In this edition
Monday: Sarepta defies the FDA; MHRA overseas reviews; BMS Reblozyl miss
Tuesday: Sanofi buys London’s Vicebio; AstraZeneca $50bn US; Sarepta halts Elevidys
Wednesday: China pharma licensing record; UK life sciences chair
Thursday: Roche US direct-to-patient; FDA priority vouchers; US flu thimerosal ban; Abivax UC data
Monday 21 July
Sarepta refused the FDA’s request to stop shipping Elevidys, its Duchenne gene therapy, after two patient deaths.
In a statement on 18 July the company said it would keep supplying ambulatory patients, arguing its reading of the data showed no new or changed safety signal in that group. It had already paused shipments to non-ambulatory patients, in whom the two deaths from acute liver failure occurred. Declining a direct request from the regulator set up an unusual public confrontation over whether the therapy stayed on the market.
Sources:
Sarepta Therapeutics provides statement on Elevidys - Sarepta Therapeutics
The MHRA now relies on overseas regulators for close to 40% of the drug applications it handles.
The UK regulator leans on approvals from trusted counterpart agencies through its International Recognition Procedure rather than assessing those files from scratch, freeing resources it wants to point at attracting more clinical trials to Britain. The figure, reported by the Financial Times, measures how far the post-Brexit agency has moved from doing its own full reviews. The MHRA’s own published performance data covers the procedure’s timescales but not the share.
Sources:
UK medicines regulator outsources almost 40% of drug applications - Financial Times
Bristol Myers Squibb’s Reblozyl failed a Phase 3 trial in anaemia caused by a rare bone marrow cancer.
On 18 July the company said the INDEPENDENCE trial, testing Reblozyl alongside a JAK inhibitor in myelofibrosis-associated anaemia, did not meet its primary endpoint of red blood cell transfusion independence over a 12-week window within the first 24 weeks, missing against placebo at p=0.0674. Secondary measures ran in Reblozyl’s favour, including deeper reductions in transfusion burden, and the safety profile was unchanged. The miss closes off one route to widening the drug’s use beyond its approved anaemia indications, and Bristol Myers Squibb said it would discuss the data with the FDA and EMA.
Sources:
Bristol Myers Squibb announces topline results from Phase 3 INDEPENDENCE trial for Reblozyl - Bristol Myers Squibb
Tuesday 22 July
Sanofi agreed to buy London vaccine startup Vicebio for $1.15 billion upfront, with up to $450 million more to come.
Announced on 22 July, the deal carries Vicebio’s early-stage combination vaccine candidates for RSV and human metapneumovirus into Sanofi’s portfolio, including a bivalent candidate in Phase 1 and a preclinical trivalent one. The candidates use Vicebio’s Molecular Clamp technology, which holds viral surface proteins in their native shape and is designed for fully liquid, refrigerator-stable combination shots. It is the second sizeable exit for a UK-founded vaccine company this cycle, and Sanofi expects to close the purchase in the fourth quarter.
Sources:
AstraZeneca said it will invest $50 billion in the United States by 2030, its largest commitment to any market.
The pledge, made on 21 July, centres on a new drug-substance manufacturing centre in Virginia, which the company calls its biggest single manufacturing investment anywhere, and adds expanded R&D across the country. The programme lands as the Trump administration threatens tariffs on imported medicines, and follows AstraZeneca’s earlier signals of frustration with UK and European pricing and research conditions. The company frames the spending as underpinning an ambition of $80 billion in total revenue by 2030, half of it from the US.
Sources:
AstraZeneca plans to invest $50 billion in the US - AstraZeneca
Sarepta backed down and agreed to halt all US shipments of Elevidys.
On 21 July, days after refusing the FDA’s request, the company told the agency it would voluntarily pause all US distribution of the Duchenne therapy from the close of business on 22 July. The reversal followed the patient deaths from acute liver failure and let the two sides complete a safety-labelling update. The climbdown ended a rare public standoff between a drugmaker and its regulator.
Sources:
Sarepta Therapeutics announces voluntary pause of Elevidys shipments - Sarepta Therapeutics
Wednesday 23 July
China now supplies a record share of the medicines big pharma licenses in, about 18% of global deals.
The Financial Times reported that multinational drugmakers have spent a record amount in 2025 on assets developed by Chinese biotechs, with roughly 18% of global pharma licensing deals now sourced from China, the largest proportion on record. The measure is a share of deal count, and it charts how far the industry has come to depend on Chinese-originated science to fill its pipelines. It reshapes where drugmakers go shopping for early-stage medicines.
Sources:
Big pharma’s record spending on China-developed drugs - Financial Times
The UK government named Steve Bates, longtime head of the BioIndustry Association, as executive chair of the Office for Life Sciences.
Announced on 22 July, the appointment puts a familiar industry figure at the centre of government life sciences policy. Bates has led the BioIndustry Association since 2012, a stretch in which the trade body pressed to restore R&D tax credits, open pension capital to biotech and broker the rescue of Silicon Valley Bank’s UK arm. The Office for Life Sciences will now report to the Business Secretary as well as the Health and the Science and Technology Secretaries.
