George Washington University professor appointed senior adviser to FDA commissioner
ROCKVILLE, Md. A research professor from George Washington University will become senior adviser to Food and Drug Administration commissioner Margaret Hamburg, the agency announced Tuesday.
The FDA appointed food safety specialist Michael Taylor, whose duties as adviser to Hamburg will include helping to develop the FDA’s budget request for fiscal year 2011 and plans for allocating resources for fiscal year 2010 and plan implementation of new food safety legislation.
“I am pleased to welcome Mike Taylor back to the FDA,” Hamburg said in a statement. “His expertise and leadership on food safety issues will help the agency to develop and implement the prevention-based strategy we need to ensure the safety of the food we eat.”
Taylor previously began working as a litigating attorney for the FDA in 1976, serving as deputy commissioner for policy from 1991 to 1994 and as administrator of the Food Safety and Inspection Service of the Department of Agriculture from 1994 to 1996.
“I am honored and grateful that commissioner Hamburg has asked me to return to the FDA in the position of senior adviser to the commissioner,” Taylor said.
Mylan gets FDA approval for AstraZeneca drug generic
PITTSBURGH The Food and Drug Administration has approved Mylan’s generic version of a drug for treating prostate cancer.
Mylan announced Tuesday the approval of bicalutamide tablets in the 50-mg strength. The tablets are a generic version of AstraZeneca’s Casodex, which had U.S. sales of $322 million for the 12 months ended March 31 in the same strength, according to IMS Health data, and global sales of $1.26 billion, according to AstraZeneca financial data.
Teva announced Monday the launch of its own version of the drug.
Merck shareholders approve merger with Schering-Plough
WHITEHOUSE STATION, N.J. It’s official: Merck & Co.’s shareholders have approved its merger with Schering-Plough.
Merck announced Friday that its shareholders voted overwhelmingly to approve the proposed merger. The preliminary tabulation indicates that more than 99% of the company’s outstanding shares voted in favor of the transaction. Merck held its special shareholder meeting in Bridgewater, N.J. on Friday to vote on the proposed merger.
“We are gratified by the shareholder confidence demonstrated through the outcome of today’s vote,” said Richard T. Clark, Merck’s chairman, president and CEO. “On behalf of Merck’s Board and management team, I want to thank our shareholders, customers and dedicated employees for their support throughout this process. We look forward to completing the merger with Schering-Plough and to creating a strong, global leader that can make a substantial difference to patients and global health care.”
As previously announced on March 9, under the terms of the agreement, Schering-Plough shareholders will receive 0.5767 of a share of new Merck common stock and $10.50 in cash for each share of Schering-Plough. For Merck shareholders, existing Merck share certificates will automatically represent an equal number of shares in the new Merck after completion of the merger.
The company expects the transaction to close in the fourth quarter of 2009, as originally planned. The transaction remains subject to the satisfaction of customary closing conditions and regulatory approvals, including expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, as well as clearance by the European Commission under the SEC Merger Regulation and certain other foreign jurisdictions.
All proxy cards and ballots submitted at the special meeting were processed by IVS Associates Inc. for final tabulation and certification. Final voting results will be publicly announced promptly after they have been tabulated and certified.