The Aleth Briefs reconstruct the week’s key developments chronologically, tracing each story to original sources wherever possible. The aim is to cut through noise, keep readers informed and capture how the week unfolded.
The week in five lines
Eli Lilly became the first $1tn drugmaker.
Medicare set 2027 semaglutide prices 71% below 2024 list.
Novo Nordisk‘s semaglutide failed in Alzheimer’s.
The UK Budget widened venture and share-option reliefs.
NICE‘s final draft backed Autolus‘s UK-invented CAR-T.
In this edition
Monday 24 November
Eli Lilly became the first healthcare company worth $1 trillion
An achievement only tech firms and Berkshire Hathaway have reached before, Lilly crossed the line on Friday 21 November, up more than 37% on the year. The engine of growth has been its two tirzepatide brands, Mounjaro for diabetes and Zepbound for obesity. Mounjaro turned over $6.5bn in Q3 2025, up 109% YoY, and Zepbound $3.6bn, up 185%, taking the two from $4.4bn to $10.1bn YoY. Novo Nordisk, losing obesity share to Lilly through the year, was down 45% for 2025 on the same day.
Eli Lilly hits $1 trillion market value, a first in health care - CNBC
Lilly Q3 2025 results - Eli Lilly
AstraZeneca will put $2bn into Maryland.
AstraZeneca will nearly double capacity at its Frederick biologics plant and bring rare-disease manufacturing onshore for the first time. The money splits between the Frederick expansion and a new clinical manufacturing site in Gaithersburg for trial supply, both of which will be operational by 2029. Across both, AstraZeneca counts 2,600 jobs supported and 300 newly created. This is the fourth announcement of 2025 under the $50bn commitment AstraZeneca set out in July.
AstraZeneca plans $2 billion manufacturing investment in Maryland, supporting 2,600 jobs and catalysing economic growth - AstraZeneca
FDA aide resignation demand withdrawn
An FDA official was told to resign before the demand was reversed, adding to signs of instability within the agency’s leadership.
Novo Nordisk’s semaglutide failed to slow Alzheimer’s in two phase 3 trials.
The evoke and evoke+ trials randomised 3,808 adults aged 55 to 85 with mild cognitive impairment or mild dementia and confirmed amyloid, to once-daily oral semaglutide 14 mg or placebo. Neither confirmed superiority on the primary endpoint, change in Clinical Dementia Rating - Sum of Boxes at week 104. Novo said treatment improved Alzheimer’s-related biomarkers but “this did not translate into a delay of disease progression,” and is discontinuing the one-year extension in both trials.
Evoke phase 3 trials did not demonstrate a statistically significant reduction in Alzheimer’s disease progression - Novo Nordisk
J&J’s posdinemab misses in phase 2 Alzheimer’s trial
Posdinemab missed the primary endpoint. The Auτonomy trial randomised more than 500 adults to a high dose, a low dose or placebo, against a primary endpoint of change in the integrated Alzheimer’s Disease Rating Scale at week 104, and J&J is discontinuing the study.
Johnson & Johnson statement on the Auτonomy study - Johnson & Johnson
Auτonomy study record (NCT04619420) - ClinicalTrials.gov
Bayer’s oral Factor XIa inhibitor cut the risk of ischaemic stroke in phase 3.
In >12,300 patients after a non-cardioembolic ischaemic stroke or high-risk transient ischaemic attack, asundexian 50 mg once daily on top of antiplatelet therapy beat placebo on the primary endpoint of OCEANIC-STROKE, with no increase in ISTH major bleeding. Bayer called it the first successful phase 3 trial of a Factor XIa inhibitor and said it would engage health authorities in preparation for submissions. Bayer’s OCEANIC-AF trial in atrial fibrillation was stopped in 2023 for inferiority to apixaban.
The FDA approved Padcev with Keytruda before and after surgery in muscle-invasive bladder cancer, five months ahead of its goal date.
