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
On Wednesday evening, a man in Massachusetts became the first person reported to have a case of monkeypox in the U.S. The man contracted monkeypox after traveling to Canada.
As the American Society of Gene & Cell Therapy’s 25th Annual Meeting wraps up, a host of life science companies touted their research and products. BioSpace looks at some of them.
Pfizer, Sarepta Therapeutics, Genethon and Solid Biosciences are working on gene therapies for Duchenne Muscular Dystrophy. Now, the four companies have teamed up.
U.K. researchers found that the first dose of any vaccine was linked with an initial 12.8% decrease in the odds of Long COVID.
Germany-based Evotec AG forged its third partnership in May, a deal with Spain’s Almirall S.A. to develop new therapeutics for severe diseases of the skin.
Enanta Pharmaceuticals’ attempt to find an effective treatment for respiratory syncytial virus (RSV) met a roadblock after its candidate failed to meet the primary endpoint in Phase II.
Following reports that Pfizer has declined study requests for Paxlovid, the company and NIH are said to be in conversation about potential studies assessing a longer treatment period of the antiviral.
Virongy is expanding again and has committed to a $471,000 expansion with up to 70 new jobs.
Spruce Biosciences is developing what could be the first new therapy treating congenital adrenal hyperplasia (CAH) since the 1960s, and a new therapy for women with polycystic ovary syndrome.
In a Phase IIb study, data showed that Prota Therapeutics’ oral immunotherapy led to 51% of children reaching clinical remission of their peanut allergy compared to placebo. See inside for this and more!