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Oncology

Xencor and Astellas Enter Collaboration for Novel Bispecific Antibody Program

MONROVIA, Calif.–(BUSINESS WIRE)–Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer, autoimmune disease, asthma and allergic diseases, today announced it has entered into a research and license agreement in which Astellas Pharma Inc. will access Xencor’s bispecific technology to advance a novel bispecific …

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Ziopharm Oncology’s Ad-RTS-hIL-12 plus Veledimex Granted Fast Track Designation from the FDA for Treatment of Recurrent Glioblastoma

BOSTON, April 01, 2019 (GLOBE NEWSWIRE) — Ziopharm Oncology, Inc. (Nasdaq: ZIOP), a clinical stage immuno-oncology company developing next generation cell and gene therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its Controlled IL-12 program, or Ad-RTS-hIL-12 plus veledimex, for the treatment …

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FDA Grants Breakthrough Therapy Designation to Selumetinib for Treatment of Neurofibromatosis Type 1

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (known as MSD outside the US and Canada) today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the investigational MEK 1/2 inhibitor and potential new medicine selumetinib. This designation is for …

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AstraZeneca Offers up to $6.9 Billion for Daiichi Sankyo’s HER2 Targeting Antibody Drug Conjugate

AstraZeneca has entered into a global development and commercialisation collaboration agreement with Daiichi Sankyo Company, Limited (Daiichi Sankyo) for trastuzumab deruxtecan (DS-8201), a proprietary antibody-drug conjugate (ADC) and potential new targeted medicine for cancer treatment. The collaboration is aligned with AstraZeneca’s science-led strategy in Oncology, which is based on four …

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Boehringer Ingelheim Enhances Oncology R&D with Novel MacroDel Delivery Technology Via Acquisition of ICD Therapeutics

INGELHEIM, Germany & BERLIN–(BUSINESS WIRE)–Boehringer Ingelheim today announced that it acquired ICD Therapeutics. The acquisition includes rights to ICD’s innovative MacroDel biologics-delivery platform. Boehringer Ingelheim will employ this platform for the development of novel therapeutics in collaboration with nanoPET Pharma GmbH, a former shareholder of ICD Therapeutics. Further details of …

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Seattle Genetics and Astellas Announce Positive Topline Results from Pivotal Trial of Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial Cancer

BOTHELL, Wash. & TOKYO–(BUSINESS WIRE)–Seattle Genetics, Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced positive topline results from the first cohort of patients in a pivotal phase 2 single-arm clinical trial known as EV-201. The cohort is evaluating enfortumab vedotin for the treatment of patients with locally advanced or metastatic …

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FDA Advances Landmark Policy Changes to Modernize Mammography Services and Improve their Quality

Today, the U.S. Food and Drug Administration announced important new steps to modernize breast cancer screening and help empower patients with more information when they are considering important decisions regarding their breast health care. For the first time in more than 20 years of regulating mammography facilities, the agency is …

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Agios Receives FDA Breakthrough Therapy Designation for Tibsovo in Combination with Azacitidine for Certain Newly Diagnosed AML Patients with an IDH1 Mutation

CAMBRIDGE, Mass., March 26, 2019 (GLOBE NEWSWIRE) — Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for TIBSOVO® (ivosidenib) in combination with azacitidine for the …

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OSE Immunotherapeutics Enters Research Collaboration with Léon Bérard Cancer Center to Use Artificial Intelligence Technologies to Identify Novel Immuno-Oncology Targets

NANTES, France, March 26, 2019 (GLOBE NEWSWIRE) — OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE), announces a new research collaboration agreement with premier cancer research hospital, Léon Bérard Cancer Center in Lyon, France, to use artificial intelligence (AI)-based bioanalysis and bioinformatics to identify novel targets in immuno-oncology. Léon Bérard Cancer Center (CLB) has both …

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Janssen Submits sBLA to the FDA Seeking Approval of Darzalex Combination for Newly Diagnosed, Transplant Eligible Patients with Multiple Myeloma

RARITAN, N.J., March 26, 2019 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of DARZALEX® (daratumumab) in combination with bortezomib, thalidomide and dexamethasone (VTd) for newly diagnosed …

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