Functional Concept – Page 2

Insmed’s Brinsupri Receives First-Ever FDA Approval for Progressive Lung Disease

1 week ago talkbio0Tagged Approved, brensocatib, Brinsupri, Bronchiectasis, CTSC gene, Inhibitor, Insmed, Lung diseases, neutrophil-mediated disease, non-cystic fibrosis bronchiectasis, Progressive, United States Food and Drug Administration

Brinsupri; Insmed; FDA approval; non-cystic fibrosis bronchiectasis; bronchiectasis; DPP1 inhibitor; brensocatib; progressive lung disease; neutrophil-mediated disease; first-in-class

Novartis antibody ianalumab clinches another Phase 3 win in rare blood disease (ITP)

2 weeks ago talkbio0Tagged Autoimmune, Autoimmune thrombocytopenia, B-cell depletion, ianalumab, Infrequent, Inosine Triphosphate, Novartis, Phase 3, platelet levels, Psychological inhibition, regulatory submissions, Sjögren 's disease, TNFRSF13C protein, human, treatment failure, VAY736

Novartis; ianalumab; VAY736; primary immune thrombocytopenia; ITP; rare disease; Phase 3; time to treatment failure; safe platelet levels; eltrombopag; autoimmune; B-cell depletion; BAFF-R inhibition; Sjögren’s disease; regulatory submissions

Novartis plans global filings after ianalumab hits primary endpoints in two Phase 3 Sjögren’s disease trials

2 weeks ago talkbio0Tagged B-cell depletion, BAFF‑R, cellular targeting, ESSDAI, ianalumab, NEPTUNUS-1, NEPTUNUS-2, Novartis, Phase 3, regulatory filings, safety profile, Sjögren 's disease

Novartis; ianalumab; BAFF‑R; B-cell depletion; Sjögren’s disease; NEPTUNUS-1; NEPTUNUS-2; ESSDAI; Phase 3; regulatory filings; first targeted treatment; safety profile

Boehringer Ingelheim breaks into oncology as FDA grants accelerated approval to Hernexeos (zongertinib) for HER2 TKD–mutated NSCLC

2 weeks ago talkbio0Tagged Accelerated, Approved, Beamion, Boehringer Ingelheim, competition, Confirmatory Trial, Enhertu, erbB-2 Receptor, Frequency of Responses, HER2-mutant, Hernexeos, Identifier, LUNG-1, Mutation, Non-Small Cell Lung Carcinoma, non-squamous NSCLC, Oncomine Dx Target Test, oral targeted therapy, Priority Review, Requirement, TKD, United States Food and Drug Administration, Zongertinib

Boehringer Ingelheim; Hernexeos; zongertinib; FDA approval; accelerated approval; non-squamous NSCLC; HER2 TKD mutations; Oncomine Dx Target Test; Beamion LUNG-1; objective response rate; first oral targeted therapy for HER2-mutant NSCLC; priority review; breakthrough therapy designation; confirmatory trial requirement; competition with Enhertu

AI, Media and the Evolution of Omnichannel in Healthcare Marketing — Ray Rosti on Episode 3 of The Next Marketing with HJ

2 weeks ago talkbio0Tagged Aortic Valve Insufficiency, Automation, Biomechanical compliance, Communications Media, connected journeys, content intelligence, Doceree, Engaged to be married, Health Care Market, Hereditary Coproporphyria, Klick Media, Measurement, omnichannel, Optimization, personalization, Pharma, Privacy, Region of interest:Presence or Identity:Point in time:*:Nominal

AI in healthcare marketing; omnichannel; first‑party data; content intelligence; media optimization; privacy and compliance; measurement and ROI; pharma marketing; Klick Media; Doceree; HCP engagement; personalization; automation; connected journeys

FDA Grants Accelerated Approval to Jazz’s Dordaviprone (Modeyso), the First Treatment for Ultra-Rare Brain Tumor

2 weeks ago talkbio0Tagged Accelerated, Approved, Brain Neoplasms, Chimerix acquisition, Confirmatory Trial, Dordaviprone, midline glioma, Modeyso, pediatric brain cancer, United States Food and Drug Administration

Dordaviprone; Modeyso; FDA approval; H3 K27M-mutant diffuse midline glioma; ultra-rare brain tumor; Jazz Pharmaceuticals; accelerated approval; pediatric brain cancer; Chimerix acquisition; confirmatory trial

HHS Cancels $500 Million in BARDA-Funded mRNA Vaccine Contracts Amid Strategic Shift

2 weeks ago talkbio0Tagged BARDA, CHARGE Syndrome, contract cancellation, COVID19 (disease), development aspects, federal funding, Moderna, mRNA Vaccine, Pfizer, Robert F. Kennedy Jr., Seqirus, Vaccines

HHS; BARDA; mRNA vaccine; vaccine development; contract cancellation; Robert F. Kennedy Jr.; COVID-19; federal funding; Moderna; Pfizer; Seqirus

Trump Announces Massive Pharma Tariffs Up to 250%, Signals Enforcement Within Days

2 weeks ago talkbio0Tagged Biopharma, Canada, fentanyl crisis, international trade, Pharma Tariffs, Sectioning technique, tariff increase, Transplant Registry Unified Management Program

Trump; pharma tariffs; tariff increase; biopharma; Canada; Section 301; international trade; fentanyl crisis

Replimune Awaits FDA Direction After Complete Response Letter for Advanced Melanoma Therapy

3 weeks ago talkbio0Tagged Accelerated, Advanced Melanoma, Approved, Cancer Therapeutic Procedure, Complete, IGNYTE trial, nivolumab, Replimune, Response Letter, RETINITIS PIGMENTOSA 1, United States Food and Drug Administration, vusolimogene oderparepvec

Replimune; FDA; Complete Response Letter; RP1; vusolimogene oderparepvec; nivolumab; advanced melanoma; cancer treatment; IGNYTE trial; accelerated approval

Novo Nordisk’s Leadership Shakeup and Wider Implications; Ex-FDA Official Takes Regulatory Role at GSK

3 weeks ago talkbio0Tagged CEO, competition, Drops - Drug Form, drug market, Leadership, Maziar Mike Doustdar, Nordisk, Obesity, Prices, Regulatory Affairs, Shakeup, SmithKline Beecham, United States Food and Drug Administration

Novo Nordisk; leadership shakeup; new CEO; Maziar Mike Doustdar; share price drop; obesity drug market; competition; GSK; regulatory affairs; Former FDA