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BioWorld - Monday, February 16, 2026
Home » Topics » Regulatory

Regulatory
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Ozempic, Wegovy pricing confab HELP’s next step

Sep. 24, 2024
By Mari Serebrov
While in the hot seat at a Sept. 24 U.S. Senate Health, Education, Labor and Pensions (HELP) Committee hearing, Novo Nordisk A/S President and CEO Lars Fruergaard Jørgensen said he would sit down with Sen. Bernie Sanders (I-Vt.) and the three largest pharmacy benefit managers to discuss lowering the list prices for the company’s popular diabetes and weight-loss drugs, Ozempic and Wegovy.
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Leung Chun-ying, vice chairperson of the Chinese People’s Political Consultative Conference (CPPCCC) at Bio Hong Kong 2024

Hong Kong’s role grows as China moves to up, reform bio sector

Sep. 24, 2024
By Marian (YoonJee) Chu
Both the biotech industry and Hong Kong have become strategic points for China as the People’s Republic of China works to lay a biotech “belt and road” through Asia to expand global influence.
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Astellas patent survives ‘natural law’ decision

Sep. 24, 2024
By Mari Serebrov
The U.S. Court of Appeals for the Federal Circuit reined in a district court that invalidated three claims in an Astellas Pharma Inc. patent protecting bladder drug Myrbetriq (mirabegron) based on a issue that was never argued.
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United Kingdom flag, map

UK’s NICE sees digital health products as aids to therapist time

Sep. 24, 2024
By Mark McCarty
The U.K. National Institute for Health and Care Excellence reported that mental health professionals experienced a dramatic increase in referrals for anxiety and depression over the past decade but noted that digital therapies might help manage the caseload, representing a significant opportunity for developers of these products.
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U.S. FDA headquarters

Tarver says collaboration, health equity prime considerations

Sep. 24, 2024
By Mark McCarty
Michelle Tarver, the acting director of the U.S. FDA’s device center appeared on a Sept. 24 webinar to discuss her priorities for the agency going forward, one of which is global health equity.
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Art concept for tumor
Immuno-oncology

FDA clears Chengdian (Suzhou) Biopharmaceutical’s IND for CD-001

Sep. 24, 2024
Chengdian (Suzhou) Biopharmaceutical Co. Ltd. has received IND clearance from the FDA, allowing it to initiate a first-in-human phase I trial of CD-001.
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Drug manufacturers next on US FTC’s rebate hit list

Sep. 23, 2024
By Mari Serebrov
When the U.S. FTC filed suit Sept. 20 against the country’s three largest pharmacy benefit managers over their alleged use of rebates to artificially inflate U.S. insulin prices, it also put the three big insulin makers, and other drug manufacturers, on notice that they could be next.
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Approved stamp
Biopharma regulatory actions and approvals August 2024

Mpox and cancer therapies among August’s 22 FDA approvals

Sep. 23, 2024
By Amanda Lanier
August saw the U.S. FDA approve 22 drugs, an increase from July's 17 but fewer than the 28 approved in June. This brings the 2024 monthly average to just over 19 approvals, outpacing last year's average of 16 per month, as well as the 12.5 per month seen in 2022 and 17 per month in both 2021 and 2020.
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Leung Chun-ying, vice chairperson of the Chinese People’s Political Consultative Conference (CPPCCC) at Bio Hong Kong 2024

Hong Kong’s role grows as China moves to up, reform bio sector

Sep. 23, 2024
By Marian (YoonJee) Chu
Both the biotech industry and Hong Kong have become strategic points for China as the People’s Republic of China works to lay a biotech “belt and road” through Asia to expand global influence.
Read More
Pills, bottle atop $100 bill

PhRMA challenge to US price negotiations lives again

Sep. 23, 2024
By Mari Serebrov
The U.S. Court of Appeals for the Fifth Circuit revived the Pharmaceutical Research and Manufacturers of America’s (PhRMA) constitutional challenge to the Medicare price negotiations, sending it back to a federal court in Texas for a do-over.
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