- Local officials excited about development of UNLV School of Medicine, medical district (reviewjournal.com)
University, health and city officials gathered… at Las Vegas City Hall offered an in-depth review of the UNLV School of Medicine’s progress in establishing the...medical school…city officials believe the school is integral to...develop a...medical district in the central valley...The district, established in 1997 to create an area of concentrated medical activity...covers 684 acres with a core 214-acre area between Charleston Boulevard and Alta Drive, from Rancho Drive to Martin Luther King Boulevard...They have invested more than $36 million in infrastructure in four years and expect to pump in another $97 million in 2018 and beyond...The investment…is expected to pay off...By 2030, the medical school is projected to have an economic impact of $1.2 billion...the growth...provides opportunities for collaboration with local physicians and allows the homegrown medical community to grow alongside the needs of the area...
- This Week in Managed Care: January 20, 2017 (ajmc.com)
Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network
- The FDA targeted DTC, video, unapproved drug promotion in 2016 (mmm-online.com)
The FDA is taking a closer look at how drugmakers use channels like direct-to-consumer advertising and video, a shift that has raised questions for pharmaceutical marketers...On its face, the FDA's Office of Prescription Drug Promotion's batch of enforcement letters in 2016 seems par for the course, with the agency issuing a total of 11 letters, compared to 2014's and 2015's totals of nine each. But these letters contain important warnings for drugmakers about the FDA's evolving views on promotion, and what channels, tactics, and drugs it's examining closely…The OPDP...issued two enforcement letters for DTC TV ads developed by Sanofi for its insulin Toujeo and Celgene for its psoriasis drug Otezla. Regulators said the ads were distracting to viewers because they used frequent scene changes — and, in Otezla's case, abrupt changes in music — to distract viewers from presented risk information...These untitled letters were noteworthy because they signal a subtle shift in enforcement actions, with the FDA now examining tactics within DTC ads rather than focusing on bigger, more serious infractions, such as omitting risk information entirely…the FDA saying the viewer couldn't understand it because the imagery was too fast moving or the music was too catchy in the background...
- No new antidepressants in sight despite growing need, experts warn (finance.yahoo.com)
It is likely to be at least 10 years before any new generation of antidepressants comes to market, despite evidence that depression and anxiety rates are increasing across the world…The depression drug pipeline has run dry partly due to a "failure of science"...but also due to big pharma pulling investment out of research and development in the neuroscience field because the profit potential is uncertain...risk aversion was understandable given uncertain returns and the approximately billion dollar cost of developing and bringing a new drug to market...Treatment for depression usually involves either medication, some form of psychotherapy, or a combination of both. But up to half of all people treated fail to get better with first-line antidepressants, and around a third of patients are resistant to relevant medications...
- Merck, Bristol-Myers agree to settle Keytruda patent suit (reuters.com)
Merck & Co said it agreed to enter into a settlement and license agreement with Bristol-Myers Squibb Co and Ono Pharmaceutical Co Ltd to resolve all global patent-infringement litigation related to its cancer drug, Keytruda...Merck will make an initial payment of $625 million to Bristol and Japan's Ono. The company will also pay a 6.5 percent royalty rate on Keytruda sales from January 2017 to December 2023, and a 2.5 percent rate for the subsequent three years...Bristol will get 75 percent of the royalties and Ono will get the rest.
- Pharmacy Week in Review: January 20, 2017 (pharmacytimes.com)
Brian Bobby, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- FDA calls for switching studies in draft interchangeability guidelines (biopharma-reporter.com)
The FDA expects biosimilar developers to provide data from switching studies to demonstrate interchangeability with a reference biologic in draft guidance...The recommendation – which is set out in long awaited draft guidance today – is that sponsors should submit data from a switching study, or studies, to the Food and Drug Administration in order to deem a biosimilar interchangeable with its reference product…The main purpose of a switching study or studies is to demonstrate that the risk in terms of safety or diminished efficacy of alternating or switching between use of the proposed interchangeable product and the reference product is not greater than the risk of using the reference product without such alternation or switch…prior to today’s draft guidance the US agency had not defined how a sponsor must go about generating such proof (interchangeability)...
- Get ready for the new USP hazardous medications standards (drugtopics.modernmedicine.com)
In February 2016, the U.S. Pharmacopeial Convention published Chapter <800> Hazardous Drugs—Handling in Healthcare Settings, which sets standards for handling these drugs. Although those standards will not be implemented until July 1, 2018, the countdown is on— and health-system pharmacists and others who deal with hazardous drugs need to start getting ready now, if they have not started already...The standards will be enforceable by the FDA, state pharmacy boards, and the Joint Commission. This makes understanding what they entail of vital importance to pharmacists and anyone who uses these drugs...Chapter <800> applies to all health care personnel who handle hazardous drugs and all entities that store, prepare, transport, or administer these drugs, with no exceptions based on size or type of facility or on the amount of drugs used...
- U.K. weighs drug rationing as NHS England’s budget tightens: report (fiercepharma.com)
Patients in the U.K. face yet another barrier to access as a tough budget situation has forced the country’s healthcare system to consider rationing costly drugs...Beginning in April, cancer patients and others could have to line up for medicines that cost NHS England more than £20 million per year...That’s even after those meds have been deemed cost-effective by the National Institute for Care and Excellence...The country’s pharmaceutical association, ABPI (Association of the British Pharmaceutical Industry) pointed out some medicines that could see rationing…The agency (NHS) determined that, based on NICE appraisals between April 2015 and July 2016, 81% of medicines would fall under the £20 million a year “budget impact threshold” for a total spend of £125 million. The 19% of drugs above the threshold had a budget impact of nearly £400 million...This is about introducing cost effective, but expensive treatments onto the NHS in a way that does not compromise its ability to fund other areas of work...
- McKesson in record $150 million U.S. settlement over suspicious drug orders (reuters.com)
McKesson Corp, one of the largest U.S. distributors of pharmaceutical drugs, will pay a record $150 million to resolve a U.S. investigation into whether it failed to report suspicious orders of addictive painkillers...Tuesday's deal...followed an earlier settlement with the company over similar violations in 2008...Under the settlement, San Francisco-based McKesson must on a staggered basis suspend sales of controlled substances from distribution centers in Colorado, Ohio, Michigan and Florida for several years...The Justice Department said the evidence showed that McKesson did not fully implement or adhere to its own compliance program designed after the 2008 settlement.