Gliosarcoma

Adam Zamecnik @a_zamecnik The UK has rejoined EU’s Horizon Europe science research programme. Image Credit: Shutterstock / vlastas The UK has re-joined the EU’s Horizon Europe science research programme after the country’s post-Brexit absence and long-stalled talks. British scientists will now be able to apply for grants and bids to take part in Horizon Europe projects, based on the UK Government’s 7 September announcement. Recommended Reports Reports LOA and PTSR Model - RRX-001 in Gliosarcoma GlobalData Reports State of the Biopharmaceutical Industry 2022 GlobalData View all As an EU member state at the time, the UK was part of the EU’s past Horizon 2020 research funding programme. This programme has since been succeeded by Horizon Europe, which uses its budget of €95.5bn to support research across the region. The programme not only offers funding for research but also provides a chance for collaboration across Europe and beyond such as Armenia, Israel, and New Zealand. “The UK’s decision to re-join the Horizon Europe funding programme will be welcomed warmly by researchers across the EU and Great Britain today,” said Dr Harshil Pate, head of scientific development at Seqera Labs after the announcement. “Tackling the many challenges facing humanity in the 21st century requires international collaboration that sees past borders, uniting our innovative research sectors to improve human health through cutting-edge discoveries in RNA vaccines, DNA analysis and more.” Whilst the UK was initially supposed to be a part of the programme as an associate, its membership was halted by disagreements with the EU over the future of trade rules in Northern Ireland. While a breakthrough in the Northern Ireland talks opened the possibility of readmission , the process faced further delays as reported by outlets at the time. However, the country has now re-joined the scheme and will be a fully associated member of the programme until it concludes in 2027, based on the 7 September announcement . The UK will start financially supporting the Horizon Europe scheme only in January 2024. Furthermore, the UK will also have a new automatic clawback that gives it compensation rights in case that British scientists receive less funding from the programme than what the country will invest. The European Commission estimates that the UK will pay almost €2.6bn per year for its participation in Horizon Europe and the Copernicus earth observation programme, which the country will also rejoin, based on a 7 September European Commission press release. However, the country will not rejoin the EU’s atomic Euratom programme. “We have worked with our EU partners to make sure that this is the right deal for the UK, unlocking unparalleled research opportunities, and also the right deal for British taxpayers,” said UK Prime Minister Rishi Sunak in the statement. The political agreement must now be approved by the European Council before being formally adopted in the EU-UK Specialised Committee on Participation in Union Programmes, per the European Commission’s statement.

Dasiglucagon is intended for usage in infants aged seven days and above with congenital hyperinsulinism. Credit: Liudmila Fadzeyeva / Shutterstock.com. The US Food and Drug Administration (FDA) has granted priority review for Zealand Pharma ’s dasiglucagon for hypoglycemia prevention and treatment in the paediatric population with congenital hyperinsulinism (CHI), a rare genetic ailment. Dasiglucagon is intended for usage in infants aged seven days and above, dosing for up to three weeks. Recommended Reports Reports LOA and PTSR Model - Aminolevulinic Acid Hydrochloride in Cervical Intraepithelial Neoplasia (CIN) GlobalData Reports LOA and PTSR Model - Pazopanib Hydrochloride in Gliosarcoma GlobalData View all Companies Intelligence Zealand Pharma AS CGM SpA View all A decision on the approval from the regulatory agency is anticipated on 30 December 2023. The regulator will carry out the review in two stages under one new drug application (NDA) to guarantee the best regulatory approach. Part one is linked to dosing with dasiglucagon for up to three weeks while part two is linked to the product’s usage beyond that time. To assess the usage of dasiglucagon for the disease beyond three weeks, the regulator sought further assessments from existing continuous glucose monitoring datasets. Zealand Pharma is expected to make the submission before the end of 2023. The Prescription Drug User Fee Act (PDUFA) date for the second part will be decided after filing data from further analyses of existing datasets sought by the FDA. The company chose CGM as a secondary outcome measure in Phase III clinical trials of dasiglucagon. Zealand Pharma chief medical officer David Kendall stated: “We believe that the decision of the FDA to provide such a fast review cycle for the first part of the NDA is a strong testament to the potential value of this product to patients. “We remain in close dialogue with the FDA and appreciate the collaborative nature of our work with the agency, recommending a review of the NDA in two parts under the same application to ensure patient access as fast as possible. “We look forward to continued dialogue with the FDA in generating additional analyses from existing datasets around the use of CGM to be submitted before the end of the year for part two of the NDA review.”

Japan approved Merck and AstraZeneca’s Lynparza for use with abiraterone and prednisolone for BRCAm castration-resistant prostate cancer. Credit: Copyright © 2023 Merck & Co., Inc., Rahway, NJ USA, and its affiliates. Merck (MSD) and AstraZeneca have received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for Lynparza to treat BRCA-mutated (BRCAm) castration-resistant prostate cancer with distant metastasis (mCRPC) in adults. A poly (ADP-ribose) polymerase (PARP) inhibitor, Lynparza is intended for use with abiraterone and prednisolone (abi/pred) for this indication. Recommended Reports Reports Japanese Encephalitis Drugs in Development by Stages, Target, MoA, RoA, Molecule Type and Key Pla... GlobalData Reports LOA and PTSR Model - Lipocurc in Gliosarcoma GlobalData View all Companies Intelligence AstraZeneca Plc Merck KGaA MSD KK NH&A LLC Ministry of Health View all The approval was based on an exploratory subgroup assessment of the double-blind, randomised Phase III PROpel clinical trial that analysed the safety, tolerability, and efficacy of Lynparza versus a placebo. According to the trial findings, treatment with Lynparza plus abi/pred showed improvements in radiographic progression-free survival and overall survival. The safety and tolerability of the Lynparza combination was found to be similar to that reported in previous trials and each medicine’s known profile. AstraZeneca oncology business unit executive vice-president Dave Fredrickson said: “This Lynparza combination has been shown to reduce the risk of disease progression or death compared to standard of care and underscores the critical importance of BRCA testing at metastatic diagnosis. “Today’s approval is a major step forward for patients in Japan with BRCAm mCRPC who urgently need new first-line treatment options.” The PARP inhibitor previously received approval in Japan for BRCAm mCRPC patients who have advanced after previous treatments comprising a new hormonal agent (NHA). Lynparza is also approved along with abi/pred for mCRPC in adults in various countries. In August 2022, Merck and AstraZeneca received European Commission (EC) approval for Lynparza as adjuvant treatment for high-risk, early-stage breast cancer.