August 11, 2025 – Talk Bio

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

Endpoints 11: Biopharma’s most promising startups revealed live in Boston this September

2 weeks ago talkbio0Tagged Aves, Biopharma, biotech startups, biotechs, Boston event, Endpoints, GALA peptide, Industry, Rating (action), real-time, State Room

Endpoints 11; biotech startups; biopharma; Boston event; State Room; awards gala; early bird rate; industry insiders; 2025 most promising biotechs; real-time reveal

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 restricts bluebird bio’s Skysona to CALD patients without suitable stem cell donors after higher blood cancer risk emerges

2 weeks ago talkbio0Tagged boxed, CALD, Cautionary Warning, Cerebral Adrenoleukodystrophy, Donor person, Elivaldogene autotemcel, gene therapy, Hematologic Neoplasms, HLA Match, label update, Leukemia, Myelocytic, Acute, MYELODYSPLASTIC SYNDROME, Safety, Skysona, United States Food and Drug Administration

FDA; bluebird bio; Skysona; elivaldogene autotemcel; eli-cel; cerebral adrenoleukodystrophy; CALD; hematologic malignancies; myelodysplastic syndrome (MDS); acute myeloid leukemia (AML); boxed warning; label update; postmarketing safety; HLA-matched donor; gene therapy safety

HHS ousts MAHA implementation lead amid rushed cancellations of $500M in mRNA vaccine contracts

2 weeks ago talkbio0Tagged BARDA, CHARGE Syndrome, Contract agreement, Gray Delany, MAHA, Moderna, mRNA contracts, Pfizer, Policy, Robert F. Kennedy, Seqirus, Shakeup, SMPX gene, Staff, terminations, Vaccines

HHS; MAHA; Gray Delany; mRNA contracts; BARDA; Robert F. Kennedy Jr.; vaccine policy; contract terminations; Moderna; Pfizer; CSL Seqirus; staff shakeup

FDA tightens Skysona label, restricting use to CALD patients without alternative options due to increased blood cancer risk

2 weeks ago talkbio0Tagged boxed, CALD, Cautionary Warning, Cerebral Adrenoleukodystrophy, Elivaldogene autotemcel, gene therapy, Hematologic Neoplasms, HLA‑matched donor, labeling changes, Leukemia, Myelocytic, Acute, MYELODYSPLASTIC SYNDROME, Safety, Skysona, United States Food and Drug Administration

FDA; bluebird bio; Skysona; elivaldogene autotemcel; labeling changes; boxed warning; hematologic malignancy; myelodysplastic syndrome; acute myeloid leukemia; cerebral adrenoleukodystrophy; CALD; HLA‑matched donor; gene therapy safety; post‑marketing reports

GSK set to receive over $500M from mRNA patent settlement tied to BioNTech–CureVac–Pfizer deal

2 weeks ago talkbio0Tagged BioNTech, BioNTech acquisition, COVID19 (disease), CureVac, global framework, Influenza virus vaccine, Licensing, Litigation, Pfizer, RNA, Messenger, royalties, settlement, SmithKline Beecham, U.S., upfront payment, Vaccines, Vaccines, Combined

GSK; CureVac; BioNTech; Pfizer; mRNA patents; settlement; royalties; COVID-19 vaccine; influenza vaccine; combination vaccines; licensing; upfront payment; US litigation; global framework; BioNTech acquisition of CureVac