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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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Neal and Azbee awards have validated our approach to reporting on the industry at a time of unprecedented shifts at the FDA and other federal agencies.
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Moderna’s mRNA-1010 was expected to contribute $1 billion to the company’s coffers by 2028. That plan is now out the window after the FDA refused to even look at the application.
Infigratinib topped “even the most optimistic expectations” for efficacy and safety in the late-stage PROPEL 3 study in achondroplasia, Truist Securities analysts said Thursday.
The sudden departure stands in contrast to other EU pharma leaders who have been given much longer transitions in recent months, including GSK’s Emma Walmsley and Novo Nordisk’s Lars Fruergaard Jørgensen.
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
In this episode of Denatured, Jennifer C. Smith-Parker speaks with Dr. Rob Monroe and Jennifer Fakish at Danaher Corporation. They discuss how antibody drug conjugates (ADCs) are transforming cancer care. With AI-powered pathology, doctors can now measure HER2 more precisely to match patients with the best treatments.
AbbVie contends that Botox should have been excluded from the IRA drug price negotiation program because it is a plasma-derived product.
The oral version of Wegovy has made GLP-1 medicines more accessible and acceptable to many patients who had steered clear of injectable versions, healthcare analytics firm Truveta suggests.
Biopharma professionals need to understand today’s job market and how they can stand out to position themselves for success. Three talent acquisition and recruiting experts discussed these topics in a BioSpace webinar, from the importance of contract work to the value of an advocate.
The rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two approved assets enough to maintain investor interest?
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.