Another of India's large generic drugmakers has found itself in serious problems with the FDA. Just a week after Ranbaxy Laboratories' $500 million settlement, Wockhardt says the FDA has issued an import alert that could cost it $100 million in lost sales.
Pfizer's "external partner management" process is not exactly "American Idol" and Pfizer's John F. Kelly is not exactly Simon Cowell, but this year the Pfizer Global Supply (PGS) unit will go through the exercise of turning a handful or two of its more than 200 contractors into stars.
In the pact, investigators at Merck Serono will join hands with experts at Quintiles to shape and guide the company's R&D strategy while the CRO manages trial planning and execution from Phase I through post-marketing studies.
Contract manufacturer Nypro is bolstering its medical device capabilities, planning to launch another factory in Ireland and employ 200 people in the process.
PRACS Institute, the CRO that attempted to rise Phoenix-like from the ashes of scandal-plagued Cetero, has reportedly slammed its doors shut, laying off hundreds of workers with virtually no notice and leaving dozens of trial participants stranded and unpaid.
For years now Big Pharma companies have been pouring billions into ambitious new research efforts in China, anxious to capitalize on one of the world's most tantalizing emerging markets. Now Pfizer officials are indicating that they plan to follow up with new collaborations in research and marketing with Chinese partners as they ally themselves with a new generation of Chinese companies.
Quintiles made it official on Feb. 15, filing to raise up to $600 million in an IPO after months of rumors and speculation.
Remember those rumors back in January about a big Quintiles IPO? Somebody had some good information. The global CRO filed its S-1 with the SEC this afternoon, outlining plans to go public in one of the biggest new industry offerings in quite some time.
With robust, 20%-plus medical device industry growth expected in India this year, homegrown companies there are producing cost effective and even advanced versions of products sold by the multinationals.
As the drug giant seeks to carve out more than $1 billion for its budget, Pfizer confirmed plans to exit a clinical research operation in Singapore.