Health

FDA approves Bayer’s Gadavist (gadobutrol) Injection as the first magnetic resonance contrast agent for evaluation of breast cancer in the United States – Gadavist-enhanced breast MRI demonstrated superior sensitivity (range: 80-89%) for the presence and extent of malignant disease compared to unenhanced breast MRI (range: 37-73%) – Sensitivity for the presence and extent of malignant breast disease ranged from 68-73% with x-ray mammography – Findings of pivotal studies consistent with clinical guidelines recommending the use of contrast-enhanced breast MRI in patients with newly diagnosed breast cancer PR Newswire WHIPPANY, N.J., June 12, 2014 WHIPPANY, N.J. , June 12, 2014 /PRNewswire/ — Bayer HealthCare announced today that the U.S. Food and Drug Administration (FDA) has approved a new indication for Gadavist (gadobutrol) injection for intravenous use with MRI of the breast to assess the presence and extent of malignant breast disease […]

D-Pharm’s DP-b99 Prevents Abnormal Neuronal Plasticity and Pathological Brain Reorganization PR Newswire REHOVOT, Israel, June 12, 2014 REHOVOT, Israel , June 12, 2014 /PRNewswire/ — D-Pharm Ltd. (TASE: DPRM) announced today, publication in PLOS ONE, of promising results from a study of its drug candidate DP-b99. The findings suggest that DP-b99 may prevent lasting alterations in neuronal function and pathological brain reorganization – a hallmark of numerous central nervous system (CNS) diseases. […]

MedNet To Unveil Multiple iMedNet EDC Delivery Options At The 2014 DIA Annual Meeting Programs Ensure iMedNet™ EDC’s Practicality for Any Research Initiative PR Newswire MINNETONKA, Minn., June 11, 2014 MINNETONKA, Minn. , June 11, 2014 /PRNewswire/ — MedNet Solutions , a global life sciences technology company specializing in clinical study management systems, will be showcasing iMedNet EDC , its flagship eClinical solution, at the 2014 Drug Information Association (DIA) Annual Meeting, June 16-18 in San Diego, California . iMedNet EDC provides a flexible, intuitive and affordable eClinical platform that effectively supports research initiatives of any size, phase or duration, in any therapeutic area, anywhere in the world. […]

Mylan Launches Generic Actonel Tablets, 150 mg PR Newswire PITTSBURGH, June 11, 2014 PITTSBURGH , June 11, 2014 /PRNewswire/ — Mylan Inc. (Nasdaq: MYL) today announced that it has launched Risedronate Sodium Tablets USP, 150 mg, the generic version of Warner Chilcott’s Actonel Tablets. […]

Elekta’s MOSAIQ Oncology Information System receives Stage 2 meaningful use certification PR Newswire ATLANTA, June 11, 2014 ATLANTA , June 11, 2014 /PRNewswire/ — Elekta’s MOSAIQ Oncology Information System (OIS) has been tested and certified as a Complete Ambulatory EHR under the Drummond Group’s Electronic Health Records Office of the National Coordinator Authorized Certification Body (ONC-ACB) program. This EHR software is compliant in accordance with the criteria adopted by the Secretary of the US Department of Health and Human Services. Drummond Group’s ONC-ACB certification program certifies that EHRs meet the meaningful use criteria for either eligible provider or hospital technology. […]

RightBio Metrics Introduces New FDA Cleared Point-of-Care Devices to Provide Safer, Cleaner and More Accurate Gastric pH Readings Pioneering medical device developer earns three FDA and CE Mark approvals for innovative bio fluid measurement technologies that assist in verifying proper nasogastric tube placement PR Newswire PHOENIX, June 11, 2014 PHOENIX , June 11, 2014 /PRNewswire/ — RightBio Metrics, an emerging leader in advanced fluid measurement technologies, today announces the availability of three new products after receiving both FDA and CE Mark approvals to distribute their point-of-care diagnostic devices. The approved devices, designed to provide safer nasogastric (NG) tube placement and accurate gastric acidity measurement using an innovative in vitro pH indicator include, RightSpot pH Indicator, RightSpot Infant pH Indicator and RightLevel pH Detector. […]

Orexigen Receives Three Month Extension of FDA NB32 Review – Agreement needs to be reached on the post-marketing obligation for continued evaluation of CV outcomes – – New PDUFA date is September 11, 2014 – PR Newswire SAN DIEGO, June 11, 2014 SAN DIEGO , June 11, 2014 /PRNewswire/ — Orexigen Therapeutics, Inc. (Nasdaq: OREX) today announced that the United States Food and Drug Administration (FDA) has extended its review of the resubmitted New Drug Application (NDA) for NB32, the Company’s investigational medication being evaluated for weight loss. The new Prescription Drug User Fee Act (PDUFA) action date has been set for September 11, 2014 […]

Strativa Pharmaceuticals Announces FDA Approval of Nascobal (Cyanocobalamin, USP) Nasal Spray Single-Use Device One Spray per Device, Without the Need for Priming, Provides Greater Ease of Use PR Newswire WOODCLIFF LAKE, N.J., June 10, 2014 WOODCLIFF LAKE, N.J. , June 10, 2014 /PRNewswire/ — Strativa Pharmaceuticals, the branded division of Par Pharmaceutical Companies, Inc., today announced that the U.S. Food and Drug Administration has approved Nascobal Nasal Spray in a single-use device. […]

