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The vibe at BIO 2026 in San Diego last week was overwhelmingly positive, with attendees observing noticeable changes at the FDA and an uptick in dealmaking and IPOs. Plus, a top medical journal this week retracted a pivotal study for Amgen’s rare disease drug Tavneos, which has been in the FDA’s crosshairs since January.
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At the BIO International Convention in San Diego, attendees marked the 50th anniversary of original biotech Genentech, reflecting on the immense challenges facing companies as China becomes a powerhouse innovator.
A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
Recent approvals for Corcept Therapeutics and Merck have injected momentum into the space, where GSK, Allarity Therapeutics, OSE Immunotherapies and others are advancing their own candidates.
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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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Johnson & Johnson’s AI investments include a research facility in San Francisco and a data science workforce of approximately 6,000 employees.
AbbVie’s $10.1 billion ImmunoGen buy and Altimmune’s Phase II win demonstrate that the antibody-drug conjugate market is red hot in cancer and GLP-1 drugs for weight loss are an absolute craze.
While Pfizer’s oral GLP-1 candidate met its primary endpoint in a Phase IIb obesity trial, twice-daily dosing of danuglipron resulted in high rates of adverse events including nausea, vomiting and diarrhea.
From the skin to the lungs to the central nervous system, biotech companies are making progress toward delivering RNA therapeutics to multiple targets throughout the body. But challenges remain.
Citing slow enrollment and low clinical rates, the late-stage “evidence trials” are being discontinued. AstraZeneca said there are no safety concerns and no impact on Lokelma’s current approved indication.
The company’s investigational c-Met protein directed antibody-drug conjugate showed a “compelling” overall response rate in patients with previously treated non-small cell lung cancer.
This week, the FDA could approve the first CRISPR-edited therapy in the U.S., while two other companies await decisions on topical drugs.
Patients treated with Altimmune’s investigational GLP-1/glucagon dual receptor agonist saw up to 15.6% weight loss, and nearly a third of those taking the highest dose lost at least 20% of their body weight.
The company is hoping the topline results for Veozah, which won FDA approval in May, will support health technology assessments for reimbursement negotiations in Europe.
The two companies have settled all pending U.S. patent litigation, clearing the way for commercialization of Samsung Bioepis’ SB17, a proposed biosimilar of Stelara.