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March 3, 2008
Pfizer has entered into an agreement to acquire Serenex, Inc., a privately-held biotechnology company with a Phase I clinical candidate and an extensive compound library that targets Heat Shock Protein 90 (Hsp90), an anti-cancer target.
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March 3, 2008
Crucell N.V. has entered into an exclusive vaccine development agreement with Wyeth Pharmaceuticals. Under the terms of the agreement, Crucell will be responsible for the development and manufacture of certain components of a vaccine for use in Wyeth…
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February 29, 2008
Baxter International is proceeding with the voluntary recall of all remaining lots and doses of its heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products. The company initially recalled nine lots of heparin sodium…
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February 29, 2008
DPT Laboratories has added preparation of the chemistry, manufacturing and controls documents (CMC) in the Common Technical Documents (CTD) format as an optional service for customers applying for approval of new drugs.
The new service provides pr…
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February 28, 2008
Cobra Biomanufacturing Plc has entered into a manufacturing development agreement with an undisclosed pharmaceutical partner to produce a protein from the SARS virus in CHO (Chinese Hamster Ovary) cells under cGMP.
Simon Saxby, Cobra Biomanufactur…
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February 27, 2008
The FDA is launching a new effort for post-approval drug safety, called "Safety First," meant to strengthen its supervision of prescription drugs after approval.
The plan, first reported by the Wall Street Journal and…
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February 27, 2008
Vetter Pharma-Fertigung GmbH & Co. has been granted approval by the FDA for the production of a client's new drug. The company will begin filling the drug at its Ravensburg Vetter South (RVS) facility. Vetter provides contract manufacturing servi…
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February 26, 2008
Bayer HealthCare AG has entered into a worldwide, non-exclusive license agreement with Millipore to use its UCOE (Ubiquitous Chromatin Opening Element) technology to manufacture its biologic drugs. The license will enable Bayer to manufacture recombi…
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February 25, 2008
United BioSource Corp. (UBC) has expanded its regulatory affairs group led by Mark Ammann, Pharm.D. and LaVonne Lang, Dr. PH. The group, based in Ann Arbor, MI, will provide a full range of services to pharma and biopharma clients, including creating…
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February 22, 2008
Azopharma Product Development Group, Inc. has opened a new facility in South Florida. The new 22,000-sq.-ft. facility will house the company’s formulation development services, small-scale manufacturing, development services and specialized ana…
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February 21, 2008
Genmab and PDL BioPharma, Inc. have entered into an agreement under which Genmab will acquire PDL's antibody manufacturing facility in Brooklyn Park, MN, for $240 million in cash. The transaction includes land, equipment and access to a leased space…
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February 20, 2008
Pfizer has entered into an agreement to acquire Encysive Pharmaceuticals, Inc., a publicly held biopharma company, for an equity value of approximately $195 million.
Pfizer will acquire the rights to Thelin, an oral, endothelin A receptor antagoni…
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February 19, 2008
GlaxoSmithKline has licensed exclusive world-wide rights to EUSA Pharma, Inc.'s preclinical human anti-interleukin-6 antibody for a consideration of as much as $44 million, which includes an upfront fee, development milestones and royalties on future…
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February 15, 2008
AstraZeneca has spun off part of its gastrointestinal research operation into a new biopharmaceutical company called Albireo. The move is part of the company's realignment plans, announced in 2006, to refocus its research away from certain areas with…
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February 15, 2008
Baxter International, Inc. has temporarily suspended production of heparin, a blood-thinner, due to reports of allergic reactions, including four deaths, primarily in patients undergoing kidney dialysis and heart surgery. Heparin, a generic drug, is…
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