Category:

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…

'Day of appreciation' becomes flashpoint over 'forced' double shifts..Merck & Co.'s plant in Pennsylvania has been impacted by the drugmaker's drastic job cuts in the last 5 years, losing hundreds of manufacturing jobs. Now, in an email exchange made public by one of the unions there, a labor official has lashed out at CEO Ken Frazier, saying workers are now forced to work 16-hours shifts,the fatigue…puts themselves and others in danger...

Every medication has risks as well as benefits, and people react to treatment differently. That’s why drug labels are pages long and filled with small print about the possible downsides. Sometimes those side effects actually exacerbate the problem the drug is intended to treat.

1. Addyi
2. Advair
3. Antidepressants
4. Osteoporosis Drugs
5. Epogen
6. MS Drugs

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.

On the flip side, AstraZeneca, GSK and J&J stock prices contracted… The first half of the year has provided a good ride for Big Pharma and its investors with indices up in the U.S. and Europe. Even Japanese drugmakers avoided the side effects of China's stock market meltdown and saw values rise 23%. But, of course, averages come from the highs and the lows and some players have actually seen share price declines during this bull market.

..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.

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...

Students in East Tennessee State University’s Bill Gatton College of Pharmacy will have the opportunity to earn a bachelor’s degree while studying for the Doctor of Pharmacy degree...The..new Bachelor of Science degree in pharmacy studies— will be of particular benefit to students who wish to pursue further graduate study, which usually requires a bachelor’s degree for admission…will allow interested students to receive an ETSU degree even if they did not start their undergraduate careers here at ETSU...

Ashley Talamo, Publisher: Pharmacy Times...(PTNN) This weekly video program highlights the latest in pharmacy news, product news, and more. (video)

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,"