Drug approval roundup – May/June 2024
This article highlights some of the key regulatory approvals granted in May and June in the EU and US so far this year, including for oligonucleotide and biologic therapies.
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This article highlights some of the key regulatory approvals granted in May and June in the EU and US so far this year, including for oligonucleotide and biologic therapies.
The new approval of KEYTRUDA (pembrolizumab) combined with chemotherapy is indicated for certain patients with the most common gynaecologic cancer, according to Merck/MSD.
The EGFR immune engager in combination with pembrolizumab is expected to be administered to the first patients in late 2024.
A personalised mRNA cancer vaccine in combination with MSD’s Keytruda cut the risk of cancer recurrence by almost half in melanoma patients.
“Injecting a virus into a patient’s brain tumour” combined with immunotherapy improved glioblastoma survival outcomes in a clinical trial.
Final draft guidance published by the National Institute for Health and Care Excellence (NICE) has recommended immunotherapy pembrolizumab drug for advanced cervical cancer.
MSD/Merck and Nectin Therapeutics have agreed to collaborate on a clinical trial for KEYTRUDA® in combination with monoclonal antibody NTX1088.
An mRNA vaccine plus KEYTRUDA® significantly improved recurrence-free survival in a Phase II trial for advanced melanoma patients.
When France's ATU reform was implemented, some viewed it as restrictive. Here, Cécile Matthews and Charlotte Capdevila explore the reform’s impact on early access to oncology drugs and products for rare diseases.
Pembrolizumab is positively recommended for triple-negative early breast cancer, according to NICE final draft guidance.
According to a new report, biologics are forecast to have $120 billion greater sales than small molecules by 2027.
Most therapeutic approaches in immuno-oncology focus on targeting the adaptive immune system; innate immunity has only recently gathered momentum. One of the most potent receptors for activating innate immune cells such as natural killer cells and macrophages is CD16A. Addressing this target mimics the body’s natural defense against potential threats,…
The March meeting saw the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommend five medications for approval including a multiple myeloma gene therapy.
Dr Roy Baynes, Merck’s head of Global Clinical Development (GCD) and Chief Medical Officer, will retire in July.
The data adds to the body of evidence relating to the use of Keytruda® as a monotherapy in second-line HCC post sorafenib.