Medical Tidbits,Bayer Submits New Drug Application for LCS-16 for Pregnancy Prevention for up to Five Years

pregnant women

WHIPPANY, N.J., Nov. 20, 2015 /PRNewswire/ — Bayer HealthCare Pharmaceuticals announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration seeking approval for LCS-16, an investigational hormonal intrauterine device (IUD) for pregnancy protection for up to five years.

The submission is based on data from the Phase III clinical trials which included 574 nulliparous and 878 parous women from North America and several European countries. The primary endpoint of the Phase III clinical trial program was contraceptive efficacy assessed by the Pearl Index read more

Vertex Receives EU Approval for ORKAMBI(R) (lumacaftor/ivacaftor), the First Medicine to Treat the Underlying Cause of Cystic Fibrosis in People Ages 12 and Older with Two Copies of the F508del MutationVertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the European Commission has granted Marketing Authorization for ORKAMBI® (lumacaftor/ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF) in people ages 12 and older who have two copies of the F508del mutation. In Europe, there are approximately 12,000 people with CF ages 12 and older who have two copies of this mutation. Vertex will now begin the country-by-country reimbursement approval process across the European Union (EU).  read more

Cambridge Medical Robotics Limited (“CMR” or the “Company”): Successful Demonstration of Prototype Universal Robotic Surgical System

CAMBRIDGE, England–(BUSINESS WIRE)–Cambridge Medical Robotics Ltd, the private company developing a next-generation robotic system for universal minimal access surgery, today announces the completion of its surgical system prototype.

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Walgreens Earns Top Marks in 2015 Corporate Equality Index

Walgreens Earns 100 percent Score for the 11th Year on Human Rights Campaign Foundation’s 14th Annual Scorecard on LGBT Workplace Equality

November 19, 2015 05:24 PM Eastern Standard Time

DEERFIELD, Ill.–(BUSINESS WIRE)–Walgreens received a perfect score of 100 percent on the 2016 Corporate Equality Index (CEI), a national benchmarking survey and report on corporate policies and practices related to LGBT workplace equality, administered by the Human Rights Campaign Foundation. This marks the 11th year Walgreens has earned a perfect score from the CEI index. read more

Advanced Bionics Receives TÜV Approval for the Naída CI Q Series of Sound Processors

— The world’s newest, most advanced family of sound processors for cochlear implant recipients is now approved in Europe —

VALENCIA, Calif.–(BUSINESS WIRE)–Advanced Bionics (AB), a global leader in cochlear implant technology and a company of the Sonova Group, announced today that the Naída CI Q30 and Q90 sound processors* have received TÜV approval, following FDA and Health Canada approval earlier this year. The Naída CI Q Series delivers advanced technology in automation, noise reduction, phone use, and waterproof protection. AB’s newest version of fitting software, SoundWave™ 2.3, also received approval. read more

Moffitt Cancer Center and Ignyta, Inc. Enter into Cancer Research Collaboration for RXDX-106

TAMPA, Fla. & SAN DIEGO–(BUSINESS WIRE)–Moffitt Cancer Center and Ignyta, Inc. (NASDAQ: RXDX) announced today that they have entered into a research collaboration relating to RXDX-106, Ignyta’s small molecule, pseudo-irreversible inhibitor of TYRO3, AXL, Mer (TAM) and cMET that is in late stage preclinical development. The collaboration, which will be conducted in the labs of Eric B. Haura, M.D., director of the Lung Cancer Center of Excellence and leader of the Chemical Biology and Molecular Medicine Program at Moffitt, will explore and develop novel protein based diagnostic assays that can assess RXDX-106 signaling activity in relevant solid tumors and associated tumor microenvironments. read more

Medtronic Statement on U.S. Department of Treasury’s Notice 2015-79

DUBLIN – Nov. 20, 2015 – Medtronic plc (NYSE:MDT) has conducted a preliminary review of the United States Department of Treasury’s Notice 2015-79, issued on November 19, 2015, which is aimed at addressing certain aspects of transactions known as “tax inversions.”  Medtronic has concluded that the actions announced in Notice 2015-79 do not have a material financial impact on the company.   Medtronic will continue to more fully assess Notice 2015-79 and will provide appropriate disclosure concerning any potential material impact on the company as necessary. read more

ImmunoCellular Therapeutics Presents Updated ICT-107 Phase 2 Survival and Immune Response Data at the Society for Neuro-Oncology Annual Meeting 2015

LOS ANGELES, Nov. 20, 2015 /PRNewswire/ — ImmunoCellular Therapeutics, Ltd. (“ImmunoCellular”) (NYSE MKT:IMUC) announced the presentation today of recently updated overall survival (OS) results and immune response data from the phase 2 trial of ICT-107 in patients with newly diagnosed glioblastoma. ICT-107 is a dendritic cell-based immunotherapy targeting multiple tumor-associated antigens on glioblastoma stem cells. The data are being presented at the 20th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology, being held in San Antonio, TX. The data from the phase 2 trial continue to indicate a survival advantage in the ICT-107 treated group compared to the control group. The data also show a significant association between immune response and survival, especially in HLA-A2 positive (HLA-A2+) patients, which is the target patient population for the phase 3 registration trial. read more

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