Trump signs executive order seeking to split MMR vaccine, overhaul childhood immunization schedule
The Trump administration's executive order aims to split the MMR vaccine into separate shots and reduce the childhood immunization schedule, facing pushback fro
BioPharma Dive · +14 outlets
Sionna Therapeutics cystic fibrosis drug fails Phase 2 trial, stock plunges
Sionna's CF drug had no meaningful additive effect when combined with Vertex's Trikafta, surprising analysts and removing a key competitive threat to Vertex.
BioPharma Dive · +14 outlets
FDA rejects ITM radiopharmaceutical therapy over manufacturing issues
The FDA rejected ITM's radiopharmaceutical cancer therapy due to manufacturing concerns, halting what was expected to be a competitor to Novartis's Pluvicto.
STAT · +6 outlets
Medicaid to stop funding some gender-affirming care for transgender minors under Trump administration
The Trump administration plans to end federal funding for certain gender-affirming treatments for transgender youth through Medicaid.
STAT · +14 outlets
Epicrispr raises $90M Series C for epigenetic editing therapy in rare muscle disease FSHD
Epicrispr closed an oversubscribed $90 million Series C to advance its first-in-class epigenetic therapy toward pivotal studies in facioscapulohumeral muscular
BioPharma Dive · +6 outlets
FDA grants accelerated approval to Replimune's herpes virus-based melanoma therapy RP1
The FDA approved Replimune's oncolytic virus therapy for melanoma after prior rejections, marking a new treatment option in skin cancer.
Medical Xpress · +12 outlets
Vaderis Therapeutics nets $152M Series B for AKT-targeting drug in rare bleeding disorder HHT
Vaderis raised a large Series B to advance engasertib, an AKT inhibitor for hereditary hemorrhagic telangiectasia, a rare bleeding disorder with no approved tre
BioPharma Dive · +1 outlets
Jazz Pharmaceuticals to buy Actio Biosciences for up to $1.3B in rare epilepsy drug deal
Jazz will acquire Actio Biosciences for $820 million upfront plus milestones, adding a rare epilepsy drug to its pipeline amid a surge in private biotech buyout
BioPharma Dive · +4 outlets
AbCellera stock surges after positive Phase 2 results for menopause hot flash treatment
AbCellera's stock soared on 'off the chart' trial results for a new treatment targeting hot flashes in menopausal women.
The Globe and Mail · +14 outlets
PDS Biotech prioritizes PDS0301 in colorectal cancer after 71% response rate, discontinues PDS0101
PDS Biotech is refocusing on PDS0301 for metastatic colorectal cancer after data showed 80% 24-month survival with liver metastases, while ending a Phase 3 tria
Stock Titan · +5 outlets
MoonLake Immunotherapeutics nanobody hits all endpoints in Phase 3 psoriatic arthritis trial
MoonLake's nanobody sonelokimab met all clinical endpoints in a Phase 3 psoriatic arthritis trial, though questions linger about data transparency.
STAT · +6 outlets
Skylark Bio launches new gene therapy trial for deafness targeting GJB2 and otoferlin mutations
Skylark Bio begins clinical testing of gene therapies for genetic deafness, joining a race with biotechs in the US, France, and China.
STAT · +2 outlets
Tenax Therapeutics heart failure drug levosimendan fails Phase 3 study
Tenax's levosimendan, unapproved in the US for decades, failed a pivotal Phase 3 trial, narrowing its potential FDA path.
STAT · +8 outlets
Sobi inks $580M deal with Innate Pharma for skin cancer drug lacutamab
Sobi licensed global rights to Innate Pharma's lacutamab for cutaneous T-cell lymphoma ahead of a pivotal trial, in a deal worth up to $580 million.
finance.biggo.com · +1 outlets
FDA approves palbociclib for HR+, HER2+ breast cancer maintenance therapy
The FDA expanded approval of Pfizer's palbociclib (Ibrance) for maintenance treatment of HR-positive, HER2-positive breast cancer.
AJMC · +14 outlets
Stopping statins in low-risk adults over 75 found safe, does not increase deaths
A new Lancet study found that discontinuing statins in people over 75 at low cardiovascular risk did not increase mortality, suggesting it may be safe.
STAT · +14 outlets
K2 Therapeutics launches with $50M seed round, ex-Legend CEO Ying Huang at helm
Singapore-based K2 Therapeutics, led by former Legend Biotech CEO Ying Huang, raised $50 million to license high-potential drugs from China.
BioPharma Dive · +1 outlets
FDA grants RMAT designation to Lexeo's LX2020 gene therapy
Lexeo Therapeutics received FDA Regenerative Medicine Advanced Therapy designation for LX2020, accelerating development of the gene therapy.
PharmaTimes · +6 outlets