News

DURHAM, N.C., Aug. 3, 2015 (GLOBE NEWSWIRE) -- Chimerix, Inc. (NASDAQ:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced completion of enrollment of the targeted 200 patients in the Phase 3 AdVise trial evaluating brincidofovir for the treatment of adenovirus infection in immunocompromised patients.

RAMSEY, N.J., July 31, 2015 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq:ADMA), a late-stage biopharmaceutical company that develops, manufactures and intends to commercialize specialty plasma-based biologics for the primary immunodeficiency (PI) population and the treatment and prevention of certain infectious diseases, announced that it has submitted its Biologics License Application (BLA) to the United States Food and Drug Administration (FDA), seeking marketing authorization for RI-002.

NEW YORK-- Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced positive top-line results from the second of two pivotal phase 3 clinical trials evaluating the efficacy and safety of two different plecanatide treatment doses (3.0 mg and 6.0 mg), taken as a tablet once-a-day, in 1337 adult patients with chronic idiopathic constipation (CIC).

ETC-1002-014 Study Meets Primary Endpoint LDL-Cholesterol Lowering Significantly Greater Than Placebo, With Neutral Effect on Blood Pressure ETC-1002 Observed to Be Safe and Well-Tolerated Conference Call and Webcast on Tuesday, July 28, 2015 at 8:00 a.m. Eastern Time ANN ARBOR, MI -- (Marketwired) -- 07/28/15 -- Esperion Therapeutics, Inc. (NASDAQ: ESPR), an emerging pharmaceutical company focused on developing and commercializing first-in-class, oral, low-density lipoprotein cholesterol (LDL-cholesterol) lowering therapies for the treatment of patients with hypercholesterolemia and other cardiometabolic risk markers, today announced positive top-line results from ETC-1002-014, a Phase 2 exploratory study evaluating the safety and efficacy of ETC-1002 (bempedoic acid) in patients with both hypercholesterolemia and hypertension.

MORRISTOWN, N.J., July 27, 2015 (GLOBAL NEWSWIRE) – Pernix Therapeutics Holdings, Inc. (NASDAQ: PTX), a specialty pharmaceutical company, today announced positive results from Category 1 (in vitro) abuse deterrence studies with ZX007, utilizing Altus Formulation’s proprietary INTELLITAB™ abuse deterrent technology platform. ZX007 is an abuse-deterrent, extended-release oral hydrocodone bitartrate formulation product in development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate, The purpose of the studies was to perform a comprehensive battery of laboratory tests to assess the physical and chemical properties of ZX007. These studies were conducted in accordance with the April 2015 Food and Drug Administration (FDA) Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling.

Peer-Reviewed Research Brief Published in Cancer Discovery First Confirmed Patient Response AURORA, Colo. and STAMFORD, Conn., July 27, 2015 (GLOBE NEWSWIRE) -- The University of Colorado Cancer Center and Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company focused on the discovery, development and commercialization of targeted cancer therapies, today announced the publication of a research brief in the online edition of the journal Cancer Discovery, describing the first patient with a tropomyosin receptor kinase (TRK) fusion cancer enrolled in the Phase 1 dose escalation trial of LOXO-101, the only selective TRK inhibitor in clinical development. Additional contributors to the paper include the Knight Cancer Institute at Oregon Health & Science University and Foundation Medicine, Inc. (Nasdaq:FMI).

SANTA CLARA, Calif., July 23, 2015. Miramar® Labs, an innovative global aesthetic company, announced today its miraDry® System received clearance from the U.S. Food & Drug Administration (FDA) for the treatment of unwanted underarm hair, and permanent reduction of underarm hair of all colors. This announcement establishes miraDry as the only technology FDA cleared for the treatment of underarm hair of all colors as well as the permanent reduction of underarm sweat.

Intellectual Property Portfolio Significantly Broadened for Its Proprietary Transdermal Delivery System PRINCETON, N.J., July 23, 2015 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc., (NASDAQ:AGRX), a women's health specialty pharmaceutical company focused on the development and commercialization of new prescription contraceptive products, today announced that the U.S. Patent and Trademark Office issued Notices of Allowance between July 21 and 23 for four patent applications with claims directed to novel transdermal contraceptive dosing regimens.

Funding to Support Further Innovation and Commercialization of MRI-Guided Radiation Therapy System July 23, 2015 CLEVELAND — July 23, 2015 — ViewRay, Inc. (OTCQB: VRAY) announced today its successful completion of a reverse merger with ViewRay Technologies, Inc. The combined entity will focus solely on the business of ViewRay, the makers of MRIdian™, the world’s first and only MRI-guided radiation therapy system that images and treats cancer patients simultaneously. ViewRay will trade on the OTC Markets under the symbol “VRAY.”

DURHAM, N.C., July 23, 2015 (GLOBE NEWSWIRE) -- Chimerix, Inc. (NASDAQ:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that its investigational antiviral brincidofovir showed a survival benefit in a pivotal study of an animal model for smallpox.