update
US FDA imposes partial hold on trials of IV formulation of Karyopharm's cancer candidate
The US FDA has placed a partial hold on trials of an injectable formulation of Karyopharm Therapeutics Inc.’s cancer candidate selinexor.
Archives for March 13, 2017
Charles River re-ups Chiesi drug discovery contract
Charles River Laboratories has extended its integrated respiratory program with Chiesi Farmaceutici, through which it identifies and tests candidates for preclinical development.
Alkem Labs hit with FDA 483 with three observations at Indian plant
The US FDA has issued a Form 483 with three observations to Alkem Laboratories after an inspection at its facility in Himachal Pradesh, India.
US FDA orders Scynexis not to start new trials of injectable antifungal
The US FDA has told Scynexis not to start trials of an injectable formulation of its candidate antifungal Scy-078 after several volunteers developed blood clots during a Phase I study.
PCI triples serialization capacity as 'crunch time' commences
PCI Pharma Services has tripled its serialization capacity ahead of US DSCSA and EU FMD deadlines with follow-on investments planned to finalize its serialization infrastructure.
Denmark clears Europharma to sell drugs after reinspection
The Danish Medicines Agency (DKMA) has cleared Europharma DK ApS to resume drug sales and distribution after the firm appointed a new managing director.
Novartis unit to consolidate Slovenian logistics in Kuehne + Nagel deal
Novartis subsidiary Lek Pharmaceuticals will consolidate its Slovenian logistics and warehousing operations from 10 sites to one.
update
Bbc license suspended by UK drug regulator
The UK MHRA has suspended Bbc Pharmaceutical Services Limited’s distribution license.
SRI secures $90m BARDA contract
SRI International will advance compounds with the potential to treat persons exposed to biological, radiation, nuclear, and chemical agents – in a deal worth up to $90m.
Hot and cold? Analysts unpack CRO market expectations
A recent CRO market report from ISR projects increasing outsourcing, though analysts remain less optimistic moving into 2017.