Pharma News

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.

GenMark Diagnostics, Inc., a leading provider of automated, multiplex molecular diagnostic testing systems, has submitted 510(k) applications to the FDA for its ePlex sample-to-answer instrument and Respiratory Pathogen Panel.

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.

With an aim to promote patient safety by ensuring presence of pharmacists in healthcare delivery of the state, the Maharashtra Registered Pharmacists Association (MRPA) has demanded the implementation of Pharmacy Practice Regulations (PPR) 2015. MRPA submitted a memorandum to Maharashtra Department of Medical Education and Research (DMER)  Minister Girish Mahajan in this regards governing Maharashtra State Pharmacy Council (MSPC) which is responsible for implementation of PPR 2015.

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.

By protesting the decision of Department of Pharmaceuticals (DoP) to consider Coronary stents in DPCO 2013, Medical Technology Association of India (MtaI) has requested the government to have a holistic view on the decision by involving all the concerned stakeholders i.e. hospitals, physicians, companies in the discussion on price regulations to arrive at a decision which is best for patient health. MTaI also requested to create a vibrant environment for the medical device sector to make innovative therapies accessible to patients and uphold & strengthen the state of healthcare already achieved in the country.