News
After years of suffering from a bear market and more than 14 months of geopolitical turmoil shaking the macroenvironment, biotech appears to be moving on.
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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.
The FDA’s decision last year to make complete response letters public provides new insight into why therapies sometimes fail to get the regulatory greenlight. Analysts say the information could help sponsors refine their regulatory strategies.
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.
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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.
THE LATEST
In a Phase II study, Jazz Pharmaceuticals’ investigational fatty acid amide hydrolase inhibitor JZP150 did not significantly improve post-traumatic stress disorder symptoms compared to placebo.
Wainua, which is jointly developed and commercialized by AstraZeneca and Ionis Pharmaceuticals, was given the FDA’s green light on Thursday and will now compete with Alnylam’s two approved hATTR-PN therapies.
Microgravity offers unique advantages when investigating cells and proteins, but collaboration and a strong ethical framework are needed to fully realize its benefits.
The company is ending its program evaluating antibody-drug conjugate tusamitamab ravtansine after a non-small cell lung cancer trial did not meet a primary endpoint.
Clene disclosed Thursday the FDA has determined that biomarker Neurofilament Light Chain reduction in its Phase II programs “were insufficient to support accelerated approval at this time.”
The regulator’s Complete Response Letter on Wednesday said Merck’s data package for gefapixant “did not meet substantial evidence of effectiveness.” The FDA also rejected the drug in 2022 due to a lack of efficacy evidence.
The oral formulation of budesonide, marketed as Tarpeyo, is the only FDA-approved therapy that significantly reduces the loss of kidney function in immunoglobulin A nephropathy patients.
The biotech’s investigational COMP360 psilocybin treatment showed positive safety and tolerability with no serious adverse events in a mid-stage study of people with post-traumatic stress disorder.
A study finds that employees are more likely to view pay for performance positively—and rise to the challenge of performing well—when they view their managers as friendly and good at their jobs.
Now designated as a Tech Hub by the White House, Alabama’s nonprofit Southern Research is winnowing its focus and investing in healthcare solutions.