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After debuting on the public markets with $256.3 million and raking in an additional $472 million, Veradermics has emerged as one of biotech’s biggest post-IPO standouts. CEO Reid Waldman credits the weight loss craze for establishing consumer-driven channels.
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Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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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.
As cell and gene therapy leaders gathered in Maryland to discuss accelerating clinical trials in children, one “cutting edge” session focused on the need to expedite more bespoke gene editing treatments like the one that saved young KJ Muldoon.
While the FDA did not announce the recipient names of the Commissioner’s National Priority Vouchers, the agency’s descriptions of the awarded products match those in development at Compass Pathways, Transcend Therapeutics and Usona Institute.