Allergies Drugs Immune Response Licensing 
The Pharma Data
OCTOBER 26, 2020
The National Institute of Allergy and Infectious Diseases (NIAID), the study sponsor, could not verify the safety issue, but their analysis also indicated there was little likelihood the antibody would help the hospitalized patients. The approval marks the first drug approved by the U.S. The drug is an orally active caspase inhibitor.
The Pharma Data
JANUARY 17, 2021
Food and Drug Administration (FDA) are starting to pick up. The drug is being developed for several indications, but the NDA is for lupus nephritis (LN), a serious inflammation of the kidneys the result of systemic lupus erythematosus (SLE). Sarah Silbiger/Getty Images. After a start-of-the-year lull, activities at the U.S.
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Delveinsight
JANUARY 21, 2021
Drugs that target the cancer-promoting proteins MDM2 and BET have been attempted in acute myeloid leukaemia (AML) and have not been all that effective on their own. The new research provides a scientific rationale to advance clinical studies of the drug combination in patients with AML. billion in total for three drugs.
Drug Discovery World
FEBRUARY 3, 2023
A research group from the National Institutes of Health has successfully developed a vaccine against Sudan virus (SUDV) based on the licensed Ebola virus (EBOV) vaccine. SUDV, identified in 1976, is one of the four viruses known to cause human Ebolavirus disease.
Pfizer
JULY 26, 2022
(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level. Emergency Use Authorization . has a fever.
The Pharma Data
JULY 8, 2021
Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. 1) The Prescription Drug User Fee Act goal date for a decision by the FDA is during the first quarter of 2022. US Food and Drug Administration. Priority Review.
Pfizer
JULY 19, 2022
The companies’ previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial that found a 30 µg booster dose of the Omicron-adapted bivalent vaccine candidate elicited a superior immune response against Omicron BA.1 is immunocompromised or are on a medicine that affects the immune system. has a fever.
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