The clearance covers enfortumab vedotin plus pembrolizumab as neoadjuvant then adjuvant treatment in adults ineligible for cisplatin. In KEYNOTE-905/EV-303, 344 previously untreated patients were randomised against surgery alone: median event-free survival was not reached against 15.7 months, a hazard ratio of 0.40, and median overall survival was not reached against 41.7 months, a hazard ratio of 0.50. Grade 3 or worse adverse events ran at 71.3% against 45.9%.
FDA approves pembrolizumab with enfortumab vedotin-ejfv for muscle invasive bladder cancer - FDA
U.S. FDA approves Padcev plus Keytruda for certain patients with muscle invasive bladder cancer - Pfizer/Astellas
Merck & Co’s partner Kelun-Biotech reported a phase 3 win for the TROP2 antibody-drug conjugate sac-TMT with Keytruda in first-line lung cancer.
In OptiTROP-Lung05, sacituzumab tirumotecan plus pembrolizumab beat pembrolizumab alone on progression-free survival at a pre-specified interim analysis, in PD-L1-positive advanced non-small cell lung cancer (NSCLC) with a tumour proportion score of 1% or more. Overall survival showed a positive trend. Kelun plans to discuss a supplemental filing with China’s regulator. Merck & Co (MSD) holds rights outside Greater China and is running 15 global phase 3 studies of the drug.
Agilent Q4 revenue of $1.9bn, up 9.4%, driven by life sciences and diagnostics.
Fiscal Q4 revenue was $1.86bn, up 9.4%, with the Life Sciences and Diagnostics Markets Group up 15% to $755m. FY2025 revenue of $6.95bn came in above guidance, and the FY2026 guide of $7.3-7.4bn implies growth of about 5 to 6.5%.
Agilent reports fourth-quarter fiscal year 2025 financial results - Agilent Technologies
Tuesday 25 November
The US and UK were reported to be near a possible agreement linking UK medicine spending and pricing to relief from US pharma tariffs.
Endpoints News, citing two UK-based sources, said the agreement could be finalised in the week of 24 November, with the UK paying more for some medicines in return for relief from pharmaceutical tariffs and a cut to the rebate rate drugmakers pay under the Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG). Neither government published anything on it by the end of the week, and the Budget on 26 November made no mention of VPAG or branded medicines pricing.
UK-US drug pricing deal could come as early as this week, sources say - Endpoints News (reported deal terms)
NICE backed Autolus’s CAR-T therapy obe-cel for NHS use in adults 26 and over.
The final draft guidance covers obe-cel (Aucatzyl) in relapsed or refractory B-cell precursor acute lymphoblastic leukaemia, with NICE putting the eligible group at around 150 people over three years. NICE’s final draft guidance recommended routine commissioning rather than the Cancer Drugs Fund, subject to appeal and final guidance. List price is £372,000 per infusion, with a confidential discount to the NHS. The CD19 CAR-T came from a team led by Martin Pule at UCL.
NICE recommends Aucatzyl (obe-cel) as a treatment option for adult patients (≥26 years) with relapsed or refractory B-cell precursor ALL - Autolus Therapeutics
The FDA approved Itvisma, an intrathecal version of Novartis’s Zolgensma.
Itvisma puts the same gene into the cerebrospinal fluid (CSF) rather than the bloodstream, as a one-time fixed dose that does not need to be adjusted for age or body weight, compared with IV Zolgensma, which is weight-based and approved only for children <2 yrs. Approval follows the phase 3 STEER trial, where motor function improved against sham over 52 weeks, supported by the open-label STRENGTH study. Novartis put the price at $2.59m, against $2.1m for intravenous Zolgensma.
Novo Nordisk’s amycretin cut weight by up to 14.5% in a phase 2 diabetes trial.
