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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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Akebia Therapeutics’s partner Otsuka Pharmaceutical Co. announced plans to terminate its global license agreements with Akebia for vadadustat.
BioSpace sat down with Axogen’s Chief Human Resources Officer Maria Martinez to understand why now is the best time to make the switch to pharma and biotech.
Kriya Therapeutics secured $270 million that will be used to advance its fully integrated gene therapy pipeline and expand engineering, manufacturing and computation.
Monday woes were shared by Bristol Myers Squibb and Synairgen, as their clinical trial candidates failed to perform as expected.
Clay Siegall resigned his role as president, CEO and a member of the board of directors of Seagen following domestic violence allegations. Roger Dansey will serve as interim CEO.
The changes are unlikely to help people in developing countries but could reduce innovation among biopharma companies and ultimately do more harm than good.
In addition to lowering of blood sugar, Mounjaro also enabled patients to lower their weight by 15 to 23 pounds. The drug compared well to other diabetes medications including Novo Nordisk’s semaglutide.
U.S. Food and Drug Administration(FDA) has granted Orphan Drug designations to Editas Medicine and Neurocrine Biosciences.
The U.S. Food and Drug Administration (FDA) has approved Mitsubishi Tanabe Pharma America’s oral alternative to its own treatment for amyotrophic lateral sclerosis (ALS).
Achilles dosed the first patient in a Phase I/IIa advanced NSCLC trial, Logic Bio’s pediatric methylmalonic acidemia study is back up and running and another look at Roche’s TIGIT flop.