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Rivals Sarepta Therapeutics and BioMarin ​Pharmaceutical are in line to become the next recipients of an FDA coupon for a fast review, each potentially picking up a sellable asset...The two companies separately received the FDA's rare pediatric disease designation for their in-development treatments for Duchenne muscular dystrophy. And if they can win approval for the drugs next year--by no means guaranteed--each will receive a voucher that promises...a 6-month FDA review for any drug, truncating the standard 10-month process. Such vouchers can be sold to the highest bidder, and their market value has skyrocketed over the past year…

What happens when a healthcare organization's employees are found to have been inappropriately accessing patient medical records? The actions of one health system might serve as an example….14 of its employees were found to have accessed a high-profile patient's medical records "without a legitimate patient care need,"…"Appropriate actions have been taken with each employee, up to and including termination,"

Picking apart biopharma’s protracted boom,…the vibe that getting drugs approved is simply much easier than it once was…. FDA has been green-lighting new drugs at an escalating rate for the past few years… some think the agency can go farther… 21st Century Cures Act,..contains a bevy of provisions designed to bring medicines to the market more quickly…The bill has faced staunch criticism from public health officials and media outlets, cautioning that there can be too much of a good thing, and improperly evaluated drugs can be just as dangerous to patients as no treatments at all.

researchers at Johns Hopkins Bloomberg School of Public Health has found that Florida’s legislative efforts to curb opioid abuse seem to be having their desired effect… statistically significant drops in the amount of opioids being prescribed and the volume in the state… opioid prescriptions dropped about 1.4%, opioid volume fell 2.4% and there was a 5.6% decrease in the morphine milligram equivalent per transaction.

..in approving Addyi, the FDA has gone overboard, exchanging greater efficiency in favor of purposeful permissiveness…it's lowering its standards on the risk/benefit equation by ignoring the realities of the Internet…agency can't control the viral campaign that's already well under way. It can't control prescribing habits or, more importantly, the demand for this drug. It can't prevent the side effects that we will now be seeing as the drug starts to become available to a much wider population than it's intended for…it's the kind of blunder that could well cost the entire industry if the inevitable backlash causes the FDA to grow overzealous about safety issues…This is a regulatory failure of the worst kind.

National Institute for Health and Care Excellence in the UK released its first guideline on antimicrobial stewardship,..is aimed at all health and social care practitioners (hospital and care home staff, general practitioners, dentists, podiatrists, pharmacists, and community nurses), commissioning and provider organizations, and users,..main recommendations are designed to promote and monitor sensible antimicrobial use through stewardship teams to review prescribing and resistance data and to provide feedback, education, and training to prescribers.

study of venom in medicine has traditionally been confined to understanding its effect as a toxin..But scientists are becoming increasingly interested in studying venom systems...to discover ingredients to make new drugs… a new technique for "milking" the Australian box jellyfish of its deadly venom,...method that he and his colleagues have developed is practical and highly efficient, and it promises to remove a major bottleneck in the field of jellyfish venom research.

With revenue sliding, margins thinning and cash flow very light, these facilities lack reserves to offset market volatility…critical access hospitals will continue to earn less, Fitch Ratings this week said it does not expect the financial struggles to affect these hospitals' credit ratings due to their near 100 percent reimbursement from Medicare and political support that will stave off any attempt to cut payments...

Huntington Memorial Hospital..it had alerted health authorities about a potential link between patients who have a pseudomonas bacteria and the Olympus Corp. duodenoscopes used to treat them… Federal regulators have attributed this to a design flaw that makes the tip of these instruments hard to clean even when following the manufacturers' guidelines.

Starting Oct. 1, Tricare beneficiaries with long-term prescriptions for brand-name　medications to treat chronic conditions will need to fill them by mail or through a military pharmacy…will not apply to prescriptions for generic drugs, for drugs prescribed to treat acute illnesses and for prescriptions covered by other medical insurance,…the government pays 32 percent less for brand-name maintenance medications filled by mail or through military pharmacies than at retail stores...