Tower Mains Weekly Newsletter

Industry Updates

The MHRA and other organisations across the UK unite to improve public involvement in research

The Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority (HRA) and other organisations have come together to improve the extent and quality of public involvement in health and social care research. This includes:

  • listening to and learning from the people and communities involved and applying and sharing that learning
  • building and sharing the evidence of how to involve the public and the impact this has
  • supporting improvements in equality, diversity, and inclusion in public involvement
  • promoting the UK Standards for Public Involvement.

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EMA issues highlights from the latest PRAC meeting

On 11th March, the European Medicines Agency (EMA) issued meeting highlights from its Pharmacovigilance Risk Assessment Committee (PRAC) held on the 7th-10th March. Highlights include a warning for flare-ups of capillary leak syndrome (CLS) to be added to the product information for the Spikevax COVID-19 vaccine and the recommendation that small vessel vasculitis with cutaneous manifestations should be added to the product information of the Janssen COVID-19 vaccine as a possible side effect.

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MHRA Inspectorate Blog: MHRA to begin pilot programme for GMP and GDP deficiencies

On 11th March, the MHRA announced it is to begin a pilot programme for GMP and GDP remediation supervision by eligible consultants acting as Compliance Monitors (CM). The CM will work with the company to deliver actions identified in a Compliance Protocol (CP), that has been agreed with the MHRA.  Upon completion of the CP, the CM will communicate to the MHRA that the company is ready for inspection.  The MHRA will then carry out an inspection to determine if the company can be removed from IAG oversight. The MHRA Inspectorate will publish a further blog to provide more details on the CM role and the application process.

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FDA approves Lynparza as treatment for patients with high-risk early breast cancer

On 11th March, AstraZeneca announced that the US Food and Drug Administration (FDA) had approved it and MSD’s Lynparza for the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery. Patients are to be selected for treatment based on an FDA-approved companion diagnostic test for Lynparza.

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MHRA publishes latest information on COVID-19 vaccines and medicines

On 15th March, the MHRA issued a roundup of information relating to COVID-19 vaccines and medicines that has been published since the February 2022 issue of Drug Safety Update, up to 11th March 2022.

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FDA approves first generic of Symbicort Inhalation Aerosol to treat asthma and COPD

On 15th March, the FDA announced it had approved the first generic of Symbicort Inhalation Aerosol for the treatment of asthma in patients six years of age and older, and the maintenance treatment of airflow obstruction and reducing exacerbations for patients with chronic obstructive pulmonary disease (COPD). This complex generic drug-device combination product is a metered-dose inhaler that contains budesonide to reduce inflammation, and formoterol, a long-acting bronchodilator that relaxes muscles in the airways to improve breathing.

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MHRA issues amiodarone reminder for healthcare professionals

On 15th March, the MHRA published a reminder of the risks of treatment and the need for monitoring and supervision when a patient is being treated with amiodarone. Healthcare professionals are reminded that patients should be supervised and reviewed regularly during treatment as the drug has been associated with serious and potentially life-threatening side effects, particularly of the lung, liver, and thyroid gland.

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FDA publishes draft guidance on the development of human gene therapy products

On 15th March, the FDA published draft guidance providing recommendations to sponsors developing human gene therapy products incorporating genome editing (GE) of human somatic cells.  Specifically, this guidance provides recommendations regarding information that should be provided in an Investigational New Drug (IND) application to assess the safety and quality of the investigational GE product, as required in Title 21 of the Code of Federal Regulations 312.23 (21 CFR 312.23).  This includes information on product design, product manufacturing, product testing, preclinical safety assessment, and clinical trial design.

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FDA publishes draft guidance on the development of CAR T cell products

On 15th March, the FDA published draft guidance intended to assist sponsors, including industry and academic sponsors, in developing chimeric antigen receptor (CAR) T cell products. The guidance provides recommendations regarding chemistry, manufacturing, and control (CMC), pharmacology and toxicology, and clinical study design. It also provides recommendations for analytical comparability studies for CAR T cell products.

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Issue Number: WN00052

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