In this edition
Monday: Pfizer buys Metsera; Trump drug-sales website; UK pharma pullback
Thursday: uniQure’s Huntington’s win; UK offers to pay more; Moderna opens a UK plant
Friday: Trump’s 100% pharma tariff; BMS Sotyktu direct discount; more obesity M&A ahead
Monday 22 September
Pfizer agreed to buy the obesity developer Metsera for up to about $7.3 billion, re-entering a market it had walked away from.
Pfizer is paying $47.50 per share in cash, roughly $4.9 billion upfront, plus a contingent value right of up to $22.50 per share tied to clinical and regulatory milestones. The milestone payments turn on the progress of Metsera’s lead assets: MET-097i, a weekly and monthly injectable GLP-1 receptor agonist in Phase 2, and MET-233i, a monthly amylin analogue in Phase 1, alongside two oral GLP-1 candidates.
The deal is Pfizer’s first large acquisition in two years and follows the failure of its own oral obesity candidate, danuglipron. It is expected to close in the fourth quarter of 2025.
Sources:
US officials are weighing a website, possibly carrying Trump’s name, to sell prescription drugs directly to patients at a discount.
Bloomberg reported the discussions, citing people familiar with them. The channel described would steer patients toward drugmakers’ own direct-to-consumer sites rather than have the government sell medicines itself, part of the administration’s drive to cut US drug prices and cut out intermediaries. No official announcement existed at the time; the concept was later unveiled as TrumpRx at the end of September.
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Bloomberg set out why global drugmakers are pausing or cancelling UK investment.
In an opinion column, Matthew Brooker argued that Britain directs relatively little of its health spending to medicines while clawing back far more in sales rebates than peer nations, using single-payer NHS buying power. He pointed to Merck’s abandoned roughly $1.3 billion London research facility, AstraZeneca’s paused £200 million Cambridge expansion and Eli Lilly’s halted £279 million London Gateway Labs.
The 2025 VPAG rebate rate for newer branded medicines was set at 22.9%, against average European clawback rates below 10%.
Sources:
Big Pharma forces Britain to take its medicine - Bloomberg Opinion
Tuesday 23 September
The FDA moved to change acetaminophen labelling as President Trump linked the painkiller, and childhood vaccines, to autism.
At a White House news conference, Trump tied autism to acetaminophen taken in pregnancy, sold in the US as Tylenol, and revived the discredited link between childhood vaccines and autism. The same day the FDA said it was initiating a safety-labelling-change process for acetaminophen and issued a Notice to Physicians about a possible association with autism spectrum disorder and ADHD, citing cohort studies including the Nurses’ Health Study II.
In its own words the agency said a causal relationship has not been established and that there are contrary studies in the literature. Tylenol maker Kenvue and medical societies disputed the link.
Sources:
FACT: Evidence Suggests Link Between Acetaminophen, Autism - The White House
The FDA revived GSK’s Wellcovorin, a branded leucovorin withdrawn from sale decades ago, promoting it as an autism treatment.
The agency said it was taking action to make leucovorin, a generic form of folinic acid, available for cerebral folate deficiency, and asked GSK to file a supplemental application to update the Wellcovorin label. Leucovorin was first approved in the 1980s and is normally used to manage the toxicity of methotrexate and related chemotherapy.
This was an announcement of action rather than a completed approval, and it rested on published literature and case reports rather than a new randomised trial. Reviving a long-dead label for a politically favoured indication is a departure from the agency’s usual evidence process.
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Bristol Myers Squibb said it will sell its schizophrenia drug Cobenfy in the UK at the same price as in the US, about $22,500 a year.
The company plans to set the UK list price at roughly $1,850 a month, equal to the US launch price, and to file with the MHRA later in 2025 through the International Recognition Procedure for a first-in-Europe launch in 2026. UK general manager Guy Oliver said BMS was committed to working with the NHS and NICE to reach eligible patients, while its chief commercial officer said the company was asking the UK to step up in recognising the value of innovative therapies.
The move lands as governments on both sides of the Atlantic try to push drug costs down, and as Washington presses companies to close the gap between US and international prices.
Sources:
Bristol Myers Squibb plans to launch Cobenfy in the UK at a list price equal to the US launch price - Bristol Myers Squibb
The FDA cleared a subcutaneous version of Merck’s Keytruda that can be injected in about a minute.
Keytruda Qlex combines pembrolizumab with the enzyme berahyaluronidase alfa, which enables rapid absorption under the skin, and it is approved across most of the adult solid-tumour indications already covered by the intravenous form. Approval rested on the Phase 3 3475A-D77 trial, which showed pharmacokinetics non-inferior to the infusion in metastatic lung cancer.
Moving the world’s biggest-selling cancer drug from a chair-side infusion to a one-minute injection is central to Merck’s defence of the franchise as intravenous biosimilars approach, with the key US patents expiring around 2028.
Sources:
FDA approves Merck’s Keytruda Qlex for subcutaneous use across most solid tumour indications - Merck & Co
Wednesday 24 September
The WHO and the UK’s MHRA rejected the Trump administration’s autism claims within a day.
The WHO said there is no conclusive scientific evidence of a link between autism and acetaminophen use in pregnancy, that no consistent association has been established, and that a robust evidence base shows childhood vaccines do not cause autism. It noted that vaccines have saved at least 154 million lives over the past 50 years.
The MHRA said its advice to pregnant women was unchanged, that there is no evidence paracetamol in pregnancy causes autism, and that paracetamol remains the recommended pain relief when used at the lowest effective dose. The rebuttals left US federal health messaging at odds with the international scientific consensus.
Sources:
WHO statement on autism-related issues - World Health Organization
Eli Lilly announced a $6.5 billion plant in Houston to make active pharmaceutical ingredients, including for orforglipron.
