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Home » Topics » Regulatory

Regulatory
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Green approved stamp

Sanofi’s Xenpozyme becomes first therapy approved for rare progressive genetic disorder ASMD

March 29, 2022
By David Ho
Sanofi SA’s enzyme replacement therapy, Xenpozyme (olipudase alfa), has been approved for use in Japan, making it the world’s first and only approved therapy to treat acid sphingomyelinase deficiency (ASMD), also known as Niemann-Pick type B disease. Sanofi’s executive vice president and global head of R&D, John Reed, hailed it as a “watershed moment” that was the culmination of 20 years of research.
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Clinical trial virtual display

MEI: FDA waves Tidal away in rough PI3K waters, wants randomized trial

March 29, 2022
By Randy Osborne
The beleaguered PI3K-delta inhibitor space took another blow after MEI Pharma Inc. and partner Kyowa Kirin Co. Ltd. said the U.S. FDA won’t greenlight zandelisib without data from a randomized study.
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EU flag, syringe, capsules

Janssen/Legend’s Carvykti headed for approval in Europe after nod from regulators

March 29, 2022
By Richard Staines
Janssen Pharmaceutical Cos, Inc.’s CAR T-cell therapy, Carvykti (ciltacabtagene autoleucel), looks set for approval in Europe after endorsement by regulators for advanced multiple myeloma. At its monthly meeting, the EMA’s Committee for Medicinal Products for Human Use recommended Carvykti for adults with relapsed and refractory disease who have received at least three prior therapies and whose cancer has worsened since their last treatment.
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Novavax’s COVID-19 vaccine granted EUA for adolescents in India

March 29, 2022
By David Ho
The Drugs Controller General of India has granted Novavax Inc. and the Serum Institute of India Pvt. Ltd. emergency use authorization (EUA) for Novavax’s protein-based COVID-19 vaccine. It was authorized for use in adolescents aged 12 to 18 years. The vaccine will be manufactured and marketed in India by the Serum Institute under the brand name Covovax.
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Innovent, Lilly receive CRL for NSCLC candidate sintilimab

March 29, 2022
By Michael Fitzhugh

Innovent Biologics Co. Ltd. and Eli Lilly and Co. are "assessing next steps" for their jointly developed PD-1 inhibitor, sintilimab, following receipt of a complete response letter (CRL) from the U.S. FDA. 



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Walvax wins NMPA nods for HPV bivalent vaccine

March 29, 2022
By Doris Yu
China’s NMPA has given a green light for Walvax Biotechnology Co. Ltd.’s human papillomavirus (HPV) bivalent vaccine to be used against HPV types 16 and 18 to prevent cervical cancer.
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Microscope

Experts: Using march-in ‘blowtorch’ on drug prices threatens US research enterprise

March 29, 2022
By Mari Serebrov
Policymakers shouldn’t look to march-in rights as a simple solution to make medical products more affordable, according to experts speaking at an Information Technology & Innovation Foundation discussion on how using the march-in provisions of the Bayh-Dole Act as price controls would threaten America’s research universities.
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Keita Mori, CEO, Sanbio

Japan’s Sanbio submits BLA for brain injury regenerative therapy under Sakigake designation system

March 29, 2022
By Tamra Sami
Regenerative medicine company Sanbio Co. Ltd. submitted its BLA for its lead mesenchymal stem cell-based treatment, SB-623, to Japan’s Ministry of Health, Labour and Welfare for chronic motor deficit due to traumatic brain injury. The application was submitted through Japan’s Sakigake designation system.
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Regulatory actions for March 29, 2022

March 29, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Biontech, Blue Lake, Cormedix, CSL, Cynavac, Galapagos, GSK, Hansa, Helsinn, Immorna, Innocare, Medison, Moberg, Moderna, Pfizer, Pipeline, Sanofi, Seqirus, Stealth, Tolerogenixx, UCB, Vir.
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Regulatory actions for March 28, 2022

March 28, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biobeat, Staar Surgical.
Read More
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