Tower Mains Weekly Newsletter
We are delighted to be able to offer bursary places on our next virtual GCP Refresher Training course with Fiona Waddell, taking place on the 28th of July 2021 (on TEAMS). To apply for a place, email firstname.lastname@example.org telling her why this would be a great opportunity for you. For full details on this course, click here.
FDA grants first full approval for treatment of Lymphoma in dogs
On 15th July 2021, the U.S. Food and Drug Administration (FDA) announced it had fully approved Tanovea (rabacfosadine injection) to treat lymphoma in dogs. Tanovea was approved using the new animal drug approval process after initially receiving conditional approval under statutory provisions related to drugs intended for uncommon diseases or conditions in major animal species (minor uses) or for use in the minor species of animals under the FDA’s Minor Use and Minor Species (MUMS) program (i.e., MUMS drugs).
EMA issues highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) meeting
On 16th July 2021, the EMA issued meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) on the 13th-15th July. Highlights include a new guideline on manufacture of the veterinary finished dosage form (EMA/CVMP/QWP/798401/2015) following the close of the public consultation and opinions on veterinary medicinal products including Apoquel and Nobilis Influenza H5N2.
EMA evaluating use of Kineret in adult COVID-19 patients at increased risk of severe respiratory failure
On 19th July 2021, the European Medicines Agency (EMA) announced it had started evaluating an application to extend the use of Kineret (anakinra) to include treatment of COVID-19 in adult patients with pneumonia who are at risk of developing severe respiratory failure. EMA’s human medicines committee (CHMP) will assess data submitted in the application to decide whether to recommend the extension of indication. Data submitted include results from two ongoing clinical studies investigating the safety and efficacy of the medicine in adult patients hospitalised with COVID-19.
MHRA’s new Chief Safety Officer, Dr Alison Cave, starts vital vigilance work
On 19th July 2021, it was announced that Dr Alison Cave commenced as Chief Safety Officer at the Medicines and Healthcare products Regulatory Agency (MHRA) where she will oversee the Agency’s vigilance work – helping ensure the safety of medicines and devices that reach the UK public and health service.
Nevro awarded FDA approval for high frequency neurostimulation in painful diabetic neuropathy
Nevro has been awarded FDA approval for its Senza spinal cord stimulator (SCS) implant, aimed at patients suffering from nerve damage associated with diabetes. The device is expected to last for 10 years without causing uncomfortable paresthesia, so the device can be used while the patient is sleeping or performing daily tasks.
MHRA issues its annual report and accounts
On 20th July 2021, the MHRA issued its annual report and accounts 2020 to 2021.
EMA starts rolling review of COVID-19 vaccine Vidprevtyn
On 20th July 2021, it was announced that the EMA’s human medicines committee (CHMP) has started a rolling review of Vidprevtyn, a COVID-19 vaccine developed by Sanofi Pasteur. The review is based on preliminary results from laboratory studies (non-clinical data) and early clinical studies in adults, which suggest that the vaccine triggers the production of antibodies that target SARS-CoV-2 and may help protect against the disease. The rolling review will continue until enough evidence is available for a formal marketing authorisation application.
Issue Number: WN00020