News
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.
FEATURED STORIES
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.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
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.
THE LATEST
Providing extra benefits and perks to parents in the workplace can be polarizing, but it doesn’t have to be.
After a series of milestone approvals in the first half of 2023, the FDA is slated to decide on four more firsts before the year’s end.
While early, the Phase I study results for 12 patients represent a promising return on Bayer’s investment in BlueRock, which it launched with Versant Ventures in 2016 and fully acquired three years later.
Overcoming an FDA rejection in January 2022, Pfizer and OPKO’s Ngenla will provide a long-acting, reduced-frequency treatment option for children with growth hormone deficiency.
The U.S. Equal Employment Opportunity Commission settled with Eli Lilly for $2.4 million after filing a suit in September over the company’s recruitment of younger workers.
Citing issues with a third-party contractor, the FDA rejected Regeneron’s regulatory application for a higher-dose regimen of Eylea, the company’s blockbuster eye injection treatment.
Despite a challenging economic climate and gloomy forecast, 2023 has still notched some mega-deals for biopharmas. BioSpace highlights the biggest deals in the industry this year.
The biopharma’s monoclonal antibody is the first to win approval for the two most common forms of generalized myasthenia gravis, a rare autoimmune and neuromuscular disorder.
Phase II results of MoonLake’s sonelokimab suggest superiority to the competition. Funds raised in the stock offering will support Phase III trials with an anticipated launch in 2027.
Though the topline data were sparse, Sanofi’s potentially first-in-class candidate amlitelimab improved Eczema Area and Severity Index scores in patients with moderate-to-severe atopic dermatitis.