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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.
Saol Therapeutics is the latest biotech to resubmit for approval of a drug rejected under former FDA Commissioner Marty Makary, following REGENXBIO and Replimune.
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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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Combined with chemotherapy, Keytruda in KEYSTONE-671 significantly improved EFS and reduced the risk of disease recurrence, progression or death by 42%, beating Imfinzi’s EFS in the AEGEAN trial.
Follow news from the American Society of Clinical Oncology 2023 annual meeting—BioSpace will be tracking key updates here throughout the conference.
The Swiss pharma’s CDK4/6 inhibitor reduced risk for recurrence by 25% when added to the standard-of-care endocrine therapy, inviting comparisons to Lilly’s Verzenio.
The company’s Humira biosimilar Yusimry will launch in July with a $995 list price. Mark Cuban’s online pharmacy will sell it at a list price of $569.27 plus fees.
The company’s aztreonam-avibactam matched the cure rate of a meropenem-based regimen in patients with drug-resistant infections.
The recent approval of Biogen’s Qalsody in SOD1–ALS highlighted the potential of ASOs in CNS diseases, while recent failures make it clear there is still work to be done.
ADCs from BioNTech, Daiichi Sankyo and Merck are the subject of high-profile abstracts featured at the oncology meeting, along with Merck’s late-breaking Phase III non-small cell lung cancer data.
Drugs that act on the CFTR protein only work in patients who produce the protein in the first place. That leaves 6% of patients hanging.
The FDA has three high-profile events this week, including one target action date and two advisory committee meetings—one to discuss potential traditional approval for Alzheimer’s drug Leqembi.
Roger Perlmutter’s company announced the addition Thursday of myriad early- to mid-stage assets in the cancer and neurodegenerative disease spaces.