Press Releases
Nycomed to acquire of majority stake in Guangdong Techpool Bio-Pharma
Nycomed announced that it is significantly expanding its presence in China through the acquisition of a majority stake in Guangdong Techpool Bio-Pharma Co., Ltd. (Techpool), a fast-growing Chinese bio-pharmaceutical company based in Guangdong. Techpool, founded in 1993, specialises in...
Press Releases
PTC Therapeutics Initiates Phase 2 Clinical Trial of Ataluren in Patients with Methylmalonic Acidemia
PTC Therapeutics, Inc. today announced that it is expanding the development of ataluren, an investigational new drug, with the initiation of a Phase 2 clinical trial in nonsense mutation methylmalonic acidemia (nmMMA). MMA is a rare genetic disorder caused...
Press Releases
Celator Pharmaceuticals completes enrollment in a second phase 2 trail of CPX-351in acute myeloid leukemia
Celator Pharmaceuticals announced that it has completed enrollment in a phase 2 multicenter, randomized, open-label clinical trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection versus intensive salvage therapy in adult patients with acute myeloid leukemia (AML) in first relapse. The study,...
Press Releases
Eurand Presents Data on ZENPEP(R) Without Proton Pump Inhibitors or H2 Receptor Antagonists in Patients With CF and Pancreatic Insufficiency
Eurand Pharmaceuticals, Inc., a subsidiary of global specialty pharmaceutical company Eurand N.V. announced additional data from a post-hoc analysis of a Phase III clinical trial with ZENPEP(R) (pancrelipase) Delayed-Release Capsules, an FDA-approved pancreatic enzyme product (PEP) for the treatment...
Press Releases
Cephalon Announces FDA Approval of Risk Evaluation and Mitigation Strategies for NUVIGIL and PROVIGIL
Cephalon, Inc. (Nasdaq: CEPH) today announced that Risk Evaluation and Mitigation Strategies (REMS) for its medications NUVIGIL(R) (armodafinil) Tablets and PROVIGIL(R) (modafinil) Tablets have been approved by the U.S. Food and Drug Administration (FDA). Both the NUVIGIL...
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FDA approves Herceptin for HER2-positive metastatic stomach cancer
Roche announced the U.S. Food and Drug Administration (FDA) has approved Herceptin (trastuzumab) in combination with chemotherapy (cisplatin plus either capecitabine or 5-fluorouracil ) for HER2-positive metastatic cancer of the stomach or gastroesophageal junction, in men and women who...
Press Releases
Amylin, Lilly and Alkermes Announce Receipt of Complete Response Letter from FDA for BYDUREON(TM)
Amylin Pharmaceuticals, Inc. Eli Lilly and Company and Alkermes, Inc.announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON(TM) (exenatide extended-release for injectable suspension). ...
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