Medical Tidbits,American Medical Association Supports Telemedicine Bill

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The American Medical Association (AMA) today supported the bipartisan Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act to expand the use of telemedicine to achieve quality care for patients.

The bill reflects the AMA’s belief that that the appropriate use of telemedicine can greatly improve access to quality care while maintaining patient safety. According to an independent study , the bill could save $1.8 billion over 10 years.

“This legislation has the potential to remove barriers to new health care delivery models that promote coordinated and patient-centered care.  Importantly, the bill aims to maintain high standards whether a patient is seeing a physician in an office or via telemedicine,” said AMA President Steven J. Stack, M.D. “Telemedicine can strengthen the patient-physician relationship and improve access for patients with chronic conditions and limited access to quality care. The AMA’s guiding principles on telemedicine seek to foster innovation while promoting quality care.”

The bipartisan sponsors see telemedicine as a way to broaden health care, reaching populations that struggle with access.

“This bill shows Congress at its best – combining deep thinking, hard work, compromise and bipartisanship. In the end, the bill could improve health outcomes and save money. We look forward to working with other supporters to advance this important legislation in Congress,” Stack said.

Valby, Denmark and Osaka, Japan, 4 February 2016 H. Lundbeck A/S (Lundbeck) and Takeda Pharmaceutical Company Limited (Takeda) today announced that the U.S. Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted 8 to 2 that the companies presented substantial evidence to support the effectiveness of Brintellix (vortioxetine) for treating certain aspects of cognitive dysfunction in adults with Major Depressive Disorder (MDD). Earlier today, the committee also discussed that cognitive dysfunction in MDD represents an appropriate drug development target. read more

American Diabetes Association® Survey Shows Summer Camp Can Positively Impact Children’s Disease Management Skills, Confidence and Stress

INDIANAPOLIS and ALEXANDRIA, Va., Feb. 3, 2016 /PRNewswire/ — A three-year survey by the American Diabetes Association (Association) shows attending summer camp can do much more than lift the spirits of children with type 1 diabetes. Surveys conducted with caregivers before and after their child attended an Association camp found the experience can increase some children’s diabetes knowledge, self-confidence, diabetes management and emotional well-being while enjoying traditional camp activities.

To help more children with diabetes experience these positive outcomes, Lilly Diabetes has once again made a commitment to the Association’s “Campership” program. The company today announced a donation of $93,000 for camp scholarships – $1,000 for each year Lilly has helped those living with diabetes since introducing the world’s first commercial insulin in 1923. Since 2008, Lilly Diabetes has donated $716,000 to the Campership program, which awards scholarships based on financial need. The donations have helped hundreds of children with diabetes attend special summer camps supported by staff and medical professionals who oversee and assist campers with daily diabetes care.  read more

Labeling update (sections 5.1 and 4.4) provides description of controlled clinical study of Abilify Maintena for treating adult patients experiencing acute relapses of schizophrenia. Positive opinion was based on Abilify Maintena demonstrating efficacy, tolerability and safety in a 12-week study in acutely relapsed adults with schizophrenia

(GLOBE NEWSWIRE) — H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Europe Ltd. (Otsuka)  today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for a type-II variation related to the update of the European summary of the product characteristics (SmPC) for Abilify Maintena.

The update of the SmPC includes new Abilify Maintena data related to its effect and safety on acutely relapsed adults with schizophrenia. The application was submitted to the European Medicines Agency (EMA) and the assessment started end November 2015.

Abilify Maintena is indicated for maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole and the new data will support the physician in transitioning patients to the prolonged release formulation after symptom control has been achieved. Abilify Maintena should not be used to manage acutely agitated or severely psychotic states when immediate symptom control is warranted. read more

Nomination Committee appointed in respect of AGM 2016 in Camurus Lund — 4 February 2016 — According to the instruction for Nomination Committee in Camurus AB adopted at the extraordinary general meeting held on 15 October 2015, the Nomination Committee for the annual general meeting 2016 shall be composed of representatives of the three largest shareholders in terms of voting rights as of 31 December 2015, along with the Chairman of the Board of Directors. The composition of the Nomination Committee has now been established, and Camurus today announced that the Nomination Committee in respect of the AGM 2016 consists of the following persons who together represent approximately 67 percent of the number of shares and votes in the company based on the last known shareholder information. read more

Osiris Therapeutics Announces Leadership Transition

COLUMBIA, Md.–(BUSINESS WIRE)–Osiris Therapeutics, Inc. (NASDAQ: OSIR), a leading cellular and regenerative medicine company focused on developing and marketing products to treat conditions in wound care, orthopaedics and sports medicine, announced today that Dwayne Montgomery, its current Chief Business Officer, has been appointed today to serve as Interim Chief Executive Officer. Frank Czworka, currently Vice President and General Manager of Wound Care, has been promoted to Chief Operating Officer. Mr. Montgomery will replace Dr. Lode Debrabandere who today has announced his resignation for personal reasons from Osiris. read more

SynteractHCR Begins 2016 at U.S. and European Events Focused on Improving Clinical Trial Processes

SAN DIEGO–(BUSINESS WIRE)–Full-service contract research organization (CRO) SynteractHCR will exhibit at the 2nd annual DPharm Europe: Disruptive Innovations to Advance Clinical Trials event Feb. 9-10 in London, and will also present and exhibit at Outsourcing in Clinical Trials West Coast 2016 (OCT West Coast) Feb. 10-11 in San Mateo, Calif. The company’s growing international footprint, particularly in the U.S. and Europe, necessitates sharing intellectual capital at global industry events in 2016.



Asterias Biotherapeutics Receives Orphan Drug Designation for AST-OPC1 for the Treatment of Acute Spinal Cord Injury

FREMONT, Calif., Feb. 4, 2016 /PRNewswire/ — Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company focused on the emerging field of regenerative medicine, today announced receipt of Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its product development candidate, AST-OPC1, for the treatment of acute spinal cord injury. read more


On World Cancer Day, ESMO, the leading European professional organisation for medical oncology, puts cancer patients centre stage by organising a workshop dedicated to exploring ways that advocacy networks can drive research. The workshop will take place in Brussels 5-7 February.

“Patients are the largest under-used resource of our health systems,” said Dr Bettina Ryll, Sweden, Chair of the ESMO Patient Advocates Working Group. “They play a crucial role in adequately capturing patient needs and influencing change, such as equitable and sustainable access to therapies; patient-centric clinical trial designs and direct contribution to pharmacovigilance in order to increase the safety of medicines by reporting side-effects.” read more

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