Tower Mains Weekly Newsletter
Regulatory Updates
MHRA guidance updates
- MHRA performance data for assessment of clinical trials and established medicines. On 14th April, the Medicines and Healthcare products Regulatory Agency (MHRA) updated performance metrics for clinical trials and established medicines assessment. Click to view source
- Apply for the early access to medicines scheme (EAMS): On 18th April, the MHRA updated fees in the guidance for guidance on applying for a promising innovative medicine (PIM) designation or scientific opinion for your medicine from MHRA. Click to view source
FDA issues guidance on animal drug user fees and fee waivers and reductions
On 13th April, the US Food and Drug Administration (FDA) issued final guidance on animal drug user fees and fee waivers and reductions. The document provides guidance on the types of fees the FDA is authorised to collect under the Animal Drug User Fee Act of 2003 (ADUFA) and how to request waivers and reductions from these fees. Click to view source
Industry Updates
biomodal releases genetics and epigenetics solution
On 13th April, biomodal announced the commercial launch of its new duet multiomics solution, the world’s first single-base-resolution sequencing technology with one workflow. The product delivers more epigenetic information from a single low-input DNA library without medical treatment or resource-intensive bioinformatics and provides a more thorough assessment of information stored in genomes, yielding new insights from biomedicine applications. It empowers applications across various fields of disease research, delivering greater biological insights into cancer, neurodegenerative disease, ageing, cell biology and population genetics.
EMA PRAC latest meeting highlights
On 14th April, the European Medicines Agency (EMA) issued highlights from its Pharmacovigilance Risk Assessment Committee (PRAC), held on the 11th-14th of April 2023. At this monthly meeting, the committee discussed its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of safety signals, risk management plans, periodic safety update reports and post-authorisation safety studies.
FDA approves cell therapy for patients with blood cancers to reduce risk of infection following stem cell transplantation
On 17th April, the FDA approved Omisirge, a substantially modified allogeneic cord blood-based cell therapy to quicken the recovery of neutrophils in the body and reduce the risk of infection. The product is intended for use in adults and pediatric patients 12 years and older with blood cancers planned for umbilical cord blood transplantation following a myeloablative conditioning regimen. The application received Priority Review, Breakthrough Therapy and Orphan designations.
WHO appoints new senior figures to drive strategic direction and initiatives
On 17th April, the World Health Organisation (WHO) announced it has appointed five new senior figures to its headquarters leadership team in Geneva. The overall leadership team has been merged to align with the Organisation’s priorities for the next five years and will work closely with the Director-General to drive forward these priorities and WHO’s ambitious transformation agenda.
FDA publishes CDER Conversation on its Office of New Drugs’ Research Program
On 17th April, the FDA’s Center for Drug Evaluation and Research (CDER) released a CDER Conversation about its Office of New Drugs’ Research Program. In this CDER Conversation, Laura Jaeger, PhD, associate director of the Research Program, talks about the program’s important work in enhancing regulatory science research.
AbbVie’s QULIPTA® approved in the US to prevent chronic migraines
On 17th April, AbbVie announced that the FDA has approved expanding the indication of QULIPTA® for the preventive treatment of migraine in adults. The approval makes QULIPTA the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent episodic and chronic migraine. QULIPTA blocks CGRP through a once-daily dose and is available in three strengths for the preventive treatment of episodic migraine – 10 mg, 30 mg, and 60 mg. Only the 60 mg dose of QULIPTA is indicated for the preventive treatment of chronic migraine.
FDA authorises changes to simplify the use of bivalent mRNA COVID-19 vaccines
On 18th April, the FDA amended the emergency use authorisations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. This includes authorising the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorised for use in the US.
ICR and NeoPhore collaborate to develop new potential cancer drugs
On 18th April, the Institute of Cancer Research (ICR) announced its scientists are teaming up with small molecule neoantigen immuno-oncology company NeoPhore to develop new potential cancer drugs. Under the terms of the agreement, the lab will use NeoPhore’s proprietary small molecule inhibitors of DNA mismatch repair (MMR) to explore single agent activity amid tumours with defined genetic backgrounds. Research by NeoPhore suggests that these first-in-class ‘MMR modulators’ can replicate clinical anti-tumour responses seen with existing immunotherapies in patients with microsatellite unstable (MSI) tumours that intrinsically lack MMR function. The collaboration will further develop NeoPhore’s innovations and ongoing research while boosting its pipeline of cancer-treating therapies.
Issue Number: WN00108
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