Sources:
New executive chair to strengthen the government’s plan for life sciences - Office for Life Sciences
Thursday 24 July
Roche said it is weighing selling medicines directly to US patients, and is in talks with the government to do it.
Chief executive Thomas Schinecker made the comments to reporters on 24 July, around the company’s half-year results, describing a model that would work across Roche’s medicines by cutting out the pharmacy benefit managers between drugmakers and buyers. It is part of a wider industry effort to head off the price cuts the Trump administration has threatened, and follows the direct-to-patient offer Bristol Myers Squibb and Pfizer made for Eliquis a week earlier. Roche’s own written results release did not mention the discussions.
Sources:
The FDA opened a priority pathway that cuts drug reviews to one or two months.
From 22 July the agency began accepting applications for its Commissioner’s National Priority Voucher pilot, which shortens review to roughly one to two months after a sponsor’s final submission, against a standard of ten to twelve. Vouchers go, on a rolling basis, to medicines that align with defined US national health priorities: responding to a public-health crisis, onshoring manufacturing, improving affordability, or addressing unmet needs. The review itself uses a team-based, tumour-board style assessment.
Sources:
Robert F Kennedy Jr ordered thimerosal removed from every US flu vaccine.
On 23 July the Department of Health and Human Services said the secretary had adopted his reconstituted advisory committee’s June vote that children, pregnant women and adults receive only thimerosal-free influenza vaccine. The mercury-based preservative appears only in multi-dose vials, about 4% of US flu supply, and manufacturers said they could cover the switch to single-dose vials without disruption. Public-health bodies note the evidence that the amount of thimerosal used in vaccines carries no health risk.
Sources:
Thimerosal removed from US flu vaccines following ACIP recommendation - Department of Health and Human Services
Abivax’s oral drug obefazimod hit its goals in ulcerative colitis, and the company launched a $400 million raise the next day.
On 22 July the French biotech said both ABTECT Phase 3 induction trials met their primary endpoint of clinical remission at eight weeks for once-daily obefazimod 50mg, with pooled placebo-adjusted remission of 16.4% and no new safety signals, in a disease short of convenient oral options. The induction programme randomised 1,275 patients, among the largest run in ulcerative colitis. On 23 July, with the shares sharply higher, Abivax launched an underwritten public offering of American depositary shares targeted at about $400 million.
Sources:
Friday 25 July
Bavarian Nordic confirmed it is in takeover talks with private equity firms Nordic Capital and Permira.
Responding to market rumours on 24 July, the Danish vaccine maker said it had been in discussions with the two firms about a potential offer, while cautioning that nothing was settled on whether a bid would come or on what terms. A successful deal would take the company, listed on Nasdaq Copenhagen, private.
Sources:
Rumours of a potential takeover offer for Bavarian Nordic A/S - Bavarian Nordic
The Trump administration asked the Supreme Court to let it cancel roughly $783 million of NIH grants.
In an emergency application filed on 24 July, the Solicitor General asked the justices to stay a Massachusetts district court order that had vacated the National Institutes of Health’s termination of grants tied to gender identity and diversity, equity and inclusion. The government argued the lower court lacked jurisdiction over the terminations, which cover about $783 million. An appeals court had declined to pause the order the week before.
Sources:
Application for stay, National Institutes of Health v. American Public Health Association (No. 25A103) - Supreme Court of the United States
An FDA official said Sarepta would have to run new studies to get Elevidys back on the market.
The official told Endpoints News that a return would need fresh trials, possibly with changes to dosing or manufacturing or with added liver-function monitoring, and that reviewers in the agency’s biologics centre were essentially unanimous against a straightforward reinstatement. It set out a longer route back than a simple lifting of the halt, with US shipments already suspended after the deaths from acute liver failure.
Sources:
US medical groups and several states are writing their own vaccine recommendations for the autumn.
Reuters reported on 24 July that professional bodies and a number of states are preparing independent guidance for the 2025-26 respiratory season, worried that federal changes under Robert F Kennedy Jr could strip recommended access to COVID-19, flu and RSV shots for healthy children and pregnant women. The move responds to his replacement of the CDC’s immunisation advisory panel. No single unified set of recommendations had been published by the week’s end.
Sources:
GSK won EU reapproval for Blenrep, even as its US decision slipped by three months.
On 24 July the company said the European Commission had cleared Blenrep in two combinations for relapsed or refractory multiple myeloma, restoring the antibody-drug conjugate to the EU after its earlier withdrawal, on the strength of the DREAMM-7 and DREAMM-8 trials. The day before, GSK had said the FDA extended its US review by three months to a 23 October action date, following the advisory committee’s vote against the proposed dose. The two decisions leave Blenrep back on the market in Europe while its American return waits on the eye-toxicity and dosing questions the FDA has raised.
Sources:
Blenrep combinations approved in the EU for relapsed/refractory multiple myeloma - GSK
GSK announces extension of US FDA review period for Blenrep - GSK