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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
Servier will pick up Ojemda, which received FDA approval in 2024 to treat pediatric glioma. The drug clocked sales of $155 million for Day One Biopharmaceuticals in 2025.
TrumpRX and DTC sales may expand prescription drug access, but they will not solve the affordability crisis by themselves.
Zealand Pharma’s shares fell 32% in early morning trading Friday after its Roche-partnered asset petrelintide failed to meet investor expectations in a mid-stage clinical trial.
The FDA granted Johnson & Johnson a Commissioner’s National Priority Voucher in December 2025 after the combination of Darzalex and Tecvayli improved progression-free survival by 83%. The new approval is for second-line treatment of the blood cancer.
Follow along as BioSpace tracks job cuts and restructuring initiatives.
UniQure does not have to drill placebo burr holes in the skulls of patients with Huntington’s disease, an unnamed FDA senior official said on Thursday. Instead, the company would anesthetize them and put “one to three nicks” in their scalp.
Psychedelics are a “game changer” in depression care, according to William Blair, but the complicated treatment regimens mean they will likely be supplanted by more-traditional options once they become available.
The alliance, which pairs Tenaya’s modality agnostic target identification and validation capabilities with Alnylam’s deep experience in RNA interference therapeutics, comes during a period of resurgence for the cardiovascular space.
UniQure’s Path for Huntington’s Gene Therapy Clouded by Ethical Questions as Potential Phase 3 Looms
While the FDA appears to be adamant that uniQure conduct a sham surgery–controlled Phase 3 trial before AMT-130 can be considered for approval, experts believe there is an alternate path forward for the therapy, perhaps even based on precedent from the recent drama surrounding Moderna’s mRNA flu vaccine.
Adam Urato, who is currently a vaccine advisor to the CDC, is closely associated with acting CDER director Tracy Beth Høeg and is a fellow skeptic of the use of selective serotonin reuptake inhibitors during pregnancy.
The timing of the partial hold is “odd,” according to analysts at Stifel, who noted that the preclinical data the FDA took issue with were filed in mid-2024.
South Korea has attracted increasing investment from the pharmaceutical industry, which is drawn to the Asian country due to its experience in antibody-drug conjugates and cell and gene therapies, according to McKinsey.
PRESS RELEASES
• Gross Profit increased 73% YoY • Gross Margin increased 500 basis points to 68% • Adjusted EBITDA loss reported at $1.46M vs $1.17M in year-ago quarter • Near-term business objectives are focused on preserving cash, stabilizing operations, and securing the financial resources required to support continuity of operations
Leading distributor of global companies including GSK/Haleon, Cargill, Reynolds, Paskesz Guri distributes reputable brands including Sensodyne, Aquafresh, Parodontax, Truvia, Diamond and more Strategic agreement supports TempraMed’s global shift from online B2C to major pharmacy networks and B2B medical payers Distribution to over 2,500 outlets including pharmacy chains, supermarkets, HMOs and independent pharmacies
Breakthrough oral CDK9 inhibitor advances care for patients with recurrent high-grade gliomas harboring IDH1/2 mutations
NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES
Approved multicenter study sponsored by Sheba Medical Center to compare group and individual MDMA-assisted therapy for 168 patients experiencing trauma-related PTSD