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BioWorld - Monday, June 5, 2023
Home » Topics » Regulatory

Regulatory
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Regulatory actions for May 23, 2023

May 23, 2023
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Artivion.
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Ayvakit product image

Following the Blueprint for expansion-ISM: FDA says yes to widened label in rare mast-cell disease

May 23, 2023
By Randy Osborne
No Comments
Blueprint Medicines Corp. scored a broader label from the U.S. FDA for Ayvakit (avapritinib), which became the first approved therapy to treat adults with indolent systemic mastocytosis (ISM).
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Congress, states staging Act 2 of US Rx pricing reforms

May 23, 2023
By Mari Serebrov
No Comments
When it comes to cutting health care costs in the U.S., last year’s Inflation Reduction Act, with its inflationary rebates and direct Medicare negotiations, was just Act 1. Now lawmakers, in both the House and Senate, are feverishly working on bipartisan scripts for Act 2 that go beyond biopharma’s role in drug prices to taking on pricing issues across the health care sector.
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Hepatitus C virus

China's NMPA approves Sanhome’s alfosbuvir for HCV

May 23, 2023
By Zhang Mengying
No Comments
Nanjing Sanhome Pharmaceutical Co. Ltd.’s Shengnuodi (alfosbuvir tablets), used as part of a combination treatment for hepatitis C, has been approved by China’s National Medical Products Administration (NMPA) through the priority review and approval procedure.
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Regulatory actions for May 23, 2023

May 23, 2023
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ABVC, Bioarctic, Biocryst, Centessa, Eisai, Freeline, Grunenthal, Hanx, Ideaya, Laekna, Polypid, Sangamo, Xbiotech.
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Regulatory actions for May 22, 2023

May 22, 2023
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beta Bionics, Orlucent.
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NovasightHybridSystem.jpg

China grants marketing approval for a hybrid intravascular imaging system

May 22, 2023
By Doris Yu
No Comments
Grand Pharmaceutical Group Ltd. obtained China’s NMPA approval for an intravascular dual-mode imaging system for coronary artery imaging, tapping into a potentially huge but very undeveloped market for imaging in percutaneous coronary interventions (PCI).
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China's NMPA approves Sanhome’s alfosbuvir for HCV

May 22, 2023
By Zhang Mengying
No Comments
Nanjing Sanhome Pharmaceutical Co. Ltd.’s Shengnuodi (alfosbuvir tablets), used as part of a combination treatment for hepatitis C, has been approved by China’s National Medical Products Administration (NMPA) through the priority review and approval procedure.
Read More
Leqembi

Pressure mounts for CMS coverage ahead of Leqembi’s ‘full’ approval date

May 22, 2023
By Mari Serebrov
No Comments
As the clock ticks toward the “full,” or traditional, approval date for Biogen Inc./Eisai Co. Inc.’s Alzheimer’s drug, Leqembi (lecanemab), the U.S. Centers for Medicare & Medicaid Services (CMS) is facing increasing pressure to get the structures in place to ensure Medicare beneficiaries have access to the drug when the approval comes.
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Regulatory actions for May 22, 2023

May 22, 2023
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bausch + Lomb, Pfizer, Rznomics, Sanofi, Satsuma, Sobi.
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