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Speaking to media on Tuesday, BIO CEO John Crowley complimented China’s rise as a biotech powerhouse but said U.S. policy needs to protect and maintain America’s lead.
FEATURED STORIES
With drug pricing now embedded in U.S. policy, business development teams in biotech and pharma are changing the way they strike deals, including acknowledging policy uncertainties with renegotiation clauses.
Former FDA, CDC and NIH leaders convene at the BIO International Convention to discuss the dismantling of the Department of Health and Human Services under the Trump administration—and where we go from here.
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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Read our takes on the biggest stories happening in the industry.
UniQure’s planned third-quarter submission for its Huntington’s disease gene therapy may be a harbinger of a more flexible FDA under acting commissioner Kyle Diamantas—but how long will it last? And how can companies be sure these positive decisions won’t just be reversed?
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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.
Facing the loss of Humira revenues from biosimilar competition, AbbVie is looking to grow its pipeline by acquiring ImmunoGen and its antibody-drug conjugate Elahere, which was granted FDA accelerated approval last year.
Listen to this in-depth discussion on how AI can help identify end-to-end data weaknesses, as well as broader implications regarding the inevitability of human interaction, with guests from GSK, IQVIA, Exelixis and DataHow.
For forms of Alzheimer’s, frontotemporal dementia and Parkinson’s caused by genetic defects, gene therapy could change the treatment landscape.