Edge Therapeutics Inc., of New Providence, N.J., said the FDA accepted its investigational new drug application for EG-1962, a bio-absorbable nimodipine microparticle formulation

according to the protocol, all patients were to have been treated with both bortezomib and lenalidomide prior to study entry...Based on the positive results GSK said it is planning to make regulatory submissions in Europe, the U.S., as well as other regions during the next few

Bristol-Myers Squibb Co., of Princeton, N.J., and AstraZeneca plc, of London, said the FDA accepted for review and granted priority designation for the biologics license application for metreleptin in metabolic disorders associated with inherited or acquired lipodsytrophy

BioMarin Pharmaceutical Inc., of San Rafael, Calif., said the FDA accepted for review the biologics license application for Vimizim (BMN-110, elosulfase alfa), an enzyme replacement therapy under evaluation for the treatment of patients with the rare lysosomal storage disorder mucopolysaccharidosis Type IVA, also called Morquio A syndrome

Teva Pharmaceutical Industries Ltd., of Jerusalem, said the FDA accepted for review the company's supplemental new drug application for Copaxone (glatiramer acetate injection) 40 mg/1mL, a higher concentration dose designed to offer a less frequent three-times-per-week dosing schedule for patients with relapsing-remitting multiple sclerosis

Seattle Genetics Inc., of Bothell, Wash., said the FDA accepted for filing its supplemental biologics license application supporting the use of Adcetris (brentuximab vedotin) for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma (HL) and systemic anaplastic large-cell lymphoma (sALCL

Biogen Idec Inc., of Weston, Mass., said the FDA accepted the firm's biologics license application for Eloctate (recombinant Factor VIII Fc fusion protein) for the treatment of hemophilia A. The application was based on results from the A-LONG program, showing that patients who injected Eloctate once weekly to twice weekly had low annualized bleeding rates

plc, of Dublin, Ireland, said the FDA accepted its supplemental new drug application for Vascepa (icosapent ethyl) capsules for use as an adjunct to diet in treating high triglycerides

plc, of Bedminister, N.J., and Dublin, Ireland, said the FDA accepted its supplemental new drug application for Vascepa (icosapent ethyl) capsules for use as an adjunct to diet in treating high triglycerides

to begin a Phase IIa trial of BL-8040, a selective antagonist of chemokine receptor CXCR4, in acute myeloid leukemia (AML...According to the terms, Shasun will be able to use the Debiopharm technology to manufacture synthetic Huperzine-A under GMP quality conditions and commercialize it in pharmaceutical and nutraceutical markets...In other news, GSK experienced manufacturing delays for manufacture and supply of Horizant (gabapentin enacarbil), partnered with XenoPort Inc., of Santa Clara, Calif

The FDA accepted a new drug application from Otsuka Pharmaceutical Co

Bayer HealthCare Pharmaceuticals Inc., of Wayne, N.J., said the FDA accepted for filing and granted priority review to its new drug application (NDA) for oral investigational compound riociguat in chronic thromboembolic pulmonary hypertension (CTEPH) that is inoperable or persistent or recurrent CTEPH after pulmonary endarterectomy and pulmonary arterial hypertension

Ampio Pharmaceuticals Inc., of Greenwood Village, Colo., said the FDA accepted its patient outcome for premature ejaculation (POPE) questionnaire, a modification of the premature ejaculation profile questionnaire that was used in two successful European Phase III trials of sexual dysfunction drug Zertane

AMAG Pharmaceuticals Inc., of Lexington, Mass., said the FDA accepted for review its supplemental new drug application (sNDA) for Feraheme (ferumoxytol) injection for intravenous use

The FDA accepted a biologics license application from Biogen Idec, of Cambridge, Mass., for marketing approval of recombinant factor IX Fc fusion protein for hemophilia B, granting a standard review timeline

Iroko Pharmaceuticals LLC, of Philadelphia, said the FDA accepted for review the new drug application (NDA) for lower-dose submicron diclofenac, a nonsteroidal anti-inflammatory drug, with a proposed indication of treatment of mild to moderate acute pain in adults

Sunovion Pharmaceuticals Inc., of Marlborough, Mass., said the FDA accepted for review its new drug application (NDA) for Stedesa (eslicarbazepine acetate) for use as a once-daily adjunctive therapy in the treatment of partial-onset seizures in patients 18 years and older with epilepsy

To date, 150 patients out of a total of 200 patients have already been recruited in 16 centers in Germany, Austria and Israel...The goal is to modulate the half-life of the therapy to increase efficacy of treatment...The company intends to start clinical trials in the third quarter

Zealand Pharma A/S, of Copenhagen, Denmark, said partner Sanofi SA, of Paris, reported that the FDA accepted for review a new drug application for lixisenatide, a once-daily prandial glucagon-like peptide-1 receptor agonist, for the treatment of adults with Type II diabetes mellitis