Artificial pancreas for type 1 diabetes control given nod by FDA
The all-in-one, Control-IQ system controlled the blood glucose levels of children aged six and over more successfully than standard technologies in a clinical trials.
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First patients dosed in GSK’s Phase III meningitis vaccine trial
The trial will assess the safety, tolerability and immunogenicity of the five-in-one MenABCWY vaccine in participants aged 10 to 25.
Vertex’s Kaftrio approved for use in Europe and made accessible on the NHS
The European Commission and European Medicines Agency have approved the triple combination Kaftrio for use in certain cystic fibrosis patients, triggering the drug to be accessible on the UK’s National Health Service.
AstraZeneca doses first patients in COVID-19 therapy trial
The Phase I trial will assess the safety and pharmacokinetics of the AZD7442 monoclonal antibody combination in 48 healthy participants.
AGGRASTAT® shows promise for treating COVID-19 thrombotic complications
According to Medicure, AGGRASTAT (tirofiban hydrochloride) has shown promise for preventing and treating thrombotic complications due to COVID-19.
FDA issues emergency use authorisation for COVID-19 convalescent plasma
The emergency use authorisation (EUA) allows the distribution and administration of COVID-19 convalescent plasma to hospitalised patients in the US.
Collaboration to develop the world’s first prophylactic gonorrhoea vaccine
Therapyx and Intravacc will jointly develop NGoXIM, a microsphere vaccine which is designed to stimulate adaptive immunity against gonorrhoea.
First patients enrolled in Phase II trial of Novavax COVID-19 vaccine
The Phase II clinical trial to study NVX-CoV2373, the Novavax COVID-19 vaccine candidate, has enrolled its first patient.
India gives nod to cell therapy for Critical Limb Ischemia (CLI)
Stempeucel®, a cell therapy for the treatment of Critical Limb Ischemia (CLI), has been approved for commercial use in India by the Drug Controller General.
FDA approves Kesimpta® (ofatumumab) for patients with relapsing multiple sclerosis
Kesimpta was approved based on trial results showing the monthly injection significantly reduced the relapse rate and disability progression of MS patients compared to a currently approved treatment.
Intraoperative radiotherapy as effective as external beam radiotherapy, finds study
Researchers reveal that for early breast cancer a single dose of targeted intraoperative radiotherapy (TARGIT-IORT) is as effective at preventing breast cancer recurrence as the standard of care.
FDA releases guidance on bioavailability and bioequivalence study samples
The FDA has released guidance on its compliance policy on reserve samples used in bioavailability and bioequivalence studies.
Sanofi to acquire Principa Biopharma for $3.68 billion
Sanofi is set to acquire Principia Biopharma Inc. for a total aggregate equity value of $3.68 billion, at $100 per share.
Tradipitant may accelerate recovery from COVID-19 pneumonia, finds interim analysis
A preliminary analysis of data from the first COVID-19 pneumonia patients enrolled in the ODYSSEY trial revealed that tradipitant may expedite clinical improvement.
EMA accepts marketing application for Spinal Muscular Atrophy treatment
The European Medicines Agency (EMA) has accepted the marketing authorisation application for Evrysdi™ (risdiplam) as a treatment of spinal muscular atrophy (SMA).
