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The discovery of a foreign substance prompted Amgen to voluntarily recall batches of the medicine Corlanor made in Italy.
FEATURED STORIES
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.
Molecular glue degraders are gaining traction in the clinic as well as funding from Big Pharma, with their potential to treat previously “undruggable” cancers and immunological diseases. Here are five clinical programs worth keeping an eye on.
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.
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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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Early-stage data shows that Viridian’s thyroid eye disease candidate induces clinically meaningful improvements in eye protrusion after six weeks of treatment.
The European Medicines Agency has widened its review of potential suicide risks associated with GLP-1 receptor agonists. The probe, which started July 3, is expected to conclude in November.
The biotech has acquired an exclusive global license for Shanghai-based DualityBio’s investigational antibody-drug conjugate for select solid tumors.
The biotech Monday announced a clinical hold on its HEMO-CAR-T candidate, which is being trialed for the treatment of acute myeloid leukemia, due to manufacturing concerns cited by the regulator.
After its Biologics License Application was rejected by the FDA, BrainStorm’s Phase III data suggest its amyotrophic lateral sclerosis candidate significantly lowers neurofilament light chain levels.
Johnson & Johnson has licensed Nanobiotix’s lead radioenhancer candidate, designed to increase the efficacy of radiation treatment in cancers, capitalizing on the latter’s rocky financial situation.
The biotech will supply Canada with fewer doses of its coronavirus vaccine while reaching a financial agreement for the forfeiting of certain doses previously scheduled for delivery.
After an initial series of legal complaints in June, Novo Nordisk filed four new lawsuits Thursday against Florida and Tennessee pharmacies for allegedly selling products containing semaglutide.
Gene editing technologies are advancing rapidly in the clinic, with the potential first approval later this year, but challenges remain.
Phase III trial data published Thursday show significant survival benefit as a first-line treatment in advanced non-small cell lung cancer patients not fit for standard platinum-based doublet chemotherapy.