All Clinical Development articles – Page 34
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NewsPh. Eur. rabbit pyrogen test replacement texts ready for public consultation
The rabbit pyrogen test replacement texts in Pharmeuropa 35.1 by the European Pharmacopoeia have been published for public comment.
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NewsSimplified HIV treatment options effective in major trial
The world‘s first international trial into second-line HIV therapy has shown two simplified treatments are at least as effective as standard of care.
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ArticleAccelerating drug development
Here, Dave Elder explores how a ‘quick-approval, quick-withdrawal from the market’ approach is used to accelerate drug development.
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NewsAstraZeneca BTK inhibitor tablet approved in EU for leukaemia
The tablet formulation for AstraZeneca’s BTK inhibitor has gained EU approval for co-administration with gastric acid-reducing agents in chronic lymphocytic leukaemia patients.
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NewsFDA approves first treatment for geographic atrophy
The first-ever treatment for geographic atrophy has been approved by the US Food and Drug Administration (FDA).
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NewsEC approves first gene therapy for haemophilia B
The first gene therapy for haemophilia B has been given conditional marketing authorisation in Europe by the European Commission.
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ArticleMedicinal cannabis: the route to good manufacturing practice registration
Following on from the first GMP registration of a cannabis API for a UK pharmaceutical facility, EPR spoke with Celadon Pharmaceuticals about how it navigated the complex regulatory landscape.
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NewsEMA releases human medicines highlights 2022 report
Medicines which represented significant progress in their therapeutic areas have been listed in the European Medicines Agency's Human Medicines Highlights 2022 report.
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NewsEnzyme replacement therapy for alpha-mannosidosis gets FDA approval
The first and only enzyme replacement therapy approved for alpha-mannosidosis in the US has been cleared for adult and paediatric patients.
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NewsFusion to acquire radiologand therapy for prostate cancer
An investigational new drug application for an ongoing Phase II trial of an alpha-emitting radiopharmaceutical will be acquired by Fusion Pharmaceuticals.
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NewsNeoadjuvant nivolumab improves long-term survival for lung cancer
Analysis of a Phase II trial for non-small cell lung cancer has suggested neoadjuvant nivolumab improved five-year recurrence-free survival compared with historical outcomes.
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ArticleKey developments: mRNA vaccines and therapeutics
EPR summarises results from key mRNA vaccine trials, highlighting the future potential of these innovative therapeutics.
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NewsCAR T-cell therapy offers substantial remission rates in trial
In a Phase III study, a CAR T-cell therapy more than tripled progression-free survival compared with standard care for triple-class exposed multiple myeloma.
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NewsPfizer and BioNTech mRNA shingles vaccine study begins
A Phase I/II trial for the first mRNA-based shingles vaccine programme has been initiated by Pfizer Inc. and BioNTech SE.
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NewsCGT Catapult to bolster new UK life sciences campus
The Cell and Gene Therapy Catapult (CGT Catapult) is set to be involved in the establishment of one of the largest life sciences campuses in Europe.
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NewsPierre Fabre to lead commercialisation of EBVALLO®
Following transfer of the European Commission marketing authorisation from Atara, Pierre Fabre will lead commercialisation of EBVALLO® in Europe.
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NewsCould oral difelikefalin be first FDA-approved drug for notalgia paresthetica?
A study by Icahn School of Medicine at Mount Sinai researchers showed oral difelikefalin could potentially relieve itching associated with notalgia paresthetica.
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NewsCD19 CAR-T agents to boost blood cancer market
GlobalData says CD19 CAR-T agents are expected to treat over 13,000 blood cancer patients annually by 2031, driving sales of Breyanzi and Yescarta.
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NewsFDA gives first RMAT designation to a cardiac gene therapy
A regenerative medicine advanced therapy (RMAT) designation has been given to a gene therapy for Danon disease by the US Food and Drug Administration (FDA).
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NewsForxiga approved in EU for chronic heart failure
Forxiga (dapagliflozin) has been approved in the EU for chronic heart failure across the full spectrum of left ventricular ejection fraction.