News & Analysis on Clinical Trial Services & Contract Research And Development
Following Wockhardt’s decision to cease supplying APIs to the EU market, the UK drug regulator MHRA (Medicines and Healthcare Products Regulatory Agency) has updated its statement of noncompliance to include all APIs made from the India-based manufacturer.
Catalent is taking aim at the Asian market with a partnership with Mitsubishi Gas Chemical Company to make cell lines for the region.
AMRI has won a $38m federal contract to support the National Institutes of Health Drug Manufacturing and Formulation Program (DMFP).
Novozymes finished 2014 with higher pharma revenues thanks in part to GSK's adoption of its albumin half-life extension technology, Veltis.
Venom produced by sea snails could be used in designing human insulin analogues or as painkiller drugs, according to a University of Utah scientist.
India-based CMO Piramal has acquired US-based sterile injectable CDMO (contract development and manufacturing organization) Coldstream Laboratories for $30.65m.
Quintiles has said Pfizer will “remain a customer” after analysts said the CRO lost out to a privately-owned contractor in the race to be the drug giant's third alliance partner.
In order to align more closely with ICH’s Q3D guideline for elemental impurities, USP has pushed back until 2018 when its chapter on elemental impurities will apply to industry.