News

Kedrion Biopharma and Kamada Ltd., two leading human-derived protein therapeutics companies, announced that KEDRAB™ has received U.S. Food and Drug Administration (FDA) approval for…
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Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and…
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Otsuka Pharmaceutical and Mylan have entered into a license agreement between their respective subsidiaries, Otsuka Novel Products GmbH (ONPG) and Mylan Pharmaceuticals Private Limited…
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Genentech announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for emicizumab…
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ViraCyte, LLC, a clinical stage biopharmaceutical company developing cellular immunotherapies for severe infections, announced publication of positive data from a Phase 2 clinical trial…
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Ethris GmbH announced a five-year strategic research collaboration with AstraZeneca and its global biologics research and development arm, MedImmune. The collaboration is focused on…
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Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved BESPONSA® (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell…
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Medivir AB and Ascletis announce that Ascletis has licensed the exclusive rights to develop, manufacture and commercialize Medivir's nucleotide polymerase inhibitor for hepatitis C,…
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Samsung Bioepis announced that it has entered into a strategic collaboration agreement with Takeda Pharmaceutical Company Limited to jointly fund and co-develop multiple novel biologic…
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Teva Pharmaceutical Industries announced the launch of generic Axiron®1 (testosterone) topical solution CIII, 30 mg/1.5 mL, in the U.S. Testosterone topical solution CIII is a…
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Valeant Pharmaceuticals International announced that the U.S. Food and Drug Administration (FDA) confirmed it intends to issue a Voluntary Action Indicated (VAI) inspection…
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Shire announces that the Marketing Authorization Application (MAA) for lifitegrast, submitted on 07 August 2017, has been validated by the UK as the Reference Member State involved in…
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Regeneron Pharmaceuticals announced that a Phase 3 study evaluating suptavumab (REGN2222), an antibody to respiratory syncytial virus (RSV), did not meet its primary endpoint of…
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After a series of thorough tests with the European Medicines Verification Organization (EMVO) for connection to the European Hub, Adents is now one of only two official “Certified…
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Array BioPharma, a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule drugs to treat patients afflicted with cancer,…
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A new consortium, led by Oxford BioMedica, will take part in a two-year, £2m project focused on gene and cell therapy manufacturing. Other partners include the Cell and Gene…
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Takeda Pharmaceutical Company Limited announced a collaboration with Stanford University to form the Stanford Alliance for Innovative Medicines (Stanford AIM), which will help transform…
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PharmaMar announced the start of a multicenter quadruple combination clinical study with Aplidin (plitidepsina), along with other compounds for the treatment of multiple myeloma.…
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Soin Neuroscience, a biotech startup based in Dayton, OH, has recently signed a drug development deal with Cleveland Diabetes Care for SNI's lead developmental pain drug TV1001SR- which…
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Avara Pharmaceutical Services has signed an agreement with Pfizer Inc. to acquire the Liscate, Italy sterile manufacturing facility. "This acquisition is an important component of our…
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