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  • The Spectranetics Corporation announced that it has submitted to the Food & Drug Administration (FDA) its Pre-Market Approval (PMA) application for the Stellarex drug-coated angioplasty balloon (DCB). Stellarex is designed to restore and maintain blood flow to the superficial femoral and popliteal arteries in patients with peripheral arterial disease (PAD).

    “The Stellarex DCB has been studied extensively in two randomized controlled trials as part of the rigorous ILLUMENATE series that enrolled more than 1,100 patients,” said Amanda Johnson, Vice President of Regulatory and Medical Affairs. “Key opinion leaders have called the results reported to date ‘remarkable,’ especially in light of Stellarex’s low drug concentration. This PMA application marks a unique and important milestone in the future landscape of treating patients with PAD.”

    President and CEO Scott Drake said, “Stellarex has been called a no-compromise solution with its low drug dosage and top-tier efficacy. The PMA application embodies our commitment to leading the way in clinical science by providing proven treatment algorithms backed by robust clinical evidence. We are preparing diligently for our launch into the United States market, which we anticipate in the second half of 2017, and are looking forward to improving patient care with this next-generation device.”

    Spectranetics launched Stellarex in Europe in January 2015. Stellarex uses EnduraCoat™ technology, a durable, uniform coating designed to prevent drug loss during transit and facilitate controlled, efficient drug delivery to the treatment site. It is not for sale in the United States.


    Stellarex enhances Spectranetics’ diversified suite of clinical solutions to treat complex cardiovascular conditions and expands its market opportunity in the projected USD 1 billion global DCB market.

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  • Roche, a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives, announced that new data from Actemra/RoActemra and Rituxan/MabThera will be presented during the 2016 American College of Rheumatology (ACR) and Association for Rheumatology Health Professionals (ARHP) Annual Meeting from 11-16 November in Washington, D.C, US. These data add to the significant body of evidence for Actemra/RoActemra and Rituxan/MabThera in RA and other serious immune-mediated conditions including GCA, systemic sclerosis (SSc), Takayasu arteritis, granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).

  • Eli Lilly and Company and Incyte Corporation  announced that new data from RA-BEACON - a pivotal phase 3 study of baricitinib in the treatment of moderate-to-severe rheumatoid arthritis (RA) - showed baricitinib demonstrated significant improvement in patient-reported outcomes and health-related quality of life (HRQOL) measures, fatigue and pain compared with placebo. The results of the study were published in Annals of the Rheumatic Diseases. The global trial is part of the ongoing study of baricitinib, a once-daily oral medication currently under regulatory review for the treatment of moderate-to-severe RA.

  • Biocon and Mylan have announced that the European Medicines Agency (EMA) has accepted for review marketing authorization application (MAA) for insulin glargine, a long-acting insulin analog used to treat adults with type 2 diabetes and adults and pediatric patients (children 6 years and older) with type 1 diabetes for the control of high blood sugar.

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  • Pfizer China announced that it has received approval from the Chinese Food and Drug Administration (CFDA) to market its pneumococcal 13-valent conjugate vaccine, Prevenar 13®, in China for active immunization for the prevention of invasive diseases (including bacteremic pneumonia, meningitis, septicemia, and bacteremia) caused by Streptococcus pneumoniae (S. Pneumoniae) serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in infants and children aged 6 weeks to 15 months. S. pneumoniae is the most common cause of invasive disease as well as pneumonia and upper respiratory tract infections

  • Pfizer Inc. announced the discontinuation of the global clinical development programmeme for bococizumab, its investigational Proprotein Convertase Subtilisin Kexin type 9 inhibitor (PCSK9i). The totality of clinical information now available for bococizumab, taken together with the evolving treatment and market landscape for lipid-lowering agents, indicates that bococizumab is not likely to provide value to patients, physicians, or shareholders. As a result, Pfizer has decided to discontinue the development programme, including the two ongoing cardiovascular outcome studies.

  • Allergan plc, a leading global pharmaceutical company, announced that it has successfully completed the acquisition of Tobira Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for non-alcoholic steatohepatitis (NASH) and other liver diseases.

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