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Regulatory
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Elderly man with clenched hands holding head

US FDA approves Rexulti as first drug for agitation in Alzheimer’s dementia

May 16, 2023
By Tamra Sami and Karen Carey
On its May 10 PDUFA date, the U.S. FDA approved serotonin-dopamine modulator Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S for agitation in Alzheimer’s dementia, marking the first approved treatment for the indication.
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BIO Korea 2023: Regulatory obstacles stall decentralized clinical trials in Korea

May 16, 2023
By Tamra Sami
Keeping patients at the center of clinical trials is how the global pharma industry views decentralized clinical trials, but bureaucratic red tape from multiple agencies is preventing companies from deploying decentralized trials in South Korea, speakers said during the BIO Korea 2023 conference in Seoul on May 11.
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Woman cooling off in front of fan

Nothing flashy: FDA approves Astellas’ menopause drug

May 16, 2023
By Lee Landenberger
The U.S. FDA has approved a non-hormonal treatment from Astellas Pharma Inc. to reduce the number and severity of hot flashes. Veozah (fezolinetant), an oral, once-daily compound that targets the neurokinin-3 (NK3) receptor, is approved for treating moderate to severe vasomotor symptoms due to menopause. It’s the first NK3 receptor antagonist the FDA has greenlighted for the indication. The approval came on May 12, well before its May 22 PDUFA date. The PDUFA date was originally set for Feb. 22 but the FDA extended it, saying it needed more time to complete the NDA’s priority review. Veozah’s wholesale acquisition cost is $550 for a month’s supply and should be available by early June.
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HTIT oral insulin capsule

HTIT expects to obtain China’s first oral insulin approval

May 16, 2023
By Doris Yu
Hefei Tianhui Incubator of Technologies Co. Ltd. (HTIT)’s NDA for recombinant human insulin capsule ORMD-0801 for type 2 diabetes is under review by the NMPA and, if approved, is expected to be the first oral insulin available in China, where regulators have been on the lookout for new treatment options for the increasingly common disease.
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Lianbio garners first Asian approval for Camzyos in Macau for hypertrophic cardiomyopathy

May 16, 2023
By Tamra Sami
Lianbio Co. Ltd. gained its first Asian approval in Macau for Camzyos (mavacamten/Myokardia Inc.) for treating adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The company in-licensed mavacamten rights from Myokardia, now a wholly owned subsidiary of Bristol Myers Squibb Co., in August 2020 for developing and commercializing mavacamten in mainland China, Hong Kong, Macau, Taiwan, Thailand and Singapore. Mavacamten was granted breakthrough therapy designation in China in February 2022 for patients with oHCM.
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Regulatory actions for May 15, 2023

May 15, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Mim Software, Novarad.
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Philips to pay $62M for violation of FCPA in China

May 15, 2023
By Annette Boyle
The U.S. Securities and Exchange Commission (SEC) reported that Royal Philips NV will pay more than $62 million in connection with “irregularities in the medical device industry” related to its Chinese subsidiaries. The charges arise from actions that occurred between 2014 and 2019 from sales of medical diagnostic equipment in China.
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Picture-1-A-Quantum-Surgical's-Epione-Robot.jpg

Quantum Surgical awarded FDA clearance for abdominal cancer robot

May 15, 2023
By Bernard Banga
Quantum Surgical SAS has obtained an extension to the FDA authorization covering its Epione robot, which can now treat abdominal cancers. “This decision now allows physicians to treat all abdominal tumors at an early stage and will ramp implementation of our Epione robotics solution in the U.S.,” said Bertin Nahum, CEO and co-founder of Quantum Surgical. Marketed in Europe and the U.S., the Epione robot has already been used to treat more than 150 patients with liver or kidney cancer.
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US flag with microscope

Biden announces choice for NIH director

May 15, 2023
By Mari Serebrov
Nearly a year and a half after Francis Collins stepped down as director of the U.S. NIH, President Joe Biden announced May 15 his intent to nominate Monica Bertagnolli as the next NIH director.
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US Supreme Court says no to skinny label case

May 15, 2023
By Mari Serebrov
To the chagrin of some and the joy of others, the U.S. Supreme Court denied cert to Teva Pharmaceuticals USA Inc. v. Glaxosmithkline May 15, leaving standing a split Federal Circuit decision that could threaten the use of FDA-approved label carve-outs, or so-called skinny labels, for generics and biosimilars.
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