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CHMP meeting highlights – February 2025
The Committee for Medicinal Products for Human Use (CHMP) recommended approval of four new medicines plus the extension of therapeutic indications for 16 medicines.
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Keytruda (pembrolizumab)
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From biologics to small molecules – the shift in biopharma’s revenue growth
Biopharma companies that experienced strong revenue growth due to COVID-19 drug sales have been overtaken by companies that developed obesity drugs in 2023, GlobalData suggests.
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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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Novel immunotherapy combination approved for endometrial cancer
The new approval of KEYTRUDA (pembrolizumab) combined with chemotherapy is indicated for certain patients with the most common gynaecologic cancer, according to Merck/MSD.
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MSD collaboration to drive development of solid tumour combination therapy
The EGFR immune engager in combination with pembrolizumab is expected to be administered to the first patients in late 2024.
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Positive results for mRNA vaccine in melanoma patients
A personalised mRNA cancer vaccine in combination with MSD’s Keytruda cut the risk of cancer recurrence by almost half in melanoma patients.
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Intratumoural viral delivery improves glioblastoma survival
“Injecting a virus into a patient’s brain tumour” combined with immunotherapy improved glioblastoma survival outcomes in a clinical trial.
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First immunotherapy recommended for advanced cervical cancer
Final draft guidance published by the National Institute for Health and Care Excellence (NICE) has recommended immunotherapy pembrolizumab drug for advanced cervical cancer.
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MSD and Nectin to collaborate on clinical trial for KEYTRUDA® combination
MSD/Merck and Nectin Therapeutics have agreed to collaborate on a clinical trial for KEYTRUDA® in combination with monoclonal antibody NTX1088.
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mRNA vaccine plus KEYTRUDA® improve melanoma survival
An mRNA vaccine plus KEYTRUDA® significantly improved recurrence-free survival in a Phase II trial for advanced melanoma patients.
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France’s ATU reform: early access remains possible, but not all diseases are equal
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.
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NICE recommends pembrolizumab for breast cancer
Pembrolizumab is positively recommended for triple-negative early breast cancer, according to NICE final draft guidance.
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Rise of biologics set to continue, says report
According to a new report, biologics are forecast to have $120 billion greater sales than small molecules by 2027.
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Engaging the innate immune system to fight cancer effectively
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,…
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EMA human medicines committee (CHMP) meeting highlights, March 2022
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.
