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FDA Approves Gavreto for the Treatment of Adults with Metastatic RET Fusion-Positive Non-Small Cell Lung 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 Gavreto™ (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by …

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Incyte Announces Pivotal GEOMETRY mono-1 Study Results of Capmatinib in Patients with METex14 Metastatic Non-Small Cell Lung Cancer Published in NEJM

WILMINGTON, Del.–(BUSINESS WIRE)–Incyte (Nasdaq: INCY) today announced that data from the Novartis pivotal Phase 2 GEOMETRY mono-1 study demonstrating that treatment with Tabrecta™ (capmatinib) resulted in positive overall response rates (ORR) with durable responses among adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that …

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Natera Announces SMART Study Data for Aneuploidy and 22q Unblinded

SAN CARLOS, Calif., Sept. 2, 2020 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a pioneer and leader in cell-free DNA testing, today announced the unblinding of the SMART clinical trial data, and the validation of an artificial intelligence-based (AI) platform as part of its Panorama non-invasive prenatal test (NIPT). Panorama with …

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Aimmune Agrees to be Acquired by Nestlé Health Science for $2 Billion

BRISBANE, Calif.–(BUSINESS WIRE)–Aug. 31, 2020– Aimmune Therapeutics Inc. (Nasdaq: AIMT), a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies, today announced that it has entered into a definitive agreement for Sociétés des Produits Nestlé, S.A. to acquire Aimmune for $34.50 per share in an all-cash transaction, implying a fully-diluted equity value …

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Twist Bioscience Announces Potent SARS-CoV-2 Neutralizing Data from COVID-19 Therapeutic Antibody Program

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Twist Bioscience Corporation (Nasdaq: TWST) today announced data demonstrating the potent neutralizing effects of multiple potential therapeutic antibodies, both Immunoglobulin G (IgG) antibodies and substantially smaller single domain VHH “nanobodies,” against SARS-CoV-2, the virus that causes COVID-19. These neutralizing effects were found to be comparable to …

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Final Analysis of the Observational GioTag Study: Sequential Afatinib and Osimertinib in Patients with EGFR Mutation-Positive NSCLC

Ingelheim, Germany, 2nd September 2020 – Boehringer Ingelheim today announced the final analysis from GioTag, a real-world retrospective, observational study.  The study assessed the impact of first-line treatment with afatinib followed by osimertinib in Del19/L858R epidermal growth factor receptor mutation positive (EGFR M+) non-small cell lung cancer (NSCLC) patients with acquired …

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Santhera Exercises Option to Obtain Worldwide Rights to Vamorolone in Duchenne Muscular Dystrophy and All Other Indications

Pratteln, Switzerland, and Rockville, MD, USA, September 2, 2020 – Santhera Pharmaceuticals (SIX: SANN) announces that it has signed agreements with Idorsia (SIX: IDIA) and ReveraGen BioPharma Inc., making Santhera a direct license holder of vamorolone. Under the agreements, Santhera has obtained an exclusive license from ReveraGen, the originator of vamorolone, for …

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FDA Approves Onureg, a New Oral Therapy, as Continued Treatment for Adults in First Remission with Acute Myeloid Leukemia

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Onureg® (azacitidine 300 mg tablets, CC-486) for the continued treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission (CR) or CR with incomplete blood count recovery (CRi) following intensive …

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FDA Accepts Vertex’s sNDA for Trikafta, Symdeko and Kalydeco for Additional CFTR Mutations

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) accepted three supplemental New Drug Applications (sNDAs) for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor), SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) and KALYDECO® (ivacaftor). These regulatory submissions are intended to expand the labels for TRIKAFTA, SYMDEKO and KALYDECO to include additional rare CFTR mutations, allowing people …

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Gilead Sciences and Jounce Therapeutics Announce Exclusive License Agreement for Novel Immunotherapy Program

FOSTER CITY, Calif. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced an agreement with Jounce Therapeutics, Inc. (Nasdaq: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, to exclusively license its JTX-1811 program. JTX-1811 is a monoclonal antibody designed to …

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