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Health care innovators recognized by the AMA’s inaugural Healthier Nation Innovation Challenge

Excellent examples of innovation that can help shape 21st century medicine were recognized as the American Medical Association (AMA) announced three teams of health care entrepreneurs selected to share $50,000 in prizes awarded by theAMA’s Healthier Nation Innovation Challenge .

In addition to $50,000, winners will gain access to the AMA’s network of partners that specialize in strategy and design support for entrepreneurs and startups, including Business Models, Inc., Edge One Medical, Healthbox, MATTER, MU/DAI and Techstars. read more

AMA Adopts New Guidance for Ethical Practice in Telemedicine

CHICAGO – New ethical guidance adopted today at the American Medical Association’s (AMA) Annual Meeting will help physicians understand how their fundamental responsibilities may play out differently when patient interactions occur through telemedicine, compared to traditional patient interactions at a medical office or hospital.

The new ethical guidance on telehealth and telemedicine was developed over the past three years by the AMA’s Council on Ethics and Judicial Affairs, and adopted by a vote of physicians from every corner of the country. The development of the new guidelines coincides with innovations in technology that are changing the ways in which people live their lives, including reshaping the ways they engage with medicine. read more

Victoza® significantly reduced the risk of major cardiovascular events and death in adults with type 2 diabetes in the LEADER trial  Novo Nordisk today announced that Victoza® (liraglutide) significantly reduced the risk of the composite primary endpoint of cardiovascular (CV) death, non-fatal myocardial infarction (heart attack) or non-fatal stroke by 13% vs placebo (95% confidence interval [CI]: 0.78; 0.97, p=0.01), when added to standard of care in 9,340 adults with type 2 diabetes at high CV risk. The main results of the LEADER trial were presented today at the American Diabetes Association’s 76th Scientific Sessions (ADA 2016) and also published in the New England Journal of Medicine (ref 1, 2). Victoza® is the only approved GLP-1 receptor agonist to demonstrate a superior reduction of major CV events vs placebo, both on top of standard of care, in a cardiovascular outcomes trial.

There was a significant 22% reduction in cardiovascular death with Victoza® treatment vs placebo (95% CI: 0.66; 0.93, p=0.007) and reductions in non-fatal myocardial infarction (HR=0.88, 95% CI: 0.75; 1.03, p=0.11) and non-fatal stroke (HR=0.89, 95% CI: 0.72; 1.11, p=0.30).(ref 1, 2)

“These findings are exciting, as it demonstrates that Victoza® can improve outcomes beyond glucose reduction and weight loss by helping to avoid cardiovascular complications and death in people with type 2 diabetes,” said Dr John Buse, chairman of the LEADER Steering Committee and chief of Endocrinology and director of the Diabetes Care Centre at the University of North Carolina School of Medicine. “Type 2 diabetes treatments that can also reduce cardiovascular risk are important since cardiovascular disease is the leading cause of death worldwide in this patient population.”

Amgen Announces FDA Advisory Committee Meeting To Review ABP 501, A Biosimilar Candidate To Adalimumab
THOUSAND OAKS, Calif. , June 13, 2016 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration ( FDA ) will review data supporting the Company’s Biologics License Application (BLA) for ABP 501, a biosimilar candidate to Humira® (adalimumab).

“With our heritage in both rheumatology and dermatology, we are committed to providing physicians and patients a variety of biologic options, which are critical for the long-term management of these serious diseases,” said Sean E. Harper , M.D., executive vice president of Research and Development at Amgen . “We look forward to discussing the comprehensive data package for ABP 501 with the members of the Committee.”

The Committee will review analytical, clinical and pharmacokinetic data from studies involving ABP 501, including results from two Phase 3 comparative efficacy and safety studies conducted in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. The Phase 3 studies met their primary endpoints showing clinical equivalence to adalimumab. Safety and immunogenicity of ABP 501 were also comparable to adalimumab. Data to support the transition of adalimumab patients to ABP 501 are included in the submission.

The FDA has set a Biosimilar User Fee Act (BsUFA) target action date of Sept. 25, 2016 for ABP 501.

