Medical Tidbits,Novartis Foundation commemorates World Leprosy Day with its continued efforts to go the last mile toward elimination

On World Leprosy Day 2016, the Novartis Foundation calls for a greater global commitment to the fight against leprosy to support efforts towards zero transmission of the disease and to reduce stigma. The Novartis Foundation continues to work with partners around the world on early detection and treatment of leprosy, proactive surveillance, the development of diagnostic tools, and contact tracing with preventative treatment.

“The dream of the Novartis Foundation is that we see the day when the number of people newly diagnosed with leprosy – especially children – is zero,” said Dr. Ann Aerts, Head of the Novartis Foundation. “Though we have seen a large reduction in the prevalence of the disease in the last 30 years, we cannot stop now. The last mile to eliminate leprosy will be tough, and to succeed we need greater awareness, more resources, and innovation. It is important for leprosy to be put back on the global health agenda to make this happen.” read more

Medtronic to Present Data on Micra® Transcatheter Pacing System at Upcoming FDA Advisory Committee Meeting

 – Medtronic plc (NYSE: MDT) will present data on the world’s smallest pacemaker, the Micra® Transcatheter Pacing System (TPS), at the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee on Feb. 18, 2016, in Gaithersburg, Maryland. According to the FDA, the committee will meet to discuss and make recommendations on clinical trial research, post-approval study design, and physician training requirements for leadless cardiac pacemaker device technology.  read more

U.S. FDA APPROVES EISAI’S ANTICANCER AGENT HALAVEN® FOR THE TREATMENT OF ADVANCED LIPOSARCOMA

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that its U.S. subsidiary Eisai Inc. has received approval from the U.S. Food and Drug Administration (FDA) of its in-house developed anticancer agent Halaven® (eribulin mesylate) for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. Halaven is the first and only single agent to demonstrate an overall survival (OS) benefit in a Phase III trial in patients with advanced or recurrent and metastatic soft tissue sarcoma (leiomyosarcoma or liposarcoma). Following approval for use in the treatment of metastatic breast cancer in the United States, this marks the second indication for which Halaven has been approved by the FDA based on a statistically significant extension of OS. read more

Illumina Signs Multiple Biobank Deals

SAN DIEGO–(EON: Enhanced Online News)–Illumina, Inc. (NASDAQ: ILMN) today announced it has signed four separate biobanking deals with Vanderbilt University, University of Colorado at Denver, Partners HealthCare, and Montreal Heart Institute to advance personalized medicine and improve health care. Under the agreements, the large sample collections housed at each institution will be genotyped using Illumina technologies. By combining genomic information with electronic medical records and clinical information, the institutions hope to accelerate discoveries that will improve human health. read more

NORDIC NANOVECTOR AWARDED NOK 15 MILLION FROM THE RESEARCH COUNCIL OF NORWAY TO RESEARCH AND DEVELOP NOVEL TARGETED THERAPEUTICS

Nordic Nanovector ASA (OSE: NANO) is pleased to announce the award of a up to NOK 15 million grant from the Research Council of Norway’s User-driven Research-based Innovation programme (in Norwegian; Brukerstyrt innovasjonsarena, BIA) to support the research and development of novel targeted therapeutics for leukemia  and non-Hodgkin Lymphoma. The award is based on the promising potential for value creation, both for patients and the society at large, as well as for Nordic Nanovector together with the high quality of research and innovation and the company’s international ambitions.

Nordic Nanovector’s Chief Scientific Officer, Jostein Dahle, commented: “This grant funding is important as it enables us to advance early stage research that leverages our expertise in ARC therapies, particularly around CD37-targeted approaches, as a means of developing a broader portfolio of products behind Betalutin® for treating malignant leukaemias and lymphomas.”

Dr. Reddy’s Laboratories Receives USFDA Tentative Approval for Zenavod™ (doxycycline) Capsules, 40 mg for the Treatment of Rosacea in Adults

HYDERABAD, India & PRINCETON, N.J.–(EON: Enhanced Online News)–Dr. Reddy’s Laboratories (BSE: 500124, NSE: DRREDDY, NYSE: RDY), announced today the U.S. Food and Drug Administration (US FDA) tentative approval for Zenavod™ (doxycycline) Capsules, 40 mg. Zenavod is a tetracycline-class drug indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. Promius™ Pharma, LLC, the U.S. subsidiary of India’s Dr. Reddy’s Laboratories will be responsible for commercializing Zenavod in the U.S. market. read more

ACADIA Pharmaceuticals Announces FDA Advisory Committee Meeting to Review NUPLAZID™ (Pimavanserin) for the Treatment of Parkinson’s Disease Psychosis

SAN DIEGO–(BUSINESS WIRE)–ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system (CNS) disorders, today announced that the Psychopharmacologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data included in ACADIA’s New Drug Application (NDA) for NUPLAZID™ (pimavanserin) for the treatment of psychosis associated with Parkinson’s disease. The Advisory Committee Meeting is scheduled for March 29, 2016. read more

Transition Therapeutics Announces Top Line Phase 2 Clinical Study Results of Diabetes Drug Candidate TT401  

TORONTO, Feb. 1, 2016 /PRNewswire/ – Transition Therapeutics Inc. (“Transition” or the “Company”) (NASDAQ: TTHI, TSX: TTH) today announced the results of a Phase 2 clinical study of drug candidate TT401 (LY2944876) for the treatment of type 2 diabetes. TT401 is a once-weekly administered oxyntomodulin analog with dual GLP-1 and glucagon agonist activity. TT401 development collaborator Eli Lilly and Company performed the Phase 2 study enrolling 420 type 2 diabetes subjects into a 24 week study consisting of a 12-week randomized blinded stage followed by a 12-week open-label stage. The study included four once-weekly dose arms of TT401 (10mg, 15mg, 30mg, 50mg), a placebo arm, and an active comparator arm (exenatide extended release – 2mg). read more

Sun Pharma launches Imatinib Mesylate in USA

NEW JERSEY, Feb. 1, 2016 /PRNewswire/ — Sun Pharma announced launch of Imatinib Mesylate Tablets (therapeutic equivalent to Gleevec® for indications approved by the FDA) in the US market. Sun Pharma’s subsidiary received final approval for Imatinib Mesylate from FDA in December 2015. Being a First-to-File product, it was granted 180 days of marketing exclusivity. read more

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