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.
List view / Grid view
News
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The new draft guidance for personalised cancer therapies addresses the questions that this new regulatory pathway creates, according to the MHRA’s Chief Executive.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.
New 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.
UK biotech on “positive trajectory”, says BIA
Cutting-edge science and large international investment are driving growth in the UK’s biotech sector, the organisation’s new report reveals.
AstraZeneca Canadian investment to drive R&D growth
The US$570m investment will contribute to advancing AstraZeneca’s global clinical pipeline, a key goal of its strategy to 2030.
Biologic 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.
FDA 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.
