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Regulatory
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Regulatory actions for Oct. 23, 2023

Oct. 23, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insulet, Huizhou Jinghao, Ludica Medical, Medtronic, Vuno.
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Pfizer wins FDA nod for pentavalent meningitis vaccine Penbraya

Oct. 20, 2023
By Randy Osborne
The U.S. FDA cleared Pfizer Inc.’s Penbraya (meningococcal groups A, B, C, W and Y vaccine), the first pentavalent shot designed to provide coverage against the most common serogroups causing meningococcal disease in adolescents and young adults through age 25.
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FDA Approved stamp with pills, bottle, blister pack
Biopharma regulatory actions and approvals September 2023

2023 US FDA approvals rise over last year, yet fall short of earlier years

Oct. 20, 2023
By Amanda Lanier
The first three quarters of 2023 delivered a mix of approval news, with an uptick in U.S. FDA clearances over the previous year, but still tracking lower than 2017-2021. Global approvals are on a different trajectory, down year over year.
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Regulatory actions for Oct. 20, 2023

Oct. 20, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Pleural Dynamics.
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Streptococcus pneumoniae in lungs
Immune

Vaxcyte's 31-valent PCV candidate VAX-31 receives IND clearance for invasive pneumococcal disease

Oct. 20, 2023
Vaxcyte Inc. has received FDA clearance of its IND application for VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease.
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Salary disparities land Pfizer with $2M back tab

Oct. 19, 2023
Pfizer Inc. entered into a conciliation agreement with the U.S. Department of Labor’s Office of Federal Contract Compliance Programs to resolve alleged compensation discrimination affecting female employees at its New York headquarters.
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Pills under magnifying glass

EC busts Rx cartel over control of API

Oct. 19, 2023
In a historic first, the European Commission (EC) sanctioned a pharmaceutical cartel focused on controlling an active pharmaceutical ingredient (API) in the European Economic Area.
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US FDA revises, finalizes vaccine and drug guidances

Oct. 19, 2023
By Mari Serebrov
As COVID-19 vaccine development continues, the U.S. FDA is releasing a revised version of its 2020 guidance, “Development and licensure of vaccines to prevent COVID-19.”
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Injection syringes

Limited semaglutide supply keeps window open for counterfeits

Oct. 19, 2023
By Mari Serebrov
Fake versions of Novo Nordisk A/S’ 1-mg Ozempic prefilled pens are sounding alarms in Europe amid an ongoing shortage of the company’s semaglutide products resulting from demand in the weight-management space.
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Wandercraft Atalante-X Exoskeleton

Wandercraft launches commercial operations of its exoskeleton in the US

Oct. 19, 2023
By Shani Alexander
Wandercraft SAS has begun commercial operations of its exoskeleton, Atalante X, in the U.S., offering another solution to the millions of people living with mobility impairments. The company also formed a partnership with the Kessler Foundation whose research team will investigate the possible benefits of the Atalante X for neurologically impaired patients, including those recovering from stroke, spinal cord injuries and motor neuron disease.
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