Makindus Receives Orphan Designation For MI-100 For Stargardt’s Disease PR Newswire DOYLESTOWN, Pa., June 10, 2014 DOYLESTOWN, Pa. , June 10, 2014 /PRNewswire/ — On June 2, 2014 Makindus, Inc. a specialty pharmaceutical company, received orphan drug designation for their lead product MI-100 from the U.S. […]

Oramed Pharmaceuticals to Present at the American Diabetes Association 74th Scientific Sessions on June 13 – 17, 2014 in San Francisco PR Newswire JERUSALEM, June 10, 2014 JERUSALEM , June 10, 2014 /PRNewswire/ — Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP) ( http://www.oramed.com ), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that three scientific abstracts summarizing studies performed with ORMD-0801, its orally ingestible insulin capsule, were accepted for inclusion at the American Diabetes Association 74 th Scientific Sessions, which will take place in San Francisco . […]

BioDelivery Sciences to Present at the William Blair and Wells Fargo Healthcare Conferences PR Newswire RALEIGH, N.C., June 10, 2014 RALEIGH, N.C. , June 10, 2014 /PRNewswire/ — BioDelivery Sciences International, Inc. […]

Pulsar Vascular Receives FDA IDE Approval for the PulseRider Aneurysm Neck Reconstruction Device for the Treatment of Intracranial Bifurcation Aneurysms PR Newswire SAN JOSE, Calif., June 10, 2014 SAN JOSE, Calif. , June 10, 2014 /PRNewswire/ — Pulsar Vascular, the innovator and developer of the PulseRider, a minimally invasive, aneurysm neck reconstruction device, announced today the United States Food and Drug Administration (FDA)’s approval of an Investigational Device Exemption (IDE) for the PulseRider. […]

Cohera Medical, Inc.’s TissuGlu Surgical Adhesive Advances to Food and Drug Administration Advisory Panel Meeting PR Newswire PITTSBURGH, June 10, 2014 PITTSBURGH , June 10, 2014 /PRNewswire/ — Cohera Medical, Inc. , a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has received notice from the U.S. […]

Acella Pharmaceuticals, LLC, Announces Approval of Tranexamic Acid Injection PR Newswire ATLANTA, June 9, 2014 ATLANTA , June 9, 2014 /PRNewswire/ — Acella Pharmaceuticals, LLC, a specialty pharmaceutical company, announces the approval of an Abbreviated New Drug Application (ANDA) 1 for Tranexamic Acid Injection 1000 mg/10mL (100 mg/mL). The Food and Drug Administration (FDA) determined that Acella’s ANDA is bioequivalent – therefore, therapeutically equivalent – to the reference listed drug, CYKLOKAPRON – Tranexamic Acid Injection Solution (Pharmacia & Upjohn, Inc.). Tranexamic Acid Injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction […]

Supplemental New Drug Application for IMBRUVICA Accepted by the U.S. FDA and Priority Review Granted PR Newswire SUNNYVALE, Calif., June 9, 2014 SUNNYVALE, Calif. , June 9, 2014 /PRNewswire/ — Pharmacyclics, Inc. […]

Mylan Launches Generic Paraplatin Injection PR Newswire PITTSBURGH, June 9, 2014 PITTSBURGH , June 9, 2014 /PRNewswire/ — Mylan Inc. (Nasdaq: MYL) today announced that it has launched Carboplatin Injection, 50 mg/5 ml, in multi-dose vials, which is the generic version of Bristol-Myers Squibb’s Paraplatin Injection. Mylan received final approval from the U.S. […]

Valeant Pharmaceuticals Announces FDA Approval Of Jublia for the Treatment of Onychomycosis PR Newswire LAVAL, Quebec, June 9, 2014 LAVAL, Quebec , June 9, 2014 /PRNewswire/ — Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) today announced that that its wholly owned subsidiary, Valeant Pharmaceuticals North America LLC, received notice that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Jublia (efinaconazole 10% topical solution), the first topical triazole approved for the treatment of onychomycosis of the toenails […]

BioDelivery Sciences Receives FDA Approval for BUNAVAIL™ (buprenorphine and naloxone) Buccal Film for the Maintenance Treatment of Opioid Dependence First and Only FDA-Approved Buccal Film Formulation of Buprenorphine and Naloxone to Compete in the $1.7 Billion and Growing U.S. Opioid Dependence Market Late Third Quarter 2014 Launch Anticipated, Utilizing Dedicated Sales Force Launch Plans to Be Discussed in Late Summer Investor Briefing PR Newswire RALEIGH, N.C., June 6, 2014 RALEIGH, N.C. , June 6, 2014 /PRNewswire/ — BioDelivery Sciences International, Inc. […]

QT Vascular Announces FDA Clearance of Chocolate PTCA Balloon Catheter Chocolate PTCA FDA clearance opens large new market opportunity PR Newswire SINGAPORE, June 5, 2014 SINGAPORE , June 5, 2014 /PRNewswire/ — QT Vascular Ltd. (QT Vascular) is pleased to announce that on 4 June 2014 , its wholly owned US subsidiary, TriReme Medical LLC, received notification from the United States Food and Drug Administration (FDA) of 510(K) clearance to market the Chocolate PTCA Balloon Catheter (Chocolate PTCA) in the United States , for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. […]

Upsher-Smith Receives Final NDA Approval For Vogelxo™ (Testosterone) Gel CIII PR Newswire MAPLE GROVE, Minn., June 4, 2014 MAPLE GROVE, Minn. , June 4, 2014 /PRNewswire/ — Upsher-Smith Laboratories, Inc ., today announced that it has received final approval from the U.S. […]