Features / Comment / Insight / Analysis / Facts
April 2023 Vol 25 Issue 3
NICE approved BMS’s Opdivo for lung cancer
Bristol-Myers Squibb’s drug Opdivo has become the first to be cleared for NHS use alongside chemotherapy to treat lung cancer, page 5
Bristol-Myers Squibb’s drug Opdivo has become the first to be cleared for NHS use alongside chemotherapy to treat lung cancer, page 5
FDA sued by US states over abortion pill access
Attorneys general from 12 Democrat-led states have complained to the FDA attempting to force it to relax restrictions on abortion access, page 7
Attorneys general from 12 Democrat-led states have complained to the FDA attempting to force it to relax restrictions on abortion access, page 7
Sooma receives FDA Breakthrough
Device designation for depression
therapy device
Sooma Medical has received FDA approval for its device to treat depression, page 12
Device designation for depression
therapy device
Sooma Medical has received FDA approval for its device to treat depression, page 12
AstraZeneca shares positive results from Imfinzi trial
AstraZeneca has shared positive results from phase 3 trial for Imfinzi treating lung cancer
Pharma giant AstraZeneca has shared positive results from a phase 3 trial on Imfinzi (durvlalumab), its resectable non-small cell lung cancer treatment, having shown a ‘significantly improved’ event-free survival.
The company shared results from the phase 3 AEGEAN trial, which demonstrated that treatment with Imfinzi, either before or after surgery, ‘significantly increased’ the time patients continued to live without recurrence or progression events. Pathologic response analyses were consistent with previous positive results from prior trials.
The trial will continue to assess secondary endpoints, such as disease-free survival and overall survival, as initially planned.
John V Heymach MD PhD, professor and chair thoracic/head and neck medical oncology at the University of Texas MD Anderson Cancer Center, commented: “Treating patients early with durvalumab both before and after surgery delivers a significant and clinically meaningful benefit in resectable non-small cell lung cancer, where new options are urgently needed to offer patients the best chance of long-term survival. The AEGEAN results provide compelling evidence that this novel durvalumab regimen can drive improved outcomes in this curative-intent setting.”
Susan Galbraith, executive vice president of Oncology R&D at AstraZeneca, added: “Patients with resectable non-small cell lung cancer face unacceptably high rates of recurrence, despite treatment with chemotherapy and surgery. We have shown that adding Imfinzi both before and after surgery significantly increased the time patients live without recurrence or progression events. We will continue to follow patients for overall survival.”
£1.6bn of research and development funding “surrendered” back to UK Treasury
A pot of £1.6bn which was originally allocated as the UK’s contribution to the €96bn Horizon Europe research funding programme ‒ run by the EU ‒ has reportedly been ‘surrendered’ to HM Treasury. The funds were promised as a foundation for a domestic scheme if the ongoing struggle around the UK’s associate membership to Horizon Europe remained unresolved.
Associate membership to Horizon Europe was included in the Brexit ‘divorce’ deal between the UK and EU, however such a deal has never been finalised due to the ongoing Northern Ireland trade border disputes between the UK and EU. In 2022, the EU withheld Horizon funding for UK projects, meaning UK applicants are having their funding covered by the UK government until the associate membership is passed.
Leading science organisations, such as the Campaign for Science and Engineering (CaSE) lobby group, have admonished the decision to ‘surrender’ the funding by the Department of Business, Energy, and Industry Strategies (CEIS), which CaSE claims came in the Central Government Supply Estimates 2022-2023.
CaSE executive director Professor Sarah Main said the withdrawal “undermines the Prime Minister’s assertions about the importance of science and innovation to the UK’s future and the creation, only this month, of a new department to pursue this agenda.”
Sir Adrian Smith, president of the Royal Society, said: “The failure of all sides to secure the UK’s association to the EU’s research programmes has now cost UK science £1.6bn. That comes on top of the talented researchers who have left the UK in order to carry on their collaborative work. How does this sit with the government’s stated mission to have the UK as a science superpower? The Treasury must now ensure that this money is reinvested in research in the coming years.”