By Bahram Hassanpourfard, Epidemiologist
Weekly briefing · 12 to 18 October 2026
Large drugmakers’ appetite for novel mechanisms and discovery platforms dominated the week, with three licensing deals each reported at $500m or more.
Pfizer agreed a research collaboration and licence with Enodia Therapeutics, potentially worth over $500m, to discover and develop Sec61 inhibitors. The work will draw on Enodia’s inhibitor families, proteomics, cryo electron microscopy data and machine learning design. It came days after Eli Lilly struck an $870m Sec61 pact with Gate Bioscience1.
Roche made its seventh China deal of the year. It licensed an RNA interference candidate targeting ALK7 from Rona Therapeutics for up to $100m in upfront and near term payments, with the total value reported at between $1bn and $1.2bn. The move puts Roche alongside Alnylam, Arrowhead, GSK and Novo Nordisk in an emerging obesity niche aimed at lowering visceral fat2.
AstraZeneca is paying insitro $40m upfront in a partnership worth up to $1.5bn to use artificial intelligence to find new targets in liver and heart disease, including MASH3.
Regulators on both sides of the Atlantic signalled changes in how they weigh evidence. The MHRA published its strategy to 2030, promising more efficient regulation of medicines and devices, centred on patients and built around AI and personalised medicine4.
The FDA expanded the label of ImmunityBio’s Anktiva in bladder cancer that has not invaded the muscle and no longer responds to BCG. The agency treated carcinoma in situ and high grade papillary disease without carcinoma in situ as clinically similar, an approach that let the company avoid the kind of randomised phase 3 trial Johnson & Johnson is running5. The agency also launched a Rare Disease Framework Initiative, set out in a white paper, to give developers clearer guidance on the evidence required, with a public meeting on 28 October6.
US approvals included Asahi Kasei’s Hovilpri, a daily pill for refractory herpes simplex lesions that came with its roughly $920m acquisition of AiCuris7. The FDA also approved Brytly, an apraclonidine eye drop for redness sold over the counter8.
On the downside, BioNTech’s mRNA immunotherapy BNT113 missed its endpoint of survival without disease progression in a phase 2/3 trial in head and neck cancer, although survival data are still immature9. Edwards Lifesciences is recalling some Sapien M3 mitral delivery systems after balloons burst during inflation. The FDA issued an early alert, and one report links the problem to a death10.
Beyond the headlines, the EMA’s human medicines committee recommended six medicines for approval at its October meeting, including Eli Lilly’s orforglipron under the name Foundayo11. It also recommended Rasonque (daraxonrasib), an oral treatment for adults with metastatic pancreatic cancer12.
In the UK, the MHRA is introducing new measures for all patients taking antidepressants, to improve how the risks of suicidal thoughts and behaviours, and of persistent sexual dysfunction, are communicated13.
Basal insulin given once a week also advanced in two markets. The MHRA authorised Onswik (insulin efsitora alfa) for adults with type 2 diabetes, which could cut injections for some patients from up to 365 a year to 5214. The FDA approved a second weekly basal insulin for the same population15.
References: 1. GEN, Fierce Biotech, Pharmaceutical Technology and 2 more · 2. Endpoints News, BioPharma Dive, Fierce Biotech and 2 more · 3. Fierce Biotech, Pharmaceutical Executive, Pharmaceutical Technology and 2 more · 4. MHRA, GOV.UK, Pharmaceutical Technology and 1 more · 5. FDA, Fierce Pharma, Pharmacy Times and 1 more · 6. FDA, Pharmaceutical Executive, Pharmaceutical Technology and 1 more · 7. MedCity News, Endpoints News, Fierce Pharma and 1 more · 8. FDA, MedPage Today, Drug Topics · 9. Endpoints News, BioPharma Dive, Fierce Biotech and 1 more · 10. FDA, MedTech Dive, Fierce Biotech · 11. European Medicines Agency · 12. European Medicines Agency · 13. MHRA · 14. GOV.UK · 15. JAMA
