Aleth LifeSci Brief: 25-29 Aug 2025
Britain's drug pricing talks collapse
ALETH / LIFESCI-BRIEF / 2025-08-29 / BRITAIN'S DRUG PRICING TALKS COLLAPSEIn this edition
Wednesday: Lilly’s oral GLP-1 in diabetes; US ties tariffs to pricing; AstraZeneca’s China rebound
Thursday: US CDC director ousted; UK Mounjaro pause; Stada revives IPO
Friday: RFK takes the CDC; Novo’s RNA deal; J&J drops arthritis combo; FDA rejects Telix scan
Tuesday 26 August
Britain’s accelerated review of its branded-medicines pricing scheme collapsed without a deal, and drugmakers warned they would move trials and investment out of the country.
The review of the 2024 Voluntary Scheme for Branded Medicines Pricing, Access and Growth, known as VPAG, closed on 22 August with government and industry unable to agree. The fight is over the rebate manufacturers pay back to the NHS on branded-medicine sales, which the industry puts at roughly 23% to 36% of revenue in Britain against low single digits in France, Germany and Spain.
The ABPI said that despite good faith on both sides the two had not found a way forward, and that the core problems the review was meant to fix were left unaddressed. Wes Streeting said he would not let drug companies rip off British taxpayers, while the government valued its rejected offer at about £1bn of rebate relief over three years. Companies responded that they would shift trials and investment elsewhere unless more of the NHS budget goes to medicines.
Sources:
Accelerated review of VPAG concludes without agreement - ABPI
Pharmaceutical firms to pull drug trials from UK in funding row - The Times
AbbVie agreed to buy Gilgamesh Pharmaceuticals’ experimental depression drug bretisilocin for up to $1.2bn, one of the largest bets yet by a big drugmaker on a psychedelic-derived medicine.
The deal, announced on 25 August, pairs an upfront payment with development milestones for bretisilocin, a short-acting serotonin 2A receptor agonist in mid-stage testing for major depressive disorder. In a Phase 2a study a single 10mg dose cut patients’ depression scores by 21.6 points on the MADRS scale against 12.1 points for a low comparator dose, with no serious adverse events reported.
Gilgamesh will spin out a new company to keep its remaining programmes, including an oral NMDA antagonist and a cardio-safe ibogaine analogue, along with an existing AbbVie collaboration.
Sources:
Terumo agreed to buy the University of Oxford spinout OrganOx for about $1.5bn, one of the largest exits yet for a British university company.
OrganOx makes normothermic machine perfusion devices that keep donor organs working outside the body so surgeons can assess them before transplant; its metra liver system won FDA approval in 2021 and has been used in more than 6,000 liver transplants. The agreement, dated 23 August and announced on 25 August, takes all of OrganOx’s shares and makes it a wholly owned subsidiary of the Japanese medical device group, which had already taken a strategic stake in the company in March.
Sources:
The US FDA suspended Valneva’s chikungunya vaccine Ixchiq after four new reports of serious adverse events, pulling the first licensed shot against the disease off the US market.
Valneva said on 25 August that the FDA’s biologics evaluation centre had decided on 22 August to suspend the vaccine’s US licence with immediate effect, stopping its sale and shipment. The four new cases, which the agency learned of after 15 August, involved chikungunya-like illness consistent with the reactions that have dogged the single-dose live vaccine in older adults.
The suspension reverses an FDA decision on 6 August to lift an earlier pause on vaccinating people aged 60 and over. Ixchiq was cleared under accelerated approval in November 2023.
Sources:
Valneva announces FDA’s decision to suspend license of chikungunya vaccine IXCHIQ in the US - Valneva
Wednesday 27 August
Eli Lilly’s oral GLP-1 orforglipron delivered 10.5% weight loss in patients who have both obesity and type 2 diabetes, a harder group to move than obesity alone, and the company said it will file for approval.
The Phase 3 ATTAIN-2 trial, reported on 26 August, tested the pill at three doses taken once a day without food or water restrictions, and all three met their primary goal and every secondary goal at 72 weeks. At the top dose patients lost an average of 10.5% of body weight against 2.2% on placebo and cut their A1C by 1.8 points, with about half reaching at least 10% weight loss. The safety profile matched the injectable GLP-1 drugs.
Lilly said the results complete the data package to file, with obesity submissions planned by the end of 2025 and type 2 diabetes submissions in 2026.
Sources:
White House officials tied their pharmaceutical tariff investigation to the drive to cut US drug prices for the first time, presenting the two as one lever.
Reporting from a cabinet meeting on 26 August, Endpoints News said administration figures publicly cast the Commerce Department’s Section 232 probe into drug imports as a way to pressure manufacturers into matching the lowest prices paid abroad, the goal of the “most favored nation” pricing programme.
Commerce Secretary Howard Lutnick and health secretary Robert F. Kennedy Jr were among those linking the tariff threat, the pricing demand and a push for direct-to-patient sales as parts of a single effort under a Trump executive order.
