Tower Mains Weekly Newsletter

Industry Updates

First adapted COVID-19 booster vaccines recommended for approval in the EU 

On 1st September, the European Medicines Agency (EMA) announced its human medicines committee (CHMP) has recommended authorising two vaccines adapted to provide broader protection against COVID-19. Comirnaty Original/Omicron BA.1 and Spikevax bivalent Original/Omicron BA.1 are for use in people aged 12 years and above who have received at least primary vaccination against COVID-19. These vaccines are adapted versions of the original vaccines Comirnaty (Pfizer/BioNTech) and Spikevax (Moderna) to target the Omicron BA.1 subvariant in addition to the original strain of SARS-CoV-2. The CHMP opinions will now be sent to the European Commission, which will adopt a final decision. 

Click to view source 

New measures to minimise risk of meningioma with medicines containing nomegestrol or chlormadinone 

On 2nd September, the EMA’s CHMP announced it had endorsed the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC), which concluded that the benefits of medicines containing nomegestrol or chlormadinone outweigh the risks, provided new measures are taken to minimise the risk of meningioma. The committee recommended that medicines containing high-dose nomegestrol (3.75 – 5 mg) or high-dose chlormadinone (5 – 10 mg) should be used at the lowest effective dose and for the shortest duration possible, and only when other interventions are not appropriate. In addition, low- and high-dose nomegestrol- or chlormadinone-containing medicines must not be used by patients who have, or have had, meningioma. The opinion has been sent to the European Commission, which will issue a legally binding decision valid across the EU. 

Click to view source 

PRAC begins review of topiramate use in pregnancy and women of childbearing potential  

On 2nd September, the EMA’s PRAC announced it had started a review of topiramate and the risk of neurodevelopmental disorders in children whose mothers were taking topiramate during pregnancy. Topiramate is a medicine used in the EU for the treatment of epilepsy, prevention of migraine, and, in some countries, in combination with phentermine for body weight reduction. The review was triggered by a recent study that suggested a potential increase in the risk of neurodevelopmental disorders, in particular autism spectrum disorders and intellectual disability, in children whose mothers were taking topiramate during pregnancy.  

Click to view source 

Imfinzi in combination with chemotherapy approved in the US as the first immunotherapy regimen for patients with advanced biliary tract cancer 

On 5th September, AstraZeneca announced its Imfinzi plus chemotherapy has been approved in the US for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC). The approval by the US Food and Drug Administration (FDA) was based on the results from the TOPAZ-1 Phase III trial and was granted after securing Priority Review and Orphan Drug Designation for Imfinzi in the US in this setting. Regulatory applications are also currently under review in other countries based on the TOPAZ-1 results. 

Click to view source 

MHRA updates guidance on Project Orbis 

On 6th September, the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on Project Orbis, a programme to review and approve promising cancer drugs helping patients access treatments faster. OPDIVO was added. 

Click to view source 

Medical devices: software applications (apps) 

On 6th September, the MHRA updated its guidance on when software applications are considered medical devices and how they are regulated. Appendices 1, 2, and 3 were added to the attachments. 

Click to view source 

ECDC and EMA release statement on booster vaccination with Omicron adapted bivalent COVID-19 vaccines  

On 6th September, the European Centre for Disease Prevention and Control (ECDC) and the EMA issued a joint statement providing updated public health considerations on the use of the newly authorised adapted COVID-19 vaccines to support the planning of the autumn and winter vaccination campaigns. 

Click to view source 

FDA guidance updates

  • M12 Drug Interaction Studies: The FDA has issued draft guidance on 26th August 2022 providing recommendations to promote a consistent approach to designing, conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical drug-drug interaction (DDI) studies during the development of a therapeutic product. Click to view source 
  • E11A Pediatric Extrapolation: The FDA has issued draft guidance on 26th August 2022 providing recommendations for and promoting international harmonisation of, the use of paediatric extrapolation to support the development and authorisation of paediatric medicines.  Click to view source 

Issue Number: WN00077

Would you like a personal copy of the Tower Mains Weekly Newsletter directly to your mailbox each month? Just send an email to with the subject “Weekly Newsletter Please”.