Oncology

FDA Grants Priority Review to Merck’s sBLA for Keytruda in Certain Patients with High-Risk, Non-Muscle Invasive Bladder 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 accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy. The application seeks approval of KEYTRUDA monotherapy …

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Bristol-Myers Squibb Announces Opdivo Plus Yervoy Fails to Meet Primary Endpoint in its Phase 3 Melanoma Study

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced results for one of the co-primary endpoints from CheckMate -915, a randomized Phase 3 study evaluating  Opdivo (nivolumab) plus Yervoy (ipilimumab) versus Opdivo alone for the adjuvant treatment of patients who have had a complete surgical removal of stage IIIb/c/d or stage IV (no evidence of …

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Dragonfly Therapeutics and AbbVie Collaborate for Autoimmune Diseases and Oncology

WALTHAM, Mass., Nov. 20, 2019 /PRNewswire/ — Dragonfly Therapeutics (“Dragonfly”), a biotechnology company developing novel immunotherapies that harness the innate immune system to treat disease, and AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced a multi-target research collaboration designed to advance a number of Dragonfly’s novel NK cell …

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Myovant Sciences Announces 97% Response Rate in Positive Phase 3 Study of Relugolix in Men with Advanced Prostate Cancer

BASEL, Switzerland, Nov. 19, 2019 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV), a healthcare company focused on developing innovative treatments for women’s health and prostate cancer, today announced that the Phase 3 HERO study of once-daily, oral relugolix (120 mg) met its primary efficacy endpoint and all six key secondary endpoints in men with …

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Personalis Enters Collaboration with Merck KGaA to Identify and Develop Novel Biomarkers for Cancer Therapies

MENLO PARK, Calif.–(BUSINESS WIRE)–Personalis, Inc. (Nasdaq:PSNL), a leader in advanced genomics for cancer, today announced a collaboration with Merck KGaA, Darmstadt, Germany, a leading science and technology company, to investigate novel biomarkers of response and mechanisms of resistance to cancer therapies. Merck KGaA, Darmstadt, Germany, will utilize Personalis’ newest cancer …

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FDA Accepts Samsung Bioepis’ BLA for SB8 Bevacizumab Biosimilar Candidate

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) under the 351(k) pathway for SB8, a biosimilar candidate referencing AVASTIN®i (bevacizumab). The BLA for SB8 was submitted by Samsung Bioepis in September 2019. If …

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CarThera and KIYATEC Collaborate in Effort to Bring Personalized Medicine to Patients Stricken by Brain Cancer

GREENVILLE, S.C. & PARIS–(BUSINESS WIRE)–KIYATEC, Inc. and CarThera announce today that they have entered into a clinical collaboration for the purpose of advancing innovation and improving treatments for patients diagnosed with glioblastoma, a highly aggressive form of brain cancer that afflicts more than 130,000 patients worldwide per year and is characterized by historically …

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Roche Acquires Promedicor for $1.4 Billion, Boosting its Fibrotic Pipeline

LEXINGTON, Mass., Nov. 15, 2019 /PRNewswire/ — Promedior Inc., today announced that it has entered into a definitive merger agreement for Roche(SIX: RO, ROG; OTCQX: RHHBY) to acquire Promedior. With this acquisition, Roche will obtain full rights to Promedior’s entire portfolio of molecules for serious fibrotic diseases, notably PRM-151. Promedior, …

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FDA Grants Accelerated Approval to BeiGene’s Brukinsa for Treatment of Mantle Cell Lymphoma Patients who Received at Least One Prior Therapy

CAMBRIDGE, Mass. and BEIJING, China, Nov. 14, 2019 (GLOBE NEWSWIRE) — BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that BRUKINSA™ (zanubrutinib) has received accelerated approval from the United States Food …

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FDA Accepts and Grants Priority Review for Selumetinib for Treatment of Neurofibromatosis Type 1

KENILWORTH, N.J.–(BUSINESS WIRE)–AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted priority review for the MEK 1/2 inhibitor selumetinib as a potential new medicine for pediatric patients …

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