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FDA Commissioner Marty Makary intends to resign on Tuesday, according to several sources. This report follows a tumultuous 13-month tenure in which Makary oversaw the controversial rejections of several rare disease drugs and “predictable volatility” within the agency.
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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.
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BMO Capital Markets analyst Evan Seigerman in a note to investors called Gilead’s third-quarter performance “consistent” and “steady,” while noting the company continues to demonstrate “reliable strength” in its human immunodeficiency virus business.
Year-over-year BioSpace data shows there are fewer job postings live on the website and far more competition for them.
Novo Nordisk’s total revenue in the third quarter missed analysts’ expectations but sales of weight loss drug Wegovy exceeded the consensus forecast. Still, the Danish drugmaker narrowed its full-year guidance for revenue and operating profit.
Analyst reactions to Donald Trump’s election victory were mixed Wednesday, with potential positives including an FTC that is likely to be more friendly to M&A, and negatives including concerns about what role Robert F. Kennedy, Jr. might play in healthcare.
With climbing biotech M&A and IPO activity following the post-pandemic slump, experts offer insights on maximizing value and otherwise capitalizing on exit opportunities.
The contract manufacturer fell short of Wall Street’s projections for its first quarter of fiscal 2025, which ended Sept. 30, 2024. The miss comes amid growing opposition to Novo Holdings’ proposed $16.5 billion acquisition of Catalent.
Truist Securities analyst Asthika Goonewardene in an investor note said data for anito-cel—particularly its safety profile—will help differentiate the CAR T therapy from Legend Biotech and J&J’s entrenched Carvykti in relapsed and refractory multiple myeloma.
BMO Capital Markets analyst Etzer Darout in a note to investors said the insurance fraud probe represents a “headline risk” to AstraZeneca, but contends that the share selloff is “overdone” and likely a knee-jerk reaction by investors.
In our anniversary episode, we discuss a rare earnings miss for Eli Lilly, a pivotal metabolic dysfunction–associated steatohepatitis victory for Novo Nordisk’s Wegovy, growing excitement about CAR Ts for autoimmune disease and the ongoing controversy over HeLa cells.
At Johns Hopkins University, the biomedical engineering program’s Design Team offering lets undergraduates dive deep into clinical projects that can help them land industry jobs, get provisional patents or even start companies.