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
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
- Ongoing CV Outcomes Trial of Ertugliflozin Expanded to Test for Superiority in CV Risk Reduction
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