FDA's biologics chief stresses need for vaccine transmission data
Incorporating disease transmission data into vaccine trial designs could add to their benefit-risk calculus, even though it will likely make vaccines more costly to develop, Peter Marks, chief of the...
View ArticleAbbVie files suit against Genmab subsidiary ProfoundBio
AbbVie has accused a Genmab subsidiary of stealing trade secrets to build a potential competitor to its ovarian cancer treatment Elahere. In a lawsuit filed on Friday in Washington federal court,...
View ArticleTrump pharma tariffs: Details on impact and timing
President Donald Trump reiterated his plans to “at some point" put tariffs on pharmaceutical goods made outside the US, taking another step toward a trade policy that the industry has been trying to...
View ArticleTrump taps acting CDC chief Susan Monarez for permanent role
President Donald Trump has nominated acting CDC director Susan Monarez to lead the agency. He posted his decision Monday on Truth Social, saying that Monarez “understands the importance of protecting...
View ArticleMerck and Hengrui strike $2B deal for Lipoprotein(a) drug
Merck has struck a licensing deal for a cardiovascular drug with Jiangsu Hengrui Pharmaceuticals, the latest in a flood of China deals being made by US and European multinationals. Under the deal,...
View ArticleHillstar Bio raises $67M for immunology drugs
The flurry of immunology biotech launches continues. Boston-based Hillstar Bio on Tuesday became the latest immunology startup launch, unveiling a $67 million Series A round funded by Droia Ventures,...
View ArticleGSK to research whether shingles vaccine can cut dementia risk
GSK is teaming up with a pair of UK-based research bodies to conduct a “real world evidence analysis” to see if its shingles vaccine Shingrix can cut the risk of developing dementia. Together with the ...
View ArticleOphthalmology startup Character Biosciences gets $93M for genetics-based...
Seven years into its existence, Character Biosciences is ready to enter the clinic with a pair of experimental medicines targeting a bustling area of ophthalmology. The New Jersey biotech aims to treat...
View ArticleCassava ends work on Alzheimer's drug; Alumis gets $40M upfront from Kaken
Plus, news about Relmada Therapeutics and Mural Oncology: Cassava Sciences finally stops work on Alzheimer’s drug: After a Phase 3 study of simufilam failed in November, Cassava said it was...
View ArticleKezar toplines small Phase 2a dataset in autoimmune liver disease
Kezar reported new data Tuesday morning from a small Phase 2a study in autoimmune hepatitis, or AIH, a condition where the immune system attacks the liver. The company tested its drug zetomipzomib in a...
View ArticleWuXi Biologics’ licensing deals help offset Biosecure threat in the US
WuXi Biologics attributed a 32.5% increase in North American revenue last year to out-licensing deals with global drugmakers despite the "dynamic political environment” in the US. That’s compared to...
View ArticleExclusive: Anti-aging mRNA therapy biotech acquires Harvard startup’s...
Turn Biotechnologies, a startup developing mRNA therapies to wind back the clock on aging cells has acquired an experimental drug delivery technology from Harvard University and Vesigen Therapeutics,...
View ArticleGSK scores FDA approval for new UTI antibiotic
GSK won approval on Tuesday for a new type of oral antibiotic to treat uncomplicated urinary tract infections. The drug, called Blujepa or gepotidacin, will be available to women and children over the...
View ArticleAxsome reports Phase 3 win for Sunosi in adults with ADHD
Axsome Therapeutics said the lower dose of its sleep disorder drug Sunosi met the primary endpoint in a late-stage test of adults with ADHD. But Wall Street analysts noted that less impressive results...
View ArticleCalculating healthcare's real costs
As you probably know by now, my ears perk up when I hear of a new way to vet the claims health tech companies make. So when Lantern released a
View ArticleIllumina adds activist investor to board, taps ex-FDA head as chair
Illumina on Tuesday added activist investor Keith Meister to its board and named director Scott Gottlieb, a former FDA commissioner, as board chair. The DNA sequencing company's stock has fallen about...
View ArticleDOGE reverses three FDA lease closures on its 'Wall of Receipts'
Elon Musk's Department of Government Efficiency has reversed its termination of three of 30 FDA site leases over the past month, including a 52,000 square-foot St. Louis-based lab that operates under...
View ArticleRevvity wins $37.8M contract to screen UK newborns for rare diseases
Diagnostics company Revvity will sequence the DNA of newborns to help identify rare genetic conditions as part of Genomic England's efforts to bolster early disease detection. Last year, Genomics...
View ArticleSenate committee backs Dr. Oz for CMS nomination
Mehmet Oz’s nomination to lead CMS will advance to the full Senate after clearing the Finance Committee on Tuesday. The committee voted 14 to 13 in Oz’s favor. Oz faced a roughly three-hour
View ArticleEisai cuts Leqembi 2027 sales projections by half
Eisai has slashed 2027 sales projections for its Biogen-partnered Alzheimer’s treatment Leqembi by roughly half. The Japanese drugmaker said it expects annual Leqembi sales to reach $1.7 billion to...
View Article