News

Jan 5 2015

Versartis Announces Positive 12 Month Data for VRS-317 from Ongoing Extension Study

Jan 5 2015
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.
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Jan 4 2015

Cempra Announces Positive Topline Phase 3 Clinical Results for Oral Solithromycin in the Treatment of Community Acquired Bacterial Pneumonia

Jan 4 2015
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).
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Dec 29 2014

Intersect ENT Announces Enrollment of First Patient in Phase III Study of In-Office Treatment for Recurrent Chronic Sinusitis

Dec 29 2014
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.
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Dec 19 2014

TransEnterix Completes Successful Pre-Clinical Robotic Surgical Procedures; Management Affirms FDA Timeline

Dec 19 2014
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.
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Dec 18 2014

Chimerix and ContraVir Pharmaceuticals Establish Strategic Collaboration for Antiviral Drug Candidate CMX157

Dec 18 2014
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®).
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Dec 15 2014

ADMA Biologics Receives $5M Tranche From Hercules Technology Growth Capital

Dec 15 2014
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.
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Dec 4 2014

ARMGO Pharma and Servier Announce Advancement of Rycal ARM210/S48168 into Clinical Stage Program Targeting Duchenne Muscular Dystrophy

Dec 4 2014
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.
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Dec 3 2014

ADMA Biologics Announces Positive Top-Line Phase III Data for Primary Immune Deficiency Disease (PIDD) Patients

Dec 3 2014
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.
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Nov 19 2014

Cempra to Receive BARDA Funding for 1b and Start-Up of Phase 2/3 Solithromycin Pediatric Studies

Nov 19 2014
$16.0 Million Will be Provided to Cover the Cost of the Study and Other Activities Specified in the Contract Phase 1b and Phase 2/3 Studies Will Test Intravenous, Oral Capsule and Oral Suspension Formulations of Solithromycin in Pediatric Patients From Newborn to 17 Years of Age CHAPEL HILL, N.C., Nov. 19, 2014 (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 it has received authorization under its existing contract for the next phase of its contract with the Biomedical Advanced Research and Development Authority (BARDA) that will provide funding of $16.0 million for two clinical studies of solithromycin. Pediatric patients from newborn to age 17 years who are enrolled in the study may receive intravenous, oral suspension or oral capsule formulations of solithromycin, an investigational, fourth generation macrolide antibiotic. In a recently completed Phase 1a study conducted in pediatric patients age 12 to 17 years, solithromycin oral capsules were well tolerated and demonstrated a pharmacokinetic profile similar to that seen in adults.
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Nov 17 2014

Pernix Submits sNDA for TREXIMET® use in Adolescent Patients

Nov 17 2014
MORRISTOWN, NJ, – (BUSINESS WIRE) – November 17, 2014 – Pernix Therapeutics Holdings, Inc. (NASDAQ: PTX) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for TREXIMET (sumatriptan / naproxen sodium) to seek approval for use in adolescent patients, age 12 – 17, for the acute treatment of migraine with or without aura.
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