Functional Concept

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

6 days 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)

1 week 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

RTW-backed startup Yarrow Bioscience signs autoimmune antibody deal with China’s GenSci

1 week ago talkbio0Tagged anti-TSHR antibody, Antibodies, Autoimmune, Changchun GeneScience Pharmaceutical, China, GenSci, GS-098, Investments, RTW, strategic partnership, Thyroid associated opthalmopathies, Yarrow Bioscience, YB-101

RTW Investments; Yarrow Bioscience; GenSci; Changchun GeneScience Pharmaceutical; autoimmune; antibody; GS-098; YB-101; anti-TSHR antibody; thyroid eye disease; China; ex-China rights; strategic partnership; licensing deal

Sanofi returns to Dren Bio for another B‑cell depletion therapy with $100M upfront

1 week ago talkbio0Tagged Antibodies, Bispecific, Autoimmune Diseases, B-Lymphocytes, Depletion, Dren Bio, Immunology, Myeloid cell engager, sanofi, strategic collaboration, upfront

Sanofi; Dren Bio; B-cell depletion; autoimmune diseases; strategic collaboration; bispecific antibody; myeloid cell engager; immunology; $100M upfront; licensing deal

Hikma announces CEO change and Board appointment

1 week ago talkbio0Tagged * * Riad Mishlawi * *, Board appointment, CEO, Changing, Darwazah, executive leadership, Hikma Pharmaceuticals, Khalid Nabilsi, London

Hikma Pharmaceuticals; CEO change; Riad Mishlawi; Said Darwazah; Khalid Nabilsi; Board appointment; executive leadership; pharmaceuticals; London; 15 December 2025

Sanofi’s multiple sclerosis drug tolebrutinib flunks Phase 3 in PPMS and faces another FDA PDUFA delay

1 week ago talkbio0Tagged BTK inhibitor, Clinical trial failure, Deferred, Mississippi (geographic location), Multiple Sclerosis, non-relapsing secondary progressive, nrSPMS, Parts per million (qualifier value), PDUFA, Progressive, Regulatory Setback, Review [Publication Type], sanofi, Tolebrutinib, United States Food and Drug Administration

Sanofi; tolebrutinib; multiple sclerosis; primary progressive multiple sclerosis; PPMS; non-relapsing secondary progressive MS; nrSPMS; Phase 3 PERSEUS trial; PDUFA delay; FDA review; BTK inhibitor; clinical trial failure; regulatory setback