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The Committee for Medicinal Products for Human Use (CHMP)’s November meeting consisted of approval recommendations for four medicines, including a biosimilar for osteoporosis and a new COVID-19 vaccine.
The EC has authorised the first UL97 protein kinase inhibitor for adults with post-transplant refractory cytomegalovirus infection.
Paper highlights trends in developing analytical procedures to assess the quality of prostaglandin analogues used to treat glaucoma.
Minoryx Therapeutics and the Neuraxpharm Group enter into a license agreement for the European rights to leriglitazone, which is currently under EMA review for the orphan indication X-linked Adrenoleukodystrophy (X-ALD).
Bepirovirsen, an antisense oligonucleotide therapy aided in long-term prevention of chronic hepatitis B in patients on and not on nucleoside/nucleotide analogues in a Phase II trial.
If successful in further clinical trials an innovative, cost-effective COVID-19 vaccine patch could be available as early as 2025.
A new project funded by Swedish innovation agency Vinnova, will help develop an AI-based quality control method for ATMP manufacturing.
Hypertension drug-resistance could no longer be a problem for patients, according to a study on Baxdrostat, shown to lower blood pressure.
Pembrolizumab is positively recommended for triple-negative early breast cancer, according to NICE final draft guidance.
Sandoz will invest €50 million in new Austrian finished dosage form manufacturing site, to support the global demand for penicillin products.
GBF announces the manufacturing of the recombinant protein - Alzheimer’s disease vaccine, AV-1980R, for use in clinical trials.
A major trial evaluating Boehringer Ingelheim’s Jardiance®, showed it reduced the risk of cardiovascular death and chronic kidney disease progression by 28 percent.
The second-ever patient has been transfused with lab-grown red blood cells in a clinical trial, promising an effective treatment for patients.
Alternative CAR-T and cell therapies increased relapsed multiple myeloma patient survival by 18 months after failed CAR-T, a study found.
A bispecific antibody for multiple myeloma gets Breakthrough Therapy Designation based on 61 percent overall response trial data.
