Specialty Pharmacy

Ironwood and AbbVie to Halt Development of MD-7246 After Drug Fails to Meet Endpoints in Phase 2 Trial in Patients with Abdominal Pain Associated with IBS-D

BOSTON–(BUSINESS WIRE)–Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a GI-focused healthcare company, today announced top-line data from a Phase II trial evaluating MD-7246 in adult patients with abdominal pain associated with irritable bowel syndrome with diarrhea (IBS-D). The Phase II trial did not meet its primary or key secondary endpoints. Based on these …

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FDA Approves Dupixent as First Biologic Medicine for Children Aged 6 to 11 Years with Moderate-to-Severe Atopic Dermatitis

PARIS and TARRYTOWN, N.Y. – May 26, 2020 – The U.S. Food and Drug Administration (FDA)  approved Dupixent® (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent is the only biologic …

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Part A of Phase 3 Trial of Dupixent for Treatment of Eosinophilic Esophagitis Meets Co-Primary Endpoints

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced positive results from Part A of the pivotal Phase 3 trial evaluating Dupixent® (dupilumab) in patients 12 years and older with eosinophilic esophagitis (EoE). The trial met both of its co-primary endpoints, as well as all key secondary endpoints. Dupixent is the first …

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Results of GERAS-US Study Demonstrate Societal Cost Burden for Patients and Caregivers During Early Stages of Alzheimer’s Disease

INDIANAPOLIS, May 19, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced baseline results from the GERAS-US Study examining the societal costs associated with mild cognitive impairment (MCI), mild dementia (MILD), and caring for someone with Alzheimer’s disease (AD). The study, published today in The Journal of Alzheimer’s Disease, …

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Axcella Announces Positive Top-Line Data from AXA1125-003 Clinical Study Showing Multifactorial Activity in Adults with NAFLD

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Axcella (Nasdaq: AXLA), a clinical-stage biotechnology company focused on leveraging endogenous metabolic modulators (EMMs) to pioneer a new approach for treating complex diseases and improving health, today announced positive top-line data from AXA1125-003. AXA1125-003 is a placebo-controlled, randomized, multi-arm clinical study assessing the impact of AXA1125 and AXA1957 on …

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Newron Terminates Program After Pivotal Trial of Sarizotan Fails to Meet Primary or Secondary Efficacy Variables in Patients with Rett Syndrome

MILAN & MORRISTOWN, N.J.–(BUSINESS WIRE)–Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, announced today that top-line results from its STARS clinical study evaluating sarizotan in patients with Rett syndrome …

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FDA Approves Neurocrine’s Once-Daily Ongentys as an Add-On Treatment for Parkinson’s Disease Patients Experiencing “Off” Episodes

SAN DIEGO – April 27, 2020 – Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily oral ONGENTYS® (opicapone) 25 mg and 50 mg capsules as an add-on treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes. As the disease …

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Data on 53 Patients Treated with Investigational Antiviral Remdesivir Through the Compassionate Use Program Published in NEJM

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced results from a cohort analysis of 53 patients hospitalized with severe complications of COVID-19 who were treated with the investigational antiviral remdesivir on an individual compassionate use basis. The majority of patients in this international cohort demonstrated clinical improvement and …

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Can-Fite Reports Positive Top Line Results from its Phase II NASH Study with Namodenoson

PETACH TIKVA, Israel–(BUSINESS WIRE)–Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory and liver diseases, today announced that its Phase II exploratory NAFLD/NASH study with Namodenoson achieved its efficacy endpoints, while continuing to demonstrate a good safety profile. …

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Axsome Announces AXS-07 Achieves Both Co-Primary Endpoints and Prevents Migraine Pain Progression in its Phase 3 Trial

NEW YORK, April 06, 2020 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that AXS-07 substantially and significantly eliminated migraine pain, and substantially and significantly prevented progression of migraine pain intensity in …

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