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EACS 2023: Gilead shares real-world evidence for Biktarvy®
Efficiency of Gilead Science’s long-term HIV treatment option with a high barrier to resistance has been further demonstrated in real-world data based on three-year study follow up.
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Therapeutics
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Targeting tumours with novel radiopharmaceuticals
In this exclusive Q&A, Dr Jack Hoppin, CEO, and Dr John Babich, Chief Scientific Officer of Ratio Therapeutics share their perspective on the evolving radiopharmaceutical landscape and why radiopharmaceutical therapeutics have significant potential in oncology.
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Regulatory-first for gene editing therapy
The world’s first investigational in vivo CRISPR-based gene editing therapy cleared for late-stage clinical development is expected to enter Phase III in late 2023.
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Sweden gets new pharmaceutical aseptic filling line
Sever Pharma Solutions’ new aseptic filling line designed for high potent injectable drugs, features the latest automated systems.
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First-in-class phosphate absorption inhibitor approved by FDA
A first-in-class treatment with a differentiated mechanism of action has been approved to reduce serum phosphorus in chronic kidney disease (CKD) in individuals for which phosphate binders are not suitable.
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Sanofi treatment could slow type 1 diabetes progression
New Sanofi Phase III trial data adds to evidence of the treatment potential for the first disease modifying therapy in type 1 diabetes.
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NICE recommends Roche biologic for lymphoma
Glofitamab is the first treatment to be recommended by the National Institute for Health and Care Excellence (NICE) at the same time as it is approved for advanced lymphoma in the UK.
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FDA issues draft guidance on alternative tools for facility assessments
As part of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA) reauthorisation negotiations, the US Food and Drug Administration (FDA) has issued new draft guidance on alternative tools for assessing drug manufacturing facilities.
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Novo Nordisk agrees $1.3bn hypertension acquisition
Novo Nordisk has set its sights on acquiring a medicine with best-in-class potential for hypertension from KBP Biosciences.
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Lonza to enhance commercial antibody-drug conjugate supply capacity
A new cGMP filling line is set to be built at Lonza’s Stein site in Switzerland, expanding filling capacity and enabling the handling and filling of bioconjugates for commercial supply.
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Follicular lymphoma BTK inhibitor recommended by CHMP
Following the CHMP’s recommendation of a follicular lymphoma combination treatment, if approved, BRUKINSA will be the first BTK inhibitor to be authorised for follicular lymphoma.
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Study reports rapid method for microbial contaminant detection
Research using fluorescent optical respirometry (FOR) illustrated successful detection of aerobic bacteria three hours after setting samples.
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Research predicts 2029 small molecule oncology market leaders
With over $7 billion sales predicted by 2029, AstraZeneca’s Tagrisso is set to lead the lung cancer small molecule treatment market, according to GlobalData.
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Key developments in pharmaceutical manufacturing – September 2023
This article outlines the recent progress of several major new manufacturing facilities that will be central in supporting the production of innovative therapies in Europe.
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MHRA regulation overhaul: new scheme for lowest-risk UK clinical trials
The Medicines and Healthcare products Regulatory Agency (MHRA) states its new scheme enables a more streamlined approach to processing Clinical Trial Authorisations (CTAs) for initial applications in late-stage clinical trials.
