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BioCentury
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BioCentury | Oct 14, 2024
Deals

Lundbeck bolts on Longboard, gains anticonvulsive in $2.6B deal

Danish pharma eyeing growth beyond loss of exclusivity for Rexulti, aiming for broad label in rare epilepsies
BioCentury | Jun 2, 2023
Product Development

Epigenome editing companies showcase progress at ASGCT

Modalis accomplishes gene activation, while Tune achieves gene repression, both in non-human primates
BioCentury | May 26, 2023
Data Byte

CHMP seeks to pull Adakveo’s conditional approval; drug has full FDA approval

EMA agency issues positive opinions on Pylclari and Ztalmy, label expansions for Opdivo and Sogroya
BioCentury | Jan 19, 2023
Politics, Policy & Law

Hopes, Fears for Orphan Drug Act

Passed 40 years ago, it may be time for ODA 2.0
BioCentury | Nov 18, 2022
Regulation

Nov. 17 Quick Takes: FDA approves Provention’s mAb to slow onset of diabetes

Plus: Rezo’s launch, deals by Regeneron-CytomX and Marinus-Tenacia, the end of a GSK-Immatics deal, and Tenaya’s funding
BioCentury | Nov 9, 2022
Regulation

Nov. 8 Quick Takes: FDA request could extend review of BioMarin’s hemophilia therapy

Plus Sanofi’s latest AI deal taps Insilico and updates from Kronos, Marinus and more  
BioCentury | Jul 15, 2022
Politics, Policy & Law

July 14 Quick Takes: Illumina, BGI end U.S. legal battle

Plus FDA delays BeiGene’s BLA, Manifold raises $40M and updates from Theravance, Marinus, and more
BioCentury | Mar 1, 2022
Data Byte

At least nine PDUFA dates on deck in March

Four submissions under FDA priority review
BioCentury | Feb 24, 2022
Deals

Amicus deprioritizes gene therapies, ends plan to merge spinout with Perceptive’s SPAC

After years of building gene therapy pipeline, Amicus refines focus to Fabry, Pompe franchises
BioCentury | Sep 29, 2021
Deals

Amicus’ Crowley to lead gene therapy spinout after SPAC deal

Amicus will be largest shareholder in newly launched Caritas, which will advance genetic medicines pipeline
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