News

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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Novartis has had a busy few days, announcing plans to shutter a Sandoz plant, a $300 million infrastructure investment, and Cosentyx, Kisqali and Tislelizumab readouts.
AstraZeneca presented data showing Imfinzi and Tagrisso boosted survival chances for patients in different forms of lung cancer at ESMO on Monday.
President Joe Biden tapped Ginkgo Bioworks veteran Renee Wegrzyn to helm the recently-established Advanced Research Projects Agency for Health (ARPA-H).
It was a busy weekend at ESMO 2022 with Merck, Astellas, Seagen, Regeneron, AstraZeneca and GRAIL all presenting data from their various cancer programs.
Pretzel Therapeutics launched Monday with $72.5 million in Series A financing to develop novel, mitochondria-based therapies to treat rare genetic disorders and diseases of aging.
Regeneron’s oncology strategy is centered around improving checkpoint inhibitor treatments with combination therapies, according to a pipeline overview presented Monday morning.
FDA
BMS announced that the FDA approved Sotyktu for adults with moderate-to-severe plaque psoriasis, marking this indication’s first oral treatment innovation in nearly a decade.
The week has seen a series of significant updates from BioVie, Regeneron, Relay Therapeutics, Oxford University, Vistagen and Palatin.
The FDA is heading into fall with a few Prescription Drug User Fee Act (PDUFA) dates. Here’s a look at this week’s upcoming action.
Now that most people in North America and Europe are vaccinated and the COVID-19 pandemic is diminishing, Moderna is looking for its second act.