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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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AbbVie and Teva are reportedly ready to pay over $5 billion to quiet the over 3,500 opioid liability lawsuits filed against them over their painkillers.
Stealth BioTherapeutics has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for elamipretide.
A recent research report points to the CDMO market heating up. P&S projected the global biologics CDMO market would hit $31.839 million by 2030.
Dr. Terry Fry, M.D., a leader in chimeric antigen receptor T-cell (CAR-T) therapies and senior vice president, head of T-cell therapeutics at Sana Biotechnology, will be heading the newly created Gates Institute.
BridgeBio announced it has signed an exclusive deal with Bristol-Myers Squibb to develop and commercialize a potential treatment for cancer.
TCR² Therapeutics provided updates regarding the 2022 first quarter financial results and progress made towards regulatory approval for gavo-cel and TC-510.
Police documents reveal a May 2 dated TRO against Siegall concerning a fourth degree domestic violence gross misdemeanor charge.
Boston-based X4 Pharmaceuticals reported its first-quarter financial report today. Of note was the company’s cash, cash equivalents & restricted cash, which was $67.7 million as of March 31, 2022.
Cullinan and Taiho announced that Taiho was acquiring Cullinan Pearl and will co-develop and co-commercialize their non-small cell lung cancer drug.
With regulatory approvals beginning to break through, attendees at ISCT’s annual meeting set out along the translational pathway. Organizers shared their findings with BioSpace.