News
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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Read our takes on the biggest stories happening in the industry.
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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With a robust pipeline, Vertex is moving beyond its market dominance in cystic fibrosis and laying claim to multiple markets in diabetes, pain, kidney disease and sickle cell disease.
A post hoc analysis of data from the Phase II CENTAUR study showed a 10.6-month longer median survival duration for AMX0035 participants, Amylyx announced Thursday.
Novartis announced on Thursday that it will be temporarily and voluntarily suspending the production of its cancer therapeutics Lutathera and Pluvicto at facilities in Italy and New Jersey.
For Terry Coelho, being CFO is about becoming a trusted strategic partner across the business. It’s about building bridges.
Illumina and Deerfield Management have entered into a five-year partnership to apply a genetic-led approach to the discovery and development of novel therapies.
Biopharma and life sciences companies from across the globe strengthen their leadership teams and boards with these Movers & Shakers.
BioCryst’s success of its Orladeyo launch in its Q1 report was overshadowed by the news that the FDA had placed a partial clinical hold on three of its clinical trials evaluating BCX9930
Researchers at the University of Illinois at Chicago have uncovered the possibility of utilizing gene editing to reverse a cause of anxiety and alcohol use disorder (AUD).
AstraZeneca and Daiichi Sankyo’s breast cancer therapeutic Enhertu received supplemental approval for an earlier form of breast cancer from the U.S. Food and Drug Administration.
Intellia’s first-quarter financial conference call and report focused on the ongoing Phase I trial of NTLA-2001 in transthyretin (ATTR) amyloidosis with polyneuropathy patients.