AMARIN CORP: Amarin Updates First Quarter Revenue Guidance, Reiterates Full Year Guidance and Updates on REDUCE-IT Cardiovascular Outcomes Study Progress and Vascepa® Promotion Initiatives

Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, today announced an update to its revenue guidance for the first quarter of 2018, reiteration of full year revenue guidance, further progress towards completing its potential landmark cardiovascular outcomes study, REDUCE-IT, and initiation of previously announced Vascepa® promotion initiatives. Read More »

AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACIST: ASHP Virtual House of Delegates Approves New Policies for 2018

ASHP’s virtual House of Delegates recently approved professional policies on gene therapy, unit dose packaging availability, and drug dosing in conditions that modify pharmacokinetics or pharmacodynamics, among other topics. Following discussion in the House of Delegates community on ASHP Connect, delegates voted online during the week of March 16–23. Read More »

ABBVIE: Upadacitinib Meets All Primary and Ranked Secondary Endpoints Including Superiority Versus Adalimumab in Phase 3 Study in Rheumatoid Arthritis

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-COMPARE clinical trial showing that after 12 weeks, upadacitinib (15 mg, once-daily) met the primary endpoints of ACR20a and clinical remissionb versus placebo.1 All ranked secondary endpoints were also achieved versus either placebo or adalimumab (40 mg every other week). Read More »

AMARIN CORP: Amarin's REDUCE-IT Cardiovascular Outcomes Study Reaches 100% Mark for Estimated Onset of Target Primary Major Adverse Cardiovascular Events

Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that its REDUCE-IT cardiovascular outcomes study of Vascepa® (icosapent ethyl) is estimated to have reached the onset of the targeted 1,612 primary major adverse cardiovascular events (MACE) specified in the study design. Read More »

ABBVIE: AbbVie and Neurocrine Biosciences Announce PDUFA Target Date of Q3 2018 for Elagolix in Endometriosis-Associated Pain

AbbVie (NYSE:ABBV), a global research and development-based biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced notification by the U.S. Food and Drug Administration (FDA) that it requires extended time to review additional information regarding the results of liver function tests provided by AbbVie in connection with its New Drug Application (NDA) for elagolix in endometriosis-associated pain. The Prescription Drug User Fee Act (PDUFA) date has been extended three months to Q3 2018. Read More »

AMGEN INCC.: Amgen Announces Rhode Island Will Be Location Of First US Next-Generation Biomanufacturing Plant

Amgen (NASDAQ:AMGN) today announced plans to build a new state-of-the-art next-generation biomanufacturing plant at its campus in West Greenwich, R.I. The new plant, the first of its kind in the United States (U.S.), will employ Amgen's proven next-generation biomanufacturing capabilities and manufacture products for the U.S. and global markets. Read More »

NOVARTIS CORPORATION: The McCourty Twins & Friends Shine a Spotlight on Sickle Cell Disease

Imagine having a chronic disease that affects almost every organ in your body and can lead to intense, debilitating pain episodes that often send you to the ER.1,2 What’s more, there are generally no warning signs, making it difficult to not only plan ahead for special events, but to keep up with the day-to-day activities most people take for granted. Too often, this is a recurring cycle for people with sickle cell disease (SCD). Read More »

MYLAN INC.: Mylan to Acquire the Global Marketing Rights to a Once-monthly Glatiramer Acetate Product through an Investment and Partnership with Israeli Company Mapi Pharma

One of the world's leading pharmaceutical companies, and Mapi Pharma Ltd., a fully integrated, clinical late stage biopharmaceutical company, today announced that the two companies will partner on the development and commercialization of GA Depot, a long-acting Glatiramer Acetate product. Mylan is acquiring global marketing rights to the product. Read More »

MYLAN INC.: Mylan Partners with Fujifilm Kyowa Kirin Biologics to Commercialize Biosimilar to Humira® (adalimumab)

Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced it is partnering with Fujifilm Kyowa Kirin Biologics Co., Ltd. to commercialize a biosimilar to Humira® (adalimumab) developed by Fujifilm Kyowa Kirin Biologics. Through the partnership agreement, Mylan will leverage its regulatory platform to seek approval and commercialize the product in Europe. Read More »

PHARMACEUTICAL CARE MANAGEMENT ASSOCIATION: Independent Drugstore Lobby Agenda Raises Government Costs, Increases Deficit

As the independent drugstore lobby descends on Capitol Hill this week to push for costly new government health mandates, the Pharmaceutical Care Management Association (PCMA) continues to highlight how pharmacy benefit managers (PBMs) reduce prescription drug costs and improve benefits for consumers, employers, unions, and public programs. Read More »