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China’s Haisco Pharmaceutical continues to wield deals, this time out-licensing rights to two late-stage programs to New Jersey biotech Nuvectis.
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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.
While drugmakers and other stakeholders want to see faster approvals, experts say the FDA’s Commissioner’s National Priority Voucher program is still bereft of important details, with candidate selection and interference from the agency’s senior leaders topping the list.
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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FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
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Due to policies regarding industry user fees, the FDA will not be able to accept any new drug applications for the duration of the government shutdown, according to Leerink Partners.
The business separation, expected to be completed by the end of 2026, will result in two new companies, one focused on biopharma operations and the other on royalty management.
The first oral BTK blocker for chronic spontaneous urticaria, Rhapsido offers a more convenient treatment option for patients who still show symptoms after antihistamine treatment.
Novo Nordisk and Heartseed first partnered in 2021 to develop an investigational cell therapy for heart failure.
M&A headlined for a second straight week as Genmab acquired Merus for $8 billion; Pfizer strikes most-favored-nation deal with White House; CDER Director George Tidmarsh caused a stir with a now-deleted LinkedIn post; GSK CEO Emma Walmsley will step down from her role; and uniQure’s gene therapy offers new hope for patients with Huntington’s disease.
J&J still holds the top deal of the year by value with its $14.6 billion buy of Intra-Cellular in January, but the next four biggest acquisitions came in the past four months.
The two most historically deal-conservative Big Pharmas have the most money to play with for a major M&A transaction, according to a recent Stifel analysis.
A new analysis from SRS Acquiom puts into perspective the headline values seen when a company announces a backloaded M&A deal. Biotechs have much on the line when they agree to deals with massive potential but little upfront.
As major pharmas pull away from the U.K. and the U.S. risks ceding its lead through a national brain drain, the U.K. must create a new, more robust model for innovation.
Talks between pharma and successive U.K. governments have failed to deliver the market access terms that the industry wants, contributing to a pullback in investment.