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

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

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