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GlaxoSmithKline plc announced the start of a phase III development programme investigating daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), as a treatment for anaemia associated with chronic kidney disease (CKD).
The phase III programme includes two studies evaluating the safety and efficacy of daprodustat compared to recombinant human erythropoietin
The Association of Indian Medical Device Industry (AiMeD) has applauded Govt’s move that comes in the wake of Finance Ministry urging RBI to undertake an audit of all investments made in medical device sector over policy loopholes and confusion over definitional distinction between medical device and pharma sector leading to increased vulnerability of Indian pharma companies and no real gains for domestic medical device manufacturing.
Homegrown specialty pharmaceutical company iX Biopharma Ltd. (iX Biopharma) is announced that the company has been granted a patent in South Africa (no. 2014/00310) for its WaferiX drug delivery technology. The patent will expire on 26 October 2030.
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Sanofi announced that the U.S. Food and Drug Administration (FDA) approved once-daily Soliqua™ 100/33 (insulin glargine & lixisenatide injection) 100 Units/mL & 33 mcg/mL for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 Units daily) or lixisenatide.
Allergan plc announced the U.S. Food and Drug Administration (FDA) has cleared the XEN® Glaucoma Treatment System (consisting of the XEN45 Gel Stent and the XEN Injector) for use in the U.S. The XEN Glaucoma Treatment System reduces intraocular pressure (IOP) in patients and is indicated for the management of refractory glaucomas, where previous surgical treatment has failed or in patients with primary open angle glaucoma, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy. XEN is implanted through an ab interno approach and reduces IOP by creating a new drainage channel with a permanent implant that becomes flexible. This provides a new treatment option for the millions of Americans with refractory glaucoma.
Allergan plc, a leading global pharmaceutical company, announced has completed the acquisition of Chase Pharmaceuticals Corporation, a clinical-stage biopharmaceutical company focused on the development of improved treatments for neurodegenerative disorders including Alzheimer's disease (AD), Allergan acquired Chase for an upfront payment of $125 million (subject to certain adjustments) and additional potential regulatory and sales milestone payments related to Chase's lead compound, CPC-201, and certain backup compounds.
More than 2 million people got infected by human immunodeficiency virus (HIV) in 2015, being sexual transmission the main channel of infection. Researchers from the Infections of the Respiratory Tract and in Immunocompromised Patients group of the Bellvitge Biomedical Research Institute (IDIBELL), led by Dr. Daniel Podzamczer, have evaluated the speed at which a new antiretroviral drug, Dolutegravir, is able to reduce the viral load in semen, an area of the body considered to be a reservoir of the virus and where access for drugs is more difficult. The results, published in Journal of Infectious Diseases, show the potential of these new treatments to reduce the chances of sexual transmission of the virus.
Pembrolizumab (trade name: Keytruda) was initially introduced for the treatment of melanoma. Since July 2016, the monoclonal antibody has also been available for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults whose tumours express the T-cell receptor ligand PD-L1 and who have received a prior chemotherapy regimen. The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether the drug offers an added benefit over the appropriate comparator therapy also for these patients.
INDIANAPOLIS - A combination of the stimulant drug methylphenidate with a process known as cognitive-behavioral rehabilitation is a promising option to help people who suffer from persistent cognitive problems following traumatic brain injury, researchers at Indiana University School of Medicine have reported.
Oragenics announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to AG013, the Company’s lead therapeutic candidate for the treatment of OM. Oragenics expects to file an Investigational New Drug (IND) update and initiate a Phase 2 study with AG013 in the United States and Europe in early 2017.
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