GlaxoSmithKline plc announced results from the paediatric ‘LABA’ (long acting beta2-agonist) safety study. VESTRI (SAS115358) compared Advair® Diskus® (FSC), a combination of the LABA, salmeterol, and the inhaled corticosteroid (ICS), fluticasone propionate (FP), to FP monotherapy in children aged 4 – 11 years. The study assessed the composite endpoint of serious asthma-related events (deaths, intubations or hospitalisations).
Orexigen Therapeutics, Inc. and Takeda Pharmaceuticals U.S.A., Inc., announced they have agreed to terminate the Amended and Restated Collaboration Agreement for CONTRAVE® (naltrexone HCl / bupropion HCl), the market leading national branded prescription treatment option for certain overweight and obese adults for chronic weight management. Completion of the transaction is subject to the parties’ receipt of clearance under the Hart-Scott-Rodino Antitrust Improvement Act (“HSR Act”).
Biopharma major Biocon on Thursday announced that its subsidiary was tying up with a Mexican firm to co-develop generic recombinant human insulin for the US market.
Baxter International Inc. announced enrollment of the first patient in a US clinical trial for VIVIA, an investigational home haemodialysis (HD) system being developed by Baxter and DEKA Research & Development Corporation.
Novimmune, announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to NI-0501 for the treatment of patients with primary HLH with refractory disease, or with recurrent or progressive disease during conventional therapy. NI-0501 is a fully human, anti-interferon-gamma (IFNγ) monoclonal antibody discovered and developed by Novimmune.
Takeda Pharmaceutical Company Limited and Frazier Healthcare Partners announced the formation of Outpost Medicine, a biopharmaceutical company focused on the development of new treatments of urologic and gynaecologic diseases and disorders.
Aralez Pharmaceuticals Inc. announced that it has resubmitted to the U.S. Food and Drug Administration ("FDA") the New Drug Application ("NDA") for its investigational candidate, YOSPRALA™ (PA32540/PA8140) for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
ResApp Health Limited , announced a positive outcome from its recent Pre-Submission Meeting with the United States Food and Drug Administration (FDA) regarding ResApp’s diagnostic mobile software application, ResAppDx.
Aeglea BioTherapeutics, Inc., announced the U.S. Food and Drug Administration (FDA) has accepted the company’s investigational new drug (IND) application for AEB1102 for the treatment of Arginase I deficiency, a urea cycle disorder that results in elevated levels of the amino acid arginine, which can lead to a range of complications including intellectual disability and spasticity.
Celator Pharmaceuticals, Inc. announced positive results from the Phase 3 trial of VYXEOS™ (cytarabine: daunorubicin) Liposome for Injection (also known as CPX-351) in patients with high-risk (secondary) acute myeloid leukemia (AML) compared to the standard of care regimen of cytarabine and daunorubicin known as 7+3. The trial met its primary endpoint demonstrating a statistically significant improvement in overall survival. Data will be submitted for presentation at the American Society of Clinical Oncology 2016 Annual Meeting.
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