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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.
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.
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.
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Coultreon Biopharma is advancing assets that target salt-inducible kinases, proteins that drive inflammation and other immune-mediated conditions.
Fresh off a major clinical win, Revolution Medicines alleges that Erasca’s pancreatic cancer drug infringes on key patent protections and that the rival has “improperly compared” the companies’ assets publicly.
The new CEO has at least five years and a large M&A war chest to position Sanofi for life after the loss of exclusivity on its cornerstone immunology product.
While tovecimig met the main goal of progression-free survival in a Phase 2/3 trial, it did not improve overall survival.
Sun Pharmaceutical is bringing Merck spinoff Organon into the fold, paying $11.75 billion in hopes of becoming a top global biosimilar player.
Eli Lilly is picking up Ajax Therapeutics and its once-daily oral blood cancer candidate. The deal follows the pharma’s buyouts of ADC specialist CrossBridge Bio and in vivo CAR T company Kelonia Therapeutics.
With Phase 3 data in hand, Intellia Therapeutics is seeking approval for its in vivo CRISPR gene editing therapy for hereditary angioedema.
FDA inspectors warned UCSF radiopharmaceutical facility that losing environmental control could pose a serious hazard to patients.
George Church’s Rejuvenate Bio is turning to social networks to help fund its work on one-time gene therapies targeting chronic diseases and root causes of aging.
After striking a Most Favored Nation deal with the White House in January, Johnson & Johnson will now offer Xarelto at 68% off on TrumpRx, dropping its price from $611.82 to $197 per 30-pill pack.