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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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Pfizer and Lilly Announce Top-line Results From Phase 3 Study of Tanezumab in Chronic Low Back Pain

Pfizer Inc. (NYSE: PFE) and Eli Lilly and Company (NYSE: LLY) today announced positive top-line results from a Phase 3 study evaluating tanezumab in patients with moderate-to-severe chronic low back pain (CLBP). In the study, treatment with tanezumab 10 mg met the primary endpoint, demonstrating a statistically significant improvement in pain at …

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FDA Announces Breakthrough Therapy Designation to CymaBay’s Seladelpar for Treatment of Primary Biliary Cholangitis

NEWARK, Calif., Feb. 15, 2019 (GLOBE NEWSWIRE) — CymaBay Therapeutics, Inc. (NASDAQ: CBAY), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for seladelpar for the treatment of early stage primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adult patients with …

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