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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.
FEATURED STORIES
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.
ALS
Biogen’s Qalsody won FDA approval in 2023 to treat a rare, genetic form of amyotrophic lateral sclerosis. On Tuesday, QurAlis presented interim Phase 2 data showing the potential of a similar drug to more broadly treat the neurodegenerative disease.
As Q1 earnings arrive, three biotechs have big quarters ahead, with two—Amylyx and Neumora Therapeutics—betting at least partly on novel assets for obesity.
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THE LATEST
Sanofi and Novartis kick off the heart of earnings season; Lilly strikes its fourth pact in as many weeks; Regeneron earns landmark approval for a gene therapy for a type of genetic deafness, and also strikes a White House deal; FDA asks Amgen to withdraw Tavneos and, separately, issues Commissioner’s National Priority Vouches to three unnamed psychedelics companies.
Angel investors are raising the bar with tighter criteria, backing strong teams, realistic markets and clear paths to exit while applying deeper, domain-specific diligence to early stage bets.
Altitude Labs, an offshoot of AI-focused techbio Recursion, is teaching scientists to build companies, one founder at a time.
With six acquisitions already this year, Eli Lilly’s business development shows no signs of stopping as executives make good on a promise to spend their GLP-1 gains.
Staff at Salt Lake City-based techbio company Recursion recently heard from Jenny and Tim Jones about their challenging family history of familial adenomatous polyposis.
AbbVie is setting up a shot to buy Kestrel Therapeutics down the line, as the biotech doses patients in a Phase 1 trial for the oral pan-KRAS inhibitor KST-6051 in solid tumors.
Topline Phase 3 results of survodutide—licensed to Boehringer Ingelheim from Zealand Pharma—are more comparable to Novo Nordisk’s Wegovy than to Eli Lilly’s Zepbound, William Blair analysts said on Tuesday.
Cancer cocktails pairing Moderna’s mRNA-4359 with Merck’s Keytruda and Marengo’s invikafusp alfa with Gilead Sciences’ Trodelvy showed promising results, while a complex combination by Agenus and MiNK Therapeutics failed to elicit an overall response.
Weight loss giant Eli Lilly has penned a DNA editing deal with Profluent Bio, continuing its dealmaking spree as well as its commitment to artificial intelligence.
The FDA has renewed calls for Amgen’s Tavneos to be pulled from the market, saying it has discovered new evidence that study personnel doctored the results of the drug’s pivotal study in order to make it look effective.