Archives for March 6, 2014

Columbia Labs Q4: Lumpy Merck sales and loss of Actavis contract mars strong year

Columbia Laboratories has reported strong annual results despite a fourth quarter affected by Actavis taking the manufacture of vaginal gel Crinone in-house and the “lumpiness” of Merck Serono.

UK Gov backs GSK-led manufacturing project citing "British prowess"

A GSK-led consortium will develop manufacturing technologies in a Government-backed scheme intended to safeguard the UK drug production sector.

Advocates say 1% funding increase in proposed US budget would "weaken" FDA

The Alliance for a Stronger FDA has expressed disappointment that President Obama’s FY 15 budget request for FDA falls short of what the agency needs to fulfill its responsibilities. 

US FDA calls for annual reports of postapproval manufacturing changes

The US FDA has released draft guidance on how post-approval manufacturing changes should be reported in annual reports.

UPDATE

Boehringer commits $450m extra to fix empagliflozin plant after FDA criticism

Boehringer Ingelheim says it will pump a further €330m ($453m) into a German manufacturing facility critised by the US FDA in its rejection of the drug empagliflozin.

Celerion expands into South Korea, CEO talks strategy with Outsourcing-pharma.com

Susan Thornton PhD, president and CEO of Celerion, broke down the company’s recent moves to partner with Seoul National University Hospital in an Outsourcing-Pharma.com exclusive.