Nicole Watkins

Ipsen Pauses Palovarotene Program After Interim Analysis Finds Phase 3 Trial Unlikely to Meet its Primary Endpoint

Ipsen (Euronext: IPN; ADR: IPSEY) today announced the decision to pause dosing patients in the global Phase III (PVO-1A-301) study designed to evaluate the efficacy and safety of palovarotene in patients with fibrodysplasia ossificans progressiva (FOP), as well as the ongoing Phase II (PVO-1A-202/204) extension studies. In both the Phase …

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Roche’s Tecentriq Fails to Meet Primary Endpoint in Phase 3 Study in Patients with Muscle-Invasive Urothelial Cancer

Basel, 24 January 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMvigor010 study evaluating Tecentriq® (atezolizumab) as an adjuvant (after surgery) monotherapy treatment did not meet its primary endpoint of disease-free survival (DFS) compared to observation in people with muscle-invasive urothelial cancer (MIUC). Safety …

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Exelixis Announces Results for Combination of Cabozantinib and Nivolumab with or without Ipilimumab in Advanced Hepatocellular Carcinoma

ALAMEDA, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (NASDAQ: EXEL) today announced phase 1/2 clinical trial results from the combination of cabozantinib (CABOMETYX®) and nivolumab (Opdivo®) with or without ipilimumab (Yervoy®) in advanced hepatocellular carcinoma (HCC). Data from the cabozantinib combination cohort of the CheckMate 040 trial will be presented on Friday, January 24 during …

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FDA Grants Accelerated Approval to Epizyme’s Tazverik for Treatment of Patients with Epithelioid Sarcoma

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Epizyme, Inc. (Nasdaq: EPZM), a biopharmaceutical company developing novel epigenetic therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of TAZVERIK™ (tazemetostat) for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma …

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Genentech’s Risdiplam Meets Primary Endpoint in Pivotal Trial in Infants with Type 1 Spinal Muscular Atrophy

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive topline results from the pivotal Part 2 of the FIREFISH study, evaluating risdiplam in infants aged 1-7 months with Type 1 spinal muscular atrophy (SMA). The primary outcome measure of the …

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Sanofi Completes Acquisition of Synthorx, Expanding its Oncology and Immunology Business

PARIS (FRANCE) – January 23, 2020 – Sanofi announced today the successful completion of its acquisition of Synthorx, Inc. (“Synthorx”) for $68 per share in cash. “The acquisition of Synthorx perfectly aligns with our R&D strategy, enhancing our position as an emerging leader in the area of oncology and immunology,” says Paul …

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New Research Shows EarlySign’s AI Solution Can Identify Prediabetic Patients at High Risk of Developing Diabetes

TEL AVIV, Israel, Jan. 22, 2020 /PRNewswire/ — Medial EarlySign (earlysign.com), a leader in machine learning-based solutions to aid in the early detection and prevention of high-burden diseases, today announced the results of a new study assessing the effectiveness of its Pre2D-Flag AlgoMarker™ algorithmic model to identify individuals at high …

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Akcea and Ionis Report Positive Topline Results from Phase 2 Study of AKCEA-APOCIII-L Rx

BOSTON and CARLSBAD, Calif., Jan. 22, 2020 /PRNewswire/ — Akcea Therapeutics, Inc. (NASDAQ: AKCA), a majority-owned affiliate of Ionis Pharmaceuticals, Inc., and Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), today announced positive topline results from the Phase 2 study of AKCEA-APOCIII-LRx in the treatment of patients with hypertriglyceridemia who are at risk …

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Quest Diagnostics Acquires Blueprint Genetics to Broaden Access to Actionable Insights for Genetic and Rare Diseases

SECAUCUS, N.J. and HELSINKI, Finland, Jan. 22, 2020 /PRNewswire/ — Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, today announced that it has acquired Blueprint Genetics in an all-cash equity transaction. Blueprint Genetics is a leading specialty genetic testing company with deep expertise in gene variant …

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FDA Approves Horizon’s Tepezza for Treatment of Thyroid Eye Disease

DUBLIN–(BUSINESS WIRE)–Horizon Therapeutics plc (Nasdaq: HZNP) today announced that the U.S. Food and Drug Administration (FDA) has approved TEPEZZATM (teprotumumab-trbw) for the treatment of Thyroid Eye Disease (TED). TEPEZZA is the first and only FDA-approved medicine for the treatment of TED, a serious, progressive and vision-threatening rare autoimmune disease that …

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