A second experimental Ebola vaccine is to be tested in a large clinical trial in the Democratic Republic of Congo (DRC) as public health authorities mobilise resources to contain an outbreak of Ebola virus disease, declared by the World Health Organization to be a public health emergency.
Kiadis Pharma NV has strengthened its scientific advisory board to guide the ongoing development of its cell therapy for patients who’ve had a stem cell transplant. This follows guidance from the European Medicines Agency that the product, ATIR101, will not be recommended for approval. ATIR101 has been under regulatory review since 2017.
Biogen Inc and Eisai Co Ltd have announced plans to seek US regulatory approval for aducanumab, a candidate treatment for early Alzheimer’s disease, just months after two Phase 3 trials for the drug were stopped for futility. The decision to proceed with registration follows discussions with the Food and Drug Administration about a larger dataset from the Phase 3 studies which showed that the drug worked at a high dose.
A new triple combination therapy for cystic fibrosis, targeting the most common genetic mutation behind the disease, has been approved by the US Food and Drug Administration. Trikafta (elexacaftor/ivacaftor/tezacaftor) is now available to patients 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. This is said to represent about 90% of all patients with the disease.
The first vaccine for the active immunisation of individuals at risk of infection from the Ebola virus is being recommended for use in countries affected by the disease including the Democratic Republic of Congo where a public health emergency has been declared by the World Health Organization.
The vaccine, Ervebo, was reviewed by the European Medicines Agency and given a positive opinion on 17 October. It was developed by Merck & Co.
The European Medicine Agency’s chief scientific committee has issued a positive opinion for Evenity (romosozumab) for the treatment of severe postmenopausal osteoporosis after initially rejecting the drug on the basis of cardiovascular safety concerns.
Denmark-based Bavarian Nordic A/S has won approval for Jynneos, a vaccine to prevent smallpox and monkeypox diseases for people at high risk of infection or in cases of a public health emergency. The development of Jynneos is the result of a 15-year partnership between Bavarian Nordic and the US government. The vaccine will become part of the US strategic national stockpile, which is the country’s largest supply of potentially life-saving medicines.
Regulatory agencies in the US, Canada and Australia have jointly approved a new treatment for endometrial cancer, the most common cancer of the female genital tract. The approval is the first of a new collaboration under which the Food and Drug Administration, Health Canada and the Australian Therapeutic Goods Administration review drug applications concurrently and issue a simultaneous decision afterwards.
The European Medicines Agency and the US Food Administration issued separate warnings on 13 September about ranitidine medicines, one of which is Zantac, which are widely used to treat heartburn and stomach ulcers. This follows tests that showed some products contained an impurity called N-nitrosodimethylamine (NDMA), classified as a probable carcinogen.
The European Medicines Agency has issued a positive opinion for the personalised therapy Xospata (gilteritinib) to treat acute myeloid leukaemia (AML) following approvals for the same drug in both the US and Japan. The developer is Tokyo-based Astellas Pharma Inc.
Xospata is being recommended as a monotherapy for the treatment of adult patients with relapsed or refractory AML with a FLT3 gene mutation. The positive opinion will need to be adopted by the European Commission before Xospata can be marketed.