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Home » Topics » Regulatory

Regulatory
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Postponed stamp on calendar

FDA pushes back PDUFA date for Daiichi Sankyo’s quizartinib

April 21, 2023
By Tamra Sami
Daiichi Sankyo Co Ltd. has experienced yet another setback with its quizartinib NDA submission, as the U.S. FDA has now extended the review period by three months to July 24, 2023, to allow additional time to review requested updates to the proposed Risk Evaluation and Mitigation Strategies. No additional efficacy or safety data has been requested.
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Regulatory actions for April 21, 2023

April 21, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apex, Aquestive, Cantargia, Carsgen, DBV, Dermata, Genentech, Innocare, Regeneron, Sanofi, Sensei, Therapeutic Solutions, Tiziana.
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Pills on a spoon

FDA’s Califf says big pharma has ‘let us down’ in failing to develop non-addictive analgesics

April 20, 2023
By Mark McCarty
The opioid crisis in the U.S. has not yet been resolved, but FDA commissioner Robert Califf said April 19 the agency could do more to resolve the crisis if Congress granted the agency the authority to require that new opioid analgesics offer superior safety relative to currently approved products. Califf laid the blame for the crisis on manufacturers in stating that drug makers had “let us down” in failing to develop novel oral analgesics that avoid the addictive properties that helped to fuel the opioid crisis.
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Regulatory actions for April 20, 2023

April 20, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: GE Healthcare, Meridian Bioscience, Noctrix Health.
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China: Vaccine platforms, research needed as pandemic wanes

April 20, 2023
While the pandemic is nearing its end, Chinese officials are calling for the development of novel, multivalent COVID-19 vaccines as an essential task moving forward. 
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US drug pricing legislation to take on the PBMs

April 20, 2023
By Mari Serebrov
The U.S. Senate Finance Committee has its work cut out for it as it crafts bipartisan legislation “that will take on the worst practices by drug-pricing middlemen and ensure that the prescription drug supply chain is pulling in the same direction: more competition and lower costs for patients and taxpayers,” committee Chair Ron Wyden (D-Ore.) said.
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China: Vaccine platforms, research needed as pandemic wanes

April 20, 2023
While the pandemic is nearing its end, Chinese officials are calling for the development of novel, multivalent COVID-19 vaccines as an essential task moving forward. To date, China has 17 COVID-19 vaccine products that have completed or are in phase III trials, according to the NMPA.
Read More
Blue puzzle pieces, red ribbon

PEPFAR challenge: Aiding young people who don’t know HIV’s ‘ugliness’

April 20, 2023
By Mari Serebrov
The success of the President’s Emergency Plan for AIDS Relief (PEPFAR) over the past 20 years is one of the biggest challenges in reaching its goal of eliminating HIV as a global public health threat by 2030, members of the U.S. Senate Foreign Relations Committee were told as they moved toward reauthorizing the program for another five years.
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Regulatory actions for April 20, 2023

April 20, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cel-Sci, CSL, Nascent, SAB, Taiho, Zucara.
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Acting director of NIH says agency is wary of using march-in rights to control drug prices

April 19, 2023
By Mark McCarty
The annual U.S. budget scrum is well underway in Washington, with drug pricing a persistent theme on Capitol Hill. Lawrence Tabak, acting director of the National Institutes of Health (NIH), said NIH’s view is that federal government exercise of march-in rights “is not the instrument to regulate drug pricing” as it would alienate drug makers and their investors, but Tabak vowed that the appropriate use of march-in rights is the subject of intense focus at the Department of Health and Human Services.
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