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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 past two years have seen a considerable shift towards remote work, but now that the pandemic is waning, BioSpace has compiled relevant data on remote work to see if it’s here to stay.
Shares of Avidity Biosciences are soaring following reported early signs of clinical activity and improvement in patients with myotonic dystrophy type 1 (DM1) treated with its RNA-based therapeutic.
The FDA’s Cardiovascular and Renal Drugs Advisory Committee stood against Cytokinetics, Inc., finding that the benefits of its heart failure hopeful didn’t outweigh its risks.
See inside for BioSpace’s compilation of the five biggest M&A deals of 2022.
In a comparison trial, BeiGene’s Brukinsa bested Janssen’s Imbruvica in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL).
Flagship Pioneering has committed $50 million to Montai Health, a biotech that aims to develop therapies for chronic diseases using molecules already found in nature.
GSK bolstered its position in the oligonucleotide therapeutics space through a four-year collaboration with Wave Life Sciences valued at up to $3.3 billion.
An investigational mRNA cancer vaccine developed by Moderna and Merck reached its primary efficacy endpoint, inducing a clinically meaningful improvement in recurrence-free survival.
On the heels of positive Phase IIb data in plaque psoriasis, Takeda is acquiring both the therapy and Nimbus Lakshmi, a wholly owned subsidiary, in a potentially $6 billion deal.
Developed initially to deliver cytotoxic payloads to tumors, antibody therapeutics are evolving to provide new, next-generation conjugates and treat various diseases beyond cancer.