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Scientists who focus only on generating data risk missing their role in shaping strategy and driving innovation.
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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.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
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
The COVID-19 research collaboration between Vir Biotechnology and GSK has largely come to an end, as Vir announced Monday it would be going it alone or with other partners.
The FDA has rejected Soligenix’s NDA for HyBryte (synthetic hypericin), a therapeutic developed to treat early-stage cutaneous T-cell lymphoma.
The Pregnant Workers Fairness Act (PWFA) has been praised by many in the life sciences who see it as a step forward in protecting the rights of pregnant employees.
Fresh off of his Sanofi exit, John Reed is joining Johnson & Johnson, where he will serve as executive vice president, pharmaceuticals, R&D.
Vivek Ramaswamy, the founder of Roivant Sciences, is officially running for president, the GOP hopeful announced Tuesday.
Clene, Inc. posted new data from a Phase II trial of CNM-AU8 in multiple sclerosis featuring MRI results it claims reinforce neurological improvements reported in November 2022.
Bristol Myers Squibb and 2seventy bio published positive results Friday from a pivotal Phase III trial of Abecma in multiple myeloma patients who had received two to four prior lines of therapy.
Sanofi’s global head of R&D, John Reed, is leaving his position to pursue another opportunity outside the company, the French multinational announced Monday.
Due to safety concerns, Aristea Therapeutics announced Friday that it was discontinuing the development of its Phase II lead program. As a result, the San Diego-based biotech is also dissolving its business.
Feb. 11 is the International Day of Women and Girls in Science. BioSpace spoke with influential women in biotech and biopharma who are working to make a difference in the lives of other women.