Life science news 17 August 2026: Donald Trump signs an executive order seeking to narrow the US childhood vaccine schedule, the MHRA makes the UK the first country in Europe to authorise Eli Lilly’s orforglipron tablet, and Jazz Pharmaceuticals pays $820 million upfront for a rare epilepsy candidate it calls a potential first-in-class therapy, in a policy-driven week for pharma, biotech and healthcare.
President Donald Trump signed Executive Order 14420 on 10 August, setting out what the White House calls Gold Standard Childhood Vaccine Recommendations and reviving an attempt to narrow the US childhood immunisation schedule that had been held up in litigation. The White House says the new categories follow a Department of Health and Human Services scientific assessment which concluded that the United States recommends more childhood vaccines than any peer nation. The order sorts routine childhood immunisations into three categories: those recommended for all children, covering measles, mumps, rubella, diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type B, pneumococcal disease, human papillomavirus and varicella; those
recommended for certain high-risk groups, including respiratory syncytial virus monoclonal antibodies, hepatitis A and B, meningococcal B, meningococcal ACWY and dengue; and those left to shared clinical decision-making, covering hepatitis A, hepatitis B, rotavirus, meningococcal disease, influenza and COVID-19, with hepatitis A, hepatitis B and meningococcal vaccines appearing in two categories at once. It further states that the combined measles, mumps and rubella vaccine should be given as three separate single-disease shots once such products are available domestically, and that childhood immunisations should be administered at separate medical visits wherever feasible. The Secretary of Health and Human Services has 90 days to bring forward plans through the HHS Task Force on Safer Childhood Vaccines covering single-vaccine options, the timing and sequencing of core vaccines, alternatives to aluminium adjuvants and improved safety surveillance, while states are advised to review school immunisation requirements and the Attorney General is directed to support legal challenges to state exemption laws.
The order itself does not mention autism, but officials at the signing event, including the President, repeatedly linked childhood vaccination to it. Andrew D. Racine, President of the American Academy of Pediatrics, said in a statement issued the same day that there is no new evidence to justify significant changes to childhood immunisation guidance, and that dozens of studies involving millions of people show no link between vaccines and autism. The order does not itself amend the federal childhood immunisation schedule, which section 3 instead directs HHS to review.
The Medicines and Healthcare products Regulatory Agency authorised orforglipron (Foundayo) on 10 August, making the UK the first country in Europe to approve the GLP-1 tablet for both weight management and type 2 diabetes. Alongside a reduced-calorie diet and increased physical activity, the medicine is authorised for weight loss and weight maintenance in adults with a body mass index of 30 or above, or between 27 and 30 with at least one weight-related comorbidity, and separately to improve glycaemic control in adults whose type 2 diabetes is insufficiently controlled. The once-daily tablet can be taken at any time of day with no food or water restrictions, starting at 0.8mg and escalating through 2.5mg, 5.5mg, 9mg, 14.5mg and 17.2mg with a minimum of one month at each dose level. Julian Beach, MHRA Executive Director of Healthcare Quality and Access, said the decision followed a rigorous assessment of the medicine’s safety, quality and effectiveness, and confirmed that, as with all GLP-1 receptor agonists, it remains a prescription-only medicine that the agency will keep under close review. Authorisation for the new indication was granted to Eli Lilly on 10 August, and the MHRA noted that the tablet is not currently available on the NHS, with any NHS use to follow an evaluation by the National Institute for Health and Care Excellence.
Jazz Pharmaceuticals announced on 10 August that it has entered into a definitive agreement to acquire privately held Actio Biosciences for $820 million upfront and up to $500 million in contingent consideration, a total potential value of $1.32 billion. The transaction brings Jazz the lead clinical asset ABS-1230, a small molecule KCNT1 ion channel inhibitor that the company describes as a potential first-in-class precision therapy for KCNT1-positive epilepsy, a rare genetic developmental and epileptic encephalopathy affecting an estimated 2,500 patients in the United States for which there are no FDA-approved treatments. Around 80 per cent of patients experience disease onset in infancy, many never reach fundamental developmental milestones such as walking or speaking, and most endure dozens to hundreds of seizures a day that resist standard antiseizure medicines. ABS-1230 has shown meaningful seizure reductions in an early proof-of-concept trial in children and is now in the Phase 1b/2a KYRON study, designed as the registrational trial to support a US new drug application, with Fast Track, Rare Pediatric Disease and Orphan Drug designations and acceptance into the FDA’s Rare Disease Evidence Principles process. Renee Gala, President and Chief Executive of Jazz, said in the announcement that the acquisition builds on the global success of Epidiolex and deepens the company’s leadership in rare and severe epilepsies. The deal is expected to close by the fourth quarter of 2026.
