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The US FDA has approved AstraZeneca's Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate or BGF 320/36/9.6μg) for the maintenance treatment of asthma in pts (≥12yrs.); regulatory review is ongoing in the EU, Japan & China
Approval was based on the P-III (LOGOS & KALOS) trials evaluating Breztri Aerosphere vs PT009, Symbicort, and PT009 + Symbicort in ~4,300…
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The US FDA has approved AstraZeneca’s Saphnelo pen (anifrolumab; 120mg, SC, QW, autoinjector) for the treatment of adults with SLE in combination with SoC
Approval was based on the P-III (TULIP-SC) trial assessing Saphnelo pen vs PBO in 367 pts (18-70yrs.) with mod. to sev. SLE while receiving SoC, which showed Saphnelo reduced disease activity (1EP); full…
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AstraZeneca has reported the global P-III (I CAN/ALXN1210-IgAN-320) trial assessing Ultomiris (IV) vs PBO in ~510 adults with IgAN who are at risk of disease progression
Trial met its 1EP of reduced proteinuria based on 24-hr. UPCR at 34wks., with effect seen as early as 10wks., while the 1EP of change in eGFR will be…
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AstraZeneca announced that tozorakimab met the 1EP in the P-III (MIRANDA) study, significantly reducing annualised rate of moderate-to-severe COPD exacerbations across pts. with COPD that still experiencing exacerbations while on inhaled SoC
In study pts. (n=1,454) received tozorakimab 300mg or PBO on top of SoC once every two weeks, including former and current smokers,…
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The biopharma industry is a multi-hundred-billion-dollar market, with a projected compound annual growth rate (CAGR) of 8.6%, the global biopharma market is expected to reach $1.41T by 2034. Eli Lilly and Co. ranked first with $65.17B, followed by Pfizer ($61.19B) and AbbVie ($61.16B), reflecting strong market concentration among large-cap innovators with diversified, high-value portfolios …
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The P-III (EMERALD-3) trial assessed single priming dose of Imjudo (300mg) + Imfinzi (1500mg) followed by Imfinzi (Q4W) + transarterial chemoembolisation (TACE) ± lenvatinib vs TACE alone in 760 pts unresectable HCC eligible for embolization
Imjudo + Imfinzi + Lenvatinib & TACE showed improved PFS (1EP) vs TACE alone, with OS (2EP) demonstrating a favorable trend in the…
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AstraZeneca reported data from replicate P-III (OBERON & TITANIA) trials assessing tozorakimab (300mg, Q4W) vs PBO over 52wks. on top of inhaled therapy in 2,306 adults with symptomatic COPD & prior exacerbations
The trial met its 1EP, reducing annualised rates of mod. to sev. COPD exacerbations in former smokers & the overall population, incl.…
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From AI-powered discovery to next-generation biologics and gene editing, 2025 was a blockbuster year for life sciences dealmaking. Pharma and biotech companies signed multibillion-dollar partnerships and acquisitions to accelerate innovation across oncology, cardiometabolic diseases, neurology, and rare disorders.
Platform technologies dominated the deal landscape, with big pharma securing access to cutting-edge modalities from bispecific…
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The EC has approved perioperative Imfinzi + FLOT for adults with resectable, early-stage & locally advanced (Stages II, III, IVA) G/GEJ cancers, based on P-III (MATTERHORN) trial; regulatory review is ongoing in Japan
In the trial, Pts (n=948) received either Imfinzi (1500mg) + FLOT or PBO + FLOT for Q4W × 2 cycles, then surgery followed by…
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FDA has granted priority review to Enhertu’s sBLA for adults with HER2+ breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment, with submission to be reviewed under Project Orbis (PDUFA: Q3’26); review is also ongoing in the EU & Japan
sBLA was backed by the global P-III (DESTINY-Breast05) trial assessing Enhertu…

