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FDA Approves ViiV Healthcare’s Rukobia, a First-in-Class Treatment for HIV in Adults with Few Treatment Options

LONDON–(BUSINESS WIRE)–ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) has approved Rukobia (fostemsavir), 600 mg extended-release tablets. Rukobia is a novel attachment inhibitor for the treatment of HIV-1 infection …

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Phase 3 Trial of Kevzara in COVID-19 Patients Requiring Mechanical Ventilation Fails to Meet Primary and Secondary Endpoints

PARIS and TARRYTOWN, N.Y. – July 2, 2020 – Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Phase 3 trial of Kevzara® (sarilumab) 400 mg in COVID-19 patients requiring mechanical ventilation did not meet its primary and key secondary endpoints when Kevzara was added to best supportive care compared to best supportive …

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CENTOGENE Receives FDA Emergency Use Authorization for COVID-19 Molecular Diagnostic Test

CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, July 02, 2020 (GLOBE NEWSWIRE) — Centogene N.V. (Nasdaq: CNTG), a commercial-stage company focused on rare diseases that transforms real-world clinical and genetic data into actionable information for patients, physicians, and pharmaceutical companies, today announced that the U.S. Food and Drug Administration (FDA) …

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MEI Pharma and Helsinn Group Discontinue Phase 3 Study of Pracinostat in AML After Interim Analysis

Lugano, Switzerland and San Diego, USA, July 2, 2020 – Helsinn, a Swiss pharmaceutical group focused on building quality cancer care and rare diseases products, and MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing potential new therapies for cancer, today announce that an interim futility analysis of …

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Alexion Completes Acquisition of Portola Pharmaceuticals

BOSTON–(BUSINESS WIRE)–Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced the successful completion of its acquisition of Portola Pharmaceuticals, Inc. (NASDAQ:PTLA). The acquisition adds Factor Xa inhibitor reversal agent Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo], marketed as Ondexxya® in Europe, to Alexion’s commercial portfolio. Andexxa is the first and only approved Factor Xa inhibitor reversal agent …

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Sarepta Therapeutics Signs Agreement with Hansa Biopharma for Imlifidase as a Pre-Treatment Ahead of Gene Therapy in Select Indications

CAMBRIDGE, Mass., July 02, 2020 (GLOBE NEWSWIRE) — Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced an agreement with Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare Immunoglobulin G (IgG) mediated diseases, for imlifidase. Under the terms of the agreement, Sarepta …

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Ipsen Joins Collaboration to Evaluate Cabozantinib Plus Atezolizumab in Metastatic NSCLC and Metastatic Castration-Resistant Prostate Cancer

Ipsen (Euronext: IPN; ADR: IPSEY), today announced it will join the Exelixis and Roche clinical collaboration and participate in the funding of the recently initiated CONTACT-01 and CONTACT-02 global Phase III pivotal trials. CONTACT-01 is evaluating the safety and efficacy of cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®) in patients …

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FDA Grants Fast Track Designation to MetVital’s Anhydrous Enol-Oxaloacetate for Glioblastoma Multiforme

SAN DIEGO, July 1, 2020 /PRNewswire/ — MetVital, Inc., a privately held biopharmaceutical company developing small molecule modulators of altered glutamate metabolism for the treatment of diseases with significant unmet medical need and commercial potential, today announces that the U.S. Food and Drug Administration (FDA) has notified MetVital that its …

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Pfizer and BioNTech Announce Early Positive Data from an Ongoing Phase 1/2 study of mRNA-based Vaccine Candidate Against SARS-CoV-2

NEW YORK & MAINZ, Germany–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced preliminary data from the most advanced of four investigational vaccine candidates from their BNT162 mRNA-based vaccine program, Project Lightspeed, against SARS-CoV-2, the virus causing the current global pandemic. The BNT162 program is evaluating at least four experimental …

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FDA Approves Bavencio as First-Line Maintenance Treatment for Locally Advanced or Metastatic Urothelial Carcinoma

Rockland, MA and New York, US, JUNE 30, 2020 – EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BAVENCIO® …

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