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Europe’s counterpart to the US Food and Drug Administration is temporarily scaling back activities as it anticipates greater-than-expected loss of staff when it relocates due to Brexit. The European Medicines Agency said Wednesday that it would scale back or suspend certain activities through next year so that it can focus on evaluating and supervising medicines ahead of a planned move from its current home in London to Amsterdam, set to take place by the date Brexit occurs, on March 30, 2019. The cutbacks will take place on Oct. 1 “at the latest.” The EMA will cut back international collaboration in areas like harmonizing global regulations, in which the agency said it will take only a reactive role. On issues like antimicrobial resistance and vaccines, it will maintain activities “as long as possible,” but review them on a case-by-case basis. Clinical data publication, development and revision of guidelines, working parties not related to products and other activities will be s...

CareCloud is dipping its toes into a variety of areas within the healthcare realm. The Miami, Florida-based company offers practice management, EHR, revenue cycle and patient experience solutions to physician practices. All the tools are in the cloud. The organization was founded in 2009 and secured its first client in early 2010. Initially, it was more heavily focused on the practice management and scheduling side, CEO Ken Comée said in a phone interview. But since its inception, the medical landscape has been changing. Along the way, the company had its own developments as well. In 2015, CareCloud announced $15 million in new funding, as well as the appointment of Comée as CEO. The next year, it raised $31.5 million in a Series C round led by Blue Cloud Ventures. PNC Financial Services Group, First Data Corporation, Norwest Venture Partners, Intel Capital, Tenaya Capital and Adams Street Partners also participated. Today, the healthcare industry is shi...

Stanford Medicine hired Dr. Tait Shanafelt as chief wellness officer last year, not so much for the well-being of the patients — but of the physicians. An oncologist and hematologist by training, Shanafelt, 46, has become a national leader in the movement to end  physician “burnout”  — the cumulative effect of years of stress that can compromise patient care and cause doctors to leave medicine. After 12 years at the Mayo Clinic, Shanafelt now heads up Stanford’s  WellMD Center , dedicated to physician health. He also serves as an associate dean of the Stanford University medical school. He lives in Portola Valley, Calif., with his wife, a nurse, who works part-time, and their four children, ages 4 to 13. Dr. Tait Shanafelt (Julie Greicius/Stanford School of Medicine) Shanafelt’s goal is to address the systemic problems in medicine — long hours, a culture of blame, endless record-keeping — and find solutions that go far beyond  yoga classes  or  free...

In the annals of the pharmaceutical industry, it’s hard to find an event more infamous than the thalidomide scandal. The drug, originally developed by German drugmaker Gr ü nenthal , was marketed in 1957 in Europe, Australia and parts of South America to treat morning sickness in pregnant women. But soon thereafter, it was blamed for severe birth defects in more than 10,000 babies across dozens of countries and an untold number of miscarriages, leading to a 1961 ban. Meanwhile, the US, the Food and Drug Administration did not approve it, and FDA scientist Frances Oldham Kelsey, who played a key role in keeping the drug from reaching American shores, died in 2015 at the age of 101. Despite the drug’s notoriety, the underlying mechanism for its infamous fetal toxicity had been poorly understood. But now, a team of researchers at the Dana-Farber Cancer Institute in Boston may have resolved the question. In addition, their research may also point the way forward in the development of ...

It came as something of a surprise when Health and Human Services Secretary Alex Azar announced that the administration was  exploring the importation of prescription drugs  to fight high domestic prices. Azar and Scott Gottlieb, commissioner of the Food and Drug Administration, who  also endorsed  the new proposal, had previously opposed the idea. But drug prices in the U.S. have continued to rise and more than 80 percent of Americans say the government should take action. President Donald Trump has said drugmakers are “ getting away with murder ” and has angrily  tweeted at companies  about individual price hikes. Although the candidate Trump supported the idea of allowing patients to import medicines, since he was elected he has not mentioned that option — which is strongly opposed by drug companies. Now, determined to explore more avenues to curb price hikes, the administration is signaling that it is willing to consider what the industry regards a...