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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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Gilead’s Selonsertib Fails to Meet Primary Endpoint in Phase 3 NASH Study

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced that STELLAR-4, a Phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of selonsertib, an investigational, once-daily, oral inhibitor of apoptosis signal-regulating kinase 1 (ASK1), in patients with compensated cirrhosis (F4) due to nonalcoholic steatohepatitis (NASH), did not …

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Alkermes Receives Complete Response Letter from the FDA for ALKS 5461 New Drug Application

DUBLIN, Feb. 1, 2019 /PRNewswire/ — Alkermes plc (Nasdaq: ALKS) today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD).   The CRL states that the FDA is unable to approve the ALKS 5461 …

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Sunovion Receives Complete Response Letter from FDA for Apomorphine Sublingual Film

MARLBOROUGH, Mass.–(BUSINESS WIRE)–Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for apomorphine sublingual film (APL-130277) to treat OFF episodes (the re-emergence or worsening of Parkinson’s symptoms otherwise controlled by medications) experienced by people …

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Genentech to Discontinue Phase 3 CREAD 1 and 2 Studies of Crenezumab in Early Alzheimer’s Disease

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today the decision to discontinue CREAD 1 and CREAD 2 (BN29552 and BN29553) Phase III studies of the investigational anti-beta-amyloid molecule crenezumab in people with early (prodromal to mild) sporadic Alzheimer’s disease (AD). …

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FDA Grants Breakthrough Device Designation to C2N Diagnostics’ Blood Test to Screen for Alzheimer’s Disease Risk

ST. LOUIS–(BUSINESS WIRE)–C2N Diagnostics today announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Device Designation for C2N’s proprietary brain amyloidosis blood test. This test will be used to screen for brain amyloid pathology in individuals being assessed for an Alzheimer’s Disease diagnosis. To qualify for …

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CVS Health Reaches Pharmacy Benefits Management System Deal with Walmart After Impasse

WOONSOCKET, R.I. and BENTONVILLE, Ark., Jan. 18, 2019 /PRNewswire/ — CVS Health (NYSE: CVS) and Walmart (NYSE: WMT) today announced the companies have reached a multi-year agreement on terms under which Walmart will continue participating in the CVS Caremark pharmacy benefit management (PBM) commercial and Managed Medicaid retail pharmacy networks. The companies are not …

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Acorda Announces The Lancet Neurology Publication of Phase 3 Data for Inbrija in Patients with Parkinson’s Disease

ARDSLEY, N.Y.–(BUSINESS WIRE)–Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that The Lancet Neurologypublished results from SPAN℠-PD, the Phase 3 pivotal efficacy trial of INBRIJA™ (levodopa inhalation powder), also referred to as CVT-301. In the study, INBRIJA 84 mg significantly improved motor function at 30 minutes during OFF periods in people with Parkinson’s taking …

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ZappRx and Bayer Partner to Improve Access to Specialty Medications

BOSTON–(BUSINESS WIRE)–ZappRx, a digital health company that streamlines the complex processes associated with prescribing specialty medications, announced an agreement with Bayer to provide a more efficient approach to the accessing of specialty medications and associated support programs. ZappRx will support patients living with two specific types of Pulmonary Hypertension (PH) and patients …

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FDA Grants Breakthrough Therapy Designation to Novartis’ Crizanlizumab for the Prevention of Vaso-Occlusive Crises in Sickle Cell Disease

Basel, January 8, 2019 – Novartis announced today that the US Food and Drug Administration (FDA) has granted crizanlizumab (SEG101) Breakthrough Therapy designation for the prevention of vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease (SCD). Also known as sickle cell pain crises, VOCs are unpredictable and extremely …

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