Sources:
US officials link tariffs with drug pricing talks - Endpoints News
AstraZeneca has steadied its business in China less than a year after a scandal engulfed its local leadership, and is deepening its bet on the market.
The Financial Times reported on 27 August that the company held its Chinese sales and escaped serious fallout from the affair, which involved the head of its China operations. China is one of AstraZeneca’s biggest revenue sources outside the United States. The recovery follows the $2.5bn it committed in March to build a sixth global research centre in Beijing, its second in China, alongside licensing deals and a vaccine manufacturing joint venture that will lift its Beijing workforce to about 1,700.
Sources:
AstraZeneca recovers in China a year after its China-head scandal - Financial Times
AstraZeneca invests $2.5bn in Beijing R&D and manufacturing - AstraZeneca
Thursday 28 August
Susan Monarez was forced out as director of the CDC about a month after the Senate confirmed her, the shortest tenure in the agency’s history.
The Department of Health and Human Services said on 27 August that Monarez was no longer director of the agency and that Secretary Robert F. Kennedy Jr had full confidence in his team, giving no reason for the removal. Her lawyers disputed the account, saying she had neither resigned nor been fired and accusing the department of weaponising public health. At least three other senior CDC leaders left in the days around her exit.
Sources:
HHS statement: Susan Monarez is no longer CDC director - US Department of Health and Human Services
Eli Lilly paused deliveries of its weight-loss injection Mounjaro to UK pharmacies as buyers stockpiled ahead of a price rise on 1 September.
The Times reported on 28 August that Lilly told wholesalers to hold supply until the new prices took effect, after a surge in demand from people trying to lock in the drug before it went up. From 1 September the list price of the highest monthly dose for private buyers rose from £122 to about £330, a step toward closing the gap between UK prices and those in other European markets.
Lilly pointed to rules against inappropriate stockpiling enforced by the MHRA and urged patients to order only what their current treatment needed.
Sources:
Stada is preparing to revive its stock market listing later this year at a valuation of about €10bn including debt.
Speaking to Bloomberg on 28 August, chief executive Peter Goldschmidt said the German drugmaker, owned by Bain Capital and Cinven since 2017, planned an IPO in 2025, possibly as early as October. The company readied a listing in March and shelved it when tariff threats unsettled pharma markets. Goldschmidt said Stada was in a stronger position now, pointing to about 50 in-licensing and business-development deals signed in the first half of the year.
Sources:
Friday 29 August
A day after removing the CDC’s director, Robert F. Kennedy Jr installed his deputy Jim O’Neill as acting head, tightening his grip on the agency as three of its senior scientists resigned.
The health department named O’Neill, its deputy secretary and a former Bush-era official close to the investor Peter Thiel, on 28 August. His appointment followed the departure of director Susan Monarez and the resignations of the CDC’s chief medical officer and the heads of its immunisation and emerging-diseases centres, several citing the politicisation of vaccine policy. Kennedy, a longtime vaccine sceptic, has used the reshuffle to press his position on shots.
Sources:
Jim O’Neill, HHS Deputy Secretary, named acting CDC director - US Department of Health and Human Services
Novo Nordisk signed a research collaboration with Replicate Bioscience worth up to $550m to hunt for new cardiometabolic drugs.
The multi-year deal, announced on 28 August, gives Novo an exclusive worldwide licence to Replicate’s self-replicating RNA platform, which prompts a patient’s own cells to make therapeutic proteins for longer than other RNA approaches. The targets are obesity, type 2 diabetes and related diseases. The payment combines cash upfront with milestones and royalties, and it comes as Novo looks to refresh an obesity pipeline under pressure from Eli Lilly.
Sources:
Replicate Bioscience announces partnership with Novo Nordisk to unlock self-replicating RNA therapies - Replicate Bioscience
Johnson & Johnson dropped a nipocalimab combination for rheumatoid arthritis after a mid-stage trial showed too little benefit to continue.
The Phase 2a DAISY study paired nipocalimab, sold as Imaavy, with an anti-TNF therapy in patients whose refractory rheumatoid arthritis had resisted treatment, and at 12 weeks the combination did not add enough over anti-TNF alone. The trial, in more than 100 patients, threw up no new safety concerns. J&J said it still backs nipocalimab in other diseases, including generalised myasthenia gravis and Sjögren’s.
Sources:
Phase 2a DAISY proof-of-concept combination study update - Johnson & Johnson
The US FDA rejected Telix’s kidney cancer imaging agent Zircaix, citing manufacturing rather than clinical problems.
In a filing on 28 August, Telix said the agency had issued a complete response letter for the PET scanning agent, which is designed to identify the most common form of kidney cancer from a scan. The FDA asked for more data to show that the version made at commercial scale matches the one used in the Phase 3 trial, and flagged deficiencies at two outside manufacturing partners that need fixing before Telix can refile.
Sources:
FDA Complete Response Letter for TLX250-CDx (Zircaix) - Telix Pharmaceuticals
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