GILEAD SCIENCES SL

FDA approves Autolus Therapeutics' Aucatzyl, a CAR-T therapy for relapsed/refractory B-cell acute lymphoblastic leukemia, priced at $525,000, 11% higher than Gilead's Tecartus. Aucatzyl aims to reduce side effects and is the first CAR-T approved without a risk mitigation plan, with 63% complete remission rate in clinical trial.

Gilead Sciences and Merck's Phase 2 trial of a once-weekly oral HIV treatment, islatravir and lenacapavir, showed 94.2% viral suppression after 48 weeks, with no detectable viral loads. The regimen is set for Phase 3 trials, with a favorable safety profile and strategic collaboration between Gilead and Merck.

KEMRI researchers urge Kenya's Pharmacy and Poisons Board to approve Cabotegravir and Lenacapavir, injectable drugs with high HIV prevention efficacy. Cabotegravir, requiring injections every 8 weeks, and Lenacapavir, every 6 months, have shown remarkable prevention rates but face high costs and regulatory delays.

The global biotechnology market is projected to reach $550.83 billion in 2024 and $2667.36 billion by 2034, driven by advancements in synthetic biology, CRISPR, and genomic sequencing. North America is expected to lead, with a revenue of $231.68 billion in 2024, due to established agricultural biotechnology and a robust GMO framework. Key players include Johnson & Johnson, Roche, Pfizer, and Novartis.

Roflumilast cream 0.15% showed high efficacy in treating mild to moderate atopic dermatitis in patients aged 6 years and older, with more patients achieving a validated IGA-AD score of 0/1 and minimal application site irritation.

Autolus Therapeutics' Aucatzyl, a CAR T-cell therapy targeting CD19, received FDA approval for treating adult B-cell precursor acute lymphoblastic leukemia (ALL). Aucatzyl differentiates itself with faster off-rate and lower complication rates, potentially improving safety and durability. The therapy's approval is based on a trial showing 42% complete remission within three months. Aucatzyl enters a market dominated by Amgen's Blincyto and Gilead's Tecartus, with potential for $300 million in peak sales.

Early iMMagine-1 trial results show antio-cel as a promising therapy for relapsed/refractory multiple myeloma, with 95% overall response rate and 62% complete/stringent response rate. The therapy demonstrated manageable safety and no delayed neurotoxicities, despite a previous FDA clinical hold.

Treatment with magrolimab plus docetaxel in metastatic non–small cell lung cancer (mNSCLC) showed peripheral CD47 saturation correlating with improved outcomes. Higher baseline CD47 expression in patients with partial or complete responses led to a median progression-free survival (PFS) of 8.9 months for those with CD47 expression on more than 50% of tumor cells, compared to 2.6 months for those with lower expression. The trial was terminated by Gilead after a global pause in enrollment.

AstraZeneca and Amgen's Tezspire showed efficacy in reducing nasal congestion and nasal polyps in a Phase 3 trial for chronic rhinosinusitis. Jazz Pharmaceuticals plans to start an early-stage study for narcolepsy treatment JZP441 in 2024. Geron secured $250 million, potentially $375 million, for its myelofibrosis drug Rytelo. Aditum Bio and Leads Biolabs formed Oblenio Bio to develop a T cell engager for autoimmune diseases. Gilead Sciences halted Trodelvy development in second-line non-small cell lung cancer, resulting in a $1.8 billion write-down. Avid Bioservices is being taken private by GHO Capital Partners and Ampersand Capital Partners in a $1.1 billion deal.

FDA considers removing oral phenylephrine from OTC guidelines due to lack of efficacy, not safety concerns. Public comments invited until May 7, 2025, before final decision. Phenylephrine is in many nasal decongestants like Sudafed and Mucinex. FDA's proposal does not affect nasal spray decongestants.