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Newborn genome sequencing project in France seeks to revolutionize early diagnosis
The Perigenomed initiative in France is advancing routine genome sequencing-based newborn screening, aiming to transform early detection of hundreds of treatable rare diseases. The program has...
Nuclidium raises $98M to advance copper-based radiopharmaceuticals for cancer
Swiss-German radiopharmaceutical developer Nuclidium secured $98 million in Series B funding to propel clinical development and expand production of its copper-based radiotheranostics. The firm’s...
FDA raises safety concerns over GSK’s multiple myeloma antibody-drug conjugate Blenrep
Ahead of an advisory committee meeting, FDA reviewers highlighted significant safety issues with GSK’s Blenrep in multiple myeloma treatment, especially high rates of severe ocular toxicities...
Breakthroughs in spatial transcriptomics and AI fuel tumor microenvironment research
Researchers at Oregon Health & Science University have developed OmicsTweezer, an AI-powered model integrating single-cell and bulk omics data to enhance tumor tissue analysis. Leveraging deep...
FDA narrows Moderna Covid vaccine approval for children, underscoring regulatory fractures
FDA’s Center for Biologics Evaluation and Research director Vinay Prasad overruled unanimous agency reviewers to limit Moderna’s Spikevax COVID-19 vaccine full approval to children aged 6 months...
Sarepta Therapeutics Restructures After DMD Therapy Safety Issues
Sarepta Therapeutics has announced a significant restructuring following safety concerns tied to its Duchenne muscular dystrophy (DMD) gene therapy, Elevidys. The company plans to cut...
Global Neurodegeneration Proteomics Consortium Unveils Biomarkers
The Global Neurodegeneration Proteomics Consortium (GNPC) has released one of the largest proteomic datasets encompassing approximately 250 million protein measurements from over 35,000 biosamples...
Sino Biopharmaceutical Acquires LaNova Medicines for $951 Million
Sino Biopharmaceutical Ltd. has agreed to acquire nearly all remaining shares of LaNova Medicines Ltd., a Chinese biotech with a pipeline of eight clinical-stage candidates including antibody-drug...
FDA Raises Concerns Over GSK’s Multiple Myeloma Drug Blenrep
Ahead of an advisory committee meeting, the FDA has flagged significant safety concerns for GSK’s antibody-drug conjugate Blenrep (belantamab mafodotin), notably high rates of ocular toxicity...
Advances in AI and Single-Cell Technologies Propel Oncology and Diagnostics
Several companies and academic groups are harnessing AI and single-cell platforms to improve cancer diagnostics and drug discovery. One Biosciences, a French startup, raised €15 million to...
FDA Urges More Data for Otsuka's PTSD Treatment Rexulti
The FDA has challenged the efficacy data package for Otsuka Pharmaceutical’s Rexulti, an add-on therapy for post-traumatic stress disorder (PTSD), requesting additional studies ahead of an...
Merck Acquires Verona Pharma, Secures Long-Term IP on COPD Drug
Merck & Co.’s $10 billion acquisition of Verona Pharma secures rights to Ohtuvayre, a novel inhaled PDE3/4 inhibitor approved for chronic obstructive pulmonary disease (COPD). Despite the...
Newborn Genome Sequencing Project in France Advances Rare Disease Detection
The Perigenomed project in France is exploring the feasibility of routine genome sequencing as part of newborn screening. With 500 babies sequenced to date and expansion plans to sequence 2,500...
Johnson & Johnson Beats Q2 Expectations Driven by Medical Devices and Pharma
Johnson & Johnson reported a strong second quarter with sales surpassing $23.7 billion, driven by medical devices which grew over 8% and pharmaceuticals exceeding $15 billion in revenue. The...
New Techniques Illuminate Brain Function and Cancer Mechanisms
Scientists are making significant strides in mapping brain activity and cellular behaviors. Harvard and Broad Institute teams identified endothelial connexin clusters critical for propagating...
Sarepta restructures amid gene therapy safety concerns and black box warning
Sarepta Therapeutics has initiated a significant restructuring after safety issues emerged with its Duchenne muscular dystrophy gene therapy Elevidys, including two patient deaths from acute liver...
Mitochondrial donation trial reports eight healthy births in UK
Researchers in the UK reported the birth of eight healthy babies following mitochondrial donation and pronuclear transfer, a technique involving DNA from three people to prevent mitochondrial...
FDA and regulatory updates challenge drug approvals and market entries
The Food and Drug Administration has recently raised questions and regulatory hurdles for several drugs. The FDA questioned the efficacy of Otsuka's Rexulti combination for PTSD, requesting more...
New advances in understanding and targeting neurodegenerative diseases
Significant progress has been made in neurodegenerative disease research through proteomics, genetics, and novel therapies. The Global Neurodegeneration Proteomics Consortium released one of the...
AI and computational tools empower drug discovery and process optimization
Artificial intelligence and advanced computational platforms are increasingly transforming drug discovery and biomanufacturing. Biotx AI, a German startup, enhances genome-wide association data...