Biologically Active Substance
Rezon Bio Launches Two State-of-the-Art CDMO Facilities for Biologics in Europe
Rezon Bio; biologics; CDMO; contract manufacturing; Gdańsk; Warsaw-Duchnice; Europe; digital innovation; GMP manufacturing; biosimilars; EMA; FDA
Eli Lilly Invests $6.5 Billion in Texas Facility to Manufacture Obesity Pill
Eli Lilly; Texas facility; obesity pill; orforglipron; pharmaceutical manufacturing; API; AI automation; supply chain resilience; job creation
Eli Lilly Picks Houston for $6.5 Billion API Manufacturing Facility
Eli Lilly; Houston; API manufacturing; $6.5 billion investment; Generation Park; small molecule medicines; pharmaceutical manufacturing; cardiometabolic; oncology; immunology; neuroscience
Ionis Heads to FDA as Antisense Therapy Aces Pivotal Study in Rare Neurological Disease
Ionis Pharmaceuticals; zilganersen; antisense oligonucleotide; Alexander disease; pivotal Phase I–III study; FDA Fast Track designation; rare neurological disease; expanded access program; walk speed improvement; Orphan Drug designation
FDA Approves Stealth BioTherapeutics’ Forzinity as First Treatment for Barth Syndrome After Rejection and Delay
FDA approval; Stealth BioTherapeutics; Forzinity; elamipretide; Barth syndrome; rare disease; mitochondrial dysfunction; accelerated approval
Big Pharma-Backed MapLight Plots IPO to Advance Neuro Pipeline
MapLight Therapeutics; IPO; neuro pipeline; Alzheimer’s disease psychosis; schizophrenia; M1/M4 muscarinic agonist; Series D financing; Morgan Stanley; biopharmaceutical; clinical trials
FDA Grants Accelerated Approval to Stealth BioTherapeutics’ Forzinity, the First Treatment for Barth Syndrome
FDA approval; Stealth BioTherapeutics; Forzinity; elamipretide; Barth syndrome; mitochondrial disease; accelerated approval; rare disease; pediatric disease; clinical trial
Recent News: Gain Peace of Mind with the Lentiviral Experts
lentiviral vectors; CAR-T therapy; gene therapy; biologics; immuno-oncology; market growth; advanced manufacturing; regulatory approval
Roche Acquires 89bio with $2.4 Billion Buyout to Enter FGF21 MASH Therapeutics Space
Roche; 89bio; acquisition; FGF21; pegozafermin; MASH; metabolic dysfunction-associated steatohepatitis; liver disease; biotech; contingent value rights; cardiometabolic diseases
Eli Lilly’s Oral GLP-1 Orforglipron Outperforms Semaglutide in Diabetes and Weight Loss Trials
Lilly; orforglipron; oral GLP-1; semaglutide; type 2 diabetes; weight loss; phase 3 trial; Novo Nordisk