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Amgen announced that the US Food and Drug Administration has approved the supplemental Biologics License Application (sBLA) for the expanded use of Enbrel (etanercept), making it the first and only systemic therapy to treat pediatric patients (ages 4-17) with chronic moderate-to-severe plaque psoriasis.
By removing the protein galectin-3 (Gal3), a team of investigators led by University of California School of Medicine researchers were able to reverse diabetic insulin resistance and glucose intolerance in mouse models of obesity and diabetes.
B12 deficiency during pregnancy may predispose children to metabolic problems such as type-2 diabetes, according to research presented today at the Society for Endocrinology's annual Conference in Brighton. These findings could lead to a review of current vitamin B12 requirements for pregnant women, whether through an improved diet or supplements.
Takeda Pharmaceutical Company Limited announced that it will present a total of 16 company-sponsored abstracts at the 58th American Society of Hematology (ASH) Annual Meeting taking place in San Diego from December 3 to 6, 2016. Takeda’s presentations at this year’s meeting will feature phase 3 and earlier-stage data from clinical studies across the company’s broad haematology-oncology portfolio.
Pharma Major Lupin Limited (Lupin) announced that it has received final approval for Norgestimate and Ethinyl Estradiol Tablets USP, 0.25 mg/0.035 mg from the United States Food and Drug Administration (FDA) to market a generic version of Janssen Pharmaceuticals, Inc.’s Ortho-Cyclen® 28 Tablets (Norgestimate/Ethinyl Estradiol). The approved product will be manufactured at Lupin’s Pithampur facility.
Cempra, Inc. announced that the majority of the U.S. Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted (7-6) that efficacy results of Cempra's solithromycin outweigh the risks for the treatment of community-acquired bacterial pneumonia (CABP).
AbbVie announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to veliparib, an oral poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, being investigated in combination with chemotherapies, such as carboplatin and paclitaxel, or radiation for the treatment of advanced squamous non-small cell lung cancer (NSCLC).
The US regulatory department is all set to launch criminal report against 14 generic pharmaceuticals for conspiring to set medicine prices.
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.
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).
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