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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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Cellectis Published Creation of “Smart CART T-Cells” for Potentially Safer, More Effective Treatments for Cancer

NEW YORK–(BUSINESS WIRE)–Regulatory News: Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Euronext Growth: ALCLS; Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), announced today a paper published in Nature Communications that describes a proof-of-concept for rewiring the cell pathway to create highly intelligent T-cells that can recognize cancerous tumors …

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Kiadis Pharma Terminates Development of ATIR101 and Focuses on Development of NK Cell Therapeutics

Amsterdam, The Netherlands, 12 November 2019 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company, today announced that it has completed a strategic portfolio review and has decided to change its strategy and focus all resources and investments on the company’s NK-cell therapy platform …

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Hologic Announces FDA Approval of 3DQuorum Imaging Technology, Powered by Genius AI

MARLBOROUGH, Mass.–(BUSINESS WIRE)–Hologic, Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has approved 3DQuorum™ Imaging Technology, powered by Genius AI™. 3DQuorum technology works in tandem with Hologic’s Clarity HD™ high resolution imaging technology to reduce tomosynthesis image volume for radiologists by 66 percent.2 In 2009, …

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FDA Grants Fast Track Designation for Viracta’s Nanatinostat Combination for Treatment of EBV-Associated Lymphomas

SAN DIEGO, Nov. 12, 2019 /PRNewswire/ — Viracta Therapeutics, Inc. (the “Company”), a precision oncology company targeting virus-associated malignancies, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for nanatinostat in combination with valganciclovir for the treatment of relapsed/refractory Epstein-Barr virus (EBV)-positive lymphoid malignancies. …

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Gossamer Bio and Merck Partner to Evaluate GB1275 in Combination with Keytruda in Selected Advanced Solid Tumors

SAN DIEGO–(BUSINESS WIRE)–Gossamer Bio, Inc. (Nasdaq:GOSS), a clinical-stage biopharmaceutical company, today announced that it has entered into a clinical collaboration agreement with Merck (known as MSD outside the US and Canada) to evaluate the combination of Gossamer’s investigational product candidate GB1275, the first-in-class oral modulator of CD11b, and Merck’s anti-PD-1 therapy, …

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