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Nucleus RadioPharma’s two sites are meant to help address the industry’s lack of manufacturing and development capabilities, as well as geographic limitations associated with the short half-life of many radioactive components.
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Previous mega blockbusters took years to reach their peak sales. Lilly’s tirzepatide franchise is on course to exceed them just a few years in.
Experts suggest the FDA’s Advanced Manufacturing Technologies designation could be a lifeline for improving production processes for approved cell and gene therapies.
Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential.
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Merck, known as MSD outside of the United States and Canada, announced positive top-line results from the pivotal Phase 3 STELLAR trial evaluating the safety and efficacy of sotatercept, an investigational activin receptor type IIA-Fc fusion protein being evaluated as an add-on to stable background therapy for the treatment of pulmonary arterial hypertension .
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Read our takes on the biggest stories happening in the industry.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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Bristol Myers Squibb’s deal announced Monday will see the pharma pay $65 million upfront to Repertoire Immune Medicines, which will develop autoimmune disease vaccines using its Decode discovery platform.
Ono Pharmaceutical will pay $25.60 per share in an all-cash deal to buy Deciphera Pharmaceuticals for its potential blockbuster oncology drugs and U.S. sales infrastructure, the companies said Monday.
Johnson & Johnson and Addex Therapeutics’ epilepsy hopeful ADX71149 did not meet its primary endpoint of time to reach baseline seizure count in a mid-stage trial, as the partners look to determine the next steps for the program.
FDA
After laying off staff in 2022 to extend its cash runway, X4 Pharmaceuticals got its drug for the ultra-rare immunodeficiency disease across the finish line on Monday.
Citing anonymous sources involved in a Phase III trial, STAT News reported Sunday that MorphoSys’ pelabresib may worsen the risk of progression to acute myeloid leukemia, potentially putting Novartis’ proposed $2.9 billion acquisition at risk.
After a record low in 2022, the pharma industry in 2023 saw a surprise rebound in productivity following one of its slowest years on record, according to a report from audit firm Deloitte.
A one-fifth dose of Bavarian Nordic’s mpox vaccine Jynneos can elicit a similar antibody response as its standard-dose regimen, according to findings presented Saturday at the European Society of Clinical Microbiology and Infectious Diseases Global Congress.
With its first-in-class endothelin and angiotensin II receptor antagonist Filspari, Travere Therapeutics is providing a more efficacious treatment option for the rare autoimmune disease.
With GLP-1 agonists slated to become the best-selling drugs in 2024, the biopharma industry is already pivoting to explore treatments that preserve muscle mass as patients shed pounds.
Humira maintained its blockbuster status and market share dominance in the first quarter of 2024, but experienced a drop in sales as biosimilar competition heated up, AbbVie reported on Friday.