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Company Plans to Complete Clinical Trial in the Second Half of 2016 and File its Resubmission to the FDA in First Half of 2017 PRINCETON, N.J., Oct. 19, 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 it has reached full enrollment in its ongoing Phase 3 SECURE clinical trial of Twirla® (AG200-15), its investigational combined hormonal contraceptive patch. The Company expects to complete the trial of over 2,000 subjects in the second half of 2016.

CLEVELAND, October 18, 2015 — ViewRay, Inc. (OTCQB:VRAY) announced today that the company has received regulatory approval from the Ministry of Food and Drug Safety (MFDS) – formerly known as the Korean Food and Drug Administration (KFDA) – to sell its ViewRay system in Korea. On October 13, 2015, the first patient treatments commenced less than four weeks after the system completed installation at Seoul National University Hospital (SNUH), a leading healthcare facility in Korea.

Solithromycin Met All FDA Primary Objectives of Non-Inferiority Compared to Moxifloxacin Two Phase 3 Trials Required by the FDA and the EMA for CABP Regulatory Filings Now Complete Rolling NDA Submission Expected to Begin 4Q 2015 Cempra to Host Webcast and Conference Call Today at 8:00 a.m. EDT CHAPEL HILL, N.C., Oct. 16, 2015 (GLOBE NEWSWIRE) -- Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced positive topline results from a global, pivotal Phase 3 clinical trial of intravenous (IV) to oral solithromycin (Solitaire-IV) in the treatment of patients with community-acquired bacterial pneumonia (CABP).

Patient Enrollment Continues for Two Additional CIMZIA Phase 3 Trials in Patients With Moderate-to-Severe Psoriasis MENLO PARK, Calif., Oct. 12, 2015 (GLOBE NEWSWIRE) -- Dermira, Inc. (NASDAQ:DERM), a specialty biopharmaceutical company focused on bringing innovative and differentiated products to dermatologists and their patients, today announced the completion of patient enrollment for the global CIMPASI-2 clinical trial of CIMZIA® (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis. Completion of patient enrollment for this Phase 3 study has triggered a milestone payment of $7.3 million payable by UCB Pharma S.A. to Dermira. Dermira expects to announce topline efficacy and safety data from the CIMZIA Phase 3 clinical development program in 2017, consistent with previous guidance, based on current patient enrollment projections for the two additional, ongoing CIMZIA Phase 3 clinical trials and following completion of the 48-week blinded treatment period in all three trials. CIMZIA is not currently approved for the treatment of psoriasis by any regulatory authority worldwide.

CLEVELAND, October 13, 2015 — ViewRay, Inc. (OTCQB:VRAY) announced today that the company has been selected to receive the 2015 Frost & Sullivan Technology Innovation Leadership Award, a prestigious recognition based on an extensive and independent Frost & Sullivan analysis of the North American Image-Guided Radiation Therapy market. ViewRay’s MRIdian® system is the world’s first and only MRI-guided radiation therapy system that images and treats cancer patients simultaneously, bringing the benefits of soft-tissue visualization and adaptive treatment to patients around the world.

BRISBANE, Calif.--(BUSINESS WIRE)--Oct. 7, 2015-- Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing desensitization treatments for food allergies, today announced that it has received the European Medicines Agency (EMA) decision endorsing the company’s pediatric investigation plan, or PIP, for AR101 for the treatment of peanut allergy. The decision follows the EMA Paediatric Committee (PDCO) positive opinion on the PIP on August 14, 2015.

FierceBiotech Names Syros Pharmaceuticals as One of Its “Fierce 15” Biotech Companies of 2015 Syros Pharmaceuticals, the industry pioneer in gene control medicines, today announced that it has been named by FierceBiotech as one of 2015’s Fierce 15 biotechnology companies. The award designates Syros as one of the most promising private companies in the biotech industry.

RAMSEY, N.J., Sept. 30, 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 treatment and prevention of certain infectious diseases, announced it has received a milestone payment from Biotest Aktiengesellschaft (Biotest AG) as a result of the filing of its Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA), in accordance with the license agreement entered into on December 31, 2012.

The U.S. Food and Drug Administration today allowed marketing of a new hearing aid that uses a laser diode and direct vibration of the eardrum to amplify sound. The combination of laser light pulses and a custom-fit device component that comes in direct contact with the eardrum is designed to use the patient’s own eardrum as a speaker and enables amplification over a wider range of frequencies for some hearing impaired persons. The EarLens Contact Hearing Device (CHD) is indicated for use by adults with mild to severe sensorineural hearing impairment.

MENLO PARK, Calif.--(BUSINESS WIRE)--Intersect ENT, Inc. (Nasdaq:XENT), a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, today announced that the company has submitted a supplemental premarket approval (PMA-s) submission to the U.S. Food and Drug Administration (FDA) to seek approval to expand the indication of the PROPEL® mini steroid releasing sinus implant to the treatment of patients undergoing frontal sinus surgery.