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As Sangamo runs out of cash, Eli Lilly and Astellas have emerged as stalking horse bidders for key assets, including a Fabry gene therapy currently being submitted for potential FDA approval.
Given its intravenous route of administration, Merck’s tulisokibart will likely “need to be meaningfully improved” over Roche’s afimkibart, which can be given subcutaneously, BMO Capital Markets analysts said. Both assets are being tested for ulcerative colitis.
Eli Lilly’s weight-loss franchise—including the tirzepatide products Mounjaro and Zepbound, and the weight-loss pill Foundayo—is projected to account for nearly half of the total sales of the top 10 drugs in 2032.
While existing antibody-drug conjugates have been incredible advancements in cancer care, patients are ready for a better experience. At the BIO International Convention in San Diego on Thursday, BioSpace will lead a discussion on the next generation of ADCs.
Despite an overall survival miss, Leerink Partners said Pfizer’s antibody-drug conjugate showed “promising” signals of efficacy in a subgroup of patients who had undergone only one prior line of treatment.
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.
Having stuck with local production in the years when offshoring to lower-cost locations was in fashion, Aquestive’s CEO is well placed to explain what the recent reshoring drive means for manufacturers.
Anticipated to be one of fastest-growing jobs in manufacturing, pharmaceutical jobs offer a salary 32% higher than the average U.S. manufacturing role.
China’s Haisco Pharmaceutical continues to wield deals, this time out-licensing rights to two late-stage programs to New Jersey biotech Nuvectis.
Among the health department’s efforts is an expedited investigational new drug pilot program that would leverage collaborations with U.S. research institutions to reduce early trial timelines by as much as 12 months.
The resubmission for RGX-121, expected in the third quarter, comes as the FDA has deemed REGENXBIO’s existing data “sufficient” to support an accelerated filing. It immediately follows a similar reversal of position regarding uniQure’s embattled Huntington’s disease gene therapy.
PRESS RELEASES
Upcoming Type B Statistical Methods Meeting expected to set stage for FDA to align with EMA and MHRA on use of Fall 2026 3-year overall survival data combined with biomarkers to support early market access
Highlights TempraMed signs non-binding LOI for exclusive distribution in Kuwait with Elegir Trading Kuwait represents a high-value market with significant demand for insulin, GLP-1 therapies, biologics, and other temperature-sensitive medications LOI includes minimum annual purchase commitments in Year 1 Expands TempraMed’s footprint across the Middle East and supports broader regional commercialization strategy Potential future expansion includes VIVI Med™, VIVI Epi™, and VIVI Cap Smart™ products