Industry News

Mithra Pharmaceuticals, a company focused on women’s health, announces that it obtained 14 Marketing Authorizations for the commercialization of its product Tibelia in the United Kingdom, Belgium, Holland, Luxembourg, Spain, Portugal, Germany, Hungary, Poland, Norway, Sweden and Finland. Mithra is still waiting for 3 MA in France, Greece and Italy that should be received by the beginning of 2017. The product based on tibolone developed by Mithra will be more competitive due to its extended shelf-life.

Biohaven Pharmaceutical Holding Company Ltd. (Biohaven), a privately-held biopharmaceutical company, has enrolled the first patient in its potentially pivotal phase 2b/3 clinical trial assessing the efficacy and safety of its drug candidate BHV-4157 in patients with hereditary spinocerebellar ataxia (SCA).

BioCardia, Inc, a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, with clinical programs in heart failure and sub-acute infarction, announced the issuance of United States Patent No. 9,517,199 relating to a method of delivering cells to patients who have chronic myocardial infarcts.

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The U.S. Food and Drug Administration (FDA) approved  Biogen’s SPINRAZA™ (nusinersen) under Priority Review for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. SPINRAZA is the first and only treatment approved in the U.S. for SMA, a leading genetic cause of death in infants and toddlers that is marked by progressive, debilitating muscle weakness.

Cipla Ltd, a global pharmaceutical company, has yielded a final approval for its lead MDI product Fluticasone + Salmeterol (Sereflo) from UK MHRA for its partner in the UK.

Avinger, Inc., a leading developer of innovative treatments for Peripheral Artery Disease (PAD),  announced that the company has received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Lightbox L250 imaging console. With this new FDA clearance, the Lightbox L250 now provides detailed measurement of vessels with a few simple taps to a touch screen, helping further improve visualization inside the vessel before, during, and after Pantheris™ Lumivascular atherectomy procedures for the treatment of PAD.

Eisai Co., Ltd. and Keio University  announced they have entered into a new joint research agreement for the discovery and development of new drugs targeting dementia. For this collaborative research, a research lab will be established, and researchers from Eisai and Keio University will work together to identify and validate novel drug targets and biomarkers that could potentially lead to the development of new therapeutics and preventive medicines for dementia.

Roche announced that the primary endpoint has been met for the phase III HAVEN 1 study evaluating emicizumab prophylaxis in people 12 years of age or older with haemophilia A and inhibitors to factor VIII. The study showed a statistically significant reduction in the number of bleeds over time in people treated with emicizumab prophylaxis compared to those receiving no prophylactic treatment. The study also met all secondary endpoints, including a statistically significant reduction in the number of bleeds over time with emicizumab prophylaxis treatment in an intra-patient comparison in people who had received prior bypassing agent prophylaxis treatment. The most common adverse events with emicizumab were injection site reactions, consistent with prior studies.

Janssen Biotech, Inc. (Janssen) announced the submission of two Supplemental Biologics License Applications (sBLAs) to the US Food and Drug Administration (FDA) seeking approval of Simponi Aria (golimumab) for the treatment of adults living with active psoriatic arthritis and the treatment of adults living with active ankylosing spondylitis (AS).

Biocartis Group NV (‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART),  announced the 510(k) submission to the U.S. Food and Drug Administration (FDA) of its rapid, fully automated molecular diagnostics platform Idylla™, consisting of the Idylla™ Instrument and the Idylla™ Console.