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Biopharma companies won’t fully capture the benefits of AI unless they reorganize their R&D units, according to McKinsey.
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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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The FDA approval of the siRNA drug Redemplo caps off a tumultuous 12 months for Arrowhead, whose partnership with Sarepta caused its own stock to drop during the gene therapy maker’s safety troubles this summer.
A week into his tenure as head of the FDA’s Center for Drug Evaluation and Research, experts agree that Rick Pazdur is the “ideal fit” to stabilize the agency. And, according to one ex-FDA official, if his CBER counterpart Vinay Prasad tries to supersede Pazdur’s authority, “there will be hell to pay.”
Winrevair yielded significant and meaningful clinical benefits for patients with combined post- and precapillary pulmonary hypertension, an indication that, according to BMO Capital Markets, has few treatment options.
Only one clinical-stage asset from the ProfoundBio acquisition remains in development: The antibody-drug conjugate Rina-S, in late-stage studies for ovarian and endometrial cancer.
Nxera, which formerly went by Sosei, will also reprioritize its pipeline to focus on obesity, metabolic and endocrine diseases.
With positive data from the Phase III HERIZON-GEA-01 study, Zymeworks and Jazz Pharmaceuticals will file an approval application for Ziihera in the first half of 2026 for the treatment of gastroesophageal adenocarcinoma.
The introduction of AbbVie’s hepatitis C drugs in 2014 forced Gilead’s hand in the fight for market dominance in hepatitis C. A similar dynamic is now playing out between Eli Lilly and Novo Nordisk in the obesity space, with some key differences.
The industry’s ability to generate a return on billions of dollars of investment rests on a heavily regulated supply chain defined by time-pressured logistics.
Halda Therapeutics is developing oral assets for prostate and lung cancer. The deal comes after Johnson & Johnson set an ambitious goal for its oncology sales by 2030.
The companies have yet to disclose how many programs they plan to collaborate on or what indications they will prioritize.