18-Dec-2014 - For the second time the US FDA has rejected two versions of Pozen’s investigational drug candidate because of issues with a supplier’s foreign manufacturing facility.
News in brief
News in brief
18-Dec-2014 - The US FDA’s pre-approval inspection at Hovione’s API plant in Loures, Portugal, covering two NDA filings, resulted in a Form 483 with three inspectional observations.
15-Dec-2014 - Manufacturers should profile the "black specks" created during excipient production and share details with customers according to guidance finalised by IPEC-Americas, which says the unavoidable particles are starting to earn drugmakers 483s.
12-Dec-2014 - AstraZeneca has continued the Big Pharma trend away from small molecule blockbusters and towards a biologics-heavy pipeline, announcing the closure of its Pulmicort facility in Massachusetts.
10-Dec-2014 - The Competition Commission of India (CCI) has approved Sun Pharma’s $3.2bn acquisition of Ranbaxy.
10-Dec-2014 - An ex-GSK staffer charged with winning manufacturing investments for the UK says fostering innovation and “fiscal attractiveness” are vital.
10-Dec-2014 - Cubist will give Merck & Co leadership of the antibiotics sector according to one analyst who says renewed interest expressed by GSK, Roche and Sanofi has not produced any Ph III candidates.
From CPHI India 2014
03-Dec-2014 - SGS has doubled testing capacity at its Mumbai facility, explaining that Indian API makers’ failure to invest in quality has been good for business.
Ingredients: Featured news
John Giannone - incoming IPEC-Americas chairman
Irwin Silverstein, COO and VP of the International Pharmaceutical Excipients...
in-Pharmatechnologist.com presents a roundup of news in the fine chemicals sector, beginning with Johnson Matthey which has started a review of its active pharmaceutical ingredient (API) business after competition in the UK impacted its third quarter margins.