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BioWorld - Tuesday, December 10, 2019
Home » Topics » Regulatory

Regulatory
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Physiq gets FDA nod for new vital signs algorithm

August 7, 2019
By Meg Bryant
No Comments
The U.S. FDA has cleared the way for Physiq Inc., of Naperville, Ill., to market its continuous ambulatory respiratory rate algorithm, adding to the company's portfolio of cloud-based analytics for biopharma and health insurance companies. The 510(k) notification will allow Physiq to boost its higher-level artificial intelligence (AI) platform with validated vital signs inputs.
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Daiichi's Turalio go-ahead casts CSF1R into spotlight; 'headroom' for Deciphera

August 7, 2019
By Randy Osborne
No Comments
Deciphera Pharmaceuticals Inc. CEO Steven Hoerter told BioWorld Asia the FDA approval of Turalio (pexidartinib) from Daiichi Sankyo Co. Ltd. last week "leaves a lot of headroom for efficacy," given the response rate of about 40%. "One of the most significant concerns that the FDA had was hepatotoxicity, which is an off-target effect," he added, so the approval came with "some fairly onerous monitoring requirements." 
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FDA makes Daiichi's Turalio first approved therapy for rare cancer

August 7, 2019
By Randy Osborne
No Comments
Tokyo-based Daiichi Sankyo Co. Ltd.'s Turalio (pexidartinib) won FDA clearance for adults with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery.
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Industry supportive of TGA's approach to managing cybersecurity for devices

July 30, 2019
By Tamra Sami
No Comments
PERTH, Australia – The Therapeutic Goods Administration (TGA) has unveiled final guidance that details how the Australian regulator considers cybersecurity risks over the life of a medical device, including whose responsibility it is to assess and communicate risk, as well as the expectations for manufacturers under the Essential Principles. Industry had voiced concerns in reaction to the draft version of the guidance – released last December – that related to proposed changes to the Essential Principles and the use of standards. The TGA had proposed two separate guidances – one for device and in vitro diagnostic manufacturers and those that develop software for medical devices and another guidance for users.
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Legislation for contact lenses, telehealth unveiled in Congress

July 30, 2019
By Mark McCarty
No Comments
Two pieces of legislation of interest to the med-tech industry are making the rounds in Washington. One would require that online sales of contact lenses be accompanied only by a prescription, and the other would bolster telehealth services for methamphetamine addiction in rural areas, where the narcotic's epidemic has taken much of its toll. The bills arrive as other developments suggest an improved environment for contact lenses and telemedicine, auguring a better market for both in the months and years ahead.
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Regulatory front

July 30, 2019
No Comments
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
No Comments
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
No Comments
“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
No Comments
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
No Comments
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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