Functional Concept

FDA Issues Draft Guidance on MRD and CR Endpoints for Accelerated Multiple Myeloma Drug Approvals

4 days ago talkbio0Tagged Accelerated, Advice, Approved, In complete remission, Multiple Myeloma, Neoplasm, Residual, United States Food and Drug Administration

FDA guidance; multiple myeloma; MRD; complete response; accelerated approval

FW In Conversation: Mineralys CEO Jon Congleton on Reviving Hypertension Innovation and Lorundrostat’s Best-in-Class Potential

1 week ago talkbio0Tagged aldosterone synthase inhibitor, conversation, For which was done, Hypertensive disease, Jon Congleton, Lorundrostat, Mineralys

Mineralys Therapeutics; Jon Congleton; lorundrostat; aldosterone synthase inhibitor; hypertension treatment; FW In Conversation

Lilly Bulks Up Inflammatory Pipeline With $1.2B Ventyx Buy, InduPro Cancer Pact

2 weeks ago talkbio0Tagged Autoimmune, cardiometabolic, Eli, Eli Lilly, Immunotherapy for cancer, InduPro * *, Inflammatory disorder, M&A, Neoplasms, Neuroinflammation, NLRP3 inhibitors, Obesity, Ventyx Biosciences, VTX3232, VTX958

Eli Lilly; Lilly; Ventyx Biosciences; InduPro; inflammatory diseases; oncology; NLRP3 inhibitors; tamuzimod; VTX2735; VTX3232; VTX958; autoimmune; obesity; cardiometabolic; neuroinflammation; M&A; biotech deal; cancer immunotherapy

FDA again rejects Vanda’s Hetlioz for jet lag after yearslong dispute and ‘long‑shot’ re‑review

2 weeks ago talkbio0Tagged Circadian Rhythms, Clinical Trial Design, collaborative framework agreement, decision letter, expansion, Hetlioz, jet lag disorder, Labels (device), NDA, phase advance protocol, Rejection, Sleep Disorders, Supplement, tasimelteon, United States Food and Drug Administration, Vanda Pharmaceuticals

Vanda Pharmaceuticals; Hetlioz; tasimelteon; jet lag disorder; FDA rejection; supplemental NDA; decision letter; phase advance protocol; circadian rhythm; clinical trial design; collaborative framework agreement; D.C. Circuit ruling; label expansion; sleep disorder drug; regulatory dispute

AstraZeneca appoints Rick R. Suarez to lead U.S. BioPharmaceuticals business and $50B investment drive

2 weeks ago talkbio0Tagged AstraZeneca, Biological Factors, Head of US, Investments, President brand of dental material, Rick R. Suarez, Surgical aspects, U.S., Virginia manufacturing facility, Wilmington Delaware

AstraZeneca; Rick R. Suarez; US President; Head of US BioPharmaceuticals Business Unit; $50 billion US investment; Virginia manufacturing facility; US operations; biopharmaceuticals; revenue goal 2030; Wilmington Delaware

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

3 weeks 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

3 weeks 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

3 weeks 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

3 weeks 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

3 weeks ago talkbio0Tagged Appointments, Avicanna, board changes, Michael Kott, Paul Fornazzari, resignation

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