employs “beautiful women” and noted a candidate’s lipstick and high heels on her job application has been fined for sex discrimination.

Catalent: Suspension at French plant likely due to human interference

17-Nov-2015 - Out-of-place softgel capsules have led to the suspension of manufacturing at a site in France, and Catalent says the problem is almost certainly due to malicious actions.

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