Get the Daily Brief
Latest Biotech News
Cogent Biosciences Advances FDA Submission for Mastocytosis Treatment
Cogent Biosciences reported positive phase 2 results for bezuclastinib, targeting non-advanced systemic mastocytosis. The drug achieved statistically significant improvements in symptom scores and...
AI and Collaborative Platforms Drive Innovation in Oncology Drug Discovery
Revolution Medicines and Iambic Therapeutics have partnered in a multi-year collaboration to harness AI technology for cancer drug discovery. Iambic will train its NeuralPLexer AI model using...
Novel Gene Therapy for Deafness Shows Hearing Restoration Across Ages
A recent trial in China demonstrated promising results for AAV-OTOF gene therapy in treating autosomal recessive deafness 9. Ten participants aged 1.5 to 23.9 years showed significant hearing...
Expansion and Strategic Growth in Biopharma Manufacturing and AI Drug Discovery
Cytiva disclosed plans to complete $1.6 billion in expansions across the US, Europe, and Asia, to meet rising demand for biopharma manufacturing capabilities and promote in-region production....
Regulatory and Litigation Developments with Potential Biotech Market Impact
FDA efforts to reduce animal testing were reaffirmed by Commissioner Marty Makary, emphasizing streamlined drug development. Meanwhile, a federal lawsuit challenges recent federal changes to...
Breakthroughs in RNA and Protein Therapeutics Enabled by AI and Novel Platforms
Emerging studies reveal advances in RNA therapeutics and protein degraders, with AI-driven methods spotlighting novel targets and improving treatment efficacy. A machine learning approach now...
Radiopharmaceuticals Surge with Actithera's $75M Clinic Entry
Actithera, a pioneering radiopharmaceutical biotech based in Oslo and Cambridge, secured nearly $76 million in Series A financing to progress its novel cancer therapy pipeline targeting fibroblast...
KalVista's Oral Therapy Gets FDA Nod for Hereditary Angioedema
KalVista Pharmaceuticals won FDA accelerated approval for Ekterly (sebetralstat), the first oral on-demand treatment for hereditary angioedema (HAE) in patients aged 12 and older. The approval...
Cogent’s Mastocytosis Drug Clears Phase II with Positive Data
Cogent Biosciences’ bezuclastinib demonstrated statistically significant improvements in indolent systemic mastocytosis during a registrational Phase II study, producing meaningful symptomatic...
ProKidney’s Cell Therapy Shows Mixed Phase II CKD Results with Stock Spike
ProKidney’s autologous cell therapy rilparencel reported a 78% slowing of kidney function decline in one patient cohort of a Phase II chronic kidney disease trial, while a second cohort showed a...
Novartis Secures Newborn Approval for Malaria Therapy Coartem Baby
Novartis gained Swiss regulatory clearance for Coartem Baby, the first malaria treatment formulated specifically for newborns and young infants. The new dosing addresses an unmet need for safe,...
Artificial Intelligence Advances Protein Engineering and Synthetic Biology
Researchers have developed new AI-driven techniques to rapidly engineer proteins by integrating structural and evolutionary constraints without custom training for specific proteins. Additionally,...
FDA Faces Staff Exodus Amid Morale Crisis Impacting Drug Reviews
The FDA is experiencing a significant morale and staffing crisis following major personnel departures in April and ongoing talent losses. This exodus threatens the agency’s capacity to maintain...
CRISPR and Gene Therapy Partnerships Push Genomic Medicine Forward
Collaborations and clinical advances mark progress in gene editing and therapeutic development. Abu Dhabi’s DoH joined forces with UCSF and Innovative Genomics Institute to establish genome...
Medical Groups Sue HHS Secretary Over Changes to COVID-19 Vaccine Policy
Six medical organizations and a pregnant physician filed a lawsuit against Health and Human Services Secretary Robert F. Kennedy Jr., challenging recent federal changes that removed COVID-19...
AI Transforms Protein and Drug Engineering
Artificial intelligence is rapidly reshaping protein engineering and drug development. University of Copenhagen secured a $109 million grant from Novo Nordisk Foundation to establish a protein...
Actithera Advances Radiopharmaceutical Cancer Drugs with $75M Funding
Actithera, a radiopharmaceutical startup with bases in Oslo and Cambridge, has raised nearly $76 million in Series A funding to develop experimental cancer drugs targeting fibroblast activation...
FDA Approvals and Regulatory Updates in Biotech and Med-Tech
Recent months have seen several key regulatory developments. The FDA granted accelerated approval to KalVista’s oral drug Ekterly for hereditary angioedema, marking a first oral option for this...
Progress and Setbacks in Duchenne Muscular Dystrophy Drug Trials
Taiho Pharmaceutical reported the failure of its phase III trial for pizuglanstat, an experimental therapy for Duchenne muscular dystrophy (DMD). The study did not meet its primary endpoint...
Kidney Disease Cell Therapy Shows Promise Despite Mixed Phase 2 Results
ProKidney announced mixed phase 2 trial outcomes for rilparencel, its autologous cell therapy targeting chronic kidney disease (CKD). One patient cohort receiving two injections demonstrated a...