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Ap­plied Ther­a­peu­tic­s' rare dis­ease drug gets a CRL
The FDA rejected Applied Therapeutics’ experimental treatment, govorestat, for a rare disease called classic galactosemia, ...
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Ad­vanz Phar­ma faces re­vo­ca­tion of Eu­ro­pean au­tho­riza­tion for liv­er dis­ease drug Ocali­va
Advanz Pharma's liver treatment Ocaliva lost EU marketing authorization following a court decision. The drug, used for ...
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No­var­tis to cut 139 jobs in NJ as part of com­mer­cial re­fo­cus
Novartis is laying off 139 employees in East Hanover, NJ, primarily affecting commercial field sales teams working on Xolair (allergy/asthma) and Tafinlar-Mekinist (cancer) treatments. The cuts, ...
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Sat­suma's NDA fil­ing af­ter CMC woes; Hov­ione's Irish and US ex­pan­sion
FDA accepts Satsuma Pharmaceuticals' NDA resubmission for STS101 migraine drug. Hovione expands facilities in Ireland and New ...
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Bris­tol My­ers sues the fed­er­al gov­ern­ment over 340B, fol­low­ing oth­er drug­mak­ers
Bris­tol My­ers Squibb is the lat­est phar­ma com­pa­ny to sue the fed­er­al gov­ern­ment over its re­jec­tion of a pro­posed new mod­el for dis­trib­ut­ing 340B drug … ...
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Out­look's shares crash as wet AMD drug flunks Phase 3 test
Outlook Therapeutics' ONS-5010 (bevacizumab) failed to meet its primary endpoint in a Phase 3 trial against Roche's Lucentis ...
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Re­cur­sion re­duces work­force; Ox­ford Nanopore teams up with UK Biobank
Recursion Pharmaceuticals laid off under 20% of staff following merger with Exscientia. Oxford Nanopore partners with UK Biobank for epigenetic dataset project. Portage Biotech continues strategic ...