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BioCentury | Feb 12, 2024
Deals
Completing long comeback, liver play CymaBay agrees to $4.3B Gilead takeout
Gilead adds seladelpar, a PBC candidate now under priority review, to liver disease arsenal
BioCentury | Sep 26, 2023
Data Byte
Intercept’s highs and lows on the way to M&A outcome
After pair of FDA setbacks in NASH, Italian pharma Alfasigma to acquire liver disease company nearly a decade after stock peaked
BioCentury | Sep 14, 2023
Regulation
Sept. 13 Quick Takes: Madrigal gets March PDUFA date for NASH therapy
Plus: Rocket parlays gene therapy update into $175M raise and updates from DalCor, Mironid, Crinetics, Shionogi, Hasten, Dewpoint and Orchid
BioCentury | Jun 1, 2023
Data Byte
At least 15 PDUFA dates on FDA’s calendar for June
Expected decisions include BioMarin’s hemophilia A gene therapy, a subQ form of argenx’s of myasthenia gravis drug, and Aldeyra’s retinal cancer candidate
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 | Mar 10, 2023
Regulation
March 10 Quick Takes: FDA approves Pfizer’s nasal spray for migraine
Plus: $50M series B, new CMO for cross-border play Allorion and updates from Merck & Co., Intercept, Iktos and more
BioCentury | Jan 20, 2023
Market Access
Jan. 19 Quick Takes: Average price cuts of 60% for new listings on China’s NRDL
Plus: Shoreline buying Editas NK assets and updates from Intercept, Roche, Seagen and more
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 19, 2022
Product Development
Big gain for Madrigal as data are more than enough for NASH submission
Needing only one of two primary endpoints, THRB agonist hits both, tripling biotech’s value and lifting others in same disease area
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