Disease or Syndrome – Page 30

Viridian Licenses Promising Eye Disease Candidates to Kissei for Japanese Market

3 months ago talkbio0Tagged Antibodies, Biopharma, Clinical Trials, Dosage Forms, Japan, Kissei, Partnership, Thyroid associated opthalmopathies, Veligrotug, Viridian, VRDN-003

Viridian Therapeutics; Kissei Pharmaceutical; veligrotug; VRDN-003; thyroid eye disease; Japan partnership; anti-IGF-1R antibodies; clinical trials; biopharma deal

FDA Misses IND Deadline for Coya’s ALS Asset, Citing Resource Constraints

3 months ago talkbio0Tagged ALS, Amyotrophic Lateral Sclerosis, Application procedure, Clinical Trials, Coya Therapeutics, Indonesian language, resource shortage, United States Food and Drug Administration

FDA; Coya Therapeutics; IND application; ALS; clinical trial delay; COYA 302; resource shortage

Vinay Prasad Departs FDA Amid Conservative Criticism and Sarepta Gene Therapy Controversy

3 months ago talkbio0Tagged CBER, conservative criticism, departure - ActRelationshipType, Drug Approval, gene therapy, Muscular Dystrophy, Duchenne, Prasad, Transplant Registry Unified Management Program, United States Food and Drug Administration, Vinay

Vinay Prasad; FDA; departure; Sarepta Therapeutics; gene therapy; Duchenne muscular dystrophy; conservative criticism; CBER; drug approval controversy; Trump administration

Novo Nordisk Appoints New CEO and Reduces 2025 Sales Guidance

3 months ago talkbio0Tagged CEO, Changing, drug competition, growth outlook, guidance cut, Leadership, Maziar Mike Doustdar, Nordisk, Obesity, Sales - occupational activity, Transition Mutation

Novo Nordisk; CEO change; Maziar Mike Doustdar; 2025 sales guidance cut; growth outlook; leadership transition; obesity drug competition

Novo Nordisk Names Insider Maziar Mike Doustdar as New CEO Amid Growth Challenges

3 months ago talkbio0Tagged Appointments, CEO, Drug Industry, drug market, growth outlook, international operations, Leadership Change, Maziar Mike Doustdar, Nordisk, Obesity

Novo Nordisk; Maziar Mike Doustdar; CEO appointment; leadership change; pharmaceutical industry; growth outlook; obesity drug market; international operations

Bausch Health to Acquire DURECT and Breakthrough Liver Disease Candidate Larsucosterol for $63M Upfront

3 months ago talkbio0Tagged Acquisition, Bausch Health, Breakthrough Therapy, Dosage Forms, DURECT, epigenetic modulator, Hepatitis, Alcoholic, Larsucosterol, Liver diseases, milestone payments, United States Food and Drug Administration

Bausch Health; DURECT; larsucosterol; liver disease; alcoholic hepatitis; epigenetic modulator; FDA Breakthrough Therapy; acquisition; pharmaceutical; milestone payments

FDA Reverses Course, Allows Sarepta to Resume Duchenne Gene Therapy Shipments

3 months ago talkbio0Tagged ELEVIDYS, gene therapy, Muscular Dystrophy, Duchenne, Pauses, Resumption, Safety, shipment, United States Food and Drug Administration

FDA; Sarepta Therapeutics; Duchenne muscular dystrophy; Elevidys; gene therapy; safety pause; shipment resumption

Bristol Myers Squibb Spins Out Five Immunology Assets into New $300M Biotech with Bain Capital

3 months ago talkbio0Tagged Afimetoran, Autoimmune Diseases, BMS-986322, Clinical Development, Immunology, Investments, Myers, squibb

Bristol Myers Squibb; Bain Capital; immunology; autoimmune disorders; biotech spinout; afimetoran; BMS-986322; clinical development; investment; new company

Apellis’ Empaveli Gains FDA Approval for Broad C3 Glomerulopathy Use, Setting Up Competition with Novartis’ Fabhalta

3 months ago talkbio0Tagged Apellis, Approved, C3 glomerulopathy, Empaveli, Fabhalta, Iptacopan, Kidney Diseases, membranoproliferative glomerulonephritis, Novartis, pegcetacoplan, Proteinuria, United States Food and Drug Administration

Apellis; Empaveli; FDA approval; C3 glomerulopathy; primary immune complex membranoproliferative glomerulonephritis; Novartis; Fabhalta; pegcetacoplan; iptacopan; proteinuria; kidney disease

DTC vs. DTP: Regulatory Uncertainty & Access Challenges Drive New Go-to-Market Models (2025 Update)

3 months ago talkbio0Tagged Access, Artificial Intelligence, Diphtheria-Tetanus-Pertussis Vaccine, Direct-to-Consumer, direct-to-patient, Ditiocarb, DTP, formulary restrictions, go-to-market models, OOP costs, pharmaceutical marketing, regulatory uncertainty, Rx abandonment, Telemedicine, United States Food and Drug Administration

DTC (Direct-to-Consumer); DTP (Direct-to-Patient); regulatory uncertainty; access challenges; pharmaceutical marketing; go-to-market models; FDA; Rx abandonment; formulary restrictions; OOP costs; telehealth; AI in marketing