The US Food and Drug Administration granted accelerated approval to iberdomide (Zenbexus, Bristol Myers Squibb) on 13 August, in combination with daratumumab and hyaluronidase-fihj and dexamethasone, for adults with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. Bristol Myers Squibb said the decision makes Zenbexus the first approved CELMoD, a class of cereblon-modulating protein degraders, and marks the arrival of a new treatment class built on the company’s targeted protein degradation platform. Efficacy was assessed in the Phase 3 EXCALIBER-RRMM trial, a two-stage, randomised, multicentre, open-label study in adults with relapsed or refractory disease who had previously received one or two prior lines, in which the Zenbexus regimen doubled minimal residual disease-negative complete response rates against daratumumab, bortezomib and dexamethasone, at 41 per cent versus 21 per cent, with a p-value below 0.0001. That measure is one of the trial’s two primary endpoints; the second, progression-free survival, is still maturing. Cristian Massacesi, Chief Medical Officer and Head of Development at Bristol Myers Squibb, said in the announcement that the approval validates years of scientific research and strengthens the company’s confidence in the approach. Full approval for the indication will depend on verification and description of clinical benefit in confirmatory trials.
In further life science news 17 August 2026, the week also brought a competitive bankruptcy auction for a gene therapy nearing filing, a firm restatement of the evidence on vaccine safety from the UK regulator, a transatlantic fibrosis combination anchored at Alderley Park, and a $2.3 billion American manufacturing commitment.
PTC Therapeutics announced on 12 August that it was selected as the winning bidder for ST-920, a BLA-stage, one-time administered AAV gene therapy for Fabry disease, in a competitive bankruptcy auction of Sangamo Therapeutics assets. The terms comprise $111 million upfront and up to $100 million in contingent milestones, made up of $80 million on accelerated approval and $20 million on traditional or full approval from the FDA, taking total potential consideration to $211 million. Sangamo filed for Chapter 11 protection in June, and Astellas Pharma had served as stalking horse bidder for the Fabry programme at $25 million upfront and up to $25 million in milestones, according to analyst commentary reported at the time, a baseline PTC’s winning bid exceeded more than fourfold after a competitive auction that ran over more than two days; Eli Lilly separately secured other Sangamo assets, including its zinc finger technology, for $50 million in cash. A rolling biologics license application for accelerated approval of ST-920 is expected to be completed in the fourth quarter of 2026, based on evidence of a favourable clinical effect on renal function and a safety and tolerability profile over 52 weeks in the Phase 1/2 STAAR study. Matthew Klein, Chief Executive of PTC Therapeutics, described it in the announcement as a unique opportunity with the potential for significant return on investment without the need for any development or commercial build. Completion remains subject to bankruptcy court approval and antitrust review, and is expected late in the third quarter or early in the fourth quarter of 2026.
The MHRA reaffirmed the safety of childhood vaccination on 12 August, two days after the US executive order, restating that vaccination remains one of the most effective and safest ways to protect against serious infectious diseases. Dr Alison Cave, Chief Safety Officer at the MHRA, said multiple large, well-conducted studies involving millions of children worldwide have consistently found no evidence that vaccines cause autism, and that the benefits of vaccination are endorsed by the NHS and all major UK public health and paediatric bodies as part of the recommended routine childhood schedule. The agency pointed to a study of 2.56 million US children that found no association between MMR vaccination before the age of two and childhood autism, a meta-analysis covering more than 1.26 million children in cohort studies, and a large-scale study that found no evidence of increased risk of neurodevelopmental disorders from early childhood exposure to aluminium-containing vaccines, noting that aluminium is not used in the MMR vaccine. The UK childhood schedule is informed by the Joint Committee on Vaccination and Immunisation, and the MHRA said it would act promptly to update guidance should new evidence indicate any change in vaccine safety, while encouraging reporting of suspected side effects through the Yellow Card scheme.
