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Home » Topics » Regulatory

Regulatory
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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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Blister drug pack atop globe

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

May 23, 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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Document illustration

Nymox receives refuse to file letter from FDA

May 23, 2022
By Lee Landenberger
The U.S. FDA sent a refuse to file letter to Nymox Pharmaceutical Corp. regarding its NDA for fexapotide triflutate, a pro-apoptotic protein intended for treating benign prostatic hyperplasia. The letter noted that more long-term safety data was needed for the application, the company said.
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Singapore

Singapore updates guidelines for software as medical devices to expand scope

May 20, 2022
By David Ho
Singapore’s Health Sciences Authority (HSA) recently updated its guidelines for software as medical devices (SaMDs) to broaden its scope on a number of related matters. The new guidelines were finalized after an industry input period when the HSA collected feedback until the middle of August 2021. It marks the second revision of HSA guidelines on SaMDs, the first revision was meted out in April 2020. 
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Regulatory actions for May 20, 2022

May 20, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anika, Nanomix, Trinity Biotech.
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Lung cancer illustration

Acea Pharma fails to win green light for abivertinib in China

May 20, 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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Foghorn’s phase I in AML on a partial clinical hold

May 20, 2022
By Lee Landenberger
In the wake of a patient’s death, the U.S. FDA has placed a partial clinical hold on Foghorn Therapeutics Inc.’s phase I study of FHD-286 in treating relapsed and/or refractory acute myelogenous leukemia (r/r AML) and myelodysplastic syndrome.
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Rare disease illustration

Rare disease therapies from Sanofi, Eiger and PTC backed by Europe’s CHMP

May 20, 2022
By Richard Staines
The first therapies for several rare diseases were among medicines given the green light by European regulators at their monthly meeting. The EMA’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for Sanofi SA’s Xenpozyme (olipudase alfa) for two types of Niemann-Pick disease and Eiger Biopharmaceuticals Inc.’s Zokinvy (lonafarnib) for children with Hutchinson-Gilford progeria syndrome or progeroid laminopathies. PTC Therapeutics Inc.’s Upstaza (eladocagene exuparvovec), the first medicine for adults and children with aromatic L-amino decarboxylase deficiency, was also backed by the CHMP.
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