October 2026 • PharmaTimes Magazine • 9
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Study highlights advance in influenza protection for older adults
CSL Seqirus has announced publication of pivotal phase 3 results for its MF59-adjuvanted cell-based higher-dose quadrivalent influenza vaccine, marking what the company describes as an important milestone in influenza prevention for older adults.
The trivalent formulation of the vaccine, marketed as AUJEMFLU, was approved earlier this year by the MHRA for adults aged 50 and above, and has also received European Commission approval.
The study is the first large-scale evaluation of an influenza vaccine that combines three established approaches to enhancing protection in older adults: MF59 adjuvant; cell-based manufacturing, and a higher-dose formulation. Each has been used separately for many years, but this is the first time they have been assessed together within a single vaccine.
Influenza continues to cause substantial illness, hospitalisations and deaths each year, with older adults particularly vulnerable due to age-related decline in immune responsiveness.
Gregg Sylvester, Chief Medical Officer and Head of Research & Development at CSL Seqirus, said: “These findings provide important new evidence for healthcare professionals, policy-makers and immunisation advisory groups considering future influenza vaccination strategies for older adults.”
Professor Colin Russell, Chair of ESWI, said: “Influenza vaccine innovation has historically progressed through incremental advances in technology and manufacturing.”
He added: “Given the continued burden of influenza-related illness, hospitalisation and death among older adults despite widespread vaccination, these findings represent an important contribution to ongoing efforts to improve protection in this vulnerable population.”
NICE backs ibrutinib regimen for untreated mantle cell lymphoma
Johnson & Johnson has welcomed Final Draft Guidance from NICE recommending Imbruvica (ibrutinib) with R-CHOP, alternating with R-DHAP or R-DHAOx, followed by ibrutinib monotherapy, for adults with previously untreated mantle cell lymphoma who are suitable for an autologous stem cell transplant.
The decision marks the first time an alternative first-line option has been supported for this patient group.
Mantle cell lymphoma is a rare and usually aggressive type of non-Hodgkin lymphoma affecting around 600 people in the UK each year. Most patients are diagnosed at an advanced stage and the condition is generally considered incurable.
Current treatment for those suitable for transplant involves intensive chemo-immunotherapy followed by ASCT and maintenance therapy.
The phase 3 TRIANGLE study showed that an ibrutinib-based regimen improved failure-free survival, progression-free survival and overall survival compared with standard care involving ASCT.
Anna Grint, Patient and Public Affairs at Lymphoma Action, said: “We welcome the approval of ibrutinib in combination with chemo-immunotherapy as an important treatment option for people with mantle cell lymphoma.”
She added: “Having access to an effective alternative that may potentially eliminate the need for a transplant means fewer side effects, a faster recovery and less disruption to daily life.”
ViiV Healthcare has secured US FDA approval for Tivicay PD for use with other antiretroviral agents in paediatric patients living with HIV-1 who weigh at least 2 kg. The decision makes Tivicay PD the first second-generation integrase inhibitor authorised for eligible newborns.
Without early diagnosis and treatment, HIV can progress rapidly in infants, with around 50% of untreated infants dying by age two.
Gilead Sciences has announced that the Scottish Medicines Consortium has accepted Livdelzi (seladelpar) for use on the NHS in Scotland for adults with primary biliary cholangitis, including pruritus, in combination with UDCA for those with an inadequate response, or as monotherapy for those unable to tolerate UDCA.
Pruritus affects up to 70–80% of people with PBC and can severely impact quality of life.
GSK has announced that the US FDA has accepted for priority review a supplemental Biologics License Application for Jemperli in previously untreated stage II and III dMMR/MSI-H locally advanced rectal cancer. Rectal cancer affects around 770,000 people globally each year and 5–10% of cases have the dMMR/MSI-H subtype. Chemotherapy, radiation and surgery remain standard treatments but can lead to lasting effects on bowel, urinary and sexual function, fertility and overall quality of life.
HepaRegeniX has received US FDA Orphan Drug Designation for darizmetinib for the prevention of post-hepatectomy liver failure. The therapy is a selective inhibitor of MKK4 designed to accelerate and enhance the liver’s natural regenerative capacity in healthy and diseased tissue.
The designation follows completion of the first pilot part of the phase 1b/2a study, which showed favourable tolerability and pharmacokinetic profiles in patients undergoing minor liver resection.
BASHH is deeply disappointed by NICE's draft recommendation not to approve lenacapavir for HIV prevention in the NHS in England. Lenacapavir is a long-acting option for HIV prevention that requires a 6-monthly injection.
NICE's draft guidance acknowledges the potential value of expanding HIV prevention options, but highlights uncertainties within the clinical and economic evidence considered by the appraisal committee.
MHRA is advising healthcare professionals to stop using and supplying certain medical devices that have been supplied on to the UK market without the appropriate conformity markings required under the UK Medical Devices Regulations 2002 and under the EU Medical Devices Regulation (EU) 2017/745.
The affected devices include products used in clinical settings for blood collection and infusion, surgical and biopsy procedures, wound management, and skin preparation.