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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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FDA
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.
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Carina Clingman answers questions about forging professional connections in-person and on LinkedIn.
Biologics have a major advantage over small molecule drugs under the Inflation Reduction Act’s provisions, according to stakeholders attending this week’s J.P. Morgan conference.
The German biotech is dropping $20 million upfront on two preclinical monoclonal antibodies for undisclosed targets developed by WuXi Biologics.
Analysts in life sciences play a crucial role in analyzing and interpreting data to support research, development and decision-making processes within the field.
Panelists at JPM’s Biotech Showcase gave positive projections as the year begins and offered advice to those in the space.
The BioSpace team is recording from San Francisco as they bring you the the latest highlights from Day 3 at JPM2024.
Triumvira Immunologics’ president and chief operating officer Rob Williamson noted that cell therapy companies might still have an uphill battle unless they can differentiate.
The Massachusetts–based startup will use the Series A funds to advance its pipeline of oral GPR17, CSF1R and TYK2 candidates.
Patients treated with AR-15512 showed higher rates of at least a 10-mm improvement in unanesthetized Schirmer’s score, a metric of tear production.