Qualitative Concept
Novartis Bets on Covalent Chemistry in $1B Matchpoint Therapeutics Deal
Novartis; Matchpoint Therapeutics; covalent chemistry; exclusive option and license agreement; inflammatory diseases; oral inhibitors; Advanced Covalent Exploration platform; drug development; biotechnology partnerships
LEO Pharma Scores FDA Approval for Anzupgo as First Treatment for Chronic Hand Eczema
LEO Pharma; Anzupgo; delgocitinib; FDA approval; chronic hand eczema; pan-JAK inhibitor; moderate-to-severe CHE; topical treatment
AstraZeneca Highlights Survival Benefit for Tagrisso Combo Amid Competition in Lung Cancer
AstraZeneca; Tagrisso; lung cancer; Johnson & Johnson; EGFR-mutated NSCLC; overall survival; chemotherapy combination; FLAURA2 trial; life-extension benefit
Avalyn Pharma Raises $100M to Advance Inhaled Lung Disease Drugs
Avalyn Pharma; $100 million Series D; inhaled lung disease medications; pulmonary fibrosis; AP01; AP02; pirfenidone; nintedanib; clinical trials; drug safety; side effects; Suvretta Capital Management; SR One; Novo Holdings
Replimune’s Shares Plunge After FDA Rejects Melanoma Drug Application
Replimune; RP1; FDA rejection; melanoma; cancer drug; Complete Response Letter; clinical trial design; objective response rate; share price drop
Alkermes Advances Narcolepsy Therapy with Promising Phase 2 Trial Results for Alixorexton
Alkermes; narcolepsy; alixorexton; Phase 2 trial; orexin 2 receptor agonist; narcolepsy type 1; normative wakefulness; late-stage testing; Vibrance-1 study; cataplexy; excessive daytime sleepiness
FDA Rejects Roche’s Columvi for Earlier-Line Diffuse Large B-Cell Lymphoma
FDA rejection; Columvi; Roche; Genentech; diffuse large B-cell lymphoma; DLBCL; STARGLO study; second-line treatment; Complete Response Letter; gemcitabine; oxaliplatin; accelerated approval; third-line therapy
FDA Advisory Committee Rejects Lundbeck and Otsuka’s PTSD Bid for Rexulti
Lundbeck; Otsuka; Rexulti; FDA advisory committee; PTSD; brexpiprazole; sertraline; clinical trials; drug efficacy; setback
Sarepta Stands Ground Against HHS Request To Stop Elevidys Shipments
Sarepta; Elevidys; FDA; HHS; gene therapy; Duchenne muscular dystrophy; drug safety; shipping suspension; patient deaths; AAVrh74; regulatory action
Pfizer Warns of ‘Near-Term Stock Out’ of Penicillin Used for Treating Syphilis in Pregnant Women After Recall
Pfizer; penicillin recall; Bicillin L-A; syphilis treatment; pregnant women; drug shortage; congenital syphilis; FDA; Extencilline; public health