News

Sep 28 2015

ADMA Biologics Recognized as One of the 50 Fastest Growing Companies in New Jersey

Sep 28 2015
RAMSEY, N.J., Sept. 28, 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 today that the Company has been recognized as one of the 50 fastest growing companies in New Jersey by NJBIZ, a leading New Jersey-focused weekly business new publication.
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Sep 28 2015

Intersect ENT Announces Positive Clinical Results from Three Studies Evaluating Steroid Releasing Implants Placed in the Physician’s Office

Sep 28 2015
MENLO PARK, Calif. & DALLAS--(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 positive results from three clinical studies evaluating treatment of patients with sinus disease in the physician’s office.
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Sep 23 2015

ZELTIQ(R) Receives FDA Clearance to Treat Submental Fat With Coolsculpting(R) Procedure

Sep 23 2015
Introduction of New CoolMini(TM) Applicator Uniquely Designed to Non-Invasively Treat Smaller Pockets of Fat PLEASANTON, CA -- (Marketwired) -- 09/23/15 -- ZELTIQ® Aesthetics, Inc. (NASDAQ: ZLTQ), a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology, today announced that it received an expanded clearance from the U.S. Food and Drug Administration (FDA) paving the way for introduction of the new, CoolMini™ applicator, which is designed to treat smaller pockets of fat, including the submental, or chin fat area, more commonly referred to as the double chin. The CoolSculpting® procedure has demonstrated in over 50 published clinical articles and 4,000 clinical trial patients to non-invasively and consistently reduce unwanted fat and the procedure has been successfully used in over two million treatments to date.
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Sep 21 2015

Chimerix Presents New Research on Hospital Readmission Rates in Hematopoietic Cell Transplant Recipients

Sep 21 2015
Opportunistic Infections Caused by dsDNA Viruses Occur Early in the Post-Transplant Period and Support Need for Preventive Therapies DURHAM, N.C., Sept. 21, 2015 (GLOBE NEWSWIRE) -- Chimerix, Inc. (NASDAQ:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, presented findings from a new study that show hospital readmissions related to opportunistic infections are common among patients following autologous and allogeneic hematopoietic cell transplant (HCT), also known as bone marrow or stem cell transplant. The study showed that of hospital readmissions related to opportunistic infections (25.8 percent of all readmissions), approximately 1 in 3 readmissions were due to double-stranded DNA (dsDNA) viral infections. Among dsDNA viral infections diagnosed after hospital discharge, almost half occurred within the first month after discharge. The study also showed that the majority of hospital readmissions among HCT recipients were major or extreme in severity. These data were presented during the 55th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Diego.
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Sep 21 2015

FDA Accepts ADMA Biologics License Application for RI-002

Sep 21 2015
RAMSEY, N.J., Sept. 21, 2015 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq:ADMA), a late-stage biopharmaceutical company that develops, manufactures, and intends to commercialize specialty plasma-based biologics, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's Biologics License Application (BLA) for RI-002 intended for the primary immunodeficiency (PI) population. PI is a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system due to either a lack of necessary antibodies or a failure of these antibodies to function properly, affecting approximately 250,000 people in the United States.
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Sep 21 2015

TransEnterix Acquires the ALF-X Surgical Robotic System

Sep 21 2015
Creates a global surgical robotics company with a compelling product portfolio Expected to accelerate commercialization timeline and revenue ramp RESEARCH TRIANGLE PARK, N.C. & MILAN--(BUSINESS WIRE)-- TransEnterix, Inc. (NYSE MKT: TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, announced today that it has acquired the surgical robotics division of SOFAR S.p.A., an Italian health care company, in a cash and stock transaction with total consideration of $99.8 million. SOFAR has developed the TELELAP ALF-X® advanced robotic system for minimally invasive surgery, which has an active CE Mark.
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Sep 19 2015

Study Demonstrates T2Candida Panel is More Sensitive and Rapid Than Blood Culture at Identifying Invasive Infections

Sep 19 2015
Data Presented at ICAAC 2015 Annual Meeting LEXINGTON, Mass., Sept. 19, 2015 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO) a company developing innovative diagnostic products to improve patient health, today announced that data on its T2Candida® Panel was presented today at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and the International Society of Chemotherapy (ICC) joint meeting in San Diego, CA. The data demonstrate that T2Candida is more sensitive and rapid than blood culture for monitoring invasive candidiasis in proven cases of infection.
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Sep 18 2015

FDA Grants Qualified Infectious Disease Product Designation to Taksta(TM) Cempra's Fusidic Acid Antibiotic

Sep 18 2015
CHAPEL HILL, N.C., Sept. 18, 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 that the U.S. Food and Drug Administration (FDA) has granted a qualified infectious disease product (QIDP) designation to Cempra's investigational antibiotic product candidate, Taksta™ (CEM-102, sodium fusidate, the sodium salt of fusidic acid). The designation is for Taksta oral tablets for the indication of acute bacterial skin and skin structure infections (ABSSSI).
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Sep 18 2015

Versartis Announces Confirmatory 18-Month Data From Ongoing Extension Study of Somavaratan in GHD Children

Sep 18 2015
Late-Breaking Data Show 3.5 mg/kg Twice-Monthly Dosing Increased Mean Peak IGF-I SDS and Stabilized 12 to 18 Month Mean Height Velocity While Maintaining Safety Profile MENLO PARK, Calif., Sept. 18, 2015 (GLOBE NEWSWIRE) -- Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing somavaratan (VRS-317), a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), today announced additional data from its ongoing Extension Study of somavaratan in pre-pubertal GHD children.
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Sep 17 2015

ADMA Biologics Receives FDA Approval for Second Plasma Collection Center

Sep 17 2015
RAMSEY, N.J., Sept. 17, 2015 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq:ADMA), a late-stage biopharmaceutical company that develops, manufactures, and intends to commercialize specialty plasma-based biologics, announced that the Company's second plasma center, located at 3000 Windy Hill Road in Marietta, Georgia has received U.S. Food and Drug Administration (FDA) approval to sell human source plasma within the U.S. This center measures over 10,000 square feet, has the potential to support over 50 donor beds and employ over 50 staff members at peak capacity. Plasma donors donating at an ADMA BioCenter may be paid as much as $300 per month.
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