The site at Generation Park will produce the small-molecule ingredients behind Lilly’s oral GLP-1 weight-loss and diabetes drug, among other medicines, and is expected to be operational within about five years, creating 615 permanent jobs and around 4,000 in construction. It is Lilly’s eighth US manufacturing site announced since 2020 and the second of four new US sites planned for the year, within a broader roughly $50 billion US commitment.
Chief executive David Ricks framed the plant as onshoring that secures faster access to orforglipron, as the administration presses drugmakers to move production onshore.
Sources:
Lilly plans to build a new $6.5 billion facility to manufacture active pharmaceutical ingredients in Texas - Eli Lilly
Eli Lilly’s chief executive called the UK “probably the worst country in Europe” for drug prices.
In a Financial Times interview, David Ricks said England was not an attractive environment for investment and that unless that changed the country would see few new medicines and little investment. He called for scrapping the VPAG clawback scheme, which he said charges companies for their own success.
The comment joins a run of manufacturer attacks on the NHS pricing regime, and follows Merck scrapping its planned London research centre and AstraZeneca pausing a £200 million Cambridge expansion earlier in the month.
Sources:
Eli Lilly boss calls UK the worst European country for drug prices - Financial Times
Bristol Myers Squibb’s iberdomide scored its first major Phase 3 win, in relapsed or refractory multiple myeloma.
In the Phase 3 EXCALIBER-RRMM trial, iberdomide combined with daratumumab and dexamethasone met one of two primary endpoints, showing a statistically significant improvement in minimal residual disease negativity rates at a planned interim analysis.
Iberdomide is an oral cereblon E3 ligase modulator, the company’s intended successor to Revlimid, whose revenue is eroding to generic competition. The trial continues toward its other primary endpoint, progression-free survival, and BMS said it would discuss the results with regulators.
Sources:
Phase 3 EXCALIBER-RRMM study of iberdomide demonstrated a significant improvement in MRD negativity in relapsed or refractory multiple myeloma - Bristol Myers Squibb
Thursday 25 September
uniQure’s AMT-130 gene therapy slowed Huntington’s disease in a pivotal trial, and its shares closed up about 248%.
In the Phase I/II study, the high dose produced a statistically significant 75% slowing of disease progression at 36 months on the composite Unified Huntington’s Disease Rating Scale, against a propensity-score-matched external control drawn from the Enroll-HD dataset. A key secondary measure of functional capacity slowed by 60%, and a marker of neuronal damage in the spinal fluid fell below baseline.
uniQure, which holds Breakthrough Therapy and Regenerative Medicine Advanced Therapy designations, plans a biologics licence application in the first quarter of 2026. If approved, it would be the first disease-modifying treatment for Huntington’s.
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The UK government said it wants to end its feud with pharma and is prepared to pay more for medicines to win companies back.
Science minister Lord Patrick Vallance told the Financial Times the country needs to fix the commercial environment “to get those companies back again,” and that all options were on the table on drug pricing. The comments follow a run of cancelled or paused UK investments by AstraZeneca, Eli Lilly and Merck in a dispute over what the NHS pays. It is the clearest signal yet that the government will move on price rather than wait the industry out.
Sources:
Moderna opened a £150 million vaccine plant in Oxfordshire and defended Britain against the “worst in Europe” label.
The Moderna Innovation and Technology Centre at Harwell is the UK’s first onshore mRNA vaccine manufacturing site, with capacity for up to 100 million doses a year and more in a pandemic, and will supply British-made mRNA respiratory vaccines to NHS seasonal programmes.
UK general manager Darius Hughes called Eli Lilly’s characterisation of the country “a little harsh” and said Moderna was in a different place. Completing the site made Moderna the rare company finishing a UK investment days after MSD, AstraZeneca and Lilly pulled back.
Sources:
Moderna opens state-of-the-art manufacturing and R&D facility in the UK - Moderna
Moderna boss defends UK in drug-pricing row as he opens £150m Oxfordshire facility - The Guardian
Friday 26 September
President Trump said the US will impose a 100% tariff on branded and patented drugs from 1 October unless a company is building a US plant.
In a Truth Social post, Trump said there would be no tariff on these products if construction had started, defining “is building” as breaking ground or under construction. The exemption turns the levy into a lever for reshoring manufacturing rather than a straight import tax. It lands on a sector where much branded supply into the US is made in Europe and Ireland, and where drugmakers had already pledged hundreds of billions in US manufacturing this year.
Sources:
Truth Social post on a 100% tariff on branded or patented pharmaceutical products - Donald J. Trump, Truth Social
Bristol Myers Squibb said it will sell its psoriasis drug Sotyktu directly to cash-paying US patients at more than 80% off the list price.
Through a new direct-to-patient platform starting in January 2026, BMS will offer Sotyktu, a first-in-class TYK2 inhibitor for moderate-to-severe plaque psoriasis, to eligible patients paying cash, routing around insurers and pharmacy benefit managers and shipping nationwide. The same announcement widened an existing direct-to-patient programme for the blood thinner Eliquis. The move follows White House pressure on drugmakers to cut what Americans pay out of pocket.
Sources:
Bristol Myers Squibb builds on Eliquis direct-to-patient program, announces new platform offering Sotyktu - Bristol Myers Squibb
Endpoints argued that Pfizer’s Metsera deal could open a fresh round of dealmaking in obesity.
The purchase, the first big-pharma buyout of an obesity biotech since Roche’s Carmot deal, gives Pfizer a late entry into a market dominated by Novo Nordisk and Eli Lilly. Endpoints framed it as a signal that other large drugmakers without a strong obesity asset may now move to buy one, pointing to Amgen, Roche, AstraZeneca and AbbVie building pipelines of their own.
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