Vancouver-based Neovasc has announced that its Tiara mitral valve has been successfully implanted in a human patient on January, 30, 2014. Following the announcement on February 3, the company's stock jumped up 35.17%. The device, which ...
Tags: Mitral Valve, health
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of Novartis’ Xolair (omalizumab) as an add-on therapy for the treatment of chronic spontaneous ...
U.S. allergists say a new long-term medication in under-the-tongue tablet form is promising and may even have the potential to cure hay fever. Officials at the American Academy of Allergy, Asthma & Immunology said allergy immunotherapy is ...
QRxPharma, an Australian-based commercial-stage specialty pharmaceutical company, has resubmitted its MOXDUO new drug application (NDA). At a meeting in early October 2013, the US Food and Drug Administration (FDA) provided QRxPharma with ...
Tags: QRxPharma, Drug Application
Discovery Laboratories (DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, has initiated the US commercial launch of Surfaxin (lucinactant) Intratracheal Suspension for the ...
The US Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee has recommended approval of Bayer’s oral soluble guanylate cyclase (sGC) stimulator, riociguat, in two forms of pulmonary ...
Tags: FDA Advisory Committee
GlaxoSmithKline (GSK) and Theravance have announced the FDA approval of Breo Ellipta as maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease (COPD) patients. The inhaled long-term, once-daily maintenance ...
Tags: GSK, Theravance, Copd Therapy
Acceleron Pharma has announced that the Gynecologic Oncology Group (GOG) has sponsored its phase 2 study of dalantercept. Patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer are taking part in the ...
Abbott has initiated a ABSORB III clinical trial of its drug eluting bioresorbable vascular scaffold (BVS) device, designed for the treatment of coronary artery disease patients. The Absorb device, which includes a multi-link stent ...
Tags: Abbott, ABSORB III clinical trial, drug eluting BVS, treatment
AMTAC Certification Services has granted CE mark for CellAegis Devices's autoRIC device. The CE mark allows CellAegis to sell autoRIC Device to 32 member countries and seven cooperating countries of the european economic area, under ...
Tags: AMTAC, CE Mark, medical device
Arena Pharmaceuticals and Eisai have announced FDA approval of Belviq (lorcaserin HCl) for chronic weight management in adults who are overweight with comorbidity or obese. The FDA approved Belviq as an adjunct to a reduced-calorie diet ...
Tags: Belviq, lorcaserin HCl, chronic weight management, Arena Pharmaceuticals
Takeda Pharmaceutical Company and Millennium: The Takeda Oncology Company have won European conditional marketing authorization for Adcetris (brentuximab vedotin). Adcetris is indicated for use in adult patients with relapsed or ...
Tags: adcetris, antibody-drug conjugate, Brentuximab vedotin, sALCL
Janssen Biotech and Janssen Biologics have submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMA) seeking approval of Simponi ...
Tags: Simponi, golimumab, active ulcerative colitis, anti-tumor necrosis factor
Takeda Pharmaceuticals America (TPA) has signed a contract to supply Omontys (peginesatide) injection to Fresenius Medical Care North America and certain of its affiliates. Omontys (peginesatide) injection is a synthetic, pegylated, ...
Purdue Pharma has announced the availability of Intermezzo sublingual tablet CIV in 1.75mg and 3.5mg dosage strengths for insomnia characterized by middle-of-the-night awakenings followed by difficulty returning to sleep. ...
Tags: Purdue Pharma, Insomnia Drug, Intermezzo sublingual tablet CIV