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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.
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Biopharmaceuticals
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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.
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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.
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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.
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Heart failure: clinical trials update 2022
EPR rounds up results from several key clinical trials on therapies for hypertension and heart failure presented at the American Heart Association’s Scientific Sessions 2022.
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Putting complex medicines under the microscope
The biological characterisation of complex medicines like nucleic acid therapeutics and antibody-drug conjugates is important to understand their biodistribution and cellular delivery. Here, Isabel Peset, Lorna FitzPatrick and Martin Main from Medicines Discovery Catapult discuss the potential for using advanced light microscopy techniques.
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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.
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Building an integrated vector supply to support autologous cell therapy for solid tumours
Facing limited viral vector manufacturing capacity, should companies consider further integrating their viral vector supply to address this issue? James Nanista and Josh Hunt of Adaptimmune reflect on the options.
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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.
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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.
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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.
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US legislative update: takeaways for European pharma
Keith A Zullow and Jenny J Zhang from Goodwin Procter examine upcoming US pharmaceutical regulation and how, if passed, it could impact European pharma/biopharma looking to access the US market.
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NICE recommends pembrolizumab for breast cancer
Pembrolizumab is positively recommended for triple-negative early breast cancer, according to NICE final draft guidance.
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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.
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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.
