Latest News
& Press Releases
Browse the latest news from BioSpace, and press releases from around the industry. Want to filter by date, keyword, and more? Search here.
TOP STORIES
Denali Therapeutics is the latest company to sell a priority review fast pass for an elevated price after the program was renewed earlier this year.
The U.S. government has argued that it pays too much of biopharma R&D costs, demanding that other high-income countries contribute fairly to global innovation efforts.
The FDA in February briefly refused to review Moderna’s flu vaccine, citing trial inadequacies, but reversed course a few days later. A verdict is expected by Aug. 5.
Memento’s lead asset is a bispecific antibody that blocks VEGF and activates Tie2. The biotech plans to test the candidate in retinal conditions such as neovascular age-related macular degeneration and diabetic macular edema.
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?
Backed by institutional investors and seasoned industry leaders, cAMPfield Therapeutics is advancing a clinical program aimed at reshaping the landscape for inflammatory bowel disease.
In this episode of Denatured, you’ll hear from Mark Lowdell, CSO & co-founder at INmuneBio Inc. and Vishwas Seshadri, CEO & director at Abeona Therapeutics. We explore how recessive dystrophic epidermolysis bullosa has become a defining case study for gene and cell therapy and what this ultra‑rare disease reveals about the future scalability of advanced therapies.
Analysts are cautiously optimistic about an IPO rebound for biopharma. BioSpace is keeping track of companies that seek to trade on the public markets this year.
The takeovers depend on Moderna reaching an agreement with the German government, which risks losing investment from drugmakers over planned healthcare reforms.
Following the mid-stage readout, Verastem Oncology has decided to move away from its investigational pancreatic cancer drug combo, instead putting resources behind its KRAS inhibitor pill for solid tumors.
RayThera will bring three preclinical assets into the Biogen fold, all with anti-inflammatory activity. The most mature of these assets is expected to enter Phase 1 development in Q3.