Tower Mains Weekly Newsletter
Regulatory Updates
MHRA guidance updates
- On 28th October, guidance on how the Medicines and Healthcare products Regulatory Agency (MHRA) approaches pharmacovigilance procedures was updated to include further details on submission requirements, in particular relating to signals. Click to view source
- On 28th October, MHRA guidance on the 150-day assessment timeline for high-quality marketing authorisation applications, including information on how to apply, was updated. Click to view source
- On 28th October, a recording was added to the webinar ‘Changes to Submitting Adverse Incidents to Medical Devices to the MHRA’ in the guidance for manufacturers on vigilance. Click to view source
- On 2nd November, the list of current members of the UK GLP (Good Laboratory Practice) Compliance monitoring programme was updated. Click to view source
Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals
On 1st November, the US Food and Drug Administration (FDA) published the S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals, which applies to all pharmaceuticals that need carcinogenicity testing as described in ICH S1A.
Industry Updates
FDA approves teclistamab-cqyv for multiple myeloma
On 25th October, the FDA granted accelerated approval to teclistamab-cqyv, the first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Due to the risks of CRS and neurologic toxicity, including ICANS, teclistamab-cqyv is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), called the Tecvayli REMS.
MHRA updates Delivery Plan 2021-2023
On 27th October, the MHRA added updates for year two to its Delivery Plan 2021-2023
FDA updates list of Breakthrough Devices
On 28th October, the FDA updated the list of Breakthrough Devices that have been authorised for marketing, which includes 56 devices. Online metrics show the number of granted Breakthrough Device designations by fiscal year and by the clinical panel, which totals 728 as of 30th September 2022. The Breakthrough Devices Program provides patients and healthcare providers with timely access to medical devices by speeding up their development, assessment, and review.
EMA recommends measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders
On 28th October, the European Medicines Agency (EMA) announced its safety committee (PRAC) has recommended measures to minimise the risk of serious side effects associated with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders. The committee recommends that these medicines should be used in the following patients only if no suitable treatment alternatives are available: those aged 65 years or above, those at increased risk of major cardiovascular problems, those who smoke or have done so for a long time in the past and those at increased risk of cancer.
EMA recommends withdrawal of marketing authorisations for amfepramone medicines
On 28th October, the EMA’s PRAC confirmed its recommendation to withdraw the marketing authorisations for amfepramone obesity medicines. This follows a re-examination of its previous recommendation of June 2022, which was requested by the companies that market these medicines. It was concluded that the benefits of amfepramone medicines do not outweigh their risks and recommended that the medicines be removed from the market in the EU.
Vaxzevria granted full marketing authorisation in the EU for the prevention of COVID-19
On 1st November, AstraZeneca announced its COVID-19 vaccine, Vaxzevria, has been granted full marketing authorisation in the EU after originally being granted conditional marketing authorisation by the EMA due to the urgency of the COVID-19 pandemic. The decision follows a positive recommendation by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
Issue Number: WN00085
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