All Pharmacovigilance and safety oversight articles – Page 7
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NewsDrug for rare form of Alzheimer’s “scientifically promising”
The anti-amyloid drug study highlights the importance of longer-term follow-up to determine benefits and risks of dementia treatments.
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NewsEuropean Commission approves Rytelo for LR- MDS-related anaemia
The European marketing authorisation offers a new treatment option for patients with transfusion-dependent anaemia in lower-risk myelodysplastic syndromes (LR-MDS), who are unresponsive to erythropoiesis-stimulating agents.
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NewsNICE recommends innovative endometriosis pill
Approximately 1,000 eligible NHS patients could benefit from the new endometriosis treatment annually.
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NewsInvestigational plaque psoriasis treatments show promise in late-stage trials
With the Phase III trials demonstrating sustained skin clearance in plaque psoriasis, this could lead to patients accessing more treatment options to manage the autoimmune inflammatory disease.
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NewsAlzheimer’s drug requires strengthened pharmacovigilance approach
Ongoing real-world safety and effectiveness monitoring of the Alzheimer’s drug lecanemab is needed to protect patients long-term, drug safety researchers urge.
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NewsCHMP 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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NewsGreener method for ethylene oxide manufacture identified
The cleaner method could significantly lower production costs and reduce carbon dioxide emissions resulting from ethylene oxide manufacturing.
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NewsNICE recommends novel immunotherapy for leukaemia
The agency’s decision means eligible adult patients in the UK are set to access the combination immunotherapy as a new treatment option for acute lymphoblastic leukaemia (ALL).
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NewsFirst-in-human data for gene therapy signals potential in childhood blindness
Developed and manufactured under a Manufacturer’s ‘Specials’ Licence (MSL), the gene therapy could provide a novel treatment option for paediatric patients at the earliest stage of the rare eye disease.
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NewsFirst-of-a-kind EU approval granted for oral small molecule
The authorisation provides a new disease modifying treatment option for European patients with the progressive condition.
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NewsAdaflex: first UK-licensed melatonin for children with insomnia and ADHD
The drug provides a regulated treatment option for families in the UK impacted by sleep disorders related to ADHD.
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NewsBiologic could reduce treatment burden for children with haemophilia A
New data suggests that once-weekly prophylaxis bispecific antibody treatment could provide an efficient and convenient option for young patients with haemophilia A.
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NewsNovel drug approved for diabetes-related vision loss
The monoclonal antibody treatment is now approved in the US for both diabetic macular oedema and wet, or neovascular age-related macular degeneration.
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NewsDraft regulatory guidance on personalised cancer therapies published
The new draft guidance for personalised cancer therapies addresses the questions that this new regulatory pathway creates, according to the MHRA’s Chief Executive.
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NewsMHRA approves SARCLISA for newly diagnosed multiple myeloma
SARCLISA (isaxtuximab) provides a new first-line treatment option for patients with multiple myeloma, offering significant improvements in progression-free survival.
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NewsCHMP meeting highlights – January 2025
In its January meeting, the EMA’s human medicines committee recommended eight new medicines, including biosimilars and a new vaccine.
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NewsNICE recommends gene therapy for severe sickle cell disease
The committee’s approval of the one-time gene therapy means the healthcare inequalities for patients with this genetic blood disorder can begin to be re-addressed.
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NewsUK enhances ILAP to accelerate access to innovative medicines
The MHRA’s refreshed guidance is the only end-to-end access pathway that enables medicine developers to collaborate with the national health system, Regulator, and HTA bodies.
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NewsNew analysis asserts survival benefit for Roche breast cancer therapy
The new data highlights the potential of the ItovebiTM (inavolisib)-based regimen as a new standard of care in advanced PIK3CA-mutated, HR-positive, HER2-negative breast cancer.
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NewsBiologic demonstrates “tremendous” potential advance in atrial fibrillation
The Phase II study validated an “incredibly safe bleeding profile” for Factor XI inhibitors as a treatment for the common cardiovascular condition.