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Hikal To Make API for Pfizer

January 7, 2008
Hikal Ltd. has entered a contract manufacturing agreement to supply Pfizer with API’s. Terms of the agreement were not disclosed.     "We are extremely pleased to be selected as a long-term contract manufacturer by Pfizer…  Read More »
Callisto, Genzyme Revise Agreement

January 7, 2008
Callisto Pharmaceuticals has restructured its license agreement with Genzyme Corp. for Atiprimod, Callisto’s lead drug candidate to treat advanced carcinoid cancer. In August 2002, Callisto’s subsidiary, Synergy, acquired worldwide exclus…  Read More »
Catalyst Biosciences, Centocor R&D Enter Discovery Pact

January 7, 2008
Catalyst Biosciences, Inc. has entered into an exclusive worldwide research and license agreement with Centocor R&D, Inc. Centocor will support Catalyst's discovery research and preclinical development of Alterase drug candidates against two targ…  Read More »
WuXi PharmaTech To Acquire AppTec

January 4, 2008
WuXi PharmaTech, a provider of pharmaceutical R&D outsourcing services based in China, has signed a definitive agreement to acquire U.S.-based AppTec Laboratory Services, Inc. in a transaction totaling approximately $151 million, which includes a…  Read More »
Azopharma Opens New Cyanta Analytical Lab Facility

January 4, 2008
Azopharma has opened a new Cyanta Analytical Laboratories facility in Maryland Heights, MO. The new 20,000-sq.-ft. lab is equipped with state-of-the-art instrumentation to support pharmaceutical and medical device product development, specifically an…  Read More »
Daiichi Sankyo, Lilly Submit NDA for Antiplatelet Drug

January 4, 2008
Daiichi Sankyo and Eli Lilly have submitted a NDA to the FDA for prasugrel, an oral antiplatelet agent initially in development for the treatment of patients with acute coronary syndrome (ACS) who are managed with percutaneous coronary intervention (…  Read More »
Addex, Merck to Develop Schizophrenia Drug

January 3, 2008
Addex Pharmaceuticals has entered an exclusive worldwide license agreement with Merck to develop ADX63365, an oral drug candidate for the potential treatment of schizophrenia and other undisclosed indications. ADX63365, currently in preclinical devel…  Read More »
PPD, Inc.

January 3, 2008
Sebastian Pacios, M.D. has been named senior vice president of clinical operations for Europe, Middle East and Africa (EMEA), PPD, Inc. Dr. Pacios will oversee Phase II-IV clinical development for the company's operations in these regions. Prior t…  Read More »
S-P's NDA Gets Priority Review

January 3, 2008
Schering-Plough's NDA for sugammadex has been assigned priority review status by the FDA. Sugammadex is specifically designed to reverse the effects of certain muscle relaxants, marketed in the U.S. as Zemuron and vecuronium bromide, which are used a…  Read More »
PRWT Acquires API Site from Merck

January 2, 2008
PRWT Services, Inc., through its wholly-owned subsidiary, Cherokee Pharmaceuticals LLC, has acquired Merck's Cherokee chemical manufacturing plant in Riverside, PA. Cherokee has also entered into a five-year supply agreement with Merck, valued at $10…  Read More »
Millennium Earns Velcade Sales Milestone

January 2, 2008
Millennium Pharmaceuticals will receive a $40 million payment from J&J subsidiary Ortho Biotech Products, L.P. for achieving a sales milestone in 2007 for Velcade outside the U.S. The two companies entered into an agreement in June 2003 fo…  Read More »
AZ Submits sNDAs for Seroquel XR

January 2, 2008
AstraZeneca submitted two sNDAs to the FDA for once-daily Seroquel XR Extended-Release Tablets in the following indications: treatment of manic episodes associated with bipolar disorder and treatment of depressive episodes associated with bipolar dis…  Read More »
New Psoriasis Indication in EU for Humira

December 21, 2007
Abbott has received marketing authorization from the European Commission for the use of Humira as a treatment for moderate-to-severe plaque psoriasis. In one clinical trial, more than 80%  of patients taking Humira achieved skin clearance of 75%…  Read More »
BASi

December 21, 2007
BASi (Bioanalytical Systems) 4Q Revenues: $10.4 million (-3%) 4Q Loss: $203,000 (net loss of $736,000 in 4Q06) FY07 Revenues: $45.2 million (+5%) FY07 Earnings: $926,000 (net loss of $2.7 million in FY06) Comments: Sales declined in 4Q…  Read More »
Akorn Passes FDA Lyo-PAI/cGMP Inspection

December 21, 2007
Akorn, Inc. has received a satisfactory inspection from the FDA as part of a pre-approval inspection of the company's lyophilization facilities in Decatur, IL. Akorn had cGMP issues in the past, but the recent inspection led the Chicago office of CDE…  Read More »

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