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New guidelines from two leading medical associations suggest that efforts to reduce bad cholesterol should focus on maintaining low levels of two key lipoproteins. Big pharma is all in, looking to improve on the standard statins to help vanquish America’s number one killer: heart disease.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
In Salt Lake City, biotech founders new and seasoned reflect on ways to ride out the industry’s challenges, such as sending cold emails to investors and learning to address leadership weaknesses.
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More than a month after failing its Friedrich’s ataxia trial, PTC Therapeutics’ vatiquinone has again missed its primary endpoint, this time in a mitochondrial disease-associated seizures study.
In its third acquisition this month, Eli Lilly is buying antibody-drug conjugates startup Emergence Therapeutics to bolster its cancer business.
After an initial rejection, BioMarin has finally secured the FDA’s approval for Roctavian, the first gene therapy in the U.S. for the most common form of the bleeding disorder.
The company Thursday reported positive topline results for a Phase III trial of its Alzheimer’s-related agitation treatment, while also disclosing improprieties by a principal investigator.
The initiatives coincide with an increase in the volume of data submitted to CDER and CBER—particularly in cell and gene therapy.
Eli Lilly announced Thursday it will acquire former collaborative partner Sigilon Therapeutics to deepen its diabetic foothold with a potentially functional cure for Type 1.
Of the 30 patients given CellTrans’ Lantidra in two studies, 21 were insulin-free for at least a year and 10 were insulin-free for more than five years.
Phase I/II data on AbbVie and Genmab’s recently approved bi-specific antibody in a second cancer indication positions them to talk to regulators about filings to challenge Roche’s Lunsumio.
The company halted studies of the treatment for a rare, advanced form of eye cancer after clinical results showed just one response in 47 patients.
The funds will support a trial of a tuberculosis vaccine developed by GSK that could potentially be the first new TB shot in a century.