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BioWorld - Friday, February 20, 2026
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Regulatory front

July 30, 2019
Teva Pharmaceutical Industries Ltd. agreed to pay the state of California $69 million in what California Attorney General Xavier Becerra Monday called the largest pay-for-delay settlement received by any state. 
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Olive Healthcare receives FDA approval for abdominal fat monitoring device Bello

July 29, 2019
By Jihyun Kim
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.
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FDA to advisory committees: we hear your opinion, but . . .

July 29, 2019
By Brian Orelli
“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.
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Another Humira biosimilar gets FDA nod, as Korea's Samsung Bioepis joins launch wait list

July 29, 2019
By Jihyun Kim
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).
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Regulatory front

July 26, 2019
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. 
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Lilly's Baqsimi sugar win may face pen headaches as Emgality gains ground

July 26, 2019
By Randy Osborne
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.
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FDA approves Baqsimi to treat severe hypoglycemia

July 25, 2019

Regulatory front

July 25, 2019
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). 
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FDA approves rituximab biosimilar Ruxience

July 24, 2019

Regulatory front

July 23, 2019
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. 
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