ORG – Page 12 – Talk Bio

Gilead’s Kite to Acquire Interius for $350M, Advancing In Vivo CAR-T Therapy

3 weeks ago talkbio0Tagged Acquisition, CAR-T, CAR-T therapy, Cell Therapy, Gilead, in vivo, Interius BioTherapeutics, Kite, device (physical object), Tecartus, Yescarta

Gilead; Kite; Interius BioTherapeutics; CAR-T therapy; in vivo CAR-T; acquisition; off-the-shelf cell therapy; $350 million; biotech; Yescarta; Tecartus; cell therapy platform

Johnson & Johnson Commits $2B to Fujifilm North Carolina Site in Latest US Manufacturing Push

3 weeks ago talkbio0Tagged Billion, Biopharma, Fujifilm, Investments, Johnson and Johnson, Manufacturing, North Carolina, Surgical construction, U.S.

Johnson & Johnson; Fujifilm; manufacturing; North Carolina; $2 billion investment; biopharma; job creation; US manufacturing

AbbVie’s Rinvoq Achieves Strong Phase 3 Results in Alopecia Areata, Clearing Key Efficacy Milestone

3 weeks ago talkbio0Tagged AbbVie, Alopecia, hair regrowth, Inhibitor, Janus kinase, Rinvoq, Salts, Score, upadacitinib

AbbVie; Rinvoq; Phase 3 trial; alopecia areata; hair regrowth; upadacitinib; SALT score; JAK inhibitor

Trump’s Most Favored Nation Policy and EU Generics: Recent Developments

3 weeks ago talkbio0Tagged drug price, EU, generics, Nation, Pharma, Policy, tariffs, Transplant Registry Unified Management Program

Trump; Most Favored Nation policy; EU generics; drug pricing; tariffs; pharma

Sarepta Extends $700M Debt to 2030, Adds Private Placement Amid Elevidys Uncertainty

3 weeks ago talkbio0Tagged Biopharma, convertible, debt maturity extension, ELEVIDYS, financial strategy, Note (document), private placement

Sarepta Therapeutics; debt maturity extension; convertible notes; private placement; Elevidys; financial strategy; biopharma

FDA Delays Decisions on Regeneron’s Eylea HD Due to Manufacturing Issues

3 weeks ago talkbio0Tagged Biosimilars, Deferred, Edema, Eylea HD, macular, manufacturing issues, Nordisk facility, Pre-filled Syringe, Regeneron, regulatory approval, Retinal Vein Occlusion, United States Food and Drug Administration

FDA delay; Regeneron; Eylea HD; manufacturing issues; Novo Nordisk facility; biosimilars; pre-filled syringe; macular oedema; retinal vein occlusion; regulatory approval

Nucleus RadioPharma Appoints Former FDA Commissioner Dr. Stephen Hahn as CEO

3 weeks ago talkbio0Tagged Appointments, biotech leadership, Cancer Therapeutic Procedure, CEO, Commissioner, Hahn, Nucleus RadioPharma, Radiopharmaceuticals, supply chain, United States Food and Drug Administration

Nucleus RadioPharma; Stephen Hahn; FDA Commissioner; CEO appointment; radiopharmaceuticals; cancer therapy; supply chain; biotech leadership

FDA Lifts Hold on Rocket Pharmaceuticals’ Pivotal Gene Therapy Study at Lower Dose

3 weeks ago talkbio0Tagged C3 complement inhibitor, Capillary Leak Syndrome, Dosage, gene therapy, Glycogen Storage Disease Type IIb, Individual Adjustment, Phase 2 Clinical Trials, Rocket, RP-A501, Study on Hold, United States Food and Drug Administration

FDA; Rocket Pharmaceuticals; gene therapy; Danon disease; clinical hold; RP-A501; dose adjustment; C3 complement inhibitor; capillary leak syndrome; patient death; Phase II trial

American Academy of Pediatrics Breaks with RFK Jr., CDC on COVID Vaccines for Kids

3 weeks ago talkbio0Tagged Academy of Pediatrics, antiarrhythmic peptide, Centers for Disease Control and Prevention (U.S.), Child, COVID19 (disease), Immunization, Pediatric brand name, Policy, public health guidance, Robert F. Kennedy, Vaccines

American Academy of Pediatrics; AAP; COVID-19 vaccine; children; CDC; Robert F. Kennedy Jr.; pediatric immunizations; public health guidance; vaccine policy

Draft MAHA Commission Report Outlines Broad Vaccine Framework and Addresses Childhood Chronic Disease

3 weeks ago talkbio0Tagged CDC, Centers for Disease Control and Prevention (U.S.), childhood vaccine schedule, Chronic disease, Commission, draft report, Drug Industry, MAHA, medical freedom, overmedicalization, vaccine framework, vaccine injuries

MAHA Commission; draft report; vaccine framework; childhood vaccine schedule; vaccine injuries; medical freedom; conflicts of interest; CDC; chronic disease; overmedicalization; pharmaceutical industry