Tower Mains Weekly Newsletter
FDA opens FY2023 grant funding application period for animal drugs for minor uses and minor species
The US Food and Drug Administration (FDA) has announced the opening of a new period for applications for grants to support the development and potential approval or conditional approval of new animal drugs intended to treat uncommon diseases (minor uses) in major species or to treat minor species (MUMS drugs). Grants awarded through the MUMS program support the FDA’s continuing mission to assure that safe and effective animal drugs are available for a wide range of species and conditions.
ICH: A Successful Hybrid Meeting
On 1st June, the International Council for Harmonisation (ICH) released details of its Assembly Meeting, held on the 21st – 24th May 2022. At the meeting – held in Athens, Greece, for the first time in a hybrid format – the Assembly reviewed the status of activity of all thirty-one of ICH’s Working Groups; received a report from the MedDRA Management Committee; and was updated on several important recent ICH activities concerning training and communication.
European Commission releases complex clinical trials Q&A
On 2nd June, the European Commission published guidance for sponsors, clinical trialists, and applicants regarding scientific aspects and the planning, set-up, submission for obtaining CT authorisation (CTA), conduct, reporting and transparency, analysis, and interpretation of complex clinical trials (CCTs) under the EU Clinical Trials Regulation (EU CTR) as well as their use in submissions for marketing authorisation. It complements and should be used with the applicable EU and ICH guidelines, particularly E6, E8, E9, E10, E16, E19, E11A, and E20 (when available).
FDA announces ADMS webinar
On 6th June, the FDA announced it will host a webinar to provide information to animal drug manufacturers about new enhancements to the free eSubmitter tool used to support the creation of electronic, secure submissions to the FDA’s Center for Veterinary Medicine (CVM) for review. The webinar, titled ‘Reporting of Veterinary Drug Supply Chain Information Using the Animal Drug Manufacturing System (ADMS) eSubmitter Tool,’ will take place from 1pm ET on Wednesday 22nd June.
WHO consultation sets priorities for monkeypox
On 3rd June, the World Health Organisation (WHO) announced that a global research consultation convened by its R&D Blueprint gathered over 500 experts and more than 2000 participants to discuss knowledge gaps and research priorities for monkeypox, given the recent outbreaks of the disease. Alongside underlining the need for expedited studies to better understand the disease epidemiology, experts highlighted research needs and emphasised the need for clinical studies of vaccines and therapeutics to better document their efficacy and understand how to use them now and in any future outbreaks.
Enhertu demonstrates potential to redefine the treatment of HER2-targetable cancers
On 5th June, it was announced that Enhertu, a specifically engineered HER2-directed antibody-drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo, reduced the risk of disease progression or death by 50% vs. chemotherapy in patients with HER2-low metastatic breast cancer. Results from the DESTINY-Breast04 Phase III trial showed that the drug demonstrated superior and clinically meaningful progression-free survival (PFS) and overall survival (OS) in previously treated patients with HER2-low unresectable and/or metastatic breast cancer with hormone receptor (HR) positive or HR-negative disease versus chemotherapy.
Issue Number: WN00064