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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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Cambrian BioPharma announced the launch of Amplifier Therapeutics, a biotech focused on developing a clinical-stage AMPK activator.
The SVB failure appears to have been caused by an underwritten public offering to raise $2.25 billion to cover security losses announced during SVB’s Q1 2023 mid-quarter update.
A recent report released by accounting and consulting firm BDO showed that over the course of 2023, 13% of life sciences companies may turn to layoffs in response to uncertain economic conditions.
Sanofi will acquire diabetes leader Provention Bio for $25 per share for a total of $2.9 billion, the companies announced Monday.
Pfizer will acquire the Seattle-based antibody-drug conjugate leader in a $43 billion deal expected to close late in 2023 or early 2024.
The California Department of Financial Protection and Innovation shut down the Silicon Valley Bank Friday, a top financial institution for the life sciences industry, leaving biopharmas scrambling.
Partners CRISPR and ViaCyte (Vertex), and Genprex are pioneers in the quest to develop a gene therapy for Type 1 diabetes.
The FDA has one target action date and one advisory committee meeting scheduled for this week. It is also gearing up for an adcomm that could prove to be pivotal for neurodegenerative diseases.
The FDA has approved Pfizer’s nasal spray, zavegepant, now to be marketed as Zavzpret, for the acute treatment of migraine in adults, the company announced Friday.
The FDA has lifted the clinical hold it had placed on the Phase Ib study following the occurrence of hematological malignancies.