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The failure of AstraZeneca and Ionis’ Wainua in a late-stage study of ATTR-CM casts doubt on Alnylam’s next-generation candidate but is good news for others in the space, including BridgeBio and Intellia Therapeutics.
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Even as FDA approvals for biologic therapies fell in the first half of 2026, regulatory experts are optimistic about a turnaround in the rare disease space after the departure of key leaders at the agency. Still, there will continue to be tension between science and politics.
Early-stage financing rounds are on track to hit their lowest dollar value in years as funders continue to eschew risky investments, experts told BioSpace.
A mostly black box since emerging with more than a billion dollars in hand, Xaira Therapeutics is slowly pulling back the curtain, revealing plans to find partners and validate its pipeline.
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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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Preliminary data from a late-stage trial of Alnylam’s RNAi therapy for ATTR amyloidosis with cardiomyopathy appear strong but details expected later this summer are critical.
The pharma giant announced Tuesday that Mikael Dolsten is leaving his role as chief science officer after more than 15 years. Pfizer is conducting an external search for a replacement with Dolsten staying on to assist in finding his replacement over next several months.
As Novo Nordisk’s weight loss drug enters the Chinese market, its patent is expiring in two years and biosimilar competition is rising.
The Federal Trade Commission on Tuesday issued an interim report on the top pharmacy benefit managers, showing that they are generating massive profit at the expense of patients by inflating prescription drug costs.
House Speaker Mike Johnson (R-La.) on Monday said he intends to have a “significant package of China-related legislation” signed into law by the end of this year, including the BIOSECURE Act which intends to stop federal contracts with Chinese “companies of concern.”
Eli Lilly’s Mounjaro outperformed Novo Nordisk’s Ozempic at inducing weight loss in obese or overweight adults, according to an observational study published Monday in JAMA Internal Medicine.
Roche’s eye implant Susvimo for patients with neovascular age-related macular degeneration is re-entering the U.S. market after the FDA approved updates to the components of the product.
The Biden administration is appealing a 2023 jury decision that declared invalid its patent protections over Gilead Sciences’ HIV prevention regimen of Truvada and Descovy.
Following a disappointing readout last year, uniQure on Tuesday posted promising Phase I/II data for its investigational gene therapy AMT-130 and nabbed the first-ever Regenerative Medicine Advanced Therapy designation from the FDA in Huntington’s disease.
The groundwork being done in 2024 is building the foundation for global collaboration in the future.