Phase III
The FDA granted Merck’s investigational 21-valent pneumococcal conjugate vaccine (V116) for IPD and pneumococcal pneumonia Breakthrough Therapy Designation.
AbbVie and Genmab announced positive topline results from their Phase I/II trial for lymphoma treatment; Sanofi posted positive results from its Phase I/II trial for the treatment of ITP.
Drug pricing watchdog ICER issued a draft report on bluebird bio’s gene therapy betibeglogene autotemcel for beta-thalassemia. The report touted the therapy’s cost-effectiveness.
Pfizer and BioNTech will submit updated data to the FDA to support the Emergency Use Authorization (EUA) of COVID-19 vaccination boosters in children between the age of 5 and 11.
Protagonist disclosed the FDA issued a letter of intent to rescind the status for rusfertide based on concerns first raised in a clinical hold placed on the drug.
ProQR Therapeutics, which is developing RNA therapies for genetic eye diseases, announced Wednesday that it will be restructuring and laying off 30% of its staff.
As the world speculates the potential impact of the novel COVID-19 variant omicron XE and subvariant BA.2, research continues to shed light on the impact and future of the pandemic.
Vertex has made a point over the past decade to make research and development a priority, investing over 70% of its expenses back into it.
Myovant said that the FDA provided notice it had found deficiencies that will preclude any potential discussion of labeling or post-marketing requirements at this time.
Hundreds of presentations on oncology research are highlighted at the AACR Annual Meeting, which is running from April 7 to 13 in New Orleans.
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