News

Phase 3 program aims to address patient need for alternative treatment options in moderate-to-severe psoriasis Program includes the first Phase 3 study in psoriasis comparing two anti-TNFs Based on current enrollment projections, top-line data from these studies are expected in 2017 MENLO PARK, Calif., and BRUSSELS, Belgium, Jan. 8, 2015 (GLOBE NEWSWIRE) -- Dermira, Inc., a specialty biopharmaceutical company focused on bringing innovative and differentiated medical dermatology products to dermatologists and their patients (Nasdaq:DERM), and UCB, a global biopharmaceutical leader (Euronext:UCB), announced today that the first patients have been dosed in the Phase 3 clinical program designed to evaluate the efficacy and safety of CIMZIA® (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis. This is an important step forward in the collaboration between Dermira and UCB in the development of solutions for patients with moderate-to-severe plaque psoriasis, a severe autoimmune disease.1 CIMZIA® is not currently approved for the treatment of psoriasis by any regulatory authority worldwide.

BOSTON, Jan. 6, 2015 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) today announced Actavis will be making a $4 million milestone payment to Paratek under the terms of the parties' collaboration for the development of sarecycline (WC3035). Under the collaboration, Actavis has initiated Phase 3 clinical trials of sarecycline in moderate to severe acne. Paratek will be entitled to additional payments upon the achievement of regulatory and commercialization milestones, including the FDA's acceptance of a new drug application (NDA) from Actavis, FDA approval and royalties on future sales.

Successful Dose Response Further Confirms Phase 3 Trial Design Company to Hold Conference Call at 8:30 a.m. ET on Monday, January 5, 2015 MENLO PARK, Calif., Jan. 5, 2015 /PRNewswire/ -- Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing a novel, long-acting form of recombinant human growth hormone (rhGH), today announced positive data from its Extension Study of VRS-317 for naive to treatment, pre-pubertal children with growth hormone deficiency (GHD). The Extension Study is a long-term safety study initiated in March 2014 as patients completed the Versartis' Phase 1b/2a clinical trial of VRS-317 in children with GHD.

CHAPEL HILL, N.C., Jan. 4, 2015 (GLOBE NEWSWIRE) -- Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics in the face of rising antibiotic resistant bacterial infections, today announced positive topline results from a global, pivotal Phase 3 clinical trial of solithromycin oral capsules (Solitaire- Oral) in the treatment of patients with community acquired bacterial pneumonia (CABP).

MENLO PARK, Calif.--Intersect ENT, Inc. (Nasdaq:XENT), a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, today announced initiation of RESOLVE II, a pivotal Phase III clinical study to support U.S. Food and Drug Administration (FDA) approval of the company's RESOLVE steroid releasing implant designed to treat patients with recurrent sinus obstruction in the office setting.

SurgiBotTM system FDA 510(k) filing on track for mid-2015 submission RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- TransEnterix, Inc. (NYSE MKT: TRXC), a medical device company that is pioneering the use of robotics and flexible instruments to improve minimally invasive surgery, today announced the successful completion of four general surgery and urology procedures using its SurgiBot system patient-side robotic surgery system. Management also stated that the preparation of its FDA 510(k) filing is proceeding as planned, and affirmed prior guidance of its intention to submit the filing in mid-2015.

ContraVir to Develop CMX157 for Multiple Antiviral Indications DURHAM, N.C. and EDISON, N.J., Dec. 18, 2014 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX) a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, and ContraVir Pharmaceuticals, Inc. (OTCBB:CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that the companies have entered into a strategic collaboration for the further clinical development and commercialization of CMX157. CMX157 is a highly potent analog of the successful antiviral drug tenofovir DF (Viread®).

RAMSEY, N.J., Dec. 15, 2014 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq:ADMA), a late-stage biopharmaceutical company that develops, manufactures, and intends to market specialty plasma-based biologics for the treatment and prevention of certain infectious diseases, today announced that it has received a $5 million tranche from Hercules Technology Growth Capital, Inc. (NYSE:HTGC), the leading specialty finance company focused on providing senior secured loans to venture capital-backed companies in technology-related markets. The $5 million was based upon ADMA achieving clinical endpoints of a Phase III clinical study of RI-002 as a treatment for Primary Immunodeficiency Disease (PIDD), under its existing loan and security agreement.

TARRYTOWN, N.Y. and SURESNES, France, Dec. 4, 2014 /PRNewswire/ -- ARMGO Pharma and Servier today announced the successful completion of preclinical efficacy and IND/CTA enabling studies with ARM210/S48168, along with a formal decision to advance the program into early clinical development initially targeting treatment for patients with Duchenne Muscular Dystrophy (DMD), the most common and severe form of muscular dystrophy.

RAMSEY, N.J., Dec. 3, 2014 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq:ADMA), a late-stage biopharmaceutical company that develops, manufactures, and intends to market specialty plasma-based biologics for the treatment and prevention of certain infectious diseases, today announced its lead product candidate RI-002 has demonstrated positive Phase III results and successfully achieved its primary endpoint.