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BioWorld - Sunday, March 7, 2021
Home » Topics » Regulatory, BioWorld Asia

Regulatory, BioWorld Asia
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COVID-19 vaccine vials

Two COVID-19 vaccines approved in China in less than 24 hours

March 2, 2021
By Sergio Held
No Comments
China’s National Medical Products Administration granted conditional approval two Chinese-developed COVID-19 vaccines in less than 24 hours on Feb. 25. One of the vaccines approved was developed by Tianjin-based Cansino Biologics Inc., and the other by China National Pharmaceutical Group (Sinopharm) through its Wuhan Institute of Biological Products subsidiary.
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Curocell scientist
Newco news

Curocell adds first South Korean IND approval for CAR T to its cart

March 2, 2021
By Gina Lee
No Comments
HONG KONG – Daejeon, South Korea-based Curocell Inc. has received the first IND approval for a CAR T therapy in South Korea from the Ministry of Food and Drug Safety (MFDS).
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Architectural pillars

Regulatory front for March 2, 2021

March 2, 2021
No Comments
The latest global regulatory news, changes and updates affecting biopharma in Asia, including: FDA, Gilead Sciences, Therapeutic Goods Administration, World Health Organization.
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Architectural pillars

Regulatory front for Feb. 23, 2021

Feb. 23, 2021
No Comments
The latest global regulatory news, changes and updates affecting biopharma in Asia, including: Indoco Remedies, Takeda, Therapeutic Goods Administration, Torrent, U.S. Court of Appeals for the Federal Circuit.
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Petri dish and capsules

Awaiting FDA decision on ibrexafungerp, Scynexis deals greater China rights to Hansoh

Feb. 23, 2021
By David Ho
No Comments
HONG KONG – Hansoh Pharmaceutical Group Co. Ltd. picked up the greater China rights to Scynexis Inc.’s lead candidate, ibrexafungerp. Hansoh will take charge of the development, regulatory approval and commercialization of the antifungal in exchange for a $10 million up-front payment and as much as $112 million in milestones.
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Australia establishes COVID-19 vaccine safety monitoring plan ahead of rollout

Feb. 23, 2021
By Tamra Sami
No Comments
PERTH, Australia – With the first COVID-19 vaccine ready to be launched in Australia, the Therapeutic Goods Administration has released guidance on its pharmacovigilance plan to track real-world safety data and adverse events following immunization.
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Baby, it’s not as cold inside: Pfizer-Biontech submits new COVID-19 vaccine storage data

Feb. 23, 2021
By Lee Landenberger
No Comments
Pfizer Inc. and Biontech SE submitted new data to the FDA showing its COVID-19 vaccine’s stability can be maintained at temperatures often found in pharmaceutical freezers and refrigerators: -13°F to 5°F (-25°C to -15°C).
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Calculator and pills

TGA seeks feedback on impact of proposed fee changes for drugs and devices

Feb. 16, 2021
By Tamra Sami
No Comments
PERTH, Australia – Australia’s Therapeutic Goods Administration is proposing changes to its fees and charges and is asking stakeholders for feedback on three different proposed fee structures for the 2021-2022 financial year.
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Bamlanivimab and etesevimab

FDA grants EUA for Abcellera-Junshi-Lilly COVID-19 treatment

Feb. 16, 2021
By Lee Landenberger
No Comments
Another monoclonal antibody therapy has entered the pandemic fray with the FDA granting emergency use authorization (EUA) for bamlanivimab (LY-CoV555) 700 mg and etesevimab (JS016 or LY-CoV016) 1,400 mg as a cocktail for treating mild to moderate COVID-19 in patients aged 12 and up at high risk for progressing to severe COVID-19 and/or hospitalization.
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Australia and coronavirus syringe

Australia’s TGA grants provisional approval to Astrazeneca’s COVID-19 vaccine

Feb. 16, 2021
By Tamra Sami
No Comments
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to Astrazeneca Pty Ltd. for its COVID-19 vaccine, a recombinant adenovirus vaccine, making it the second COVID-19 vaccine to receive regulatory approval in Australia, following the Jan. 26 provisional approval for Pfizer Australia Pty Ltd.’s COVID-19 vaccine, branded Comirnaty.
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