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Food and Drug Administration on Tuesday issued new recommendations aimed at reducing the risk of Zika virus transmission through donated human tissues and cells used in surgical or reproductive procedures, such as umbilical cord blood, corneas and heart valves...The guidance is part of the agency's ongoing efforts to protect human cellular, tissue and blood products from potential contamination with Zika virus..."Though there is more to be learned about the transmission of Zika virus, given what we know about the virus at this point, which also is informed by our understanding of similar viruses, we must address the potential risk of Zika virus transmission by human cells and tissues," Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement...Under the new recommendations, donors should be considered ineligible if they were diagnosed with Zika virus infection or were in an area with active virus transmission, or had sex with a male with either of those risk factors, within the past six months...

AstraZeneca has sold rights to a non-core drug to a unit of Kyowa Hakko Kirin for an upfront payment of $70 million, a day after getting $500 million for two ageing heart medicines...The British-based drugmaker has been divesting peripheral products to help pay the bills as it invests in new medicines, while taking a profit hit from the loss of patent protection on a raft of former blockbusters...Such divestments, or "externalization" deals, contributed $1.1 billion to revenue last year and the company has said the figure is likely to be higher in 2016.

Jerry McKee, PharmD, assistant director of Community Care of North Carolina, discusses the goals of the Pharmacy Home Project.

Takeda is going behind closed doors with its first DTC campaign for Entyvio (vedolizumab), a new biologic treatment for inflammatory bowel diseases. Bathroom doors, that is...The Japanese drugmaker uses a series of bathroom doors in its ad campaign, asking if it's "time for a different perspective." A...TV spot launched Feb. 7...has racked up $2.9 million on more than 2,000 airings...This condition is such an isolating condition and such a stressful condition. Patients are kept from doing the important things they want to be doing in their lives and as a result they miss out on a lot...In testing many different creative ideas with Crohn's and ulcerative colitis patients...the bathroom doors resonated well because patients noted it is a view they are all too familiar with...But some patients even took it to the next level in saying that the doors metaphorically represent that barrier between their disease and being able to do all of the things they want to do. Emotionally, we've touched upon the reality of their disease in a very obvious bathroom door representation, but also a representation of just barriers in general...Analysts have projected blockbuster-level sales for Entyvio by 2020...Marketing will be key to gaining share in a crowded IBD space where it's up against established...brands such as AbbVie's Humira, Amgen's Enbrel, and Johnson & Johnson's Remicade...

Joe Moose, owner of Moose Professional Pharmacy, discusses the new responsibilities that pharmacy technicians are assuming.

Gregg Alton has what seems like a disorienting job at Gilead Sciences Inc. He’s paid to figure out how to sell the drug Sovaldi, which infamously retails in the U.S. at $1,000 a pill, for relatively next to nothing...The instructions for pricing the cure, which wipes out hepatitis C in just 12 weeks, basically go like this: "Get to as many patients as possible in low-income nations --and not lose money," Alton says. "It’s very simple."...Actually, it’s not so simple, but it is controversial. Decisions about what to charge around the world for life-saving remedies have spurred debate ever since Big Pharma began offering some discounts after a backlash in the ’90s, when groundbreaking HIV treatments reduced deaths in wealthy countries and not poor ones. Criticism has been harsh with Sovaldi, one of the most expensive and best-selling drugs in history...He offers a rare look at how a pharmaceutical giant walks the line between shareholder expectations on the one hand and global public health needs on the other. It starts with his team looking at the map through the lens of per-capita income. Countries that are well-off go into one bucket. The rest are sorted by wealth and rate of hepatitis C infection...What’s frustrating, he says, is that the good Gilead does in other countries is overshadowed by reverberations from the U.S. sticker shock. However his company tries to explain the value it brings to patients, it can’t compete, he says. "It’s never going to be as powerful as ‘$1,000 a pill? Is that fair?’"

Women may experience small benefits with a drug approved last year in the U.S. to treat low sexual desire in women, but at a high risk of experiencing unpleasant side effects...The findings "suggest that the benefits of flibanserin are marginal," given that one in three women experience side effects, of which the most common ones include dizziness, sleepiness, nausea, and tiredness...Flibanserin, marketed by Valeant as Addyi, was approved by....to treat premenopausal women with hypoactive sexual desire disorder...the drug comes with a...black-box warning - the FDA's strongest - that women may suffer severe low blood pressure or faint if they take the drug with alcohol, certain medications or have liver problems...Jaspers (Dr. Loes Jaspers, of Erasmus University Medical Center in Rotterdam, the Netherlands) said their findings suggest the FDA should reconsider its approval of flibanserin but cautioned that the agency may have taken other factors into account to make its decision...

Physicians across the United States routinely offer medical advice on social media — but often fail to mention that they have accepted tens and sometimes hundreds of thousands of dollars from the companies that make the prescription drugs they tout...A STAT examination of hundreds of social media accounts shows that health care professionals virtually never note their conflicts of interest, some of them significant, when promoting drugs or medical devices on sites such as Facebook, Instagram, and Twitter. The practice cuts across all specialties...the growing use of social media by medical professionals raises serious ethical questions — and makes it impossible for patients or other doctors to know whether a physician’s enthusiasm or disdain for any particular drug may have been influenced by payments from the pharmaceutical industry...Under legislation passed in 2010, drug and medical device companies are required to report payments to doctors for promotion, consulting, and other services. The information is collected by the federal Department of Health and Human Services and posted in a public database. Most medical journals now also require researchers who submit articles to disclose payments they have received from the industry...But social media is a new frontier...

The nation's largest endoscope distributor will pay $623.2 million to resolve civil and criminal allegations that it paid kickbacks to hospitals and doctors in exchange for purchasing its devices, the Justice Department announced...Olympus Corporation of the Americas has agreed to pay a record-setting $310.8 million to settle civil claims that it violated the False Claims Act because its claims were tainted by illegal kickbacks. The sum is the largest ever paid by a medical-device company over violations related to the federal anti-kickback law...Olympus will also pay a $312.4 million criminal penalty over the allegations. The company admitted to paying doctors and hospitals in the form of consulting payments, travel, meals, grants and free endoscopes in exchange for their business...the kickbacks helped the company make more than $600 million in sales and gross profits of more than $230 million...The civil settlement resolves a lawsuit originally brought by whistle-blower John Slowik, a former chief compliance officer for the company. In successful False Claims Act cases, whistle-blowers are entitled to a portion of whatever money the government is able to recover. Slowik will receive $51 million...

Rose Bengal (PV-10), a cheap industrial chemical that turns yarn and food bright red, has been used as a diagnostic staining agent for some time. Now, some scientists are looking at its potential to fight various forms of cancer...Provectus Biopharmaceuticals...is testing a reformulated version of the industrial dye on melanoma, the deadliest form of skin cancer...Rose Bengal’s potential against cancer was discovered by accident. The salt was first patented in 1882 as a wool dye and has been used for years as a diagnostic stain in tests for jaundice in newborns and to detect eye damage...In 1998, scientists....were looking for a safe photoreactive agent to use in an investigation of lasers against cancer. Rose Bengal fit the bill...As it turned out, the Rose Bengal solution appeared to work on its own to dissolve tumors when directed injectly (directly injected) into them...Provectus executives say the small development tab—along with relatively low manufacturing costs and easy handling requirements—could make PV-10 a less expensive new treatment...Provectus plans to put itself up for sale once its drug is approved...