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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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Biopharma and life sciences organizations from across the globe provide updates on their businesses and pipelines.
In its financial results for 2021, Takeda announced that it has decided to discontinue the development of TAK-609, a therapeutic for Hunter Syndrome.
Usama Malik, the former chief financial officer of Immunomedics, has been indicted for insider trading, five months after the U.S. Securities and Exchange Commission leveled charges.
Less than one month after he was appointed as chief financial officer of Moderna, Jorge Gomez abruptly departed the company due to an ongoing investigation at his former company.
The FDA has given approval for the commercialization of Eli Lilly and Company and Incyte’s Olumiant, setting a precedent for upcoming COVID-19 treatments.
Flagship Pioneering has partnered with Novo Nordisk to build a portfolio of potential treatments for cardiometabolic and rare diseases.
An investigation conducted by the U.S. House of Representatives shows Emergent was forced to destroy nearly 400 million doses of the vaccine. The company disputes the report’s claim.
Jacqueline Shea will take over as the new CEO and announced plans to discontinue its Phase III Innovate trial to prioritize its heterologous booster strategy for COVID-19.
The revised PDUFA action date for miglustat is August 29, 2022, while the new date for cipaglucosidase alfa is October 29, 2022. Amicus expects the agency to approve the applications together.
AstraZeneca and Sanofi’s Phase-III and Phase-IIb clinical trials investigating the efficacy of nirsevimab shows 79.5% efficacy in the prevention of lower respiratory tract infections.