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Novartis will continue to be on the lookout for bolt-on deals below $2 billion, CEO Vas Narasimhan said Tuesday on the pharma’s second quarter earnings call—though major pickups aren’t completely off the table.
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After the trailblazing approval of Sanofi’s Tzield for stage 3 type 1 diabetes, several companies, including SAB Biotherapeutics and Eledon Pharmaceuticals, are vying for a spot in the landscape with innovative approaches—and experts say there’s room for all of them.
Poised to become the first company to achieve a regulatory filing for a cell therapy in autoimmune disease, Kyverna Therapeutics is building a pipeline-in-a-product to change the treatment paradigm.
New mid-stage data from Biogen’s Ionis-partnered therapy diranersen served to both validate the tau hypothesis in Alzheimer’s disease and raise questions that could soon be elucidated by anti-tau candidates from Denali Therapeutics, Eisai and Eli Lilly.
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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 is currently reviewing Vertex Pharmaceuticals’ povetacicept, with a target action date of Nov. 30. If approved, the drug could benefit from campaigns from Novartis and Vera Therapeutics for their recently approved IgAN therapies Fabhalta and Trutakna.
Structural gaps in areas including clinical execution and funding limit India’s ability to scale up innovation, according to a report from Boston Consulting Group and HealthKois.
BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026.
Camlipixant, which GSK picked up in its $2 billion buyout of Bellus Health in April 2023, “is unlikely to transform patient care,” the pharma said.
Insmed’s inhalable candidate showed “impressive” long-term efficacy in pulmonary arterial hypertension, according to analysts at Guggenheim Partners, with functional and biomarker improvements through one year of follow-up.
Journal publications that suggested changes in FDA guidelines do not “communicate FDA policy or interpretation of a regulatory issue,” acting director Kyle Diamantas wrote in a letter to House Energy & Commerce committee ranking member Diana DeGette.
The FDAs enforcement action against Purolea Cosmetics Lab offers an early look at how the agency expects AI-generated work to fit within existing quality systems, with experts saying human oversight and quality controls remain essential.
With the AtaiBeckley acquisition, Eli Lilly is jumping into psychedelics, a drug class that Jefferies analysts say could herald the “biggest change” for the field of psychiatry.
Merck’s once-daily pill is the first oral PCSK9 inhibitor to hit the market for high cholesterol, beating AstraZeneca in the race to develop more accessible treatment options.
Braveheart Bio is looking to take on Bristol Myers Squibb in hypertrophic cardiomyopathy, while Attovia Therapeutics wants to challenge Sanofi and Regeneron’s Dupixent. Vogenx, meanwhile, is looking to establish its name in the cardiometabolic space.