Could 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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Novel 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.
CD19 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.
FDA 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).
Forxiga 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.
MSD 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.
BMS 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.
First-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.
Pembrolizumab plus chemo improves endometrial cancer survival
An interim analysis of a Phase III trial showed pembrolizumab plus chemotherapy significantly improved survival in endometrial cancer.
ABPI 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.
France 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.
MHRA 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.
First 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.
Pharmapack Europe Awards 2023 winners announced
Awards for innovative drug delivery solutions, reusable connected devices and recyclable packaging have been announced at Pharmapack Europe 2023.
Clinical 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.
