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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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The life sciences industry saw modest salary growth compared to recent years and gaps persisted for women and racial and ethnic minorities.
To hone in on its growth areas, Novartis is looking to trim its ophthalmology portfolio and sell off some of its assets, according to a Bloomberg report published Tuesday.
Cambrian BioPharma announced the launch of Amplifier Therapeutics, a biotech focused on developing a clinical-stage AMPK activator.
The SVB failure appears to have been caused by an underwritten public offering to raise $2.25 billion to cover security losses announced during SVB’s Q1 2023 mid-quarter update.
A recent report released by accounting and consulting firm BDO showed that over the course of 2023, 13% of life sciences companies may turn to layoffs in response to uncertain economic conditions.
Sanofi will acquire diabetes leader Provention Bio for $25 per share for a total of $2.9 billion, the companies announced Monday.
Pfizer will acquire the Seattle-based antibody-drug conjugate leader in a $43 billion deal expected to close late in 2023 or early 2024.
The California Department of Financial Protection and Innovation shut down the Silicon Valley Bank Friday, a top financial institution for the life sciences industry, leaving biopharmas scrambling.
Partners CRISPR and ViaCyte (Vertex), and Genprex are pioneers in the quest to develop a gene therapy for Type 1 diabetes.
The FDA has one target action date and one advisory committee meeting scheduled for this week. It is also gearing up for an adcomm that could prove to be pivotal for neurodegenerative diseases.