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  • Celltrion Healthcare receives EC approval for the first high concentration, low-volume and citrate-free biosimilar adalimumab, Y

    Celltrion Healthcare announced the European Commission (EC) has granted marketing authorisation for Yuflyma™ (CT-P17), an adalimumab biosimilar, across all thirteen intended indications for the treatment of multiple chronic inflammatory diseases.

  • ENHERTU now Available in U.S. for HER2 Positive Unresectable or Metastatic Breast Cancer


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    Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that ENHERTU® (fam-trastuzumab deruxtecan-nxki), a HER2 directed antibody drug conjugate, is now available by prescription in the U.S.

  • Merck Establishes Strategic Oncology Collaboration with Taiho and Astex


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    MSD outside the United States and Canada, announced an exclusive worldwide research collaboration and license agreement with Taiho Pharmaceutical Co, Ltd., (“Taiho”) and Astex Pharmaceuticals (UK), a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd. (“Astex”), focused on the development of small molecule inhibitors against several drug targets, including the KRAS oncogene, which are currently being investigated for the treatment of cancer.

  • Bristol-Myers Squibb announces USFDA Breakthrough Therapy Designation for ORENCIA(abatacept)


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    Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for ORENCIA® (abatacept) for the prevention of moderate to severe acute graft-versus-host disease (GvHD) in hematopoietic stem cell transplants from unrelated donors. There are no approved therapies for the prevention of acute GvHD, a potentially life-threatening medical complication that can impact patients receiving such transplants for the treatment of certain genetic diseases and hematologic cancers.

  • Insilico Medicine Develops and Validates Powerful AI System To Transform Drug Discovery


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    Insilico Medicine has developed GENTRL, a new artificial intelligence system for drug discovery that dramatically accelerates the process from years to days. In the industry’s first successful experimental validation of such AI technology for drug discovery in cells and animals, Insilico successfully tested the technology by creating a series of entirely new molecules capable of combating disorders like fibrosis.

  • Sun Pharma and SPARC Announce US FDA Approval of XELPROS™


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    Sun Pharma Advanced Research Company Ltd. announced U.S. Food and Drug Administration (USFDA) approval for the New Drug Application (NDA) of XELPROSTM (latanoprost ophthalmic emulsion) 0.005% for the reduction of elevated intraocular pressure (IOP, or pressure inside the eye) in patients with open-angle glaucoma or ocular hypertension. This approval is from Sun Pharma’s Halol (Gujarat, India) facility.

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  • Nebula Genomics Raises $4.3M Seed Financing From Leading Tech and Biotech VCs


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    Nebula Genomics announced that it has raised $4.3M million in seed financing with participation from 10 leading venture capital firms. The funds will support the company’s mission to usher in the era of personal genome sequencing by creating a trusted, secure, and decentralized marketplace for genomic data. The company also has forged a partnership with Veritas Genetics, the leading whole genome sequencing and interpretation company, that will connect the Nebula marketplace to Veritas’ Arvados open-source software platform.

  • KaNDy Therapeutics Successfully Raises £25 Million in a Series C Financing


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    KaNDy Therapeutics, a clinical-stage Women’s Health company, today announces it has successfully closed a Series C financing round, raising £25 million from new US investor Longitude Capital, and existing internationally recognised life sciences investors Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners and OrbiMed.

  • USFDA approves Vertex Pharma's KALYDECO


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    Vertex Pharmaceuticals Incorporated announced the U.S. Food and Drug Administration (FDA) approved KALYDECO® (ivacaftor) to include use in children with cystic fibrosis (CF) ages 12 to <24 months who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to KALYDECO based on clinical and/or in vitro assay data.

  • BioNTech and Pfizer collaborate to develop influenza vaccines


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    BioNTech AG, a rapidly growing biotechnology company focused on precise immunotherapies for the treatment of cancer and infectious disease, today announced that it has entered into a multi-year research and development (R&D) collaboration with Pfizer Inc. to develop mRNA-based vaccines for prevention of influenza (flu).

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