News

The failure of Roche’s Ionis-partnered tominersen in Huntington’s disease may indicate that Wave Life Sciences’ allele-specific antisense oligonucleotide candidate WVE-003 is on the right track, according to analysts at Rodman & Renshaw.
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The lineup at the Alzheimer’s Association International Conference will provide critical insight into where the industry is headed with regard to targets being explored to vanquish the elusive neurodegenerative disease.
Regulators on both sides of the Atlantic are pushing for the withdrawal of the rare disease treatment that accounted for just 1% of Amgen’s 2025 revenue. Nevertheless, Amgen continues to defend the medicine, which was acquired in the $3.7 billion buyout of ChemoCentryx.
Psychedelics are gaining momentum in depression, with one treating physician predicting that the drug class could “wipe out the SSRIs” if safety and durability hold up.
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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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Kindness. Respect. Innovation. Only one of those words typically features in biotech mission statements, but at Ikena Oncology, all three are important – and have been from day one.
FDA
Mid-November is a relatively quiet period for the U.S. Food and Drug Administration in terms of its scheduled PDUFA dates. Read on for more.
Amgen plans on investing $365 million in the site, including the introduction of 400 new job openings through the operations of its pharmaceutical packaging and assembly facility.
FDA
Ardelyx, Inc. is lacing up the gloves and preparing to wade into the ring with the U.S. Food and Drug Administration to dispute the July rejection of its chronic kidney disease drug, tenapanor.
bluebird bio has completed the spin-off of its oncology programs into the new business entity, 2seventy bio, Inc, which will begin trading on the Nasdaq this morning under the ticker symbol “TSVT.”
The first week of November was marked by numerous clinical trial announcements. Here’s a look.
The U.S. government canceled a contract with Maryland-based Emergent BioSolutions, which earlier in the year ruined about 15 million doses of the Johnson & Johnson COVID-19 vaccine.
Pfizer plans to seek Emergency Use Authorization for an antiviral COVID-19 treatment following an interim analysis of Phase II/III data that show statistically and clinically meaningful results.
Moderna reported its third-quarter earnings, and since it currently only has one commercial product, its COVID-19 vaccine, that was the financial focus.
Isomorphic Laboratories has expressed plans to foray into drug discovery and development by tapping into the technology of its sister company DeepMind.