Disease or Syndrome – Page 25

FDA Delays Draw Contrasting Responses: Neurizon Cites Agency Strain, Omeros Takes Softer Tone

3 months ago talkbio0Tagged agency staffing shortages, Amyotrophic Lateral Sclerosis, delays, narsoplimab, NUZ-001, Omeros Corporation, regulatory review, Study on Hold, Transplantation, United States Food and Drug Administration

FDA delays; Neurizon Therapeutics; Omeros Corporation; regulatory review; NUZ-001; narsoplimab; ALS; transplant drugs; agency staffing shortages; clinical hold

FDA Grants Full Approval to Precigen’s Papzimeos for Rare Disease RRP

3 months ago talkbio0Tagged Approved, Episodic, gene therapy, Immunotherapy, Infrequent, orphan drug designation, Papzimeos, Precigen, Recurrent respiratory papillomatosis, RRP, United States Food and Drug Administration

Precigen; Papzimeos; FDA approval; recurrent respiratory papillomatosis (RRP); gene therapy; immunotherapy; rare disease; Orphan Drug designation

HHS Revives ’90s-Era Task Force to Improve Childhood Vaccine Safety

3 months ago talkbio0Tagged Adverse reactions, Advisory Committees, Centers for Disease Control and Prevention (U.S.), CHARGE Syndrome, Childhood, Childhood Vaccines, Jay Bhattacharya, NIH Mouse, Robert F. Kennedy Jr., United States Food and Drug Administration, Vaccine Safety, Vaccines

HHS; childhood vaccines; vaccine safety; task force; Robert F. Kennedy Jr.; Jay Bhattacharya; NIH; FDA; CDC; vaccine oversight; adverse reactions; childhood immunization schedule

Sarepta Sells $174 Million Stake in Arrowhead to Fund Milestone Payment Amid Cash Crunch

3 months ago talkbio0Tagged Arrowhead, Cash Crunch, Collaboration, milestone payment, Myotonic Dystrophy, private block trade, RNA Interference, SRP-1003, stake sale

Sarepta Therapeutics; Arrowhead Pharmaceuticals; cash crunch; stake sale; milestone payment; RNAi collaboration; SRP-1003; myotonic dystrophy; private block trade

Eli Lilly and Superluminal Ink $1.3B Pact Targeting GPCRs in Obesity, Cardiometabolic Diseases

3 months ago talkbio0Tagged Artificial Intelligence, cardiometabolic diseases, Eli, Eli Lilly, equity, GPCRs, Investments, MC4R, MC4R protein, human, milestones, Obesity, Partnership, Superluminal Medicines

Eli Lilly; Superluminal Medicines; GPCRs; obesity drugs; cardiometabolic diseases; AI drug discovery; MC4R; partnership; milestones; equity investment

CytomX Continues Phase I ADC Study After Patient Death

3 months ago talkbio0Tagged ADC, Clinical Trials, Colorectal Carcinoma, CX-2051, CytomX, Kidney Failure, Acute, Patient Death, Phase I, Safety, therapeutic autologous dendritic cells, United States Food and Drug Administration

CytomX; CX-2051; Phase I; ADC; colorectal cancer; patient death; acute kidney injury; clinical trial; safety; FDA; trial continuation

NIH and HHS Cancel Major mRNA Vaccine Research Funding, Citing Lack of Public Trust

3 months ago talkbio0Tagged BARDA, COVID19 (disease), grant cancellation, Jay Bhattacharya, mRNA Vaccine, NIH Mouse, public trust, research funding, RFK Jr., Vaccination Hesitancy

NIH; mRNA vaccine; public trust; research funding; BARDA; COVID-19; vaccine hesitancy; RFK Jr.; Jay Bhattacharya; grant cancellation

Response Pharma: RDX-002 Limits Weight Regain After GLP-1 Therapy – Positive Phase II Results Announced

3 months ago talkbio0Tagged cardiometabolic health, Discontinuation (procedure), Glucagon-Like Peptide 1, iMTP, Inhibitor, Obesity, Phase 2 Clinical Trials, postprandial, RDX-002, Response process, Triglycerides, weight regain

Response Pharmaceuticals; RDX-002; GLP-1 discontinuation; weight regain; obesity; Phase II clinical trial; postprandial triglycerides; cardiometabolic health; iMTP inhibitor

Insmed Secures FDA Approval for First DPP1 Inhibitor in Lung Disease

3 months ago talkbio0Tagged Approved, brensocatib, Brinsupri, Bronchiectasis, CTSC gene, Inhibitor, Insmed, Lung diseases, United States Food and Drug Administration

Insmed; FDA approval; DPP1 inhibitor; Brensocatib; Brinsupri; bronchiectasis; lung disease

Insmed’s Brinsupri Receives First-Ever FDA Approval for Progressive Lung Disease

3 months ago talkbio0Tagged Approved, brensocatib, Brinsupri, Bronchiectasis, CTSC gene, Inhibitor, Insmed, Lung diseases, neutrophil-mediated disease, non-cystic fibrosis bronchiectasis, Progressive, United States Food and Drug Administration

Brinsupri; Insmed; FDA approval; non-cystic fibrosis bronchiectasis; bronchiectasis; DPP1 inhibitor; brensocatib; progressive lung disease; neutrophil-mediated disease; first-in-class