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THE GOOD
Approvals & Labels

Johnson & Johnson's IMAAVY (nipocalimab) wins EU approval for generalised myasthenia gravis as first FcRn blocker
Antibody, autoimmune, FcRn blocker, generalized myasthenia gravis, immunoglobulin G reduction - Read more

Lupin receives FDA tentative approval for siponimod tablets targeting relapsing forms of multiple sclerosis
Small molecule, neurological, multiple sclerosis, generic drug, sphingosine-1-phosphate receptor modulator - Read more

FDA approves Ayrmid's Omisirge (omidubicel-onlv) as first cell therapy for severe aplastic anemia treatment
Cell therapy, hematological disorders, stem cell transplant, severe aplastic anemia, graft-versus-host disease - Read more

THE GOOD
Business Development & Partnerships

Immortal Dragons, Etheros partner on aging disease drugs targeting oxidative stress with fullerene derivatives
Equity investment, neurological, small molecule, longevity, antioxidant technology - Read more

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THE GOOD
Clinical Trials

Pfizer's Hympavzi shows Ph3 success reducing bleeding in hemophilia A and B patients with inhibitors
Protein therapy, blood disorders, tissue factor pathway inhibitor, hemophilia, bleeding prevention - Read more

Encoded Therapeutics reports 78% seizure reduction with ETX101 gene therapy in Ph1/2 Dravet syndrome trial
Gene therapy, neurological, AAV gene therapy, Dravet syndrome, SCN1A gene - Read more

Praxis stops Ph2 EMBOLD trial early for efficacy, relutrigine targets developmental and epileptic encephalopathies
Small molecule, neurological, sodium channel blocker, epilepsy, developmental and epileptic encephalopathies - Read more

Vertex's Casgevy (exagamglogene autotemcel) hits Ph3 goals in children with sickle cell disease and beta thalassemia
Cell therapy, hematological disorders, CRISPR, sickle cell disease, beta thalassemia, pediatric - Read more

Gilead's anito-cel (anitocabtagene autoleucel) shows no delayed neurotoxicities in Ph2 relapsed refractory multiple myeloma study
Cell therapy, cancer, CAR-T, multiple myeloma, BCMA target - Read more

Eli Lilly's Jaypirca (pirtobrutinib) meets primary endpoint in Ph3 trial versus Imbruvica for chronic lymphocytic leukemia
Small molecule, cancer, BTK inhibitor, chronic lymphocytic leukemia, Bruton tyrosine kinase - Read more

Rapport Therapeutics reports positive Ph2 results for RAP-219 in focal onset seizures with 70% reduction
Small molecule, neurological, epilepsy, focal onset seizures, RAP-219 - Read more [Paywall]

THE GOOD
Earnings & Finances

UCB raises 2025 guidance above €7.6B ($8.85B) driven by exceptional Bimzelx performance and strong patient demand
Monoclonal antibody, autoimmune, financial, strategic - Read more

THE GOOD
Fundraises

TauC3 Biologics raises $2.5M investment, developing TBL-100 antibody for neurodegeneration
Neurological, antibody, tauopathies, preclinical, biomarker discovery - Read more

Protara raises $75M public offering, funding TARA-002 clinical development program
Clinical-stage, oncology, rare disease, transformative therapies - Read more

Dasan Pharmaceutical raises $10M funding, IPO prep and global CDMO expansion
CDMO, manufacturing, pharmaceutical ingredients - Read more

THE GOOD
Lawsuits

German court grants Halozyme preliminary injunction halting Merck & Co.'s Keytruda SC launch activities over patent dispute
Monoclonal antibody, oncology, strategic, competitive - Read more

THE GOOD
Regulatory

FDA lifts partial clinical hold on Vanda Pharmaceuticals' motion sickness drug tradipitant following dispute resolution
Small molecule, neurological, regulatory, operational - Read more

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THE BAD
Clinical Trials

Guard Therapeutics discontinues RMC-035 development after Ph2b POINTER study fails to meet primary endpoints in cardiac surgery patients
Protein therapy, cardiovascular, peptide therapy, acute kidney injury, cardiac surgery - Read more

THE BAD
Regulatory

NICE raises UK drug cost-effectiveness threshold to £35,000, ($46K) delaying current reviews until April
Regulatory, financial, strategic, operational - Read more

THE UGLY
Regulatory

mRNA coalition warns FDA turmoil from staff changes threatens public health trust
mRNA vaccine, infectious disease, regulatory, operational - Read more

CDC panel weakens newborn hepatitis B vaccine recommendations, shifting to shared decision-making approach
Vaccine, infectious disease, regulatory, operational - Read more

You’re all caught up on the latest Pharma & Biotech News!

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