All articles by Catherine Eckford – Page 68
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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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NewsNovel two-chamber setup could predict HPAPI dustiness
A two-chamber setup (TCS) for containment investigations could predict the dustiness of HPAPIs in a sealed system at different flow conditions.
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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.
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NewsMSD and Nectin to collaborate on clinical trial for KEYTRUDA® combination
MSD/Merck and Nectin Therapeutics have agreed to collaborate on a clinical trial for KEYTRUDA® in combination with monoclonal antibody NTX1088.
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NewsBMS in-licensed PKC theta inhibitor enters clinical trials
A potentially first-in-class PKC theta inhibitor, in development for immunology and inflammation indications, has entered first-in-human trials in the US.
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NewsFirst-in-class therapy shows potential for chronic fibrosis
A novel, first-in-class oral therapy showed meaningful improvement in over half of scleroderma patients in a Phase II trial for serious inflammatory and fibrotic diseases.
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NewsPembrolizumab plus chemo improves endometrial cancer survival
An interim analysis of a Phase III trial showed pembrolizumab plus chemotherapy significantly improved survival in endometrial cancer.
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NewsABPI warns against revenue clawback rate rises
The Association of the British Pharmaceutical Industry (ABPI) has urged immediate government action is needed against the planned UK statutory revenue clawback rate rise for branded medicines.
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NewsFrance gets new sterile liquid drug manufacturing facility
A new manufacturing facility for sterile injectable drugs has opened in France, housing lines for products such as antibody drug conjugates.
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NewsMHRA approves first oral advanced therapy for Crohn’s disease
The MHRA has approved the first marketing authorisation globally for the use of RINVOQ®▼ (upadacitinib) in Crohn's disease.
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NewsFirst biosimilar to HUMIRA® available in US
AMJEVITA™, the first biosimilar to Humira® is now available in the US, based on four years of real-world experience in over 300,000 patients.
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NewsPharmapack Europe Awards 2023 winners announced
Awards for innovative drug delivery solutions, reusable connected devices and recyclable packaging have been announced at Pharmapack Europe 2023.
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NewsClinical Trials Information System mandatory in EU
Use of the Clinical Trials Information System is now mandatory for new clinical trial applications in the EU, says the European Medicines Agency.
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NewsPharmaceutical sterility testing market to grow from $2.07b in 2027
Research suggests that the global sterility testing market will see a nearly $200 billion increase in spending on new products in the next five years.
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NewsFirst medicine approved in EU for eosinophilic esophagitis
Dupixent® has been approved by European Commission as the first and only targeted medicine indicated for eosinophilic esophagitis.
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NewsThree-year patent strategy for greater medicine access announced
The Medicines Patent Pool's 2023-2025 strategy plans to expand medicine access by improving the availability of innovative medicines in low- and middle-income countries.
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NewsCitrate-free HCF of adalimumab biosimilar gets positive opinion
A positive opinion has been adopted by the CHMP for a citrate-free high concentration formulation of its biosimilar Hyrimoz® (adalimumab).