The 448-patient study tested the amylin and GLP-1 receptor co-agonist in type 2 diabetes inadequately controlled on metformin, over up to 36 weeks. On an on-treatment basis, the once-weekly injection reduced weight by up to 14.5% against 2.6% on placebo and cut HbA1c by up to 1.8 points, with 89.1% of patients getting below 7%. Novo now plans a phase 3 in type 2 diabetes in 2026.
Novo Nordisk phase 2 trial with amycretin reports significant weight loss and HbA1c reduction in type 2 diabetes - Novo Nordisk
Abbott is replacing about 3 million FreeStyle Libre 3 glucose sensors in the US after a manufacturing fault made some read glucose too low.
The correction covers Libre 3 and Libre 3 Plus sensors from a single production line. Abbott warned that undetected low readings over an extended period may lead to incorrect treatment decisions. It reported 736 severe adverse events and seven deaths globally as potentially associated, of which 57 severe events and no deaths were in the US. Abbott says it has found and fixed the manufacturing cause.
Wednesday 26 November
Medicare set 2027 prices for Novo’s semaglutide products 71% below 2024 list.
The negotiated maximum fair price, effective 1 January 2027, is $274 for a standardised 30-day supply across Ozempic, Rybelsus and Wegovy, against a $959 2024 list-price benchmark. CMS’s 15 negotiated prices are 38%–85% below 2024 list prices. CMS put the saving at $12bn on 2024 volumes, or $8.5bn once Coverage Gap Discount Program spending is counted. Ozempic, Rybelsus and Wegovy are the largest line item at $15.2bn of Part D gross costs across 2.3m enrollees.
CMS delivers savings for seniors on 15 major drugs for cancer and chronic disease - Centers for Medicare & Medicaid Services (CMS)
Fact sheet: Medicare Drug Price negotiated prices for 2027 - CMS
Thirty investigators searched Sanofi’s Paris HQ in an inquiry into laundering the proceeds of tax fraud.
Le Monde broke the story and had it confirmed by the Parquet National Financier (PNF). The preliminary investigation, open since January 2024, also names Lactalis and AXA, and turns on tax-driven financing structures a Societe Generale unit built for large French companies. Sanofi said it considers it complied with all applicable law, reserves its rights and will cooperate.
The FDA proposed moving molecular companion diagnostics out of its highest-risk class, cutting them from premarket approval to the 510(k) route.
The proposed order creates a device type at 21 CFR 866.6075 for nucleic acid-based test systems used with an approved oncology therapeutic, covering four product codes across real-time PCR, sequencing, next-generation sequencing and melt-curve analysis. The scope stops at molecular oncology tests. Protein and immunohistochemistry companion diagnostics are untouched.
Thursday 27 November
The UK Autumn Budget doubled VCT limits and widened EMI share options.
From April 2026 the annual VCT and EIS investment limit goes to £10m, or £20m for knowledge-intensive companies, with lifetime limits of £24m and £40m and the gross assets test up to £30m before a share issue. VCT income tax relief drops from 30% to 20%. Enterprise Management Incentive schemes move to a 500-employee limit, a £120m gross assets test, a £6m option pool and a 15-year holding period, with the notification requirement (a procedural trap for companies) gone from April 2027.
Budget 2025: Strong foundations, secure future - HM Treasury
Friday 28 November
UK screening advisers back targeted PSA testing for men with BRCA variants
The UK National Screening Committee proposed regular PSA testing for men with a confirmed BRCA1 or BRCA2 variant, while recommending against a national population-wide prostate cancer screening programme. The committee cited false positives and negatives from PSA tests, the difficulty of separating indolent from aggressive cancers, and the serious impacts of overtreatment. The proposal followed a letter from more than 120 MPs, led by Rishi Sunak, pressing for targeted screening.
UK NSC opens consultation on draft prostate cancer screening recommendation - UK National Screening Committee
>120 MPs warn ‘frozen’ diagnosis system is costing lives - Prostate Cancer Research