Tower Mains Weekly Newsletter
Regulatory Updates
MHRA guidance updates
- Medicines: reclassify your product: On 6th April, the Medicines and Healthcare products Regulatory Agency (MHRA) updated the approved list of reclassifications in the guidance on applying to move a medicine to a different classification. Click to view source
- Good clinical practice for clinical trials: On 6th April, the MHRA updated guidance on how to show the MHRA how you are meeting good clinical practice (GCP) standards and what to expect from an inspection. Click to view source
- Export drugs and medicines: special rules: On 13th April, the MHRA updated guidance on how to obtain permission to export certain drugs and medicines. Click to view source
FDA guidance updates
Risk-based approach to monitoring of clinical investigations: On 11th April, the FDA issued final guidance on a risk-based approach to monitoring clinical investigations. This intends to provide information on risk-based approaches to monitoring the conduct of clinical investigations of human drug and biological products, medical devices, and combination products. Clinical investigation monitoring is a quality control tool for determining whether investigation activities are being carried out as planned. Click to view source
FDA issues draft guidance on transdermal and topical delivery systems for ANDAs: On 13th April, the US Food and Drug Administration (FDA) issued two draft guidances on assessing transdermal and topical delivery systems for ANDAs:
- Assessing the Irritation and Sensitisation Potential of Transdermal and Topical Delivery Systems for ANDAs: This revised draft guidance provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation and sensitisation (I/S) potential of a proposed transdermal or topical delivery.
- Assessing Adhesion with Transdermal and Topical Delivery Systems for ANDAs Draft Guidance for Industry: This revised draft guidance provides recommendations for the design and conduct of studies evaluating the adhesion performance of a transdermal or topical delivery system.
Industry Updates
Investigational personalised mRNA cancer vaccine takes a positive step
On 6th April, Moderna, Inc., a biotechnology company pioneering mRNA therapeutics and vaccines, and Merck announced that mRNA-4157/V940, an investigational personalised mRNA cancer vaccine, in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, has been granted Priority Medicines (PRIME) scheme designation by the European Medicines Agency (EMA) for the treatment of patients with high-risk stage III/IV melanoma following complete resection. The EMA granted PRIME scheme designation based on positive data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial.
ICH M7(R2) Guideline reaches Step 4 of the ICH Process
On 6th April, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) announced its ICH M7(R2) guideline on the “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” and the accompanying M7(R2) addendum “Application of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes” have reached Step 4 of the ICH Process.
US indications for IMBRUVICA® for the treatment of patients with mantle cell lymphoma withdrawn
On 6th April, the Janssen Pharmaceutical Companies of Johnson & Johnson in collaboration with its alliance partner, Pharmacyclics, an AbbVie Company, announced the intent to voluntarily withdraw the US indications for IMBRUVICA® for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, and for the treatment of patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy. The decision was made in consultation with the FDA, consistent with FDA procedural guidance on accelerated approvals. After discussing results with the companies, the FDA advised that the primary outcomes from the Phase 3 confirmatory studies for the indications were considered insufficient to support conversion to full approval.
EMA issues latest Human Medicines Highlights newsletter
The EMA has issued the April issue of its Human Medicines Highlights newsletter. The newsletter provides key information for patients, consumers, and healthcare professionals.
FDA announces final decision to withdraw approval of Makena
On 6th April, the FDA announced its decision to withdraw approval of Makena, a drug that had been approved under the accelerated approval pathway to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth. Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce.
MISHA Knee System authorised for marketing in the US
On 11th April, the FDA announced it has authorised for marketing the MISHA Knee System, an implant placed alongside the knee joint to help reduce the amount of load carried by part of the joint. The MISHA Knee System is indicated for patients with osteoarthritis of certain parts of the knee who have failed to find relief with surgical or non-surgical treatment and are still experiencing pain that interferes with activities of daily living.
MHRA cell therapy research evaluates immune-stimulant cancer therapies to reduce side effects
On 13th April, the MHRA published findings from research evaluating two different approaches to cancer therapies which harness the immune system to determine which better targets cancer cells and would reduce side effects for patients. The report ‘Antibody conjugates for targeted delivery of Toll-like receptor 9 agonist to the tumor tissue’, published in the PLOS ONE journal, highlights MHRA research which showed that genetic engineering of antibodies used to activate and support the immune system against cancer leads to improvements in their reliability and effectiveness.
FDA announces joint psychopharmacologic drugs advisory committee and the peripheral and central nervous system drugs advisory committee meeting
On 14th April, the FDA will hold a joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee to discuss supplemental new drug application efficacy supplement for Rexulti tablets, submitted by Otsuka Pharmaceutical Company, Ltd., and Lundbeck, Inc., for the proposed treatment of agitation associated with Alzheimer’s dementia. Rexulti is currently approved as an adjunctive therapy to antidepressants for the treatment of major depressive disorder in adults and the treatment of schizophrenia in adults and pediatric patients ages 13 years and older.
Issue Number: WN00107
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