News
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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Read our takes on the biggest stories happening in the industry.
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.
THE LATEST
Galmed announces positive late-stage results in biopsy-proven NASH patients.
In a recently published study, MD Anderson researchers achieved curative responses in pancreatic cancer models by targeting checkpoints in T cells and myeloid suppressor cells.
Geron announced Wednesday positive topline results from the Phase III IMerge trial evaluating the telomerase inhibitor, imetelstat, in lower-risk myelodysplastic syndromes patients.
Backed by Versant and Genentech, Belharra Therapeutics launched Wednesday with $130 million in total financing to advance its novel chemoproteomics platform.
Vera Therapeutics’ stock crashed following the reveal of data from a Phase IIb study of atacicept in IgAN.
BrainStorm Cell Therapeutics appoints a new co-CEO as it prepares for a January 11th Type A meeting for ALS hopeful NurOwn.
Amgen’s Repatha may cause cardiac harm, according to a reassessment of the biologic’s late-stage trial data.
Gilead and EVOQ Therapeutics announced a partnership to develop immunotherapies for rheumatoid arthritis and lupus.
Aurinia and Sun Pharma agree to file a joint motion to dismiss a key patent dispute.
Chemomab’s experimental antibody shows promise in NASH.