Agios’ Sickle Cell Trial Falls Short as Mitapivat Fails to Significantly Reduce Pain Crises
Agios; mitapivat; Pyrukynd; sickle cell disease; pain crises; clinical trial; Rise Up trial; hemoglobin response
PBMs and FTC Battle in Court Over In-House Insulin Pricing Challenge Intensifies
PBMs; FTC; insulin pricing; rebate schemes; antitrust lawsuit; administrative proceedings; drug affordability; Caremark Rx; Express Scripts; OptumRx
Novartis Raises Sales Targets for Key Cancer Drugs, Tweaks Yearly Growth Guidance
Novartis; Kisqali; Scemblix; Pluvicto; sales guidance; peak sales forecast; cancer drugs; breast cancer; leukemia; pharmaceutical industry
Japan Approves Anti-CD19 Monoclonal Antibody UPLIZNA for Suppression of Relapse in Immunoglobulin G4-Related Disease (IgG4-RD)
UPLIZNA; Inebilizumab; Anti-CD19 monoclonal antibody; IgG4-related disease (IgG4-RD); Immunoglobulin G4; Japan approval; Relapse suppression; MITIGATE trial; Mitsubishi Tanabe Pharma; Ministry of Health, Labour and Welfare
MediKarma Scales Its Clinical And Commercial Acumen With Appointment Of Dr. Scott Howell As Chief Clinical Officer And Angela Breton As Chief Revenue Officer
MediKarma; Scott Howell; Angela Breton; Chief Clinical Officer; Chief Revenue Officer; AI-driven platform; patient data; proactive care
Roche Bags EU Nod for SC Formulation of Lunsumio, Re-Igniting Bispecific Battle with Tepkinly
Roche; Lunsumio; subcutaneous; EU approval; conditional marketing authorisation; follicular lymphoma; bispecific antibody; Tepkinly; CD20xCD3; relapsed/refractory; GO29781 study
Alkermes Ups Bid for Avadel Amid Lundbeck’s Competing Offer in Narcolepsy Drug Takeover Battle
Alkermes; Avadel Pharmaceuticals; Lundbeck; bidding war; Lumryz; narcolepsy; acquisition; contingent value right; pharma M&A; idiopathic hypersomnia
US-Backed Group Reports Success with New Tuberculosis Treatment in Phase 2 Study
tuberculosis; TB Alliance; Phase 2 clinical trial; sorfequiline; SPaL regimen; pretomanid; linezolid; drug-resistant TB; ultra-short regimen; US support; clinical trial results
FDA Pushes for Onshoring and Improved Data Fidelity in Generic Drug User Fee (GDUFA IV) Negotiations
FDA; onshoring; data fidelity; generic drugs; user fee; GDUFA IV; manufacturing; bioequivalence; public health; performance metrics
Nxera Pharma to Cut 15% of Workforce in Japan and UK as Part of Restructuring Plan
Nxera Pharma; workforce reduction; restructuring; Japan; UK; R&D operations; profitability; GPCR pipeline; organizational optimization