Tower Mains Weekly Newsletter
FDA publishes guidance on the development of drug products including those that contain nanomaterials
On 21st April, the US Food and Drug Administration (FDA) published final guidance on the development of human drug products, including those that are biological products in which a nanomaterial is present in the finished dosage form. Nanotechnology can be used in a vast array of FDA-regulated products, such as human drug products, including those that are biological products. It may be used to create drug products in which nanomaterials serve a variety of functions, as active ingredients or inactive ingredients, including carriers loaded with an active ingredient.
EMA facilitating access to diabetes treatments for non-EU patients
On 22nd April, the European Medicine Agency (EMA) announced its human medicines committee (CHMP) has given a recommendation for two diabetes mellitus treatments, Actrapid and Insulatard, for use outside the EU. Both treatments are human insulins that have been centrally authorised in the EU since 2002 and were submitted to the agency under a regulatory procedure (Article 58 of Regulation (EC) No 726/2004) known as EU Medicines for all (EU-M4All).
MHRA launches consultation on proposal to make Aquiette 2.5mg tablets available from pharmacies
On 23rd April, the Medicines and Healthcare products Regulatory Agency (MHRA) launched a public consultation on the proposal to make Aquiette 2.5mg tablets available from pharmacies. The drug is for treatment of long-standing (present for over 1 month) symptoms of overactive bladder (OAB) which are not controlled by bladder training alone, in women 18 to 65 years of age. The agency encourages pharmacists, GPs and other health care professionals, the public and women to take part in the reclassification consultation. The deadline for comments is 11:45pm on 13th May 2022.
European Immunisation Week 2022: Statement by Executive Director Emer Cooke
On 25th April, the European Medicine Agency (EMA) released a statement by Executive Director Emer Cooke as part of this year’s European Immunisation Week. There are vaccines against more than 20 life-threatening diseases including polio, diphtheria, tetanus, whooping cough, COVID-19, influenza, and measles, and it is estimated that these vaccines prevent between two and three million deaths every year worldwide. Emer shares her thoughts and discusses the facts and history of some of the most recognised vaccines.
FDA approves first COVID-19 treatment for young children
On 25th April, the FDA expanded the approval of the COVID-19 treatment Veklury to include paediatric patients 28 days of age and older weighing at least 3 kilograms with positive results of direct SARS-CoV-2 viral testing, who are hospitalised, or have mild-to-moderate COVID-19 and are at substantial risk for progression to severe COVID-19, including hospitalisation or death. This action makes the treatment the first approved COVID-19 treatment for children less than 12 years of age.
Enhertu granted Breakthrough Therapy Designation for patients with HER2-low metastatic breast cancer
On 27th April, it was announced that Enhertu – a specifically engineered HER2-directed antibody-drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo – has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of adult patients with metastatic HER2-low (IHC 1+ or IHC 2+/ISH-negative) breast cancer. The treatment has now been granted five Breakthrough Therapy Designations, including three in breast cancer and one in both lung and gastric cancers.
MHRA updates information about the Pfizer/BioNTech vaccine
On 27th April, the MHRA updated information to Summary of Product Characteristics and Patient Information Leaflets (purple cap and orange cap).
Issue Number: WN00058