2022 WHO Biosimilar Guideline improves access, IGBA says
Under the revised 2022 WHO Biosimilars Guideline, IGBA says regulatory authorities can confidently revaluate biosimilar access requirements.
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Early efficacy of arthritis therapy predicts long-term benefits
Tremfya® trial analysis showing early skin and enthesitis response for active psoriatic arthritis could indicate long-term clinical response including disease remission.
EMA human medicines committee (CHMP) highlights, November 2022
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.
First oral treatment approved for post-transplant refractory cytomegalovirus
The EC has authorised the first UL97 protein kinase inhibitor for adults with post-transplant refractory cytomegalovirus infection.
QA of prostaglandin analogues for glaucoma treatment
Paper highlights trends in developing analytical procedures to assess the quality of prostaglandin analogues used to treat glaucoma.
Minoryx and Neuraxpharm team to provide new therapy for rare CNS disorders
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).
Oligonucleotide therapy helps to prevent chronic hepatitis B
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.
First needle-free COVID-19 vaccine patch
If successful in further clinical trials an innovative, cost-effective COVID-19 vaccine patch could be available as early as 2025.
Swedish innovation agency invests in new ATMP QC method
A new project funded by Swedish innovation agency Vinnova, will help develop an AI-based quality control method for ATMP manufacturing.
New medicine can overcome resistance to hypertension drugs
Hypertension drug-resistance could no longer be a problem for patients, according to a study on Baxdrostat, shown to lower blood pressure.
NICE recommends pembrolizumab for breast cancer
Pembrolizumab is positively recommended for triple-negative early breast cancer, according to NICE final draft guidance.
Sandoz to invest €50 million in antibiotic manufacturing facility
Sandoz will invest €50 million in new Austrian finished dosage form manufacturing site, to support the global demand for penicillin products.
Manufacturing of anti-tau Alzheimer’s disease vaccine for clinical trials
GBF announces the manufacturing of the recombinant protein - Alzheimer’s disease vaccine, AV-1980R, for use in clinical trials.
Empagliflozin reduces risk of chronic kidney disease progression
A major trial evaluating Boehringer Ingelheim’s Jardiance®, showed it reduced the risk of cardiovascular death and chronic kidney disease progression by 28 percent.
First patients given lab-grown blood cell transfusion
The second-ever patient has been transfused with lab-grown red blood cells in a clinical trial, promising an effective treatment for patients.
