Oncology

FDA Accepts and Grants Priority Review for Bristol-Myers’ BLA for Lisocabtagene Maraleucel for Large B-Cell Lymphoma

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its Biologics License Application (BLA) for lisocabtagene maraleucel (liso-cel), the company’s autologous anti-CD19 chimeric antigen receptor (CAR) T-cell immunotherapy with a defined composition of purified CD8+ and CD4+ CAR …

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FDA Grants Priority Review to Deciphera’s Ripretinib in Patients with Advanced Gastrointestinal Stromal Tumors

WALTHAM, Mass.–(BUSINESS WIRE)–Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its New Drug Application (NDA) seeking approval for ripretinib, the Company’s investigational broad-spectrum KIT and PDGFRα inhibitor, for the treatment of patients with advanced gastrointestinal stromal tumors (GIST). The FDA …

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In Phase 3 Study Merck’s Keytruda in Combination with Chemo Meets Primary Endpoint as First-Line Treatment for Metastatic TNBC

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-355 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy met one of its dual primary endpoints of progression-free survival (PFS) in patients with metastatic triple-negative breast cancer …

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Astex Announces FDA Accepts for Priority Review its NDA for Oral C-DEC for the Treatment of MDS and CMML

PLEASANTON, Calif.–(BUSINESS WIRE)–Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Japan, today announced that the U.S. FDA has accepted for Priority Review its NDA for oral C-DEC (cedazuridine and decitabine) as a treatment for adults with previously untreated intermediate- and high-risk MDS including CMML. …

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Advaxis and Personalis Enter Research Agreement to Deploy ImmunoID NeXT Platform in the ADXS-503 Clinical Program

PRINCETON, N.J. & MENLO PARK, Calif.–(BUSINESS WIRE)–Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, and Personalis Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, today announced a collaboration to leverage Personalis’ ImmunoID NeXT™ Platform in Advaxis’ ongoing Phase 1/2 …

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Cannabics Pharmaceuticals Collaborates with RCKMC to Develop Cannabis Strains Targeting Gastrointestinal Cancers

TEL AVIV, Israel and BETHESDA, Maryland, Feb. 11, 2020 /PRNewswire/ — Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a leader in personalized cannabinoid medicine focused on cancer and its side effects, announced today that it has signed a Memorandum Of Understanding with RCK Medical Cannabis to develop cannabis chemovars targeted to treat …

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Xtandi Demonstrates Significant Improvement in Overall Survival in Phase 3 Trial in Non-Metastatic Castration-Resistant Prostate Cancer

TOKYO and NEW YORK, February 11, 2020 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pfizer Inc. (NYSE: PFE) announced today results of the final overall survival (OS) analysis from the Phase 3 PROSPER trial, which evaluated XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) versus …

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FDA Accepts and Grants Priority Review to Incyte’s Capmatinib for Advanced Non-Small Cell Lung Cancer

WILMINGTON, Del.–(BUSINESS WIRE)–Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to the New Drug Application (NDA) for capmatinib, an investigational, selective MET inhibitor, as a treatment for first-line and previously treated patients with locally advanced or metastatic MET exon 14 …

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FDA Grants Fast Track Designation to NANOBIOTIX NBTXR3 for Treatment of Head and Neck Cancer

NANOBIOTIX (Paris:NANO) (Euronext: NANO – ISIN: FR0011341205 – the “Company”), a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the …

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Eagle Pharmaceuticals Receives Final FDA Approval for Pemfexy (Pemetrexed for Injection)

WOODCLIFF LAKE, N.J.–(BUSINESS WIRE)–Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that it has received final approval from the U.S. Food and Drug Administration (“FDA”) for its novel product, PEMFEXY™ (pemetrexed for injection), a branded alternative to ALIMTA®. “We are pleased to receive final approval from FDA …

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