Scientists Race to Test Treatments as Ebola Outbreak Widens
Scientists in the Democratic Republic of Congo are treating a widening Ebola outbreak caused by the Bundibugyo virus, which has infected 695 people and killed 138. The makeshift Rwampara treatment center provides intensive supportive care, improving survival compared with past outbreaks. However, existing WHO‑approved drugs target the classic Ebola virus and are not proven against Bundibugyo, leaving a critical therapeutic gap. Researchers are racing to test repurposed antivirals and develop virus‑specific treatments.
Amgen Shores up Tavneos’ FDA Defense with Duke Data Analysis
Amgen has asked the FDA for a hearing to contest the agency’s demand that it withdraw Tavneos, its rare‑inflammatory disease drug. The company engaged the Duke Clinical Research Institute to conduct a fully blinded, independent re‑adjudication of the Phase 3 ADVOCATE...
Suven Life Sciences to Present Research Posters at APSS Meet in US
Suven Life Sciences, a clinical‑stage biopharma focused on CNS disorders, will present three research posters at the SLEEP‑2026 meeting in Baltimore. The posters highlight Samelisant’s positive Phase 2 efficacy data for excessive daytime sleepiness, the design of a Phase 2 study targeting...
FDA Grants Priority Review for Roche’s Tecentriq Combo sBLA
Roche has secured FDA priority review for its adjuvant Tecentriq (atezolizumab) and Tecentriq Hybreza combo with chemotherapy in stage III dMMR/MSI‑H colon cancer. The review, triggered by the Phase III ATOMIC trial, targets a decision by October 9, 2026. ATOMIC demonstrated a 50% reduction...
From Automation to Autonomy: How Agentic AI Is Redefining Biopharma’s Digital Workforce
Agentic AI is moving biopharma beyond narrow automation toward bounded autonomy, enabling software agents to manage multi‑step workflows with contextual awareness. These agents break primary objectives into subtasks, operate in parallel, and coordinate through a central layer that handles sequencing,...
The BioPharm Brief: CAR-T Progress, ADC Momentum, Biosimilar Expansion
Imviva Biotech presented data on its off‑the‑shelf CAR‑T candidate CTD402, reporting an 86% overall response rate in adult relapsed/refractory T‑ALL and an 80% complete remission rate in pediatric patients. Immunome dosed the first patient in a Phase 1 trial of IM‑1617,...
New Treatment Shows Promise for Patients with Rare Blood Disorder
A Phase 1 trial of autologous regulatory T‑cell (T‑reg) therapy in six patients with severe or treatment‑resistant aplastic anemia demonstrated safety and early efficacy. The treatment involved extracting patients' T‑regs, expanding them in a GMP facility, and delivering two infusions two...
Lupus Patients in England in Remission After Pioneering NHS Trial of GM Therapy
A pioneering NHS trial at University College London Hospitals used CAR‑T cell therapy to treat nine patients with severe lupus, achieving remission in five participants after an average 11‑month follow‑up. The therapy, which genetically reprograms a patient’s own T‑cells, was...
Non-Compliance Letters Under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act
The FDA has published a table of drug and biologic sponsors who received PREA Non‑Compliance letters under section 505B(d)(1) of the FD&C Act. These letters are issued when sponsors miss deadlines for required pediatric assessments, molecularly targeted cancer investigations, or pediatric...
FDA Accepts Immunotherapy Drug for Review in Colon Cancer Treatment
The FDA has accepted Genentech’s supplemental Biologic License Application for atezolizumab (Tecentriq) in stage III dMMR colon cancer, citing data from the phase III ATOMIC trial. The study of 712 patients showed a 50% reduction in recurrence or death, with 86.3% disease‑free...
Non-Viral Delivery of Full DMD mRNA Targets Muscles
A biotech firm announced a non‑viral lipid‑nanoparticle platform that delivers full‑length dystrophin (DMD) mRNA directly to skeletal muscle. In pre‑clinical mouse studies the single injection restored up to 45% of normal dystrophin levels and improved muscle function. The approach sidesteps...
S9 Nonclinical Evaluation for Anticancer Pharmaceuticals--Questions and Answers
The FDA issued a final guidance document (Docket FDA‑2009‑D‑0006) to answer common questions about implementing ICH S9, the international standard for non‑clinical evaluation of anticancer pharmaceuticals. Updated in June 2018, the Q&A aims to smooth the transition for developers struggling with...
New mRNA Delivery Platform Restores Muscle Function in DMD Models
Researchers at UT MD Anderson have engineered skeletal‑muscle‑targeted extracellular vesicles (t‑EVs) to deliver full‑length DMD mRNA systemically in mouse models of Duchenne muscular dystrophy. The treatment restored dystrophin production, markedly improving muscle strength, endurance, and overall function. Safety studies in...
Reduced-Frequency Dosing of FDA-Approved Bispecific Antibodies in Relapsed/Refractory Multiple Myeloma: A Systematic Review of Maintaining Efficacy While Reducing Infection- Related...
Bispecific antibodies targeting BCMA and GPRC5D have reshaped treatment for relapsed/refractory multiple myeloma, delivering overall response rates of 61‑70% but causing grade ≥3 infections in nearly half of patients on weekly dosing. A systematic review of 14 studies involving more than...
Ziftomenib Plus 7+3 Yields Strong Responses in NPM1-Mutated, KMT2A-Rearranged AML: Eunice S. Wang, MD
Ziftomenib combined with standard 7+3 intensive chemotherapy produced an overall response rate of roughly 93% in a frontline cohort of 99 newly diagnosed AML patients with NPM1 mutations or KMT2A rearrangements. Complete remission or CR with partial hematologic recovery reached...