Oncology

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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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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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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Seattle Genetics Announces Positive Topline Results from Phase 2 Trial of Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer

BOTHELL, Wash.–(BUSINESS WIRE)–Seattle Genetics, Inc. (Nasdaq:SGEN) today announced positive topline results from the phase 2 single-arm clinical trial known as innovaTV 204 evaluating tisotumab vedotin administered every three weeks for the treatment of patients who have relapsed or progressed on or after prior treatment for recurrent or metastatic cervical cancer. Results …

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FDA Approves Merck’s Keytruda for First-Line Treatment of Patients with Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) …

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FDA Approves Genentech’s Phesgo for Treatment of Patients with HER2-Positive Breast Cancer

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Phesgo™, a fixed-dose combination (FDC) of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous (SC, under the skin) injection in …

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Aldevron Announces Agreement with Ziopharm Oncology for neoGMP Production of Sleeping Beauty Plasmid DNA to Express TCRs for Treatment of Solid Tumors

FARGO, N.D.–(BUSINESS WIRE)–Aldevron, a leading provider of products and services for the biotechnology industry, today announced an agreement with Ziopharm Oncology to produce plasmid DNA for T cell therapy of solid tumors. Aldevron has developed the neoGMP® service level designed to address this new and rapidly growing market. “We are pleased …

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New Study Demonstrates the Ability of myPath Melanoma to Accurately Classify Lesions Ruled Indeterminate by Standard Pathological Assessment

SALT LAKE CITY, June 25, 2020 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, announced today that a new study published in Future Medicine demonstrates the ability of myPath® Melanoma to accurately classify skin lesions ruled indeterminate by standard pathological review.  “This validation study for …

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FDA Approves Merck’s Keytruda for Treatment of Patients with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable …

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