All Pharmacovigilance and safety oversight articles – Page 7
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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The new draft guidance for personalised cancer therapies addresses the questions that this new regulatory pathway creates, according to the MHRA’s Chief Executive.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.
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NewsFDA approves innovative monotherapy for treatment-resistant depression
J&J’s standalone small molecule drug was approved based on evidence of improvement of depressive symptoms without the need for patients to take a daily oral antidepressant.
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NewsEarly-phase ATMP clinical trials see promising growth
Cell and Gene Therapy Catapult's (CGT Catapult) findings attest to the UK remaining “a highly attractive destination for clinical trials”.
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NewsNew guidance to aid cost-effectiveness analysis of new drugs
The report aims to support development of economic models for health technology assessment (HTA) decision making, as there has been “little change in guidance on the use of surrogate endpoints in HTA since 2018”.
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NewsLilly IBD biologic receives expanded US approval
The drug is the first biologic in over 15 years to have disclosed two-year Phase III efficacy data in Crohn's disease at the time of approval.
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NewsLong-term potential revealed for novel modifier gene therapy
The positive two-year findings from the Phase I/II gene therapy trial in retinitis pigmentosa reiterate the potential of mutation-agnostic therapies.
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NewsAstraZeneca’s PARP inhibitor newly recommended by NICE
The regulatory recommendation provides a targeted therapy option for eligible patients with the most common cancer in the UK.