Pharmaceutical

GSK's Blenrep Gains EU Backing in New Combo Use GSK CHMP Blenrep Novatis GSK’s Blenrep gains CHMP recommendation for combination use in multiple myeloma, marking a comeback after U.S. withdrawal. Novartis withdraws Lutathera EU expansion. Other CHMP approvals and rejections detailed.
Trodelvy Shows Strong Solo Efficacy in TNBC Gilead Trodelvy Gilead’s Trodelvy shows significant solo efficacy in the ASCENT-03 trial, outperforming chemotherapy in previously untreated TNBC patients not eligible for immunotherapy.
PacBio Expands Long-Read Sequencing Presence in China Amid Illumina Ban PacBio Illumina Biotech PacBio strengthens its presence in China by expanding distribution of its hi-fi long-read sequencers with Haorui Gene, filling the gap left by Illumina’s import ban amid ongoing US-China trade tensions.
Samsung Biologics to Spin Off Biosimilars Unit Samsung Biologics Biotech Samsung Biologics plans to spin off its biosimilars subsidiary, Samsung Bioepis, by October 2025 to address conflict-of-interest concerns and enhance investor value, while continuing strong growth in its CDMO business.
Novo Nordisk Targets Wegovy Growth with New Strategy Novo Nordisk Wegovy Novo Nordisk offers a discounted Wegovy price for new patients and launches the “Choose the Real Thing” campaign as the FDA ends compounded semaglutide sales. The company also intensifies legal action against compounders amid rising competition.
GSK Gains Ground in COPD Market with Nucala GSK FDA GSK’s Nucala has received FDA approval as an add-on treatment for eosinophilic COPD, positioning it against Dupixent. Backed by strong trial results, GSK targets $669M in peak annual sales for the new indication.
Zentiva to Launch eGERD Drug Across Europe AstraZeneca Zentiva Zentiva signs €220M deal with Cinclus Pharma to commercialize linaprazan glurate for eGERD treatment across Europe. The partnership marks Zentiva’s shift into specialty medicines.
FDA Requests COVID-19 Vaccine Label Updates on Heart Risks Moderna FDA BioNTech Pfizer The FDA has requested Pfizer/BioNTech and Moderna update COVID-19 vaccine labels to reflect myocarditis and pericarditis risks in males aged 16-25. This update aligns with new FDA vaccine approval guidelines focusing on high-risk groups.
Pfizer's Talzenna Label Bid Faces Setback FDA Pfizer The FDA’s advisory committee unanimously rejected Pfizer’s proposal to expand Talzenna’s use for prostate cancer patients without HRR mutations, citing insufficient evidence from the TALAPRO-2 trial.
Lilly Challenges Medicare's Exclusion of Obesity Drugs Eli Lilly Zepbound Eli Lilly challenges CMS's 2026 Medicare Part D ruling that excludes coverage for obesity drugs like Zepbound and Wegovy, citing risks to patient care and provider autonomy amid rising concerns over healthcare access and costs.

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