ePT--the Electronic Newsletter of Pharmaceutical Technology, Oct 6, 2011 - Pharmaceutical Technology

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ePT--the Electronic Newsletter of Pharmaceutical Technology, Oct 6, 2011
News
FDA Proposes Enhancing Search Criteria for Inspections Database
By Erik Greb
FDA may consider whether to add specific search criteria (e.g., those that would enable product-specific or violation-specific searches) to its inspections database to make it user-friendly and improve data analysis. The idea was included in a list of eight draft proposals for increasing transparency that the agency published on Oct. 3, 2011.
Private Equity Firms to Acquire PPD for $3.9 Billion
By Amy Ritter
The CRO Pharmaceutical Product Development (PPD) will be acquired by the Carlyle Group and Hellman and Friedman in a deal valued at approximately $3.9 billion. PPD shareholders will receive $33.25 per share in cash, and PPD will become a privately held company after completion of the transaction.
EMA Invites Feedback on Biosimilar and Vaccine Concept Papers
By Rich Whitworth
EMA released two concept papers for consultation that address the need to revise existing guidelines on biosimilar medicines and influenza vaccines.
Takeda Completes Nycomed Acquisition
By Stephanie Sutton
Takeda Pharmaceutical Company has completed its acquisition of Nycomed for EUR 9.6 billion ($12.9 billion) on a cash-free, debt-free basis. In addition, Takeda has named Frank Morich, Takeda's executive vice-president of internal operations (Americas/Europe), as Nycomed's CEO.
Servier and Galapagos Form Cancer Collaboration
By Stephanie Sutton
Servier and the Belgium-based biotechnology company Galapagos are embarking on a multiyear strategic alliance to develop new cancer therapies. As a result of the alliance, Galapagos could receive milestone payments of more than EUR 250 million ($332 million).
Week of Oct. 3, 2011: Merck Serono and Ono Pharmaceutical Sign MS, Cancer Pacts; Roche Names Rainer Metternich Head of Small-Molecule Research; and More
Merck Serono and Ono Pharmaceutical Sign MS, Cancer Pacts; Roche Names Rainer Metternich Head of Small-Molecule Research; and More.

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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