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FDA grants Priority Review to Roche’s baloxavir marboxil for the treatment of influenza
Roche announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review for baloxavir marboxil as a single-dose, oral…
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Aquinox Announces Topline Results of Phase 3 LEADERSHIP 301 Clinical Trial in Interstitial…
Aquinox Pharmaceuticals announced that the Phase 3 LEADERSHIP 301 clinical trial evaluating once-daily, oral rosiptor (AQX-1125) for the treatment of interstitial cystitis/bladder pain…
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Sanofi completes its acquisition of Ablynx following the expiration of the Squeeze-out Procedure
Sanofi and Ablynx announced today that Sanofi has now acquired all outstanding shares (including shares represented by American Depositary Shares (“ADSs”)), warrants and convertible…
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Merck Signs Exclusive Agreement with HistoCyte Laboratories to Distribute Pathology Technology
Merck announced that it has entered into an agreement with HistoCyte Laboratories Ltd, Tyne, U.K., to be the exclusive multinational distributor of the company’s portfolio of cell line…
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Janssen’s Tremfya (guselkumab) receives its first two positive Health Technology Assessments in…
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the United Kingdom’s National Institute for Health and Care Excellence (NICE) has published positive…
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Asterias Biotherapeutics Announces First Patient Dosed in First-in-Human Clinical Study of…
Asterias Biotherapeutics announced enrollment and dosing of the first subject in the first-in-human Phase 1 clinical trial of AST-VAC2 in the United Kingdom. This initial clinical…
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Thermo Fisher Scientific Opens U.S. Precision Medicine Science Center
Thermo Fisher Scientific Inc. officially opened its U.S. Precision Medicine Science Center (PMSC) in Cambridge, Mass. The Center offers access to advanced "omics" technologies and…
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FDA Approves Genentech’s Rituxan (rituximab) For Pemphigus Vulgaris
Genentech announced that the U.S. Food and Drug Administration (FDA) has approved Rituxan (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris (PV), a…
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GE Healthcare FlexFactory Helps XPH Scale Up Industrialization of TCR T-Cell Immunotherapy Drugs
GE Healthcare will provide Xiangxue Pharmaceutical Co., Ltd. (XPH) with a FlexFactory for cell therapy, a semi-automated end-to-end manufacturing platform, to help scale up, digitize…
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Vetter Strikes out on New Pathways to Further Develop the Injection Process
How can digital trends be used purposefully in regards to the application of injection systems? That is the key question being addressed by Vetter’s Open Innovation Challenge. This new…
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Blueprint Medicines and CStone Pharmaceuticals Announce Exclusive Collaboration and License…
Blueprint Medicines Corporation and CStone Pharmaceuticals announced an exclusive collaboration and license agreement for the development and commercialization of avapritinib, BLU-554…
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Celltrion Launches Bio CDMO Business for the Development of New Drugs
Celltrion made an announcement that it will launch Bio CDMO (Contract Development and Manufacturing) business, in a bid to pursue open innovation for development of new drugs, at the…
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FDA and EMA Accept Regulatory Submissions for Review of Talazoparib
Pfizer Inc. announced that the U.S. Food and Drug Administration accepted for filing and granted Priority Review designation to the company’s New Drug Application for talazoparib. The…
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Sensei Biotherapeutics Reports New Data from Phase 1 Clinical Trial of SNS-301
Sensei Biotherapeutics announced the publication of data from the company’s multi-center Phase 1 clinical trial to assess safety and immunogenicity of SNS-301 (formerly PAN-301) in…
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Daiichi Sankyo Announces Launch of Immune-mediated Inflammatory Diseases Consortium for Drug…
Daiichi Sankyo Company announced the launch of Immune-mediated Inflammatory Diseases Consortium for Drug Development (hereafter, the consortium) to research and discover drugs for…
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FDA expedites review of Novartis drug Promacta for first-line severe aplastic anemia (SAA)
Novartis announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) and granted Priority Review designation to Promacta…
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MIT team develops single-injection vaccine for the polio virus
A new nanoparticle vaccine developed by MIT researchers could assist efforts to eradicate polio worldwide. The vaccine, which delivers multiple doses in just one injection, could make…
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Amgen Enters Groundbreaking Collaboration To Improve Symptom Management During Cancer Treatment
Amgen announced a groundbreaking collaboration with the National Cancer Institute(NCI), the Federal Communications Commission (FCC) Connect2Health Task Force, the University of Kentucky…
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FDA to review Zynquista (sotagliflozin) as potential treatment for type 1 diabetes
The U.S. Food and Drug Administration (FDA) has accepted Sanofi's regulatory filing for Zynquista (sotagliflozin). The investigational oral treatment would be used in addition to…
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LYRICA (pregabalin) Oral Solution CV Phase 3 Trial in Pediatric Epilepsy Meets Primary Endpoint
Pfizer announced positive top-line results of a Phase 3 study examining the use of LYRICA (pregabalin) Oral Solution CV as adjunctive therapy for partial onset seizures in pediatric…
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