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Gilead Presents New Data for Investigational Combination Therapy Treatment for Nonalcoholic Steatohepatitis

FOSTER CITY, Calif.–(BUSINESS WIRE)–Apr. 11, 2019– Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from the company’s clinical research program in nonalcoholic steatohepatitis (NASH) being presented at The International Liver Congress™ 2019 in Vienna. The data support Gilead’s efforts to develop combination therapies to target different aspects of NASH, evaluate the utility …

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Alkermes Announces Positive Topline Results from Study of Aristada and Invega Sustenna for the Treatment of Schizophrenia

DUBLIN, April 9, 2019 /PRNewswire/ — Alkermes plc (Nasdaq: ALKS) today announced positive topline results from ALPINE (Aripiprazole Lauroxil and Paliperidone palmitate: INitiation Effectiveness), a first-of-its-kind, six-month study evaluating the efficacy, safety and tolerability of ARISTADA® (aripiprazole lauroxil) and INVEGA SUSTENNA® (paliperidone palmitate) when used to initiate patients experiencing an …

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Avanir Reports Phase 3 Data of Investigational AVP-786 for the Treatment of Moderate-to-Severe Agitation in Patients with Alzheimer’s Dementia

ALISO VIEJO, Calif., March 25, 2019 /PRNewswire/ — Avanir Pharmaceuticals, Inc. announced today the results from the first study of the company’s phase 3 clinical development program investigating the efficacy, safety and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of moderate-to-severe agitation in patients with Alzheimer’s …

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Eisai Initiates Phase 3 Trial of BAN2401 in Early Alzheimer’s Disease

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced that a global Phase III clinical study (Clarity AD/Study 301) of BAN2401, an anti-amyloid beta protofibril antibody, in patients with early Alzheimer’s disease has been initiated. BAN2401 is being jointly developed by Eisai and Biogen Inc. (Headquarters: Cambridge, Massachusetts, United …

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Conatus’ Investigational Emricasan Fails to Meet Primary Endpoint in Phase 2b Trial in NASH Fibrosis

SAN DIEGO, March 21, 2019 (GLOBE NEWSWIRE) — Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) today announced top-line results from the company’s Phase 2b ENCORE-NF clinical trial in patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH) and liver fibrosis. The trial’s primary endpoint was a ≥1 CRN fibrosis stage improvement with no worsening of steatohepatitis …

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Biogen and Eisai Discontinue Phase 3 Trials of Aducanumab in Alzheimer’s Disease

CAMBRIDGE, Mass., March 21, 2019 (GLOBE NEWSWIRE) — Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced the decision to discontinue the global Phase 3 trials, ENGAGE and EMERGE, designed to evaluate the efficacy and safety of aducanumab in patients with mild cognitive impairment due to Alzheimer’s disease and mild …

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Biohaven Secures a Priority Review Voucher for its Rimegepant Zydis for Treatment of Migraine

NEW HAVEN, Conn., March 18, 2019 /PRNewswire/ — Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological and neuropsychiatric diseases, including rare disorders, today announced that the company has purchased a U.S. Food and Drug Administration (FDA) priority review voucher (PRV) …

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FDA Approves Dupixent for Moderate-to-Severe Atopic Dermatitis in Adolescents

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent can be used with or …

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FDA Approves Janssen’s Spravato CIII Nasal Spray Medication for Treatment-Resistant Depression

TITUSVILLE, N.J., – (March 5, 2019) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved SPRAVATO™ (esketamine) CIII nasal spray for use in conjunction with an oral antidepressant in adults with treatment-resistant depression (TRD).1 People who are currently struggling with major …

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FDA Grants Priority Review Designation for Lilly’s Emgality Injection for Preventive Treatment of Episodic Cluster Headache

INDIANAPOLIS, March 5, 2019 /PRNewswire/ –Eli Lilly and Company(NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for its supplemental Biologics License Application (sBLA) for Emgality® (galcanezumab-gnlm) injection for the preventive treatment of episodic cluster headache in adults. Priority Review aims to expedite the review of applications for drugs …

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