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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.
FDA
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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Talaris Therapeutics is cutting one-third of its workforce and dropping two clinical trials studying its lead candidate.
Aera Therapeutics emerged from stealth mode Thursday with a platform based on the work of Feng Zhang, Ph.D. and ex-Alnylam executive Akin Akinc at the helm.
Skye Bioscience, Inc. (OTCQB: SKYE) (“Skye” or the “Company”), a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma, has appointed Dr. Deborah Charych to its board of directors effective immediately.
Taxpayer-funded research in biosciences will no longer sit behind paywalls. Instead, all of this data will be publicly available for no cost.
Spanish drugmaker Grifols announced a comprehensive plan Wednesday to improve its efficiency and cost-effectiveness – a move that will reportedly cost some 2,000 U.S. jobs.
Arrowhead Pharmaceuticals has gained full rights to ARO-PNPLA3, formerly JNJ-75220795, the company announced Wednesday.
Genome engineering company Replay and the MD Anderson Cancer Center have joined forces to launch Syena, an oncology product company.
Biogen’s 2022 fourth-quarter and full-year report comes the day after an additional warning on the company’s first Alzheimer’s drug came to light.
Curie.Bio launched this week with $520 million to take early startups from ground zero through Series A funding.
Enveda’s primary R&D efforts will focus on inflammation, fibrosis and neurosensory biology within the GI, dermatology and pulmonary therapeutic areas.