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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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The next six months for the FDA are primed to be as groundbreaking as the first six, with Eli Lilly’s donanemab and Lykos Therapeutics’ MDMA-assisted PTSD therapy on the docket, among others.
Ascidian Therapeutics will receive $42 million upfront from Roche, and up to $1.8 billion in milestone payments and royalties, to discover RNA exon editing candidates for neurological diseases.
Following two deaths due to presumed sepsis, the FDA has placed a partial clinical hold on three trials for Zentalis’ azenosertib including a Phase I in solid tumors, Phase II in platinum-resistant ovarian cancer and Phase II in uterine serous carcinoma.
Bucking its recent winning streak in oncology, AstraZeneca reported Tuesday that its AKT inhibitor Truqap failed to significantly boost overall survival in patients with triple-negative breast cancer.
Promising data from the DREAMM-7 and DREAMM-8 trials have revitalized GSK’s blockbuster goals for its antibody-drug conjugate Blenrep, positioned as a second-line treatment for multiple myeloma.
FDA
Merck on Monday secured the FDA’s green light for its 21-valent pneumococcal vaccine Capvaxive, which covers serotypes responsible for around 84% of invasive pneumococcal disease cases.
FDA
The FDA is facing four big target action dates in the final week of June, including one label expansion for a bispecific antibody and another for an investigational gene therapy.
BioSpace’s ⁠Lori Ellis⁠ and ⁠Chantal Dresner⁠ bring live updates from ⁠the first day of #DIA2024⁠ in San Diego.
The hold on BioNTech and MediLink’s antibody-drug conjugate candidate BNT326/YL202 has halted enrollment in a Phase I U.S. trial in patients with non-small cell lung cancer or breast cancer, following multiple deaths.