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PR News Wire (Free subscription) | 10/19/2009
TUSTIN, Calif., Oct. 19 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHMD) today announced that Dr. Robert Garnick has joined the company as the head of regulatory affairs. Dr. Garnick was formerly the senior vice president of regulatory, quality and compliance at Genentech. During his 24-year career at Genentech, he was responsible for 17 new product approvals...
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Medical News Today (Free subscription) | 18 hours ago
... is within 300 days. "We are pleased to have completed another key milestone in our North American regulatory strategy for Ceplene®," stated Jack Talley, President and Chief Executive Officer of EpiCept. "As the next step in this process, we are focused on the filing of a New Drug Application for Ceplene® with the U.S. Food and Drug Administration for AML remission maintenance. As...
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Fiercebiotech (Free subscription) | 11/06/2009
... development and commercialization of blinatumomab, Micromet can develop an integrated clinical and regulatory strategy across multiple commercial territories, starting with the first pivotal study that we expect to initiate in 2010." - read Micromet's release Related Articles: Micromet inks $475M antibody deal with Sanofi Micromet raising up to $80M to fund acquisitions, research...
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Market Wire (Free subscription) | 11/04/2009
... Learned and Where are We Going? A CMO's Perspective
John McGrath, Lonza Biologics
-- Global Regulatory Strategies for Validation and Transfer of Biotech
Processes and Products
Robert L. Garnick, Ph.D., Lone Mountain Biotechnology and Medical
Devices, Inc.
-- The Critical Elements of a Successful Regulatory Filing for Outsourcing
Biopharmaceutical Manufacturing
Terry...
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PR News Wire (Free subscription) | 10/30/2009
... surgery and abdominal surgery. The FDA provided AcelRx with guidance on Phase 3 study design, regulatory strategy, and NDA requirements. Commenting on the meeting, Pamela Palmer, MD, PhD, AcelRx Chief Medical Officer stated, "We are glad to have FDA input on the NDA requirements for this novel approach to post-operative pain management. Given this guidance, our path to market...
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The Earth Times Online Newspaper (Free subscription) | 10/30/2009
... surgery and abdominal surgery. The FDA provided AcelRx with guidance on Phase 3 study design, regulatory strategy, and NDA requirements. Commenting on the meeting, Pamela Palmer, MD, PhD, AcelRx Chief Medical Officer stated, "We are glad to have FDA input on the NDA requirements for this novel approach to post-operative pain management. Given this guidance, our path to market is now...
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Food and Drug Adminstration (FDA): CDRHNew (Free subscription) | 10/22/2009
The committee will discuss and make recommendations regarding the agency's regulatory strategy for Full Field Digital Mammography (FFDM) Devices.
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Contract Pharma Breaking News (Free subscription) | 10/19/2009
Dr. Robert Garnick has joined Peregrine Pharmaceuticals as the head of regulatory affairs. Dr. Garnick was formerly the senior vice president of regulatory, quality and compliance at Genentech. During his 24-year career at that company, he was responsible for 17 new product approvals, including most of the company's top selling monoclonal antibody therapeutics such as Rituxan, Herceptin,...
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AirTransportNews.aero (Free subscription) | 10/26/2009
... to offer a comprehensive range of services to airlines and start-up carriers at a time when regulatory hurdles are exceptionally challenging. Their offering includes tailored start-up support packages for new entrant operators. With backgrounds in airline operations, airline start-ups, licensing and management, finance, law and aviation IT, Constellation’s directors will lend support and...
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TravelDailyNews.com (Free subscription) | 10/26/2009
Five aviation professionals combining the depth of expertise that you would typically find in an airline’s boardroom have joined forces to create an all new advisory agency - Constellation Aviation Consulting Limited (CACL). Based in Central London, the associates are pooling their resources and skillsets to offer a comprehensive range of services to airlines and start-up carriers at a time when regulatory...
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Business Wire (Free subscription) | 09/30/2009
... of Ophthalmology. These highly regarded experts will advise the company on its clinical programs, regulatory strategy and provide strategic guid
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aids-write.org (Free subscription) | 09/25/2009
... cannabis collective. Instead, the ordinance seeks to regulate collective patient gardens – a regulatory strategy rejected by the committee earlier this year. The City Attorney arranged for a parade of officials to reinforce his position that sales of cannabis are illegal in all circumstances. Representatives from the Long Beach District Attorney and City Attorney’s offices inexplicably...
