Tower Mains Weekly Newsletter
Company Updates
MHRA guidance updates
- Export drugs and medicines: special rules. On 5th September, the Medicines and Healthcare products Regulatory Agency (MHRA) updated guidance on getting permission to export certain drugs and medicines. Details on applying for an export licence were removed and linked to the controlled drugs page was added. Click to view source
FDA guidance updates
- Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex: Developing Drugs for Treatment. On 5th September, the US Food and Drug Administration (FDA) published final guidance to assist sponsors in the clinical development of drugs for the treatment of nontuberculous mycobacterial pulmonary disease (NTM-PD) caused by Mycobacterium avium complex (MAC). Click to view source
- DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry. On 6th September, final guidance was published to identify the standards necessary to facilitate the adoption of secure, interoperable, electronic data exchange among the pharmaceutical distribution supply chain, and clarifies the trading partners, products, and transactions subject to such standards. Click to view source
- Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions. On 7th September, draft guidance was published in response to public feedback, and to continue to modernise the framework for 510(k) review. The FDA is issuing this draft guidance to provide our current thinking on the use of clinical data in 510(k) submissions to enhance the predictability, consistency, and transparency of the 510(k) Program. Click to view source
- Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission. On 7th September, draft guidance was published with recommendations proposing factors for consideration as best practices for choosing a predicate device that focuses on characteristics of the predicate, including selecting a predicate device that was cleared using well-established methods, meets or exceeds expected safety and performance, is without unmitigated use-related or design-related safety issues, and is without an associated design-related recall. Click to view source
Industry Updates
WHO initiative signs new licensing agreements on COVID-19 technologies
On 29h August, the COVID-19 Technology Access Pool (C-TAP), a multi-stakeholder partnership to facilitate the sharing of intellectual property (IP), knowledge and innovations announced three new licensing agreements acquired through the Medicines Patent Pool (MPP). The agreements include the following licenses to transfer know-how, materials and clinical data needed in different countries:
- Medigen Vaccine Biologics Corp, the first private manufacturer, is offering its patent and know-how for a COVID-19 vaccine that has seen more than three million doses administered across seven countries. It is the first time that a vaccine manufacturer is using the WHO C-TAP model – a win-win opportunity for the manufacturer, recipients of the technology and, most importantly, patients in need around the world. The agreement will enable licensing of IP facilitating technology transfer and staff training.
- Spanish National Research Council (CSIC) is sharing a second license for a COVID-19 vaccine prototype. The agreement includes plant visits and training, direct assistance, and ongoing consultation with recipient manufacturers, including on quality and regulatory matters.
- The University of Chile is sharing its technology for a COVID-19 assay for quantification of neutralising antibodies.
23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 cleared for marketing
On 1st September, the FDA cleared for marketing the updated 23andMe Personal Genome Service (PGS) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants). It is a direct-to-consumer (DTC) test that reports selected BRCA1/BRCA2 genetic variants from human saliva collected from individuals 18 years or older. The test was updated to add 41 BRCA1/BRCA2 variants to the previously authorised test and is the latest example of the FDA’s ongoing commitment to advance access to safe and effective DTC genetic testing intended to aid patients in having informed conversations with their healthcare providers.
PRAC recommends new measures to avoid topiramate exposure in pregnancy
On 1st September, the European Medicine Agency’s safety committee (PRAC) recommended new measures to avoid exposure of children to topiramate-containing medicines in the womb, because the medicine may increase the risk of neurodevelopmental problems after exposure during pregnancy. The companies that market topiramate must carry out drug utilisation studies and surveys of healthcare professionals and patients to assess the effectiveness of the new measures.
Consultation launched on draft guidance for the assessment and management of acute respiratory infections
On 1st September, the National Institute for Health and Care Excellence (NICE) announced the launch of a consultation on draft guidance for the assessment and management of acute respiratory infections in people over 16. The guideline covers diagnosing and managing suspected ARIs, including pneumonia, respiratory viruses, and flu in adults and aims to improve initial assessments and access to face-to-face appointments as well as the management of conditions to help reduce hospital admissions. The consultation runs until 5pm on Friday, 15th September.
Intelligent OMICS Ltd partners with Janssen in AI-driven research
On 1st September, Intelligent OMICS, a biotechnology company that applies artificial intelligence (AI) to accelerate drug discovery, announced a target discovery collaboration with Janssen Research & Development, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The collaboration will combine Intellomx’s proprietary AI platform, which integrates multi-omics data and deep learning algorithms to uncover novel disease mechanisms and therapeutic opportunities for treatment, with Janssen’s expertise in data science, oncology research and development.
Vitestro starts blood-drawing device clinical trial
On 5th August, Vitestro, a company focused on advanced medical robotics, announced the launch of an A.D.O.P.T. (Autonomous Optimisation and Performance Testing) Trial for its autonomous blood drawing device. The device combines AI-based, ultrasound-guided 3D reconstruction with the robotic insertion of a needle, ensuring accurate, consistent venipuncture. A prototype has previously been tested with 1,500 patients. With an anticipated sample size of over 10,000 patients, this is the most significant study worldwide to date of autonomous blood collection.
Issue Number: WN00128
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