HONG KONG – Olive Healthcare Inc., a South Korean biotech startup, said its abdominal fat scanner Bello has received an FDA approval to sell the device in the U.S. The company said it plans to launch the scanner in the country this December, after a market test. The miniature device is portable with a weight of 3.8 oz (107 g), measuring 3.9 inches (10 centimeters) long, 3.1 inches wide and 1.9 inches high.

“It’s a rare window into seeing how the FDA makes decisions because the proceedings are open unlike many of the other decisions they make,” Audrey Zhang, a medical student at the New York University School of Medicine, said on why she decided to embark on crunching the numbers from 376 votes by FDA advisory committee meetings from 2008 to 2015.

HONG KONG – Samsung Bioepis Co. Ltd., a South Korean biosimilar developer, said the FDA approved its July 2018 application for Hadlima (adalimumab-bwwd), a biosimilar referencing Abbvie Inc. blockbuster TNF-blocker Humira (adalimumab).

In what it called one of the largest pharmaceutical settlements on behalf of end payers in an antitrust case in the last decade, law firm Hausfeld reported this week that it reached a $55 million settlement with Celgene Corp. in a long-running class action, In re Thalomid and Revlimid Antitrust Litigation. 

Eli Lilly and Co.'s FDA win with Baqsimi (glucagon) nasal powder, the first non-injected therapy to gain clearance for emergency treatment of hypoglycemia, makes the rescue of severely hypoglycemic patients quicker and easier, and coming down the pike are more treatments that could simplify therapy.

The FDA's Arthritis Advisory Committee (AAC) Thursday will consider a supplemental new drug application for Boehringer Ingelheim GmbH's Ofev (nintedanib) capsules as a treatment for systemic sclerosis-associated interstitial lung disease (SSc-ILD). 

The U.K.'s National Institute of Health and Care Excellence (NICE) said Monday it will be reviewing the methods it uses to develop guidance on drugs, medical devices and diagnostics so it can optimize its evaluation methods to ensure high quality and good value.