BioCentury | Apr 15, 2021
Regulation

April 14 Quick Takes: GSK stops two trials of ICOS agonist; plus Trodelvy, Amylyx, Junshi, Jazz, MitoChem

...label in China for Junshi’s PD-1 mAbShanghai Junshi Biosciences Co. Ltd. (HKEX:1877; Shanghai:688180) said China’s National Medical Products Administration...
BioCentury | Apr 7, 2021
Product Development

How COVID-19 brought China vaccine play CanSino onto the global stage

...study. On March 22, CanSino said China’s National Medical Products Administration...
BioCentury | Mar 31, 2021
Regulation

March 31 Quick Takes: Basket of EU approvals includes MS, SMA drugs; plus Amarin, AbbVie, Cara-Vifor

...treat focal onset seizures.Zai gains China approval of QinlockZai Lab Ltd. (NASDAQ:ZLAB; HKEX:9688) said China’s National Medical Products Administration...
BioCentury | Mar 25, 2021
Regulation

March 24 Quick Takes: A first for Twist, Biotia and a refusal-to-file letter for Novo; plus Novartis’ radioligand, Zealand, four Japan approvals and more

...the targeted radioligand therapy candidate.CStone lands China nod for GavretoCStone Pharmaceuticals Co. Ltd (HKEX:2616) said China’s National Medical Products Administration...
BioCentury | Mar 23, 2021
Product Development

March 22 Quick Takes: Ionis falls as Genentech halts Huntington’s trial; plus Pfizer, Evotec-Takeda, Everest, BioCryst and Odonate

...million in milestones per program, plus tiered royalties. A first for Everest Everest Medicines Ltd. said China’s National Medical Products Administration...
BioCentury | Feb 24, 2021
Product Development

Feb. 24 COVID Quick Takes: China reviewing CanSino’s vaccine; plus AZ’s vaccine in Ghana, NIH’s ‘Long COVID’ initiative, Celltrion and more

...By Paul Bonanos, Associate Editor CanSino Biologics Inc. (HKEX:6185) said China’s National Medical Products Administration is reviewing its application...
BioCentury | Feb 9, 2021
Product Development

Feb. 8 Quick Takes: FDA approves TG’s lymphoma therapy; plus uniQure, Astellas, BMS, Viiv, Avrobio and Veru

...Huntingtin (HTT) gene.China’s NMPA clears use of Astellas’ XospataXospata gilteritinib gained conditional approval from China’s National Medical Products Administration...
BioCentury | Feb 5, 2021
Product Development

Feb. 5 Quick Takes: FDA approves BMS’s liso-cel; plus AZ’s Imfinzi fails in head and neck cancer trial and updates on Reistone, Spero, Innovent and more

...study on the advice of a safety review board.Approval in China for AstraZeneca, Innovent drugsChina’s National Medical Products Administration...
BioCentury | Feb 4, 2021
Product Development

Vaxart falls on mixed Phase I readout for COVID-19 vaccine; plus BMS-Rockefeller mAb cocktail deal and vaccine updates for Sputnik V, Novavax, Bharat-Ocugen and Sinovac

...regimens. Sinovac seeking conditional authorization of vaccine in ChinaSinovac Biotech Ltd. (NASDAQ:SVA) submitted an application to China’s National Medical Products Administration...
BioCentury | Jan 21, 2021
Product Development

Jan. 20 Quick Takes: AZ, Daiichi get Enhertu approvals in gastric, breast cancer; plus EdiGene, Merck, Oxford, BMS and Omeros

...treat HER2-positive metastatic breast cancer. EdiGene’s CRISPR therapy for β thalassemia moves into clinicEdiGene Inc. said China’s National Medical Products Administration...
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BioCentury | Apr 15, 2021
Regulation

April 14 Quick Takes: GSK stops two trials of ICOS agonist; plus Trodelvy, Amylyx, Junshi, Jazz, MitoChem

...label in China for Junshi’s PD-1 mAbShanghai Junshi Biosciences Co. Ltd. (HKEX:1877; Shanghai:688180) said China’s National Medical Products Administration...
BioCentury | Apr 7, 2021
Product Development

How COVID-19 brought China vaccine play CanSino onto the global stage

...study. On March 22, CanSino said China’s National Medical Products Administration...
BioCentury | Mar 31, 2021
Regulation

March 31 Quick Takes: Basket of EU approvals includes MS, SMA drugs; plus Amarin, AbbVie, Cara-Vifor

...treat focal onset seizures.Zai gains China approval of QinlockZai Lab Ltd. (NASDAQ:ZLAB; HKEX:9688) said China’s National Medical Products Administration...
BioCentury | Mar 25, 2021
Regulation

March 24 Quick Takes: A first for Twist, Biotia and a refusal-to-file letter for Novo; plus Novartis’ radioligand, Zealand, four Japan approvals and more

...the targeted radioligand therapy candidate.CStone lands China nod for GavretoCStone Pharmaceuticals Co. Ltd (HKEX:2616) said China’s National Medical Products Administration...
BioCentury | Mar 23, 2021
Product Development

March 22 Quick Takes: Ionis falls as Genentech halts Huntington’s trial; plus Pfizer, Evotec-Takeda, Everest, BioCryst and Odonate

...million in milestones per program, plus tiered royalties. A first for Everest Everest Medicines Ltd. said China’s National Medical Products Administration...
BioCentury | Feb 24, 2021
Product Development

Feb. 24 COVID Quick Takes: China reviewing CanSino’s vaccine; plus AZ’s vaccine in Ghana, NIH’s ‘Long COVID’ initiative, Celltrion and more

...By Paul Bonanos, Associate Editor CanSino Biologics Inc. (HKEX:6185) said China’s National Medical Products Administration is reviewing its application...
BioCentury | Feb 9, 2021
Product Development

Feb. 8 Quick Takes: FDA approves TG’s lymphoma therapy; plus uniQure, Astellas, BMS, Viiv, Avrobio and Veru

...Huntingtin (HTT) gene.China’s NMPA clears use of Astellas’ XospataXospata gilteritinib gained conditional approval from China’s National Medical Products Administration...
BioCentury | Feb 5, 2021
Product Development

Feb. 5 Quick Takes: FDA approves BMS’s liso-cel; plus AZ’s Imfinzi fails in head and neck cancer trial and updates on Reistone, Spero, Innovent and more

...study on the advice of a safety review board.Approval in China for AstraZeneca, Innovent drugsChina’s National Medical Products Administration...
BioCentury | Feb 4, 2021
Product Development

Vaxart falls on mixed Phase I readout for COVID-19 vaccine; plus BMS-Rockefeller mAb cocktail deal and vaccine updates for Sputnik V, Novavax, Bharat-Ocugen and Sinovac

...regimens. Sinovac seeking conditional authorization of vaccine in ChinaSinovac Biotech Ltd. (NASDAQ:SVA) submitted an application to China’s National Medical Products Administration...
BioCentury | Jan 21, 2021
Product Development

Jan. 20 Quick Takes: AZ, Daiichi get Enhertu approvals in gastric, breast cancer; plus EdiGene, Merck, Oxford, BMS and Omeros

...treat HER2-positive metastatic breast cancer. EdiGene’s CRISPR therapy for β thalassemia moves into clinicEdiGene Inc. said China’s National Medical Products Administration...
Items per page:
1 - 10 of 301