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Regulatory
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Canbridge obtains first approval for Alagille syndrome in China

June 6, 2023
By Doris Yu
Canbridge Pharmaceuticals Inc. obtained marketing approval from China’s NMPA for CAN-108 (Livmarli; maralixibat chloride oral solution) to treat cholestatic pruritus in 1-year-old or older patients with Alagille syndrome, a development that the company touted for how quickly it followed similar approvals elsewhere.
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Canbridge obtains first approval for Alagille syndrome in China

June 6, 2023
By Doris Yu
Canbridge Pharmaceuticals Inc. obtained marketing approval from China’s NMPA for CAN-108 (Livmarli; maralixibat chloride oral solution) to treat cholestatic pruritus in 1-year-old or older patients with Alagille syndrome, a development that the company touted for how quickly it followed similar approvals elsewhere.
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Infant receiving vaccine

FDA adcom to consider the what-ifs of RSV vaccine, infant prophylactic

June 6, 2023
By Mari Serebrov
Having already notched approvals in the EU and U.K., Astrazeneca plc hopes to prime the pump for a U.S. approval of nirsevimab as a respiratory syncytial virus (RSV) prophylactic for infants when it makes its case June 8 before the FDA’s Antimicrobial Drugs Advisory Committee.
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Lab glassware and scientist

Will R&D be an unintended consequence of new US drug policies?

June 6, 2023
By Mari Serebrov
As Monica Bertagnolli, U.S. President Joe Biden’s choice to be the next NIH director, meets with senators to gather support for her confirmation, she’s sure to be grilled by some of them about her stance on whether the agency can march in on drug patents based on a drug’s list price. Up until now, NIH directors have said no. A change in that policy, along with nearly flatline NIH spending and other new government initiatives, could impact private investment in drug R&D by increasing the cost of research and lowering the return on investment.
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Joel Latham, CEO, Incannex Healthcare Ltd.
Newco news

Incannex is changing treatment paradigms with pipeline of psychedelics and cannabinoids

June 6, 2023
By Tamra Sami
Incannex Healthcare Ltd. had quietly been developing its commercialization plans for psychedelic clinics well before Australia’s Therapeutic Goods Administration announced it would allow psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) to be prescribed by authorized psychiatrists for treatment-resistant depression and post-traumatic stress disorder.
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Regulatory actions for June 5, 2023

June 5, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Galderma, Masimo, Sparrow Bioacoustics.
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Abiomed’s fix for purge issues in some Impella 5.5 units falters

June 5, 2023
By Mark McCarty
The U.S. FDA reported a class I recall for a subset of the Impella 5.5 with Smartassist due to leakage of purge fluid from a pump sidearm that could ultimately lead to a loss of pump function. Abiomed Inc., the maker of the device, had previously introduced corrective measures intended to suppress the problem with leakage, but those corrections have not completely resolved the problem, leading to the withdrawal of 466 units that were distributed in the U.S. between Sept. 8, 2021, and March 6, 2023.
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China increases antimonopoly law enforcement in the biopharmaceutical industry

June 5, 2023
By Zhang Mengying
Antimonopoly regulators in China are rebooting efforts to keep industries in check and may be zeroing in on the biopharma space.
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Regulatory actions for June 5, 2023

June 5, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: American Regent, Avadel, Bioinvent, Canbridge, Daiichi Sankyo, Foghorn, Hemogenyx, Innovent, Kyverna, Springworks, Theratechnologies.
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Regulatory actions for June 2, 2023

June 2, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Armis.
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