Archives for October 13, 2014

News from edqm 50th anniversary conference

IPEC calls for inclusion of excipient compound monographs in Ph. Eur.

'Excipient compound' monographs should be included in the European Pharmacopoeia according to IPEC, which argues they would help manufacturers and promote acceptance of the standards outside Europe.

US FDA approves Gilead's $1,125 a pill combination Hep C drug

Gilead says its hepatitis C combination drug Harvoni will deliver significant healthcare savings in the long-term despite its $1,150 (€885) a pill price tag.

CDMOs: Leave aseptic manufacturing to the Vetters of this world, says Aesica

Aesica has turned its back on sterile injectables manufacturing and, in an exclusive interview, told Outsourcing-Pharma.com there is now limited steriles capability in the UK following the exit of other key players. 

Thermo Scientific assesses PK/PD analysis tool after study shows bioequivalence data discrepancies

Thermo Scientific is assessing its PK/PD data analysis software after a technical paper found discrepancies in results that may have affected drug approvals.

News from CPhI

DSM cuts out China's ATS-8 intermediate middlemen with enzyme-made statin APIs

Royal DSM has launched a statin API it claims is made using a green production method that reduces reliance on intermediate suppliers.