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.
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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).
Moderna to supply US with initial 100 million doses of COVID-19 vaccine
Moderna will supply the US with at least 100 million doses of mRNA-1273, its COVID-19 vaccine candidate currently in Phase III clinical trials.
Researchers find three drugs on market that induce side effects in C. elegans
A study has found that three prescription drugs on the market cause unexpected side effects in the C. elegans worm, meaning they could have unknown effects in humans.
AstraZeneca to supply Europe with up to 400 million doses of COVID-19 vaccine
An agreement between AstraZeneca and the European Commission means the company will supply up to 400 million doses of its AZD1222 COVID-19 vaccine.
