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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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A pre-specified interim analysis of Junshi Biosciences’ Phase III Neotorch trial showed its anti-PD-1 monoclonal antibody, toripalimab, met its primary endpoint in non-small cell lung cancer (NSCLC).
Servier and Taiho Oncology announced Tuesday that Lonsurf in combination with bevacizumab improved overall survival rates in patients with refractory metastatic colorectal cancer.
Shockwave Medical bolsters medical device portfolio with acquisition of Neovasc.
Edesa Biotech’s EBO1, a monotherapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD), showed mixed results compared to placebo in Phase II, the company announced Tuesday.
TC BioPharm and MD Anderson signed a three-year collaboration to better understand the role of gamma delta T cells in cancer treatment.
Massachusetts-based biotech Leap Therapeutics announced Tuesday that it had entered into a merger deal with the privately-held Flame Biosciences, Inc.
Elicio Therapeutics entered into a merger agreement as a wholly-owned subsidiary of Angion Biomedica Co. on Tuesday, becoming a Nasdaq-listed company.
If the letter of intent to acquire your company has been signed, you might be asking what happens next. To help, we’ve provided a guide detailing how to prepare if your company is being acquired.
A novel base editing approach shows a cardioprotective effect in a preclinical study.
The FDA approved Novo Nordisk’s Rybelsus as a first-line treatment option for adults with type 2 diabetes, signaling a shift from its previous indication as a second-line approach.