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BioCentury
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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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