The Aleth Briefs trace each story to its original source and show how the week unfolded.
The week in five lines
The US and UK struck a zero-tariff drug deal.
Eli Lilly said the deal was not enough to unfreeze its UK investment.
The FDA lost its (new) CDER chief Pazdur, appointing Hoeg as replacement.
A German court blocked Merck‘s subcutaneous Keytruda.
BMS delayed its Cobenfy Alzheimer’s readout.
In this edition
Monday: US-UK drug deal; WHO obesity guideline; Belite Stargardt win; Regeneron-Tessera gene writing
Tuesday: FDA Pazdur exit; Medline US IPO; FDA primate testing
Monday 1 December
The US and UK announced an (in principle) pharma deal, with the US offering tariff protection in exchange for higher UK prices for new medicines.
The agreement in principle keeps US import duties on UK pharma exports at zero for at least three years, which the government said was the lowest rate of any country. In return, the UK will increase the net price it pays for new medicines by 25% and cut the rebate rate drugmakers repay under the Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG) to a maximum of 15% in 2026, from 23%.
NICE separately confirmed it would lift its infamous cost-effectiveness threshold from a range of £20,000 to £30,000 up to a range of £25,000 to £35,000 per quality-adjusted life year (QALY) from April 2026, its first increase since 1999.
Landmark UK-US pharmaceuticals deal to safeguard medicines access - GOV.UK
US government announces agreement in principle with the United Kingdom on pharmaceutical pricing - Office of the United States Trade Representative
Changes to NICE’s cost-effectiveness thresholds confirmed - NICE
The WHO issued its first guideline on GLP-1 obesity medicines.
The World Health Organization issued a conditional recommendation that GLP-1 drugs such as Wegovy and Mounjaro may be used for long-term treatment of obesity in adults, its first such guideline, while cautioning that fewer than one in ten eligible people will have access by 2030. It urged governments to widen access and pressed manufacturers to raise production and cut prices.
WHO issues global guideline on use of GLP-1 medicines in treating obesity - WHO
WHO says weight-loss drugs ‘new chapter’ in fight against obesity - The Guardian
Belite Bio’s tinlarebant succeeded in a phase 3 Stargardt disease trial.
In the phase 3 DRAGON trial in 104 adolescents and young adults, once-daily oral tinlarebant cut the growth rate of retinal atrophy lesions by 36% against placebo (p=0.0033). Stargardt, an inherited disease causing progressive sight loss from childhood, has no approved treatments. Belite plans to file with the FDA in H1 2026.
Regeneron put $150m into Tessera Therapeutics’ gene-writing therapy for a genetic lung and liver disease.
The pair will jointly develop and commercialise TSRA-196, an in vivo gene-writing candidate for alpha-1 antitrypsin deficiency (AATD) that aims to correct the mutation at the SERPINA1 gene. Tessera takes $150m in upfront / equity, with up to $125m more in milestones, and the two will split worldwide costs and profits 50:50. This is one of the largest industrial bets yet on gene writing, which sits between gene editing and gene replacement and has no approved product.
Tuesday 2 December
Rick Pazdur, the FDA’s top drug regulator, is leaving weeks after taking the job.
STAT reported that Pazdur, who took over CDER on 11 November after decades running FDA oncology reviews, filed to retire by month’s end. His exit followed a memo from CBER director Vinay Prasad and friction over Commissioner Marty Makary’s priority vouchers and hiring. By STAT’s account, he is CDER’s fourth director departure in 2025, a churn BIO called a weakness that rival China could exploit.
Richard Pazdur, FDA’s top cancer drug regulator, set to retire - STAT News
Medline prepared for a $5bn flotation, set to be the largest US listing of 2025.
Bloomberg reported that the medical-supplies group, taken private in 2021 by Blackstone, Carlyle and Hellman & Friedman, could begin marketing the IPO as soon as next week and was seeking $2bn from cornerstone funds before taking orders.
The FDA moved to cut primate testing from antibody safety studies.
The agency published draft guidance identifying antibody types for which long non-human primate toxicity studies can be reduced or dropped in favour of a weight-of-evidence assessment. A typical antibody programme can use more than 100 primates at $50k in costs each. It is the latest step in the FDA’s move away from animal testing.
Wednesday 3 December
BMS delayed the year-end readout of its Cobenfy trial in Alzheimer’s psychosis.
Bristol Myers Squibb identified “irregularities due to clinical trial execution at a small number of study sites“ in the phase 3 ADEPT-2 study and will exclude these from the primary analysis. After an FDA-agreed interim look, the data monitoring committee recommended the trial continue by enrolling more patients, pushing the readout to the end of 2026. Cobenfy is the schizophrenia drug BMS paid $14bn for Karuna to get, with Alzheimer’s psychosis the indication meant to take it beyond its first market.
