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Home » Topics » Regulatory

Regulatory
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China’s Alpha Biopharma seeks new drug status for EGFR-TKI product

Jan. 31, 2023
By Zhang Mengying
Alpha Biopharma Ltd. submitted an NDA in China for zorifertinib, a next-generation EGFR tyrosine kinase inhibitor (EGFR-TKI) to treat advanced EGFR-mutated non-small-cell lung cancer with central nervous system metastases. Zorifertinib is the first EGFR-TKI to be tested in a clinical study for this patient population, according to the company.
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FDA grants breakthrough therapy designation to Abbisko’s CSF-1R inhibitor, pimicotinib

Jan. 31, 2023
By Tamra Sami
The U.S. FDA granted breakthrough therapy designation to Abbisko Therapeutics Co. Ltd.’s pimicotinib for patients with tenosynovial giant cell tumors who are not able to have surgery.
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China approves two oral drugs to treat COVID-19

Jan. 31, 2023
By Zhang Mengying
China’s NMPA granted conditional approvals to two COVID-19 drugs under a special examination and approval procedure aimed at addressing urgent needs. The approvals are both for oral small-molecule drugs for adult patients with mild to moderate COVID-19 infections. One of the approved drugs is Simcere Pharmaceutical Group Ltd.’s Xiannuoxin (simnotrelvir/ritonavir). The other is Shanghai Junshi Biosciences Co. Ltd.’s VV-116 (deuremidevir hydrobromide).
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China grapples with regulating online drug sales

Jan. 31, 2023
By Tamra Sami
China’s National Medical Products Administration is grappling with how to regulate drugs that are sold online as it issued new provisions under the country’s Drug Administration Law that allows prescription drugs to be sold online for the first time.
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Chinese flag, pills

China adds 111 new drugs to NRDL, focus on innovation

Jan. 31, 2023
By Zhang Mengying
Citing efforts to “encourage innovation,” China’s National Healthcare Security Administration included 111 new drugs in its National Reimbursement Drug List (NRDL). The adjustment, shared Jan. 18, 2023, also removed three drugs, leaving the latest NRDL with a total of 2,967 drugs. Most of the newly added drugs are recently approved drugs, with many making it to the market in the last five years. Twenty-three were approved in 2022.
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Australian flag on laptop screen with health professional

Australia begins first independent review of its health technology assessment process

Jan. 31, 2023
By Tamra Sami
The Australian government has begun its closely watched independent review of the health technology assessment (HTA) process in the country, and it delivered a first peek at what it will consider. This independent review of the HTA system is the first of its kind in nearly 30 years.
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IV drips

FDA lifts clinical hold on Astellas Fortis AAV gene therapy trial in Pompe disease

Jan. 31, 2023
By Tamra Sami
The U.S. FDA has lifted the clinical hold on Astellas Pharma Inc.’s Fortis phase I/II trial evaluating AAV gene replacement therapy AT-845 in adults with late-onset Pompe disease.
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India drug regulations under the scanner again after fresh WHO alert on contaminated cough syrup

Jan. 31, 2023
By T.V. Padma
India’s drug regulatory system is under the lens again after the World Health Organization’s (WHO) latest medical product alert on two substandard cough syrups manufactured in the country.
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Regulatory actions for Jan. 31, 2023

Jan. 31, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axonics.
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Regulatory actions for Jan. 31, 2023

Jan. 31, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbisko, Alpha, Eisai, Escient, Huidagene, Junshi, Moderna, Nanoscope, Novelmed, Regeneron, Sandoz, Sanofi, Xeris, Zai.
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