Industry News

- Read more about GSK file US approval for once-daily closed triple combo therapy FF/UMEC/VI for patients with COPD
GlaxoSmithKline plc and Innoviva, Inc. announced the filing by GSK of a regulatory submission with the US Food and Drug Administration for the once-daily, closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg) for patients with chronic obstructive pulmonary disease (COPD). This follows the announcement earlier this year of plans to bring forward the timing of the US filing from the first half of 2018.
- Read more about GSK begin phase III programme with daprodustat for anaemia associated with chronic kidney disease
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
- Read more about AiMeD Applauds Government's Move of Asking RBI to Examine Foreign Investments in Medical Devices Sector
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.
- Read more about iX Biopharma's WaferiX drug delivery technology get South African patent
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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- Read more about FDA Approval Sanofi’s Soliqua™ 100/33, for the Treatment of Adults with Type 2 Diabetes
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.
- Read more about Allergan get FDA Clearance for the XEN® Gel Stent
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.
- Read more about Allergan acquires Chase Pharmaceuticals for $125 million
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.
- Read more about U.S. FDA Grants Fast Track Designation to Oragenics’ AG013 for Oral Mucositis
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.
- Read more about SuperSonic Imagine’s Aixplorer® Ultrasound System Added to Knoxville Comprehensive Breast Center
SuperSonic Imagine announced the installation of its flagship Aixplorer ultrasound system at Knoxville Comprehensive Breast Center in Tennessee. The Aixplorer system provides premium breast imaging and unique innovations including real-time ShearWave™ Elastography (SWETM).
- Read more about Novartis acquires Selexys Pharmaceuticals Corporation
Novartis announced it has acquired Selexys Pharmaceuticals Corporation, a company specializing in development of therapeutics in certain hematologic and inflammatory disorders. Novartis exercised its right to acquire Selexys following receipt of results of the SUSTAIN study, a Phase II trial evaluating the use of SelG1, an anti-P-selectin antibody, in the reduction of vaso-occlusive pain crises in patients with sickle cell disease (SCD). Results from the study will be presented during the Plenary Scientific Session at the 58thAmerican Society of Hematology (ASH) Annual Meeting on December 4, 2016, in San Diego, California.