First-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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Novartis nets potential first-in-class medicine in new cardiovascular acquisition
The potentially multi-billion-dollar deal strengths Novartis’ late-stage pipeline for cardiovascular therapies, signalling advancement of novel treatments for heart disease.
Adaflex: 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.
AstraZeneca cancels £450m Liverpool vaccine facility expansion
Under growing global competition, this development highlights potential challenges for the UK to uphold large-scale pharmaceutical investments.
Biologic 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.
Novel 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.
Draft 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The new draft guidance for personalised cancer therapies addresses the questions that this new regulatory pathway creates, according to the MHRA’s Chief Executive.
Moderna reports record for UK clinical trials in 2023/24
The announcement follows the completed construction of Moderna’s MITC and progress in its long-term partnership with the UK government.
MHRA 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.
FDA sends warning letter to KVK-Tech manufacturing facility
A warning letter has been sent by the US FDA to KVK-Tech regarding cGMP violations at their drug manufacturing site, including for data integrity.
CHMP meeting highlights – January 2025
In its January meeting, the EMA’s human medicines committee recommended eight new medicines, including biosimilars and a new vaccine.
NICE 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.
UK 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.
Takeda plans 2026 CEO succession
The biopharmaceutical company’s executive transition follows a multi-year succession process to support its next chapter.
Enhancing spectroscopy analysis with machine learning
The spectroscopy-based study highlights the importance of integrating data-driven approaches to enhance isomer discrimination.
