BioCentury | Jan 22, 2021
Regulation

Jan. 21 Quick Takes: FDA approves ViiV’s long-acting HIV therapy; plus Menarini, Incyte, Moderna, Genentech

...plc (LSE:GSK; NYSE:GSK), Pfizer Inc. (NYSE:PFE) and Shionogi & Co. Ltd....
BioCentury | Dec 19, 2020
Regulation

U.K. selects first drugs for pathfinding antimicrobial resistance initiative

...and Fetcroja cefiderocol (Fetroja —U.S.) from Shionogi & Co. Ltd....
...inform the subscription payment price Pfizer and Shionogi...
...NXL104/ceftazidime (Former), ceftazidime/avibactam (Generic), Zavicefta (Other), Avycaz (Other) Pfizer Shionogi & Co. Ltd. bee2021 antimicrobial...
BioCentury | Nov 24, 2020
Product Development

Nov. 23 Quick Takes: NIH panel says bamlanivimab should not be considered COVID-19 SOC; plus Eiger, Shionogi-Roche, Kiniksa, Schrödinger, Halozyme-Horizon and Immunicum-DCPrime

...label expanded to include post-exposure flu preventionFDA expanded its approval of Xofluza baloxavir marboxil from Shionogi & Co. Ltd....
BioCentury | Jun 2, 2020
Regulation

June 1 Quick Takes: CHMP recommendations, plus FDA action on AbbVie-Neurocrine, Shionogi, AZ, Lilly, Genentech

...Shionogi antibiotic FDA accepted and granted Priority Review to an sNDA for Fetroja cefiderocol from Shionogi & Co. Ltd....
...and Robin Sawka, BioCentury Staff Piqray, alpelisib (BYL719) Rozlytrek, entrectinib (RG6268, rxdx-101) Johnson & Johnson Novartis AG AbbVie Inc. Neurocrine Biosciences Inc. Shionogi & Co. Ltd. AstraZeneca...
BioCentury | May 28, 2020
Product Development

May 27 Quick Takes: EC approves Zeposia in RRMS; plus Dupixent approved in children, La Jolla, Shionogi, Alnylam and Bold

...2H19 for its IV artesunate, LJPC-0118, to treat severe malaria. Shionogi acquires CNS partner Tetra Shionogi & Co. Ltd....
...acquire neurology company Tetra Therapeutics for up to $500 million in regulatory and commercial milestones. Shionogi...
...disease and is in Phase II testing for Fragile X syndrome. Under a 2018 deal, Shionogi...
BioCentury | Mar 10, 2020
Product Development

March 9 Quick Takes: A first for Boehringer’s Ofev; plus Cel-Sci’s COVID-19 therapy, Sinopharm, AZ, Urovant, Hengrui, Trevena, and Tetra-Shionogi

...Aug. 7 PDUFA date (see “FDA Rebuffs Trevena’s Olinvo” ). Tetra takeout option for Shionogi Shionogi & Co. Ltd....
BioCentury | Feb 29, 2020
Regulation

Lilly’s Emgality fails to win CHMP support for cluster headaches

...treat cluster headaches with Emgality in its February roundup, which included a positive opinion on Shionogi’s...
...to prevent episodic cluster headaches. CHMP’s positive opinions included an MAA for Fetcroja cefiderocol from Shionogi & Co. Ltd....
...galcanezumab-gnlm (LY2951742) Vargatef, nintedanib (BIBF 1120, ofev, BIBF1120) Alunbrig (Brand), AP26113 (Compound #), brigatinib (Generic) Eli Lilly and Co. Shionogi & Co. Ltd. Boehringer...
BioCentury | Jan 8, 2020
Company News

Management tracks: Fred Hutch taps BMS CSO Lynch; plus GSK, Rubius, Provention, Antengene, Revitope, Compugen, Wellington, Adamas, Arcturus and Turnstone

...team. Before joining ViiV, which is an HIV-focused JV of GSK, Pfizer Inc. (NYSE:PFE) and Shionogi & Co. Ltd....
BioCentury | Jan 7, 2020
Company News

Management tracks: New director for CMS’s CMMI, plus FibroGen, Turning Point, Akcea, Antengene, Biocon and more

...company DeepBiome Therapeutics Inc. as CBO. He was SVP, corporate development and commercialization strategy at Shionogi & Co. Ltd....
BioCentury | Dec 24, 2019
Company News

Regulatory roundup: BioMarin poised to have first U.S., EU hemophilia gene therapy; plus Allergan, Eisai, FibroGen, ViiV and Vero

...virologically suppressed adults. Viiv, a JV of GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), Pfizer Inc. (NYSE:PFE) and Shionogi & Co. Ltd....
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BioCentury | Jan 22, 2021
Regulation

