Tower Mains Weekly Newsletter
Company Updates
Katarina: Celebrating 10 years at Tower Mains
Join us in celebrating a milestone as we honour Katarina Eghan, who is marking an incredible ten years with Tower Mains. Since joining our team in 2013, Katarina has made a huge impact on the company, bringing her expertise and dedication to every aspect of her work. Click here to hear directly from Katarina as she reflects on her journey with us.
Regulatory Updates
MHRA guidance updates
- Medicines: Marketing Authorisation Holders’ submission of Nitrosamine risk evaluation, risk assessment and confirmatory testing. On 17th April, guidance was added for Marketing Authorisation Holders (MAHs) regarding step 2 submission requirements where nitrosamines are determined to be non-mutagenic. Click to view source
- Notifying MHRA about a clinical investigation for a medical device. On 23rd April, links were added to guidance for manufacturers on clinical investigations and information for clinical investigators. Click to view source
FDA guidance updates
- Promotional labelling and advertising considerations for prescription biological reference and biosimilar products. On 24th April, the US Food and Drug Administration (FDA) published revised draft guidance addressing questions companies may have when developing FDA-regulated promotional labelling and advertisements for prescription reference products licensed under section 351(a) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(a)) and prescription biosimilar products, including interchangeable biosimilar products, licensed under section 351(k) of the PHS Act (42 U.S.C. 262(k)). Click to view source
Industry Updates
CureVac and MD Anderson collaborate to develop new cancer vaccines
On 16th April, CureVac N.V., a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), and the University of Texas MD Anderson Cancer Center announced a co-development and licensing agreement to develop novel mRNA-based cancer vaccines. The partnership will combine CureVac’s unique end-to-end capabilities for cancer antigen discovery, mRNA design, and manufacturing and MD Anderson’s expertise in cancer antigen discovery and validation, translational drug development, and clinical research.
New clinical trial aims to investigate skin patches to spot lung transplant rejection
On 16th April, it was announced a new trial, SENTINEL, is set to investigate whether skin patches can be used as an early warning system to identify if lung transplants are being rejected, so treatment can begin sooner, reducing the chance of longer-lasting organ damage. The SENTINEL trial is run by the Surgical Trials Units at the University of Oxford in collaboration with NHS Blood and Transplant and the five UK lung transplant centres and funded by the Medical Research Council (MRC) and National Institute for Health and Care Research (NIHR) partnership.
FDA’s CDRH issues 2024 Safety and Innovation Reports
On 17th April, the FDA’s Center for Devices and Radiological Health Center (CDRH) issued two companion reports that detail the Center’s commitment to further advance the FDA’s core pillars of safety and innovation. The CDRH 2024 Safety Report is an update to the 2018 Medical Device Safety Action Plan and features steps taken in recent years to ensure the safety of medical devices keeps pace with the evolving technology. The CDRH 2024 Innovation Report highlights the work to advance innovation and the progress made to make the US market more attractive to top device developers.
Genentech’s Alecensa® approved as the first adjuvant treatment for ALK-positive early-stage lung cancer
On 18th April, Genentech, a member of the Roche Group, announced the FDA approval of Alecensa® for adjuvant treatment following tumour resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test. The approval was based on a Phase III ALINA study showing Alecensa reduced the risk of disease recurrence or death by an unprecedented 76% in people with ALK-positive early-stage resected NSCLC.
EMA releases meeting highlights from the latest CVMP meeting
On 19th April, the European Medicines Agency (EMA) issued meeting highlights from its Committee for Veterinary Medicinal Products (CVMP), held on the 16th -18th April 2024.
FDA approves new bladder cancer drug
On 22nd April, the FDA approved Altor BioScience’s first-in-class interleukin (IL)-15 superagonist nogapendekin alfa inbakicept-pmln (Anktiva), plus bacillus Calmette-Guérin (BCG), for the treatment of certain non–muscle-invasive bladder cancers that fail to respond to BCG alone. Approval was based on findings from a single-arm, phase 2/3 open-label QUILT-3.032 study, which included 77 patients with BCG-unresponsive, high-risk disease following transurethral resection.
New recommendations to strengthen supply chains of critical medicines
On 23rd April, the European Medicines Agency (EMA) published recommendations developed by its Medicines Shortages Steering Group (MSSG) to address vulnerabilities in the production and delivery of medicines included in the Union list of critical medicines and strengthen their supply chain.
LifeArc to launch national research centres to unlock tests and treatments for rare diseases
On 23rd April, LifeArc announced the LifeArc Translational Centres for Rare Diseases (including the LifeArc Centre for Rare Mitochondrial Diseases, LifeArc Centre for Rare Kidney Diseases, LifeArc Centre for Rare Respiratory Diseases and the LifeArc Centre for Acceleration of Rare Disease Trials) has been awarded nearly £40million over five years and will focus on areas where there is a significant unmet need. This includes research centres that will bring together leading scientists and rare disease clinical specialists from across the UK for the first time, encouraging new collaborations across different research disciplines and providing improved access to facilities and training.
FDA approves new treatment for uncomplicated Urinary Tract Infections
On 24th April, the FDA approved Pivya tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. Pivya’s efficacy in treating females 18 years of age or older was assessed in three controlled clinical trials comparing different Pivya dosing regimens to placebo, another oral antibacterial drug and ibuprofen.
Issue Number: WN00159
Would you like a personal copy of the Tower Mains Weekly Newsletter directly to your mailbox each month? Contact us here with the subject “Weekly Newsletter Please.”