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BioCentury | Apr 3, 2024
Data Byte

Last minute flurry brings FDA’s first-quarter NME approvals to 10

Highlights include accelerated approval of first MASH therapy; plus Merck’s disease-modifying PAH therapy and Idorsia’s antihypertensive 
BioCentury | Oct 25, 2023
Finance

Oct. 25 Quick Takes: U.K. takes next step in pension fund reforms

Plus: CBC-backed R-Bridge realizes royalty exit, and updates from Akebia, DermBiont, GSK and Flashpoint
BioCentury | Jun 23, 2023
Regulation

CHMP departs from FDA again in neuro, with Amylyx’ ALS therapy

CHMP’s June opinions: Amylyx therapy denied, plus positive opinions for two new medicines and eight label extensions
BioCentury | Feb 1, 2023
Data Byte

At least nine PDUFA dates on deck in February

Decisions include GSK’s daprodustat, and two sBLAs for Regeneron’s Eylea
BioCentury | May 13, 2022
Regulation

May 13 Quick Takes: China proposes exclusivity for orphan, pediatric drugs

Plus FDA approves Lilly’s Mounjaro, Akebia loses partner, UCB psoriasis candidate hits FDA snag, and updates from Mitsubishi, BridgeBio and more
BioCentury | Mar 2, 2022
Product Development

March 1 Quick Takes: Setbacks in C. diff for Pfizer, Finch

Plus Karyopharm tumbles, Epizyme cuts, and updates from Alnylam, Novavax, Gilead and more
BioCentury | Dec 14, 2021
Deals

CSL gains iron and kidney products, plus innovative pipeline, in $11.7B Vifor takeout

In deal for Vifor, Australia’s CSL adds registration-stage therapies, established nephrology and iron deficiency products
BioCentury | Oct 1, 2021
Distillery Therapeutics

HIF-PH inhibitors for manganese toxicity

BioCentury | Aug 20, 2021
Deals

Aug. 19 Quick Takes: FTC readies trial on Grail deal as Illumina says takeout is complete 

Plus Junshi-Coherus, FibroGen, EpiEndo, BMS-bluebird, Roche
BioCentury | Aug 11, 2021
Regulation

FibroGen looking to EU decision, new indications for roxadustat as FDA requests another trial

EU decision could come as early as this month 
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