The Phase III trial will evaluate the safety and efficacy of Pfizer’s PF-06939926 gene therapy in 99 paediatric Duchenne muscular dystrophy patients across 15 countries.
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In a Phase II trial, a cannabidiol (CBD) sublingual tablet reduced pain scores in patients with diabetic peripheral neuropathy by approximately 50 percent.
The trial of DSP-0038, an Alzheimer’s disease psychosis drug designed using artificial intelligence, will assess its ability to improve the behavioural and psychological symptoms of dementia.
Organicell’s Zofin™ therapy has been approved by the Pakistani regulators to be used for a patient with severe COVID-19 on compassionate grounds.
In three Phase I/II trials an experimental gene therapy caused all but two patients with severe combined immunodeficiency to acquire and retain robust immune function for more than two years.
The Comirnaty® vaccine’s emergency use authorisation has been extended to allow its administration to those 12 years of age and above in the US.
The International Coalition of Medicines Regulatory Authorities (ICMRA) and WHO are calling on pharma to provide voluntary unrestricted access to trial results data.
The indication of Benlysta (belimumab) was extended after it significantly improved renal outcomes in those with active lupus nephritis.
In the trial, 57 percent of patients with moderate to severe psoriasis treated with 120mg of sonelokimab achieved total skin clearance in 24 weeks.
Tagrisso (osimertinib) was approved for an indication extension after it reduced risk of death by over 80 percent in certain early-stage non-small cell lung cancer patients.
Preliminary Phase II data shows a dose of mRNA-1273.351, Moderna’s strain-matched booster, is safe and may offer protection against the B.1.351 and P.1 variants of concern.
A three-dose regimen of Plasmodium falciparum sporozoites under chemoprophylaxis (PfSPZ-CVac) was shown to be safe, well tolerated and highly effective in a Phase II trial.
New data shows NVX-CoV2373 offered complete protection against severe COVID-19 and 60 percent efficacy against infection with the B.1.351 variant in healthy adults.
Xtandi™ (enzalutamide) was approved for metastatic hormone-sensitive prostate cancer after it reduced the risk of radiographic progression or death by 61 percent in a trial.