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
Analysts at Guggenheim Partners expect Voyxact to see “broad commercial uptake” given its relatively broad label compared with previous accelerated approvals for IgA nephropathy.
The discounts should be compared against the drugs’ “ultimate net price” rather than their indicated list price to gauge the true impact of the negotiations, BMO Capital Markets analysts said.
Imfinzi is the first immunotherapy approved for perioperative use to treat gastric and gastroesophageal junction cancers.
A coordinated national effort is emerging to bring alternatives to animal testing into routine preclinical use, backed by a fresh FDA roadmap and a global coalition of scientific and industry partners.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
The FDA approved an intrathecal form of Novartis’ spinal muscular atrophy gene therapy Zolgensma on Monday, broadening access to patients two years and older in what one Stanford Medicine professor called a “game changing advance” for the field.
At one point in merger negotiations with Novartis, Avidity CEO Sarah Boyce and her team walked, cutting off access to a data room and moving on to a capital raise.
Follow along as BioSpace tracks job cuts and restructuring initiatives.
Novo Nordisk’s amycretin showed no weight-loss plateau over 36 weeks in patients with type 2 diabetes, suggesting its efficacy could become even stronger with longer follow-up, according to analysts at BMO Capital Markets.
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.
Tecvayli plus Darzalex led to an 83% boost to progression-free survival versus the current standard therapy in relapsed or refractory multiple myeloma, results analysts at Guggenheim Securities called “remarkable.”
Richard Pazdur, the new director of the Center for Drug Evaluation and Research, raised concerns amid the rollout of several FDA initiatives seeking to shorten the drug review process.
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