Salix Pharmaceuticals and Pharming Group have announced that the US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) Action Date to 16 July 2014 for the Biologics License Application (BLA) for the ...
Tags: Drug, Pharming Group
DTect-All(TM) platform will be used to screen for GPCR-directed allosteric modulator antibodies Domain Therapeutics, a biopharmaceutical company specializing in the research and development of new drug candidates targeting G ...
Tags: DTect-All(TM)
Zimmer Spine, a provider of musculoskeletal health solutions, has launched its Puros demineralized bone matrix (DBM) block and strip in the US, designed to stimulate natural bone formation processes in spine surgical procedures. Puros ...
Zymeworks Inc. today announced that it has entered into a licensing and collaboration agreement with ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company, to develop an undisclosed number of novel bi-specific antibody ...
Immunocore Limited, the Oxford-based biotechnology company developing novel biological drugs to treat cancer and viral disease, today announced that it has entered into an oncology research collaboration and licensing agreement with ...
Tags: Immunocore, oncology research, collaboration and licensing agreement
Genzyme, a Sanofi company (EURONEXT:SAN and NYSE:SNY), announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental Biologics License Application seeking approval of ...
Tags: Genzyme, Biologics License Application, Lemtrada, multiple sclerosis
Takeda Pharmaceutical Company Limited ("Takeda") and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., today announced that the United States (U.S.) Food & Drug Administration (FDA) has extended the Prescription Drug User ...
Tags: Takeda Pharmaceutical Company Limited, Prescription Drug User Fee Act
Industry Veterans Bring 360o Insight to Developing Managed Market Solutions for Stakeholders HealthSTAR Communications, a leading healthcare communications company, today announced the formation of HEALTHSTAR Market Access, LLC, a ...
Stelis Biopharma and Pieris, a next generation therapeutic protein R&D firm, have started a long-term collaboration for clinical development and commercialization of multiple novel Anticalin-based protein therapeutics worldwide, primarily ...
BioWa, a wholly owned subsidiary of Kyowa Hakko Kirin, and Lonza, a biotechnology company, have entered into a licensing agreement with MedImmune, the global biologics research and development arm of AstraZeneca. MedImmune has licensed ...
Baxter International has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for the approval of a recombinant antihemophilic porcine sequence factor VIII called 'OBI-1' for the treatment of patients ...
The European Commission (EC) has granted marketing authorisation for AstraZeneca's new four-in-one influenza vaccine Fluenz Tetra for the prevention of influenza in children and adolescents from 24 months up to 18 years of age. The ...
Tags: Chronic Hepatitis, Medicine
Roche and Molecular Partners have entered into a research collaboration and licensing agreement to discover, develop and commercialize several proprietary therapeutics incorporating Molecular' DARPin biologics conjugated to toxic agents ...
Tags: Roche, Molecular Partners
OncoMed Pharmaceuticals and Celgene have entered into an agreement to jointly develop and commercialize about six anti-cancer stem cell (CSC) product candidates from OncoMed's biologics pipeline, including demcizumab (OMP-21M18, Anti-DLL4). ...
Tags: clinical studies, Medicine, OncoMed
Biogen Idec announced that the US Food and Drug Administration (FDA) has extended its review of a marketing application for the long-lasting recombinant factor IX Fc fusion protein Alprolix for haemophilia B by three months. The company ...