Category:

Food and Drug Administration calls a ‘breakthrough’ drug is often not the same as what a layperson would call a breakthrough,…FDA uses the term...for smaller advances, than people use it colloquially, and this may lead patients to have unwarranted confidence in new drug claims…the...Safety and Innovation Act (2012),..allows the FDA to give breakthrough designation to any drug treating a serious or life-threatening condition that "may demonstrate a substantial improvement over existing therapies"…"Breakthrough" is an aspirational term, chosen for the 2012 act to help expedite the new drug approval process,...

Specialists in infectious disease are protesting a gigantic overnight increase in the price of a…drug that is the standard of care for treating a life-threatening parasitic infection…Daraprim, was acquired in August by Turing Pharmaceuticals, a start-up run by a former hedge fund manager (Martin Shkreli). Turing immediately raised the price to $750 a tablet from $13.50,…price increase is not an isolated example… most of the attention on pharmaceutical prices has been on new drugs… there is also growing concern about huge price increases on older drugs, some of them generic,… some price increases…have resulted from a business strategy of buying old neglected drugs and turning them into high-priced specialty drugs.

Bond issuance by nonprofit hospitals has reached $18 billion to date for 2015, returning to the highest level since 2012. Bloomberg's Kate Smith looks into the role played by the Affordable Care Act in the resurgence of hospital bond offerings...

Doug Long, vice president of industry relations at IMS Health, talks about how the movement toward value-based care in the US health system affects community pharmacy.

Telehealth represents a burgeoning,…opportunity for pharmacy operators, one that has the potential to not only drive traffic into a store, but also to drive new customers into that store…Pharmacy represents a…touchpoint for telehealth operators...making pharmacies that provide access to telehealth services a convenient and less-expensive option for those consumers who are assuming a greater portion of their individual healthcare costs…also an opportunity to improve outcomes through telehealth/retail pharmacy partnerships…many…doctor associations,…support telehealth models,..making retail pharmacy operators fielding in-store telehealth services attractive care partners for health systems.

Back when Martin Shkreli was CEO of Retrophin, he managed to grab a few headlines by buying an old rare-disease drug, Thiola, and raising the price 2000%. Now that he's on to his next company, Turing Pharmaceuticals, he's done himself one better, by buying another old drug and boosting the price 5000%....The drug is Daraprim, which Shkreli's Turing Pharmaceuticals bought a few weeks ago from Impax Laboratories…immediately hiked the price from $13.50 per pill to $750…. Shkreli's extreme sticker shock strategy on an ancient therapy, though, has become the kind of lightning rod for the controversial pricing issue that the industry will find it hard to defend against in the lead-up to a presidential election.

Medicare donut hole forces participants to face an expensive gap in coverage in their Part D prescription drug plans… the costs of prescription drugs covered by a plan get split up in various ways, depending on your total prescription costs for a given year… donut hole simply forced participants to pay these additional drug costs entirely on their own, causing huge financial stress… Affordable Care Act,…started to fill in the donut hole… Over time,..discounts will gradually rise…by 2020, participants will pay only 25% of the net cost of brand-name and generic prescription drugs.

Gianrico Farrugia, CEO of Mayo Clinic…laid out his vision of the immediate future of precision medicine at this week’s Individualizing Medicine Conference…He discussed the issues around patient engagement, reimbursement, data security and salience of President Obama’s Precision Medicine Initiative. In terms of immediate potential,…there are five fields worth watching:

• Pharmacogenomics
• Liquid biopsy
• Non-invasive prenatal testing
• Whole genome sequencing
• Microbiome

CNBC's Bertha Coombs reports on the hit to biotech stocks after Hillary Clinton's tweet criticizing drug price gouging.

At least three reviewers recommended against Addyi (flibanserin) approval..They warned about possible side effects and expressed concern that “the marginal clinical benefits do not outweigh the serious risks,” according to a memo posted online that summarized the analysis within the U.S. regulatory agency… One reviewer particularly wanted more study of the interaction between Addyi and alcohol because the tests were conducted almost exclusively with men… FDA had rejected the drug,…in 2010 and 2013 before approving it in August...