Welcome to the latest edition of the Life Sciences Voice Top Five Newsletter, your source for the latest developments in the world of life sciences industry! This week we take a look at Gilead’s acquisition of CymaBay for a whopping $4B, Gritstone Bio securing federal funding of $433M for covid vaccine testing, the FDA approving the first oral suspension for eosinophilic esophagitis (EoE) by Takeda, and other top news!
Gilead Sciences Acquires CymaBay for $4.3 Billion
Gilead Sciences’ strategic acquisition of CymaBay Therapeutics for $4.3 billion aims to expand its liver disease treatment portfolio beyond HIV drugs. The purchase includes CymaBay’s experimental drug, seladelpar, anticipated to generate $1.9 billion in sales by 2029 if approved. Despite recent setbacks in clinical trials, this move underscores Gilead’s commitment to diversification and long-term growth.
Gritstone Bio Secures $433 Million for COVID Vaccine Testing
Gritstone Bio receives significant federal funding for its COVID-19 vaccine, CORAL, despite a delay in phase 2b trials due to manufacturing issues. The delay, seen as potentially beneficial, aims to enhance trial quality. Utilizing self-amplifying technology, CORAL seeks to overcome limitations of mRNA vaccines, with plans to compare efficacy against existing COVID-19 vaccines.
Johnson & Johnson’s Nipocalimab Shows Promise for Autoimmune Diseases
Johnson & Johnson’s phase 3 trial success with nipocalimab for generalized myasthenia gravis (gMG) opens discussions for regulatory approval. Despite competition, J&J aims to differentiate through efficacy and safety, targeting an 80% reduction in immunoglobulin G (IgG). Additionally, positive results in treating Sjögren’s disease underscore nipocalimab’s potential in autoimmune therapy.
FDA Approves Takeda’s Eohilia for Eosinophilic Esophagitis
Takeda’s Eohilia, an oral suspension of budesonide, gains FDA approval for treating eosinophilic esophagitis (EoE), becoming the first oral medication sanctioned for this condition. Despite initial setbacks and rejection in late 2021, Takeda resubmitted Eohilia, emphasizing strong efficacy data and unmet patient needs. The approval reflects Takeda’s collaborative efforts with EoE communities, marking a significant milestone amidst recent business challenges.
CSL Behring’s CSL112 Fails to Meet Heart Attack Prevention Targets
CSL Behring’s extensive clinical trial, AEGIS-II, evaluating CSL112’s efficacy in preventing heart attack recurrence, falls short of expectations. Despite substantial investment and optimism, CSL112 did not significantly reduce major adverse cardiovascular events compared to a placebo within the critical 90-day window. While CSL112 shows no safety concerns, further analysis is needed to determine its future trajectory, acknowledging the setback in reshaping cardiovascular treatment.
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