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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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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
Real estate development firm Sterling Bay launches life sciences division starting with Lincoln Yards, a 320,000 square foot site on the Chicago River.
The new financing will help the Boston-based biotech accelerate the development of its siRNA-based therapies for immuno-dermatology indications.
Seamless Therapeutics launched Wednesday with $12.5 million in seed financing to develop its programmable recombinases for gene editing.
In spite of a tumultuous economy, many life science companies have started the year off strong. With plans to expand its team and pipeline in the coming year, Takeda is one of them.
Job hopping– frequently changing jobs, typically within a short period of time – gained popularity with the onset of COVID-19 and is still popular now. Here’s what recruiters think about job hopping.
Bellicum Pharmaceuticals has ended the only clinical trials evaluating its GoCAR-T cell product in combination with rimiducid following serious safety concerns.
Mediar Therapeutics added another $85 million to its coffers Wednesday to take its first-in-class fibrosis therapies to clinic.
Jounce Therapeutics has received an unsolicited and non-binding acquisition proposal from Concentra Biosciences, looking to buy 100% of Jounce’s equity at a per-share price of $1.80 in cash.
Weeks after the FDA rejected Veru’s Emergency Use Authorization bid for sabizabulin in COVID-19, the company announced plans to continue with late-stage development of the drug.
CytoDyn has spent the past two years under siege. In an exclusive interview, Cyrus Arman, president, told BioSpace how the company is looking to turn the page.