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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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Genentech (Roche) reported Wednesday that its Phase III SKYSCRAPER-01 trial failed to meet its co-primary endpoint of progression-free survival (PFS).
BioSpace spoke with industry experts to find out the differences between working in pharma and biotech and how to know if a pharma company is right for you.
ICER recommended two out of three outpatient treatments for COVID-19 in today’s market, singling out molnupiravir as having inadequate evidence that it is better than symptomatic care.
Nuvig plans to use its funding to advance its lead molecule, complete some pre-IND enabling studies and move the molecule to the clinic to begin Phase I studies.
Bristol Myers Squibb announced it is extending and expanding its strategic partnership with Evotec in targeted protein degradation, marking its second protein degradation deal this month.
Cortexyme has entered into a deal to acquire Novosteo. Once the deal is finalized, the companies will enter the rare disease space and operate under the name Quince Therapeutics.
Current COVID-19 booster shots have a problem: they last only about four months and appear to have limited efficacy in a vaccinated population. Clearly, a more durable approach is needed.
Despite posting its first profitable quarter as a commercial stage company, shares of Novavax plunged 20% in Tuesday trading due to the slower-than-expected rollout of its COVID-19 vaccine.
Idorsia is no longer continuing research into the use of ACT-539313 to treat binge eating disorders after failing to meet the primary endpoint in its latest trial.
Twist Bioscience and Astellas Pharma have entered into a collaboration to identify therapeutic antibodies to reduce tumor microenvironment-mediated immunosuppression.