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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 | Mar 14, 2024
Regulation
Madrigal’s MASH drug is approved, now it’s time to build the market
FDA approves Rezdiffra as first MASH therapy
BioCentury | Mar 6, 2024
Product Development
Clinical report: Akero’s efruxifermin shows deepening treatment effect at 96 weeks
Plus: Novo positions Ozempic to add CKD to label and updates from Apogee, RegenxBio, Ironwood
BioCentury | Feb 6, 2024
Product Development
Clinical roundup: Data for Lilly’s tirzepatide, GSK’s Blenrep, 4D, Vertex and more
Lilly’s dual GLP-1R/GIP agonist shows early efficacy in MASH; Blenrep combo beats Darzalex combo in MM
BioCentury | Jan 20, 2024
Finance
Buysiders are all about market-creating catalysts in 2024
BioCentury’s 32nd Buyside View finds MASH, obesity and pain are among the year’s most closely-watched categories
BioCentury | Oct 10, 2023
Product Development
Akero’s NASH readout spreads worries to others in class
Despite miss on fibrosis endpoint, biotech touts strong performance on disease resolution, says totality of data support Phase III start
BioCentury | May 17, 2023
Data Byte
Comparing Phase II NASH data from Viking and Madrigal
Viking’s VK2809 appears to reduce liver fat as well as Madrigal’s resmetirom, which went on to show efficacy in Phase III
BioCentury | Mar 22, 2023
Data Byte
How 89bio’s Phase IIb NASH data match up with Akero’s in FGF21 class
Planned Phase III trials would clarify benefit compared with other classes ahead in regulatory queue
BioCentury | Dec 23, 2022
Regulation
Dec. 23 Quick Takes: Lunsumio first bispecific for follicular lymphoma
Plus: FDA rebuffs Ipsen’s palovarotene; Amgen, LegoChem in ADC deal; spending bill to Biden; and updates from UCB, Intercept, Galapagos, Ryvu and more
BioCentury | Dec 22, 2022
Regulation
Dec. 21 Quick Takes: Cash for NASH as Madrigal and Terns raise funds
Plus: FDA, EMA reviewing Pfizer’s etrasimod for ulcerative colitis and updates from ADC, AZ, CytoDyn, NGM-Merck and more
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