Tower Mains Weekly Newsletter
Industry Updates
EMA reviewing data on paternal exposure to valproate
On 16th August, the European Medicines Agency (EMA) announced its Pharmacovigilance Risk Assessment Committee (PRAC) is reviewing data on the potential risk of neurodevelopmental disorders (NDDs) in children conceived by fathers taking valproate medicines. The review is focussing on data from a retrospective observational study conducted by companies as an obligation following a previous review of valproate use during pregnancy. This retrospective observational study compared the risk of NDDs (including autism spectrum disorder) in children born to men taking valproate with the risk in children born to men taking lamotrigine or levetiracetam (other treatments for epilepsy). It was carried out using multiple registry databases in Denmark, Norway, and Sweden. The PRAC will review the required data as they become available and make an EU-wide recommendation.
CervoMed announces merger with EIP Pharma
On 16th August, CervoMed Inc., a clinical-stage company focused on developing treatments for degenerative diseases of the brain, announced the finalisation of its merger with EIP Pharma Inc. The combined company will continue to operate under CervoMed Inc. and will focus on advancing its lead drug candidate neflamapimod, an oral stress kinase inhibitor, which is currently being developed for the treatment of dementia with Lewy bodies (DLB) and other degenerative diseases of the brain.
FDA approves first treatment for fibrodysplasia ossificans progressiva
On 17th August, the FDA announced it has approved Sohonos (palovarotene) capsules for the reduction in the volume of new heterotopic ossification (extra-skeletal bone formation) in adults and children aged 8 years and older for females, and 10 years and older for males with fibrodysplasia ossificans progressiva. Sohonos is the first drug approved for patients with fibrodysplasia ossificans progressiva and is taken once daily.
EMA accepts LEO Pharma’s MAA for delgocitinib cream to treat moderate-to-severe chronic hand eczema
On 18th August, LEO Pharma A/S announced that the EMA has validated the marketing authorisation application (MAA) for delgocitinib cream, an investigational product and topical pan-Janus kinase (JAK) inhibitor for the treatment of adult patients with moderate to severe chronic hand eczema (CHE). The acceptance of this MAA marks the beginning of the formal review procedure for this potential new treatment by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
New research reveals polio detection times could be halved using a scientific detection method
On 18th August, its was revealed that new research has shown that the time to detect polio could be halved using a technique called Direct molecular Detection and Nanopore Sequencing (DDNS). The research was jointly conducted by researchers at the Institut National de Recherche Biomédicale in Kinshasa who implemented DDNS in the Democratic Republic of the Congo (DRC) for the detection of polio outbreaks in collaboration with the MHRA, Imperial College London, the University of Edinburgh, and various laboratories of the World Health Organisation (WHO) Global Polio Laboratory Network (GPLN), with support from the Bill and Melinda Gates Foundation. Faster detection of polio in the regions where outbreaks still occur allows for faster response by authorities through targeted, localised vaccination campaigns, minimising the opportunity for the virus to spread.
WHO launches a new Global Initiative on Digital Health supported by the G20 Presidency
On 19h August, the WHO and the G20 India presidency announced a new Global Initiative on Digital Health (GIDH) at the Health Minister’s Meeting of the G20 Summit hosted by the Government of India. The new GIDH initiative will operate as a WHO-managed network and platform to support the implementation of the Global Strategy on Digital Health 2020–2025 and aims to bring countries and partners together to achieve measurable outcomes
First vaccine for pregnant individuals to prevent RSV in infants approved in US
On 22nd August, the FDA approved Pfizer’s Abrysvo, the first vaccine approved for use in pregnant individuals to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age. The vaccine is approved for use at 32 through 36 weeks gestational age of pregnancy and is administered as a single-dose injection into the muscle.
MHRA guidance updates
- Medical devices: UK approved bodies. On 24th August, the Medicines and Healthcare products Regulatory Agency (MHRA) published the Intertek Medical Notified Body UK Ltd Medical Devices Scope to its guidance on UK-approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). Click to view source
- Nitrosamines impurities in medicines. On 24th August, guidance was published to help medicine manufacturers meet safe limits on levels of nitrosamine impurities in medicines. Click to view source
Issue Number: WN00126
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