Functional Concept

Sanofi calls FDA rejection of potential MS blockbuster tolebrutinib “unexpected” amid evolving agency views on benefit–risk

4 days ago talkbio0Tagged BTK inhibitor, Complete Response Letter, DILI, Mississippi (geographic location), Multiple Sclerosis, nrSPMS, PERSEUS trial, perspectives, Progressive, Rejection, sanofi, Tolebrutinib, United States Food and Drug Administration

Sanofi; tolebrutinib; multiple sclerosis; nrSPMS; BTK inhibitor; FDA rejection; complete response letter; DILI; primary progressive MS; Perseus trial; evolving FDA perspectives

Sanofi calls FDA rejection of potential MS blockbuster tolebrutinib “unexpected” amid evolving agency views on benefit–risk

4 days ago talkbio0Tagged BTK inhibitor, Complete Response Letter, DILI, Mississippi (geographic location), Multiple Sclerosis, nrSPMS, PERSEUS trial, perspectives, Progressive, Rejection, sanofi, Tolebrutinib, United States Food and Drug Administration

Sanofi; tolebrutinib; multiple sclerosis; nrSPMS; BTK inhibitor; FDA rejection; complete response letter; DILI; primary progressive MS; Perseus trial; evolving FDA perspectives

Sanofi calls FDA rejection of potential MS blockbuster tolebrutinib “unexpected” amid evolving agency views on benefit–risk

4 days ago talkbio0Tagged BTK inhibitor, Complete Response Letter, DILI, Mississippi (geographic location), Multiple Sclerosis, nrSPMS, PERSEUS trial, perspectives, Progressive, Rejection, sanofi, Tolebrutinib, United States Food and Drug Administration

Sanofi; tolebrutinib; multiple sclerosis; nrSPMS; BTK inhibitor; FDA rejection; complete response letter; DILI; primary progressive MS; Perseus trial; evolving FDA perspectives

Avicanna Announces Changes to its Board of Directors

1 week ago talkbio0Tagged Appointments, Avicanna, board changes, Michael Kott, Paul Fornazzari, resignation

Avicanna; board changes; Michael Kott; Paul Fornazzari; appointment; resignation

Novo Nordisk Wins FDA Approval for First Oral GLP-1 Wegovy Pill in Obesity Treatment

3 weeks ago talkbio0Tagged Approved, Glucagon-Like Peptide 1, Novo Nordisk, Obesity, oral semaglutide, United States Food and Drug Administration, Wegovy pill

Novo Nordisk; Wegovy pill; FDA approval; oral semaglutide; obesity treatment; GLP-1

FDA Approves Novo Nordisk’s Wegovy Pill as First Oral GLP-1 for Weight Management

3 weeks ago talkbio0Tagged Approved, Novo Nordisk, Obesity, oral semaglutide, United States Food and Drug Administration, Wegovy pill

Novo Nordisk; Wegovy pill; FDA approval; obesity treatment; oral semaglutide

Recent Biotech News: Altimmune’s Pemvidutide Advances in MASH, Emerging China Obesity Players, and Ipsen Phase 2 Setback

3 weeks ago talkbio0Tagged Altimmune, China, Failed, IMPACT trial, Ipsen, MASH, Obesity, pemvidutide, Phase 2, United States Food and Drug Administration

Altimmune; pemvidutide; MASH; Phase 2b; IMPACT trial; FDA; China obesity; Ipsen; Phase 2 fail

Coloplast announces changes to Executive Leadership Team

3 weeks ago talkbio0Tagged Administration occupational activities, Anthropological Culture, Changing, coloplast, ELT, Executive Leadership Team, Interventional Urology, Johns, Kevin Hardage, Leadership, Persons, Transition Mutation

Coloplast; Executive Leadership Team; ELT changes; Interventional Urology; People & Culture; Kevin Hardage; Tommy Johns; leadership transition; management changes

Lilly seeks rapid FDA approval for oral GLP-1 orforglipron after positive obesity “switching” study

4 weeks ago talkbio0Tagged Approved, Clinical Trials, Eli, Glucagon-Like Peptide 1, injectable incretins, national priority review voucher, Obesity, Oral cavity, orforglipron, Phase 3 trial, United States Food and Drug Administration, Wegovy, weight maintenance, Zepbound

Eli Lilly; orforglipron; oral GLP-1; FDA approval; national priority review voucher; ATTAIN-MAINTAIN trial; obesity treatment; weight maintenance; Zepbound; Wegovy; injectable incretins; Phase 3 trial

GSK wins FDA approval for ultra-long-acting asthma drug Exdensur (depemokimab)

4 weeks ago talkbio0Tagged Approved, Asthma, biology (field), Depemokimab, dosing, eosinophilic, Exdensur, IL-5 Inhibitor, Phenotype, Severe (severity modifier), SmithKline Beecham, twice-yearly, type 2 inflammation, ultra-long acting, United States Food and Drug Administration

GSK; Exdensur; depemokimab; FDA approval; severe asthma; ultra-long-acting biologic; twice-yearly dosing; type 2 inflammation; eosinophilic phenotype; IL-5 inhibitor