FDA grants COVID-19 treatment Fast Track designation
The designation should expedite the development and review of AB201, a recombinant protein therapy being tested in hospitalised COVID-19 patients.
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The designation should expedite the development and review of AB201, a recombinant protein therapy being tested in hospitalised COVID-19 patients.
Researchers have shown that recipients of the Bacillus Calmette-Guérin (BCG) vaccine are less likely to contract COVID-19 in a new study.
A single-use, self-administered microneedle vaccine has been developed to provide immunisation against infectious diseases.
PhRMA and other organisations have challenged action by the HHS and FDA that permits the importation of drugs from Canada without drug manufacturers’ oversight.
Zokinvy (lonafarnib) capsules have been approved for the treatment of Hutchinson-Gilford progeria syndrome and certain progeroid laminopathies in patients over one year old.
The Emergency Use Authorization (EUA) is based on a trial in which casirivimab and imdevimab reduced hospitalisations in mild to moderate COVID-19 patients.
Both the UK and US have said that, if approved, the Pfizer and BioNTech COVID-19 vaccine could be administered to people as early as December.
The companies suggest if the Emergency Use Authorization (EUA) is approved, high-risk patients in the US could begin receiving the BNT162b2 vaccine by the end of December 2020.
Ibezapolstat cured all 10 patients of their Clostridioides difficile infections and prevented recurrence for at least 30 days.
The FDA has issued an Emergency Use Authorization for baricitinib in combination with remdesivir to treat COVID-19 in hospitalised patients.
The analysis reveals that mRNA-1273 was generally well tolerated and prevented COVID-19 with an efficacy of 94.5 percent in a Phase III study.
G Balaji and Ravi Kalla explains how Pharma 4.0 can be implemented at a CRO to enable work to continue even during a global pandemic.
The neutralising antibody therapy bamlanivimab (LY-CoV555) is authorised for emergency use in recently diagnosed patients who are at risk of developing severe COVID-19.
The acquisition will strengthen Merck’s oncology pipeline with VLS-101, an investigational antibody-drug conjugate in trials for haematological malignancies and solid tumours.
The COVID-19 vaccine candidate BNT162b2, made by Pfizer and BioNTech, has demonstrated over 90 percent efficacy in its first interim analysis during its Phase III trial.