TOP STORIES
Theranos’ lab practices “pose immediate jeopardy to patient safety” according to a letter from the U.S. Department of Health and Human Services on Monday. The company has 10 days to correct these practices. Theranos said the following in a statement:
This survey of our Newark, CA lab began months ago and does not reflect the current state of the lab. As the survey took place we were simultaneously conducting a comprehensive review of our laboratory’s systems, processes and procedures to ensure that we have best-in-class quality systems. We value engagement with our regulators, and are committed to ensuring that all our labs operate at the highest standards. We are still reviewing the report, but we addressed many of the observations during the survey and are actively continuing to take corrective action. A full plan of correction will be submitted to CMS within days.
– Fortune, Wall Street Journal, TechCrunch
LIFE SCIENCES
Novartis said it now takes longer to gain insurance coverage for new drugs in the U.S. than it does in Europe, and that’s depressing profits. — Reuters
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
A newly published study gives researchers their “first biological handle” on understanding causes of schizophrenia, though it is not expected to produce treatments anytime soon. — The New York Times
Pulse Therapeutics, a startup that’s developing a magnet-based treatment for blood clots, has raised more than $10 million in a VC round led by NanoDimension. — St. Louis Business Journal
Consumers still favor brand-name statins over generics, consumer health website Treato said. — PR Newswire
PAYERS-PROVIDERS
A California teen who traveled to El Salvador in November tested positive for the Zika virus, Los Angeles County Department of Public Health officials announced. The girl, the third confirmed U.S. resident with the virus, has since recovered. — Reuters
Stanford Medicine and Intermountain Healthcare are teaming up on clinical research and innovations in patient care and medical education. — Business Wire
Why is it so hard to integrate data from different participants in Accountable Care Organizations? Well, for one thing, 23 percent of ACO providers still have paper records. Just a third are on a single EHR, a new study from the Pharmacy Benefit Management Institute found. — Healthcare IT News
One percent of all active U.S. physicians are responsible for 32 percent of malpractice payments, a study in the New England Journal of Medicine found. — HealthDay
The insurance subsidiary of Texas Children’s Hospital is adding 500 jobs, thanks to an expansion of the state’s STAR Kids Medicaid program. — Houston Business Journal
A former deputy chief of elections for the city of Philadelphia, has been charged with defrauding a community psychiatric clinic that she was board president of. — Philadelphia Inquirer
TECHNOLOGY
The next big thing in wearable tech could be a sensor that measures sweat. — Nature
Expect five areas of health IT to grow by 200 percent or more in 2016, according to HIMSS Analytics. — Healthcare IT News
Emory University has developed an app to help clinicians and patients with newly diagnosed end-stage renal disease assess treatment options. — iMedicalApps
A bidding war is developing for Toshiba Medical. — MassDevice
Pamplona Capital Management has completed its $2.7 billion privatization of healthcare revenue-cycle management company MedAssets. — PE Hub
POLITICS
Sen. Joe Manchin (D-West Virginia) said he would filibuster the confirmation vote for Robert Califf to head the FDA, citing the need for action on opiod abuse. — BioCentury
The Canadian Medical Association told a parliamentary committee that physicians with moral objections to assisted dying should be able to refuse to provide the service. — CBC News
Vice President Joe Biden has spent many hours getting up to speed on cancer research, but the goals of the White House’s cancer moonshot remain vague. — STAT
A group of California cities and politicians wants to require pharmacies to take back and dispose of expired meds, and they want the pharma industry to pay for it, in the name of water safety. — San Francisco Business Times
Massachusetts Attorney General Maura Healey is investigating whether Gilead Sciences is violating state law with high prices on hepatitis C treatments Sovaldi and Harvoni. — Reuters
A LITTLE BIT EXTRA
What do cartoon porcupines, snot monsters, moths and dancing bladders have in common? They’ve all been used to sell brand-name drugs. — FiercePharmaMarketing
Photo: Mario Tama/Getty Images
