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FDA recently granted accelerated approval for obeticholic acid (Ocaliva, Intercept Pharmaceuticals, Inc.) for the treatment of primary biliary cholangitis.

After initially rejecting calcifediol (Rayaldee, Opko Health) for chronic kidney disease earlier this year because of manufacturing concerns, FDA approved the drug four months ahead of its new timeline.Rayaldee extended release capsules is the first drug to receive FDA approval for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D levels less than 30 ng/mL.

Integrating IoT devices within healthcare systems allows professionals and individuals to have access to new health-related data used for informed, personalized healthcare applications and situations.

Soon after FDA warned about a potential increased risk of foot and leg amputations with the use of the type 2 diabetes medication canagliflozin (Invokana and Invokamet, Janssen Biotech), the agency strengthened the existing warning about the risk of acute kidney injury with Invokana and Invokamet, as well as dapagliflozin (Farxiga and Xigduo XR, AstraZeneca).

The ER Savings Initiative is designed to deliver care in a hybrid model that collaborates with health systems to eliminate the unnecessary use and costs of their ERs.

Teva Pharmaceuticals is temporarily suspending sales and distribution of its sumatriptan iontophoretic transdermal system (Zecuity) patch for migraines, after FDA said it is investigating the risk of serious burns with the use of the patch.

FDA approved the first US vaccine for cholera, Vaxchora, made by PaxVax Bermuda Ltd. in Hamilton, Bermuda. Vaxchora is the only single-dose vaccine for cholera currently licensed anywhere in the world.

Precision medicine isn’t just about genomics anymore. With the field moving forward as the next step in population health management, environmental, social and lifestyle factors that live outside the medical system are increasingly important to target treatments and engage patients. That means health plans also need innovative technology solutions to capture, store and integrate this crucial information.

Physicians need to be well-versed in the evolving government requirements for billing, reimbursement and overall healthcare delivery/patient experience. One expert outlines these important items for physicians to watch.