Jan. 21 Quick Takes: FDA approves ViiV’s long-acting HIV therapy; plus Menarini, Incyte, Moderna, Genentech

...plc (LSE:GSK; NYSE:GSK), Pfizer Inc. (NYSE:PFE) and Shionogi & Co. Ltd....
BioCentury | Dec 19, 2020
Regulation

U.K. selects first drugs for pathfinding antimicrobial resistance initiative

...and Fetcroja cefiderocol (Fetroja —U.S.) from Shionogi & Co. Ltd....
...inform the subscription payment price Pfizer and Shionogi...
...NXL104/ceftazidime (Former), ceftazidime/avibactam (Generic), Zavicefta (Other), Avycaz (Other) Pfizer Shionogi & Co. Ltd. bee2021 antimicrobial...
BioCentury | Nov 24, 2020
Product Development

Nov. 23 Quick Takes: NIH panel says bamlanivimab should not be considered COVID-19 SOC; plus Eiger, Shionogi-Roche, Kiniksa, Schrödinger, Halozyme-Horizon and Immunicum-DCPrime

...label expanded to include post-exposure flu preventionFDA expanded its approval of Xofluza baloxavir marboxil from Shionogi & Co. Ltd....
BioCentury | Jun 2, 2020
Regulation

June 1 Quick Takes: CHMP recommendations, plus FDA action on AbbVie-Neurocrine, Shionogi, AZ, Lilly, Genentech

...Shionogi antibiotic FDA accepted and granted Priority Review to an sNDA for Fetroja cefiderocol from Shionogi & Co. Ltd....
...and Robin Sawka, BioCentury Staff Piqray, alpelisib (BYL719) Rozlytrek, entrectinib (RG6268, rxdx-101) Johnson & Johnson Novartis AG AbbVie Inc. Neurocrine Biosciences Inc. Shionogi & Co. Ltd. AstraZeneca...
BioCentury | May 28, 2020
Product Development

May 27 Quick Takes: EC approves Zeposia in RRMS; plus Dupixent approved in children, La Jolla, Shionogi, Alnylam and Bold

...2H19 for its IV artesunate, LJPC-0118, to treat severe malaria. Shionogi acquires CNS partner Tetra Shionogi & Co. Ltd....
...acquire neurology company Tetra Therapeutics for up to $500 million in regulatory and commercial milestones. Shionogi...
...disease and is in Phase II testing for Fragile X syndrome. Under a 2018 deal, Shionogi...
BioCentury | Mar 10, 2020
Product Development

March 9 Quick Takes: A first for Boehringer’s Ofev; plus Cel-Sci’s COVID-19 therapy, Sinopharm, AZ, Urovant, Hengrui, Trevena, and Tetra-Shionogi

...Aug. 7 PDUFA date (see “FDA Rebuffs Trevena’s Olinvo” ). Tetra takeout option for Shionogi Shionogi & Co. Ltd....
BioCentury | Feb 29, 2020
Regulation

Lilly’s Emgality fails to win CHMP support for cluster headaches

...treat cluster headaches with Emgality in its February roundup, which included a positive opinion on Shionogi’s...
...to prevent episodic cluster headaches. CHMP’s positive opinions included an MAA for Fetcroja cefiderocol from Shionogi & Co. Ltd....
...galcanezumab-gnlm (LY2951742) Vargatef, nintedanib (BIBF 1120, ofev, BIBF1120) Alunbrig (Brand), AP26113 (Compound #), brigatinib (Generic) Eli Lilly and Co. Shionogi & Co. Ltd. Boehringer...
BioCentury | Jan 8, 2020
Company News

Management tracks: Fred Hutch taps BMS CSO Lynch; plus GSK, Rubius, Provention, Antengene, Revitope, Compugen, Wellington, Adamas, Arcturus and Turnstone

...team. Before joining ViiV, which is an HIV-focused JV of GSK, Pfizer Inc. (NYSE:PFE) and Shionogi & Co. Ltd....
BioCentury | Jan 7, 2020
Company News

Management tracks: New director for CMS’s CMMI, plus FibroGen, Turning Point, Akcea, Antengene, Biocon and more

...company DeepBiome Therapeutics Inc. as CBO. He was SVP, corporate development and commercialization strategy at Shionogi & Co. Ltd....
BioCentury | Dec 24, 2019
Company News

Regulatory roundup: BioMarin poised to have first U.S., EU hemophilia gene therapy; plus Allergan, Eisai, FibroGen, ViiV and Vero

...virologically suppressed adults. Viiv, a JV of GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), Pfizer Inc. (NYSE:PFE) and Shionogi & Co. Ltd....
Items per page:
1 - 10 of 845