GlaxoSmithKline

The global oncology precision medicine market was valued at USD 53.2 billion in 2023 and is expected to grow at a 10.4% CAGR from 2024 to 2032, driven by rising cancer incidence and increasing demand for personalized therapies. Key segments include breast cancer, oral administration, small molecules, and kinase inhibitors. North America leads in market share, with the U.S. accounting for USD 19.7 billion in 2023. Prominent companies include AbbVie, AstraZeneca, and Pfizer, with recent strategic acquisitions enhancing their oncology portfolios.

GSK sues Moderna for patent infringement on mRNA vaccine technology, claiming Moderna's COVID-19 vaccines rely on GSK's foundational patents from a team led by Christian Mandl at Novartis. GSK seeks damages and licensing fees.

The COPD market in the 7MM is projected to grow from $11.5bn in 2023 to $30.8bn in 2033, driven by recent approvals like Sanofi/Regeneron’s Dupixent and anticipated pipeline agents. Biologics targeting moderate-to-severe exacerbators show promise, with Dupixent expected to reach $6.57bn by 2033. Late-stage pipeline products, including AstraZeneca’s Fasenra and GSK’s Nucala, aim to address unmet needs, while GSK’s Trelegy Ellipta is expected to grow to $2.16bn by 2033. Potential barriers include loss of exclusivity and the $35 inhaler cap in the US.

Tulisokibart maintained clinical and endoscopic improvements in IBD patients through week 50 in phase II trial extensions, with 48% of ulcerative colitis patients and 56% of Crohn's disease patients achieving clinical remission. The drug was well-tolerated with no identified safety signals.

Wave Life Sciences' clinical trial results show RNA editing success in treating alpha-1 antitrypsin deficiency, with significant increases in AAT protein levels and no serious side effects, marking a milestone for RNA editing technology.

FDA accepts NDA for gepotidacin (GSK) for uUTIs in females 12+; grants Priority Review with action date in March 2025. If approved, gepotidacin could be the first-in-class oral antibiotic for uUTIs in over 20 years. Phase 3 trials (EAGLE-2, EAGLE-3) showed gepotidacin's non-inferiority and superiority to nitrofurantoin, with common adverse events being diarrhea and nausea.

FDA accepts GSK's marketing application for gepotidacin, an oral antibiotic for uUTIs in females, granting Priority Review with a PDUFA date of March 26, 2025. Gepotidacin, part-funded by BARDA, showed non-inferiority to nitrofurantoin in phase 3 trials and potential as the first new oral antibiotic class for uUTIs in over 20 years.

GSK seeks FDA approval for gepotidacin, an oral antibiotic for uncomplicated urinary tract infections, potentially the first in a new class in over 20 years. The FDA granted Priority Review with a PDUFA date of March 26, 2025, based on phase 3 trials showing non-inferiority and superiority to nitrofurantoin.

Wave Life Sciences' WVE-006 shows proof-of-mechanism data in Phase 1b/2a RestorAATion-2 study for alpha-1 antitrypsin deficiency (AATD), confirming first-ever RNA editing in humans. WVE-006 restores wild-type M-AAT protein, with 6.9 micromolar mean at day 15, and has a favorable safety profile. GSK holds global license, with Wave eligible for up to $525 million in milestones and royalties.

Nodenza Venture Partners launched to support early-stage and pre-commercial biotech & medtech companies, focusing on disruptive technologies and therapies with potential for exceptional patient benefits. The team, led by Ross Morton, combines expertise in drug development and commercialization to invest in 3-4 opportunities in the first year.