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Home » Topics » Regulatory

Regulatory
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U.K. flag and capsules

UK’s MHRA tackles Rx supply chain issues

May 24, 2022
By Mari Serebrov
With drug shortages becoming a fact of life during the pandemic, the U.K.’s Medicines & Healthcare Products Regulatory Agency (MHRA) is issuing two guidances to help ensure access to essential medicines in Great Britain and Northern Ireland, especially during shortages and public health emergencies.
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Vtama.png

Itching to go: With an FDA approval, Dermavant joins a busy psoriasis market

May 24, 2022
By Jennifer Boggs and Lee Landenberger
Dermavant Sciences Inc. has received its first FDA approval with the agency’s blessing of Vtama (tapinarof) for treating plaque psoriasis in adults. The treatment is also the first FDA-approved, steroid-free topical medication in its class in addition to being the first psoriasis novel topical chemical entity introduced to the market in the past 25 years.
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FDA icons

Updated guidance latest US FDA tool against drug-resistant bugs

May 24, 2022
By Mari Serebrov
The U.S. FDA’s approval, in recent years, of new medicines that can fight certain drug-resistant bugs makes it possible to conduct noninferiority trials of potential antibacterial therapies in patients with infections caused by those bugs since active controls are now available.
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Regulatory actions for May 24, 2022

May 24, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anumana, Caredx, Cytek Biosciences, Inheart, Invenio Imaging, Rapidai.
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Blister drug pack atop globe

‘East to West’ movement of trial data raising diversity, quality concerns

May 24, 2022
By Mari Serebrov
Just in case the U.S. FDA didn’t get the message from its advisory committee about drug applications based solely on clinical trial data from China, a trio of U.S. lawmakers wrote to FDA Commissioner Robert Califf to voice their concerns about the “current ‘East to West’ movement of clinical data” to support the approval of me-too drugs.
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Lung cancer illustration

Acea Pharma fails to win green light for abivertinib in China

May 24, 2022
By Doris Yu
Zhejiang Acea Pharmaceutical Co. Ltd. failed to obtain marketing approval from China’s NMPA for its third-generation EGFR tyrosine kinase inhibitor, abivertinib. The NDA was based on a phase II trial of abivertinib in patients with EGFR Thr790Met point mutation-positive non-small-cell lung cancer with disease progression from prior EGFR inhibitors.
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Global pandemic threat

Too little, too late: WHO panel says the world is vulnerable to another pandemic

May 24, 2022
By Lee Landenberger
A year after the World Health Organization's (WHO) Independent Panel for Pandemic Preparedness and Response called for reforms to make COVID-19 the last pandemic, the panel remains solidly frustrated in its lack of progress. The WHO’s director general, Tedros Adhanom Ghebreyesus, emphatically agreed on May 18, saying he was taken aback by data showing COVID-19 cases rose in four out of the six WHO regions just in the past week.
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Regulatory actions for May 24, 2022

May 24, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Altamira, Astrazeneca, Bharat, Biohaven, Depymed, Eiger, Greenwich, Immunitybio, Immunogen, Nymox, Ocugen, Regeneron, Salubris, Sanofi, Therapeuticsmd.
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FDA website and logo

FDA pilot program would take a bite out of reliance on ethylene oxide as sterilant

May 23, 2022
By Mark McCarty
Ethylene oxide (EtO) has been a mainstay in medical device sterilization for decades, but fears of carcinogenicity sparked protests outside EtO sterilization plants in Georgia and Illinois in 2018. While the COVID-19 pandemic overrode those concerns for two years, the FDA has opened a pilot program for conversion of sterilization methods that would require fewer regulatory filings than would otherwise be the case.
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Meeting illustration

Board quotas struck down in California

May 23, 2022
By Mari Serebrov
Although it was recently overturned in a legal challenge, a short-lived California state law mandating gender quotas for corporate boards may have made a few drug and device companies based in the state think twice about the makeup of their boards.
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