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
UCB shared positive top-line results Friday from two Phase III studies of bimekizumab for adults with moderate to severe hidradenitis suppurativa.
Autolus Therapeutics is calling the Phase II FELIX trial, assessing its next-generation CAR-T therapy obe-cel for leukemia, a win after an interim analysis revealed an overall remission rate of 70%.
A combination of Exelixis’ cabozantinib and Roche’s Tecentriq missed the primary endpoint of overall survival in a Phase III study.
ImmunoGen entered into a clinical collaboration deal with Gilead Sciences Friday to evaluate the safety and efficacy of two drugs that, when used in concert, have the potential to treat AML.
At ASH 2022, established hematology leaders like AstraZeneca, Janssen and Merck will showcase new data, and new players like Vega Therapeutics will launch new programs.
AstraZeneca posted two mid-stage wins at the 2022 San Antonio Breast Cancer Symposium on Thursday, touting the efficacy of capivasertib and camizestrant against breast cancer.
Compass’ twin clinical updates regarding its lead candidate spotlight the promise of psychedelic medicine.
Instil Bio is discontinuing the development of its unmodified tumor-infiltrating lymphocyte (TIL) therapeutic, ITIL-168, and laying off 60% of its staff.
Those who work in the biopharma industry often see more setbacks than successes. To understand how to overcome failures, BioSpace spoke with two experts on coping with setbacks and staying positive.
Sanofi has terminated its global development and commercialization pact with Revolution Medicines, Inc. for their SHP2 inhibitor drug candidate,