Skye Bioscience and Redx Pharma announced on 14 August that they have entered into a definitive transaction agreement under which Nasdaq-listed Skye will acquire the entire issued share capital of Alderley Park-based Redx via a scheme of arrangement under Part 26 of the UK Companies Act 2006. Although Skye is the acquiring entity, the structure amounts in substance to a reverse takeover: pre-transaction Skye holders are expected to own around 5.4 per cent of the combined company, pre-transaction Redx holders around 46 per cent and investors in the concurrent financings around 48 per cent. The combined company plans to operate as Fibrx Therapeutics, trade on Nasdaq, remain headquartered at Alderley Park and be led by Redx’s current management team and board, with Lisa Anson, Chief Executive of Redx, presenting alongside Skye Chief Executive Punit Dhillon on a joint investor call the same day. The transaction is supported by concurrent financings of approximately $125 million in aggregate gross proceeds, comprising a $67.9 million concurrent financing in Skye, a $36 million Redx Series A led by Abingworth with the British Business Bank and Redmile, and an equity line facility of up to $22 million. The lead programme will be RXC008, Redx’s gastrointestinal-restricted pan-ROCK inhibitor for fibrostenotic Crohn’s disease, which has an open US investigational new drug application, FDA Fast Track designation and a planned Phase 2 study with topline data expected in the second half of 2028. Both boards have unanimously approved the deal, the financings are expected to fund operations into 2029, and completion is targeted for the fourth quarter of 2026 subject to shareholder and regulatory approvals, Nasdaq listing approval and sanction of the scheme by the High Court of Justice of England and Wales.
Mereo BioPharma and Sentynl Therapeutics announced on 11 August an option and license agreement covering US commercial and global manufacturing rights to alvelestat for alpha-1 antitrypsin deficiency-associated lung disease. Alvelestat is a neutrophil elastase inhibitor being readied for Phase 3 by London-headquartered Mereo and, the companies say, would if approved be the first oral treatment for the rare, progressive genetic lung disease, which affects an estimated 50,000 to 80,000 people in the United States. The agreement gives Sentynl, a wholly owned subsidiary of India’s Zydus Lifesciences, the exclusive right to acquire a US commercialisation licence while Mereo retains rights in the rest of the world, and grants Sentynl global manufacturing rights. Mereo receives a non-refundable option fee and, on exercise, is eligible for $40 million in upfront and research and development payments, up to $435 million in potential milestones and double-digit tiered royalties on US net sales, with Sentynl funding the Phase 3 programme on option exercise and Mereo leading the study, which could begin in early 2027.
Bristol Myers Squibb announced on 10 August that it has selected Houston, Texas, as the site for a new multi-modal manufacturing campus representing an investment of approximately $2.3 billion. The 600,000 square foot site at Generation Park will create nearly 500 skilled jobs and is designed to be modular and multi-modal from the outset, allowing the company to reconfigure capacity and to manufacture small molecules, biologics and antibody-drug conjugates across a range of disease areas, supporting drug product and finished goods manufacturing from late development through launch. Christopher Boerner, Board Chair and Chief Executive of Bristol Myers Squibb, said in the announcement that the investment reflects confidence in continued American leadership in biopharmaceutical innovation and forms part of the company’s $40 billion commitment to invest in the United States over five years across research and development, technology and domestic manufacturing. The announcement adds to a run of large US manufacturing commitments from major drugmakers responding to tariff pressure and onshoring policy, and follows Eli Lilly’s active pharmaceutical ingredient plant at the same Houston complex.
That’s your life science news 17 August 2026 digest, back next Monday with the latest from pharma, biotech and healthcare at www.lifesciencedaily.news. Catch up on the 10 August news roundup.
