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Gilead: Trial Failure, Withdraws Approval of Trodelvy for Bladder Cancer TreatmentGileadGilead has voluntarily withdrawn Trodelvy's accelerated approval for bladder cancer after a failed confirmatory trial. While the drug's effectiveness in other cancers remains unaffected, the failure casts a shadow on its future, as competitors advance in the TROP2 ADC market.
5 Strategies to Make New Drugs Surpass Their PredecessorsFive strategies to outperform first-in-class (FIC) drugs and achieve best-in-class (BIC) status. From identifying new indications and enhancing selectivity to optimizing pharmacokinetics and developing dual-function molecules.
FDA approves AbbVie's 24-hour subcutaneous infusion therapyAbbVie
FDAThe FDA has approved AbbVie’s VYALEV (ABBV-951), a 24-hour continuous subcutaneous infusion therapy for advanced Parkinson's disease. This first-of-its-kind treatment, based on levodopa, offers significant improvements in motor fluctuations and prolongs "on" time with fewer complications.
A Leading Asian Pharmaceutical Company Launches GLP-1 MicroneedleDaewoong PharmaDaewoong Therapeutics, a subsidiary of Daewoong Pharmaceutical, has launched CLOPAM®, an innovative GLP-1 microneedle platform designed to treat diabetes and obesity. This dissolvable microneedle patch offers pain-free drug delivery, reducing hospital visits and enhancing patient adherence.
Johnson & Johnson: Cuts 5 Pipelines, Including Neurology and OncologyJohnson & JohnsonJohnson & Johnson's Q3 2024 report reveals major pipeline cuts, including mid-stage neurology and oncology programs. Despite positive results in Alzheimer's and depression treatments, the company halted key projects in Parkinson’s, bipolar disorder, and mantle cell lymphoma.
Pfizer's RSV Vaccine Shows 90% Efficacy Against Severe Respiratory DiseasesPfizerPfizer's RSV vaccine, Abrysvo, shows 90% efficacy against severe respiratory illness in older adults, highlighting its potential as RSV cases rise. Despite CDC's narrower vaccination guidelines, Abrysvo remains a key product, nearing $1 billion in sales within seven months of FDA approval.
Bluebird Bio Gene Therapy Linked to Blood CancerBluebird bioBluebird Bio faces a dramatic fall in valuation after seven children develop blood cancer following treatment with its gene therapy, Skysona. Once valued at $30 billion, Bluebird now struggles below $1 billion.
Top 10 Key Readouts in Q4 2024 Drug DevelopmentTop 10 key clinical readouts in drug development for Q4 2024, spanning treatments for obesity, depression, Alzheimer's, pain, muscular atrophy, schizophrenia, and more. These updates involve a variety of drug modalities including monoclonal antibodies, CAR-T, proteins, and peptides.
FDA Approves Roche's PI3Kα Inhibitor - Doubled PFS!FDA
RocheThe FDA approved Genentech's PI3Kα inhibitor, Inavolisib (Itovebi), in combination with palbociclib and fulvestrant for advanced breast cancer patients with PIK3CA mutations. The therapy showed a significant 57% reduction in disease progression in the Phase III INAVO120 trial.