More US FDA draft guidance for compounders
The US FDA has proposed more new rules for compounders three years after a deadly meningitis outbreak was linked to unsafe manufacturing practices at a pharmacy in Massachusetts.
Archives for February 16, 2015
PE-backed Laurus Labs sets up US drug ingredients business
Warburg Pincus-backed HIV drug ingredient firm Laurus Labs has set up a US presence and development facility in a bid to win more North American customers.
Enteris plans to beat established API CMOs on lead times
Enteris Biopharma says it can compete with established API CMOs by offering shorter lead times and greater flexibility.
inVentiv ups early phase offering with new clinic in Miami
CRO inVentiv Health announced late last week new plans to open a Phase I/IIA clinic in Miami, thereby expanding its early phase clinical services to the US.
US FDA working to make clinical trials less wasteful
The US FDA is looking to set up master protocols that can continuously run and help cut down on waste that’s prevalent in the clinical trial industry, Director of FDA's Center for Drug Evaluation and Research Janet Woodcock said in an interview.
Charles River ‘hot in pursuit’ of discovery company acquisitions
Charles River Laboratories is nearing the acquisition of an early-stage drug discovery company, CEO James Foster told attendees at the Leerink Swann Global Healthcare Conference last week.