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
Biomarkers as a surrogate endpoint in ALS will go on trial on March 22 as Biogen and Ionis’s tofersen faces the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee.
Sangamo Therapeutics lost two powerhouse partners Friday after it reported that both Novartis and Biogen discontinued focusing on gene regulation therapies in the neurology space.
On Feb. 28, Novavax issued a candid warning to investors: it may not be able to continue operations beyond February 2024. BioSpace takes a deep dive into the vaccine maker’s prospects.
For Daiichi Sankyo, recent results from the Phase III CLEAR trial of Esperion Therapeutics’ Nexletol (bempedoic acid) were not convincing enough to trigger a milestone payment.
An advisory committee will meet March 22 to discuss the fate of Biogen and Ionis’ ALS hopeful tofersen. For that and more, see inside.
Pfizer and Astellas announced positive topline Phase III results Thursday for Xtandi plus leuprolide in non-metastatic castration-sensitive prostate cancer.
Amgen is terminating 450 workers in hopes of weathering dropping drug prices and rising inflation. This is Amgen’s second round of job cuts this year.
The FDA will hold an advisory committee meeting for Sarepta’s investigational gene therapy for Duchenne muscular dystrophy ahead of its May 29, 2023 action date.
Real estate development firm Sterling Bay launches life sciences division starting with Lincoln Yards, a 320,000 square foot site on the Chicago River.
The new financing will help the Boston-based biotech accelerate the development of its siRNA-based therapies for immuno-dermatology indications.