Specialty Pharmacy

Lundbeck’s Vyepti Meets Co-Primary Endpoints in RELIEF Study in Patients with Migraine

COPENHAGEN, Denmark, Aug. 31, 2020 /PRNewswire/ — H. Lundbeck A/S (Lundbeck) today announced headline results from the parallel group, double-blind, randomized, placebo-controlled RELIEF study[i] that assessed the efficacy and tolerability of Vyepti when initiated during a migraine attack in patients who are candidates for preventive therapy. The study met statistical …

Read More »

AbbVie Submits Regulatory Application to FDA for Rinvoq for Treatment of Adults with Active Ankylosing Spondylitis

NORTH CHICAGO, Ill., Aug. 25, 2020 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced that it has submitted an application for a new indication to the U.S. Food and Drug Administration (FDA) for RINVOQ™ (upadacitinib; 15 mg, once daily), a selective and reversible JAK inhibitor, for the treatment of adult patients with active …

Read More »

New England Journal of Medicine Publishes Positive Phase 3 Evinacumab Results in Patients with Severe Inherited Form of High Cholesterol

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the New England Journal of Medicine (NEJM) published positive results from the Phase 3 trial of evinacumab in 65 patients with homozygous familial hypercholesterolemia (HoFH). Evinacumab is an investigational medicine that binds to and blocks the function of angiopoietin-like 3 (ANGPTL3), and is the first medicine of its …

Read More »

Kedrion and Kamada Announce Post-Marketing Pediatric Trial of a Human Rabies Immune Globulin Met its Primary Objective

REHOVOT, Israel and FORT LEE, N.J., Aug. 19, 2020 (GLOBE NEWSWIRE) — Kamada Ltd. (NASDAQ & TASE: KMDA) and Kedrion Biopharma, two leading biopharmaceutical companies specialized in plasma-derived protein therapeutics, today announced results from a U.S. post-marketing pediatric trial of KEDRAB® (Rabies Immune Globulin [Human]). The study represents the first …

Read More »

FDA Approves Trevena’s Olinvyk, a New Opioid for Intravenous Use in Hospitals, Other Controlled Clinical Settings

CHESTERBROOK, Pa., Aug. 10, 2020 (GLOBE NEWSWIRE) — Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved OLINVYK in adults for the management of …

Read More »

FDA Grants Priority Review to Biogen and Eisai’s Investigational Alzheimer’s Disease Drug Aducanumab

CAMBRIDGE, Mass. and TOKYO, Aug. 07, 2020 (GLOBE NEWSWIRE) — Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer’s disease. The application has been granted Priority …

Read More »

Genfit Announces Pivotal Publication of NIS4 Technology to Identify Patients with At-Risk NASH in The Lancet Gastroenterology & Hepatology

Lille (France), Cambridge (Massachusetts, United States), August 05, 2020 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and chronic liver diseases, today announced that pivotal data describing the derivation and validation of NIS4™ has been accepted for publication by The Lancet …

Read More »

Merck and Hanmi Pharmaceutical Enter into Licensing Agreement to Develop Efinopegdutide, an Investigational Once-Weekly Therapy for NASH

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Hanmi Pharmaceutical today announced that the companies have entered into an exclusive licensing agreement for the development, manufacture and commercialization of efinopegdutide (formerly HM12525A), Hanmi’s investigational once-weekly glucagon-like peptide-1 (GLP-1)/glucagon receptor dual agonist, for the treatment …

Read More »

AbbVie Announces Positive Phase 3 Data for Atogepant in Migraine Prevention

NORTH CHICAGO, Ill., July 29, 2020 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced that the Phase 3 ADVANCE trial evaluating the investigational medicine atogepant, an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) met its primary endpoint of statistically significantly greater reduction in mean monthly migraine days, compared to placebo, for …

Read More »

Chiasma Announces 48-Week Safety and Efficacy Data from Open-Label Extension Study of its Phase 3 Trial of Mycappsa in Acromegaly

NEEDHAM, Mass., July 27, 2020 (GLOBE NEWSWIRE) — Chiasma, Inc. (NASDAQ: CHMA), a commercial stage biopharmaceutical company utilizing its delivery platform technology to develop oral therapies to reduce the burden of chronic injections for people with rare diseases, today announced 48-week, open-label efficacy and safety data from the Phase 3 …

Read More »