Medical Tidbits,St. Jude Medical Furthers the Company’s Legacy of Heart Valve Excellence With US Launch of the Trifecta Surgical Valve With Glide Technology

breaking medical device news

ST. PAUL, Minn.–(BUSINESS WIRE)–St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the U.S. launch of the company’s most advanced tissue valve — the Trifecta™ valve with Glide™ Technology (GT) — for the treatment of patients diagnosed with unhealthy, damaged or malfunctioning aortic heart valves. Designed with feedback from a cohort of international physicians, the Trifecta GT tissue valve offers patients the benefit of enhanced valve delivery to ease implantation in challenging anatomies and during minimally invasive surgical approaches. read more

8 Reasons Why the World Is a Far Better Place Today For Girls Around the Globe

Women Deliver 2016–the largest gathering dedicated to the health, rights and wellbeing of girls and women around the world–kicks off in Copenhagen this week. The goal of the conference? Bring together world and private-sector leaders, policymakers, journalists, advocates, researchers and young people to discuss one big topic–how to make the world a better place for babies, girls and women the world over. read more

Ongoing US study shows that IdeS allows for transplantation of highly sensitized patients

An initial evaluation of the ongoing US study with IdeS at Cedars Sinai Medical Center shows that IdeS completely eliminates donor specific antibodies and allows for kidney transplantation in all sensitized patients. These results are for four patients that were included in the US study as of January 2016. As of today 10 patients have been treated and subsequently transplanted. Initial results from the study will be presented by Professor Stanley Jordan, the study’s principal investigator, at the 2016 American Transplant Congress (ATC) in Boston on June 14 at 6:00 pm. read more

ASTRAZENECA ANNOUNCES POSITIVE RESULTS FROM BENRALIZUMAB
PHASE III PROGRAMME IN SEVERE ASTHMA

Benralizumab first AstraZeneca respiratory biologic to complete Phase III

AstraZeneca today announced that benralizumab, a potential new medicine and anti-eosinophil monoclonal antibody, was well tolerated and achieved the primary endpoint in two pivotal Phase III registrational trials (SIROCCO and CALIMA), demonstrating significant reductions in the annual asthma exacerbation rate compared to placebo.  Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said: “Severe asthma affects the health and quality of life of millions of people around the world, and exacerbations can be life threatening for these patients. We are pleased with the top-line results from these pivotal trials as they demonstrate the potential for benralizumab to improve outcomes for patients with severe asthma. Benralizumab is AstraZeneca’s first respiratory biologic and its development underscores our commitment to transform the treatment of asthma and chronic respiratory disease with our next generation of respiratory medicines.” read more

Novo Nordisk files for regulatory approval in the US of long-acting factor IX for the treatment of haemophilia B

Novo Nordisk today announced the submission to the US Food and Drug Administration (FDA) of the Biologics License Application for the approval of long-acting factor IX, nonacog beta pegol. Nonacog beta pegol is a glycopegylated recombinant factor IX with a significantly improved pharmacokinetic (PK) profile, developed for patients with haemophilia B. read more

Biogen Announces Collaboration with University of Pennsylvania on Multiple Gene Therapy Programs

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Biogen (NASDAQ:BIIB) today announced a broad collaboration and alliance with the University of Pennsylvania (“Penn”) to advance gene therapy and gene editing technologies. The expansive research and translational development collaboration has multiple objectives, but will primarily focus on the development of therapeutic approaches that target the eye, skeletal muscle and the central nervous system (CNS). Another important aspect of the alliance will focus on validating next-generation gene transfer technology using adeno-associated virus (AAV) gene delivery vectors. The collaboration will also explore the expanded use of genome editing technology — the insertion, deletion or replacement of DNA in the genome of an organism — as a potential therapeutic platform. read more

South Korea is first to approve next generation lung cancer treatment olmutinib (BI 1482694 / HM61713)

INGELHEIM, Germany–(EON: Enhanced Online News)–Olmutinib* (BI 1482694 / HM61713) has been approved in South Korea for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer, who had been previously treated with an EGFR tyrosine kinase inhibitor (TKI). The approval represents a first for regulatory authorities in South Korea and is a major breakthrough for patients. The compound will be distributed in South Korea by Hanmi Pharmaceutical Co. Ltd under the name olmutinib. read more

European Scleroderma Trial Investigating Cytori Cell Therapy to Be Presented in Japan

SAN DIEGO & TOKYO–(BUSINESS WIRE)–Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today that on May 18, 2016, an update regarding the French SCLERADEC I and II clinical trials investigating the use of Cytori Cell Therapy in the treatment of scleroderma-related hand dysfunction will be delivered at the 104th Annual Meeting of the Japan Society of Aesthetic Surgery in Tokyo, Japan.  read more

Foundation Medicine Receives Patent Covering Fundamental Methods in Comprehensive Genomic Analysis in Cancer

CAMBRIDGE, Mass.–(EON: Enhanced Online News)–Foundation Medicine, Inc. (NASDAQ:FMI) today announced that the U.S. Patent and Trademark Office has issued U.S. patent number 9,340,830, entitled, “Optimization of Multigene Analysis of Tumor Samples.” The patent, which is assigned to Foundation Medicine, includes fundamental claims describing methods of analyzing a cancer patient’s tissue or blood specimen to detect multiple classes of genomic alterations. The patent carries a term extending to 2032. The company is also pursuing patent applications covering aspects of its genomic analysis platform with the European Patent Office and in other jurisdictions outside the United States.

A New Clinical Study Provides Evidence That Patient-Specific, Virtual Reality Based Preoperative Surgical Simulation Improves Surgical Efficiency for Neurovascular Surgery, Published in Journal of Neurosurgery

CLEVELAND–(BUSINESS WIRE)–Surgical Theater, a world-leader in next-generation medical virtual reality, announces the first clinical research study examining the effects of their technology is now published in one of the leading peer-reviewed journals in the field of neurosurgery, the Journal of Neurosurgery (2016 May 13:1-7, epub ahead of print). read more

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