Aug 18 Portola Pharmaceuticals said on Wednesday its investigational drug AndexXa did not get approval from the U.S. Food and Drug Administration.AndexXa is being developed for patients being treated with a Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.Factor Xa plays a key role in blood coagulation.The FDA also sought additional information related to manufacturing of the drug.Portola is developing drugs related to thrombosis and other hematologic diseases.Portola's shares fell 11 percent to .69 in regular trading on Wednesday, and a further 12 percent in after-hours trade. (Reporting by Bhanu Pratap in Bengaluru; Editing by Sunil Nair)
FDA Grants Soligenix Orphan Drug Designation for Dusquetide for Treatment of Macrophage Activation Syndrome
PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Office of Orphan Products Development of the US Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient dusquetide for treatment of macrophage activation syndrome (MAS). Dusquetide has previously received orphan drug designation for the treatment of acute radiation syndrome (ARS). Dusquetide is an innate defense regulator (IDR), a new class of short, synthetic peptides that accelerates bacterial clearance and resolution of tissue damage while modulating inflammation following exposure to a variety of agents including bacterial pathogens, trauma, radiation and/or chemotherapy.
Three CardioCell-Sponsored Studies Reveal Results at the European Society of Cardiology (ESC) Congress 2016
PRNewswire/ -- EUROPEAN SOCIETY OF CARDIOLOGY CONGRESS 2016 – CardioCell LLC, a global biotechnology company that uses allogeneic stem cells for cardiovascular indications, announces results from three of its sponsored studies are accepted for presentation at ESC Congress. Each study – a Phase IIa clinical trial and two pre-clinical studies – applies CardioCell's unique ischemia-tolerant mesenchymal stem cells (itMSCs) for cardiovascular indications. Visit the presentations as follows:
PRNewswire/ -- Janssen Biotech, Inc. announced today a supplemental Biologics License Application (sBLA) for daratumumab (DARZALEX®) has been submitted to the U.S. Food and Drug Administration (FDA). The application seeks to expand the current indication, using daratumumab in combination with lenalidomide (an immunomodulatory agent) and dexamethasone, or bortezomib (a proteasome inhibitor [PI]) and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. Daratumumab received Breakthrough Therapy Designation from the FDA for this pending indication on
Juniper Pharmaceuticals Reports Results from Phase 2b Clinical Trial of COL-1077 Lidocaine Vaginal Gel in Gynecologic Procedure Pain
PRNewswire/ -- Juniper Pharmaceuticals, Inc. (Nasdaq: JNP) ("Juniper" or the "Company"), a women's health therapeutics company, today announced that a recently completed Phase 2b clinical trial evaluating its 10% lidocaine bioadhesive vaginal gel, COL-1077, for the reduction of pain intensity in women undergoing an endometrial biopsy with tenaculum placement did not achieve its primary and secondary endpoints. The safety and pharmacokinetic (PK) profiles of COL-1077 were consistent with what has been observed in prior clinical trials of the lidocaine bioadhesive vaginal gel.
nVivo Therapeutics Announces Fifth Patient Conversion in INSPIRE Study of the Neuro-Spinal Scaffold™
InVivo Therapeutics Holdings Corp. (NVIV) today announced that the ninth patient implanted with the Neuro-Spinal Scaffold™ in the INSPIRE study has improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury in the time between the two- and three-month evaluations. This is the fifth out of the eight patients (62.5% conversion rate) in follow-up to have had an AIS grade improvement to date. Several large natural history databases indicate that fewer than 16% of patients with complete thoracic injuries have an AIS grade improvement by six months post-injury.* Historical conversion rates are lowest for patients with high thoracic (T2-T5) injuries, with fewer than 8% of patients converting by six months post-injury. The neurological level of injury for this patient was T4.
Mayne Pharma Acquires Rights to a Portfolio of Dermatology Foam Products Including Fabior® and Sorilux®
GREENVILLE, N.C.--(BUSINESS WIRE)--Mayne Pharma (ASX: MYX) is pleased to announce it has acquired a portfolio of on-market dermatology Foam Assets from GSK for US.1 million. The Foam Assets include US rights to Fabior and Sorilux, Canadian rights to Luxiq® and Olux-E® and Mexican rights to betamethasone foam. Under the terms of the agreement Mayne Pharma will acquire the approved regulatory filings, trademarks, marketing materials, select product inventory, related medical and technical data and will acquire or obtain licenses for related patents.
European Commission Grants Marketing Authorization for Teva’s CINQAERO® (reslizumab)
JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the European Commission has granted marketing authorization for CINQAERO® (reslizumab) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. CINQAERO® is a humanized interleukin-5 antagonist monoclonal antibody for add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus another medicinal product for maintenance treatment. For more information, visit www.tevapharm.com.
Inspyr Therapeutics Announces the Initiation of a Phase 2 Clinical Trial of Mipsagargin for Newly Diagnosed Prostate Cancer Patients
SAN ANTONIO--(EON: Enhanced Online News)--Inspyr Therapeutics, Inc. (OTCQB: NSPX), a biotech company developing a novel prodrug therapeutic for the treatment of cancer, today announced that the first patient has been treated in a Phase 2 investigator-sponsored clinical trial to evaluate the safety and activity of mipsagargin in patients newly diagnosed with prostate cancer. The trial is being conducted at The University of Texas Health Science Center (UTHealth) at Houston with Robert Amato, D.O., Professor and Director, University of Texas/Memorial Hermann Cancer Centers, as principal investigator. Mipsagargin is a first-in-class agent with a novel mechanism of action that targets prostate-specific membrane antigen (PSMA), a highly expressed enzyme on the surface of prostate cancer cells.
Fresenius Kabi Announces Major Investment in U.S. Manufacturing Expansion of Melrose Park, Illinois Site Will Create State-of-the-Art Urban Manufacturing Campus
LAKE ZURICH, Ill.--(EON: Enhanced Online News)--Fresenius Kabi announced today it will invest approximately 0 million over 10 years to expand the company’s Melrose Park site which manufactures generic, sterile injectable pharmaceuticals used in hospitals and clinics throughout the United States. The expansion of the current Melrose Park site into a manufacturing campus is a multi-stage, multi-year project with ground breaking planned for 2017 and final project completion in 2026.
Magnetic Surgical System by Levita Magnetics Receives FDA Clearance Breakthrough technology obtains de novo clearance for use in gallbladder surgery
SAN MATEO, Calif.--(EON: Enhanced Online News)--Levita Magnetics, a medical technology company, today released a first-of-its-kind magnetic surgical system. The platform, which recently received CE Mark and FDA clearance, represents one of the key surgical advancements in the last decade. Initially indicated for gallbladder removal surgery, it is used to magnetically retract and maneuver the gallbladder, reducing the number of incisions. Magnetic surgery is so unique that the FDA created a new category to accommodate this technology.