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Home » Topics » Regulatory

Regulatory
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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.
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Cloud/cybersecurity illustration

European Commission moves on cybersecurity, data security with two proposals

March 28, 2022
By Mark McCarty

The European Commission has acted to thwart cybersecurity risks with a proposed cybersecurity regulation and separate proposal for information security. What is not clear, however, from these proposals is whether they would interact with existing EU rules governing cybersecurity for medical devices, raising the prospect that medical technologies will be subject duplicate oversight for cybersecurity.


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Xzing Technology’s disposable endoscope gains NMPA approval

March 28, 2022
By Zhang Mengying
Shenzhen Xzing Technology Co. Ltd.’s Endofresh disposable upper gastrointestinal (GI) endoscope has granted the NMPA’s class II approval. The company said the approved product is used for upper gastrointestinal GI endoscopy, diagnosis and treatment.
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U.S. flag and White House podium

White House budget draft includes proposals for expanded US FDA regulation of drugs, devices

March 28, 2022
By Mark McCarty
The Biden administration has floated a budget proposal for fiscal year 2023, which includes $49 billion for the National Institutes of Health (NIH) and an additional FDA budget authority of $356 million over the current fiscal year. However, the budget also includes legislative proposals, such as a virtual inspection requirement for device manufacturing facilities and compulsory studies of drug shelf life to evaluate finished drug stability beyond the labeled expiration.
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