The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee has completed its meeting regarding a supplemental new drug application (sNDA) for the inclusion of data from a pivotal cardiovascular outcomes trial in the labeling for liraglutide (Victoza, Novo Nordisk) injection.

FDA Commissioner Scott Gottlieb, MD, has announced in a blog post that the agency plans to hold a public meeting on July 18 to identify ways pharmaceutical companies are using FDA rules—including the standards and procedures related to generic drug approvals—to place obstacles in the way of generic competition.

The Centers for Medicare and Medicaid Services (CMS) has issued a proposed rule that would make changes in the second year of the Quality Payment Program, as required by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).

The Trump administration believes that reining in regulations on pharmaceutical companies is the best way to control the cost of drugs, the New York Times reports.

Major insurers have announced that they’ll not participate in the Obamacare market exchanges next year, and time’s running out for those health plans still on the fence since they must file their intentions and proposed premium rates today.

Senate Republicans are preparing to vote on repealing the Patient Protection and Affordable Care Act (PPACA) next week, according to an article posted on the Politico website. Senators are expected to begin reviewing the text of the bill as soon as the end of this week.

Americans with five or more chronic conditions make up 12% of the population but account for 41% of total health care spending, according to a new report from the RAND Corporation. In an article posted on the RealClear Health website, Dr.

A new study has found that certain factors are linked with a person’s decision to leave the hospital against the advice of his or her care provider. Some of these factors are more pronounced in older versus younger individuals.

After last month’s terrorist attack in Times Square, doctors and nurses at NYC Health & Hospitals/Bellevue raced to save a high school senior who had sustained serious injuries to her legs, abdomen, and pelvis. The girl was hemorrhaging internally, and transfusions couldn’t keep up with the blood loss. She was about to go into cardiac arrest.

The FDA has approved delafloxacin (Baxdela, Melinta Therapeutics) for the treatment of adults with acute bacterial skin and skin-structure infections (ABSSSI) caused by susceptible bacteria.

Troubled teens with substance abuse or mental health problems should take to the woods and, with the aid of trained therapists, work out their problems. It sounds like a great idea. It is also an expensive idea, $500 a day for weeks- or months-long treatment, by some estimates.

GOP Senate leaders hope to marshal a vote on their health care bill by next Thursday before the July 4 break, the Wall Street Journal reports. But many Senate Republicans have yet to see the proposed legislation and some are not happy with what they are hearing about it.

While Senate Republicans are busy drafting their health care plan behind closed doors, The Hill has speculated on where they might be headed. The article discusses six key initiatives that are likely to be included in the bill.

1. The phase-out of Medicaid expansion will be slowed down.

Kaiser Health News (KHN) has examined documents that shed light on the activities of a White House working group that meets regularly to discuss the cost of pharmaceuticals. The documents reveal that the group’s behind-the-scenes deliberations may be unduly influenced by the pharmaceutical industry.

Writing in a blog post, FDA Commissioner Scott Gottlieb, MD, has announced that his agency is preparing to launch a digital health innovation plan that will “include a novel, post-market approach” to digital devices. As part of that approach, the FDA also plans to release new guidance for manufacturers of digital health products.

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