Capricor’s deramiocel hit its primary endpoint in a phase 3 DMD trial.
HOPE-3 randomised 106 participants with Duchenne muscular dystrophy (DMD); in the primary PUL analysis of 105 evaluable patients, the cell therapy slowed loss of upper-limb function by 54% against placebo (p=0.029), with a supportive cardiac signal. The FDA rejected Capricor’s first application earlier in 2025.
Pharvaris’s deucrictibant Phase 3 succeeded, challenging Ekterly
In the RAPIDe-3 trial, the oral drug brought relief from an acute attack in a median 1.28 hours against more than 12 hours on placebo (p<0.0001), with most attacks settled by a single capsule. Pharvaris plans to file with the FDA in H1 2026 for on-demand treatment, where KalVista’s Ekterly reached the market first.
Medtronic’s Hugo robot cleared FDA, its first US foothold against Intuitive
The clearance covers prostate, kidney and bladder procedures, about 230,000 US operations a year, on the strength of the Expand URO study. Hugo has been sold in more than 30 countries for years while Intuitive Surgical’s da Vinci has long held a near-monopoly on robotic surgery in the US.
Medtronic announces FDA clearance of Hugo robotic surgery system
Eli Lilly won an earlier-line FDA approval for Jaypirca in CLL.
The expansion allows Jaypirca (pirtobrutinib), the sole non-covalent BTK inhibitor, to treat relapsed or refractory CLL/SLL after a covalent BTK inhibitor, converting its December 2023 accelerated approval into a traditional one. In the Phase 3 BRUIN CLL-321 trial, Jaypirca cut progression or death risk by 42%, positioning it directly after covalent options like AZ’s Calquence or AbbVie’s Imbruvica.
US FDA approves expanded indication for Lilly’s Jaypirca - Eli Lilly
Thursday 4 December
The FDA named Tracy Beth Hoeg acting director of CDER
Reuters reported that Hoeg, who joined the FDA in April 2025 and helped lead a review of Covid vaccine safety, would take over the Center for Drug Evaluation and Research (CDER) after Rick Pazdur’s sudden departure. The centre that clears every new US medicine is now on its second interim leadership change in a month.
AstraZeneca partnered again with Neurimmune, committing up to $780m
AZ’s Alexion rare-disease unit will develop and commercialise NI009, a preclinical antibody targeting the light-chain fibrils that drive AL amyloidosis. Neurimmune will receive an undisclosed upfront payment, up to $780m in contingent milestones and tiered royalties. It follows a first, much smaller Neurimmune deal about four years ago.
Lilly said UK-US pricing deal not enough to unfreeze its paused UK investment.
Chief executive David Ricks told the FT that Lilly would wait to see how promises on medicine spending and faster approvals worked in practice before restarting the paused Lilly Gateway Labs incubator it halted earlier in 2025 over NHS pricing terms.
Eli Lilly reconsiders UK biotech incubator, pauses buildout - FierceBiotech
A German court blocked Merck’s subcut Keytruda on Halozyme injunction.
A Munich court granted Halozyme a preliminary injunction barring Merck from distributing subcutaneous Keytruda in Germany over imminent patent infringement. The under-the-skin formulation key to Merck’s loss of exclusivity defence strategy for its infused version affects one of Europe’s largest markets.
Halozyme wins preliminary injunction against Merck’s Keytruda SC in Germany
Bloomberg: Pentagon pushed to add WuXi AppTec to Chinese military list.
Fierce Pharma reported that Bloomberg uncovered a 7 October letter in which Deputy Defense Secretary Stephen Feinberg urged Congress to add eight firms, including WuXi AppTec, to the Department of Defense’s Section 1260H list. WuXi survived last year’s Biosecure Act with its US business intact, but a listing puts those ties back under defense procurement review. Close to four in five US biopharma companies rely on Chinese firms for some part of their supply chain.
After dodging Biosecure threat, WuXi AppTec in Pentagon’s crosshairs - Fierce Pharma
Friday 5 December
Royal Society president UK research facilities “third worldish” next to China’s.
Sir Paul Nurse told The Times that British research infrastructure was looking “increasingly third-worldish“ beside China’s, and urged closer scientific ties with Beijing. He noted the UK invests only about 0.5% of GDP in science, leaving it low in the international tables, as China presses ahead with large-scale investment.
UK research facilities look ‘increasingly third-worldish’ next to China’s - The Times
New president speaks out on challenges to science - Royal Society