Aarti Shah named chief information officer

INDIANAPOLIS, June 13, 2016 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced the promotion of Aarti Shah, Ph.D., to senior vice president and chief information officer effective July 1. She has been the global brand development leader for immunology since 2013.

Shah joined Lilly in 1994 as a senior statistician after completing her doctorate in applied statistics from the University of California, Riverside. During her career at Lilly, she has held many technical and administrative leadership positions, both in the United Statesand abroad, including serving as vice president for biometrics and advanced analytics and as executive director of global information sciences.

In her new role, she will lead the efforts of a worldwide IT organization with more than 1,300 employees, in addition to many contractors and external business partners, to deliver innovative IT solutions to the business. She will report to Derica Rice, Lilly’s executive vice president of Global Services and chief financial officer.

Zecuity (sumatriptan) Migraine Patch: UPDATED Drug Safety Communication – FDA Evaluating Risk of Burns and Scars

 UPDATED 06/13/2016: Zecuity manufacturer Teva Pharmaceuticals has decided to temporarily suspend sales, marketing, and distribution to investigate the cause of burns and scars associated with the Zecuity patch.  Health care professionals should discontinue prescribing Zecuity, and patients should stop using any remaining patches and contact their prescribers for an alternative migraine medicine.  Please refer to the Dear Health Care Provider letter and the updated Drug Safety Communication for more information.

EISAI PRESENTS LATEST PHASE I/II DATA ON IN-HOUSE DEVELOPED ANTI-FRACTALKINE ANTIBODY E6011 RESULTS SUGGEST SAFETY, TOLERABILITY AS WELL AS CLINICAL ACTIVITY IN RHEUMATOID ARTHRITIS AND CROHN’S DISEASE

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that interim analyses on the latest data for the world’s first anti-fractalkine monoclonal antibody E6011, discovered by Eisai’s research subsidiary KAN Research Institute Inc. (Headquarters: Hyogo, President and Representative Director: Toshio Imai), from two respective Phase I/II clinical studies in Crohn’s disease and rheumatoid arthritis (Study 101 and Study 103) showed positive results for safety and tolerability, and exploratory assessment suggested clinical activity for E6011. These data have been presented at a number of recent academic conferences.
Merck and Pfizer Announce Two Pivotal Phase 3 Studies for Ertugliflozin, an Investigational SGLT-2 Inhibitor, Met Primary Endpoints, Showing Significant A1C Reductions in Patients with Type 2 Diabetes | Pfizer: One of the world’s premier biopharmaceutical companies

  • Ongoing CV Outcomes Trial of Ertugliflozin Expanded to Test for Superiority in CV Risk Reduction
 Merck (NYSE:MRK), known as MSD outside the United States and Canada, in partnership with Pfizer Inc. (NYSE:PFE), today announced that two Phase 3 studies (VERTIS Mono and VERTIS Factorial) of ertugliflozin, an investigational oral SGLT-2 inhibitor for the treatment of patients with type 2 diabetes, met their primary endpoints. The study results showed statistically significant reductions in A1C (a measure of average blood glucose) for both ertugliflozin doses tested (5 mg and 15 mg daily). These results from the VERTIS clinical development program of ertugliflozin will be presented for the first time at the 76th Scientific Sessions of the American Diabetes Association, which are being held in New Orleans from June 10-14, 2016.

PSR Orphan Experts and Raremark announce strategic partnership in rare disease

HOOFDDORP, The Netherlands & LONDON–(BUSINESS WIRE)–PSR Orphan Experts, a specialty orphan drug consulting and clinical research company, and Raremark, a new online service for families affected by rare disease, today announced a strategic partnership to accelerate the development of new treatments. read more

Taiga Biotechnologies Awarded Orphan Drug Designation for Stem Cell Therapy

Protein treated cells could improve bone marrow transplant

AURORA, Colo.–(EON: Enhanced Online News)–The Food and Drug Administration has given Taiga Biotechnologies Inc. Orphan Drug Designation for an experimental product designed to treat children with a rare immune deficiency that forces them to live in a sterile environment. read more

 

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