VICTORIA, British Columbia — Eupraxia Pharmaceuticals Inc. (“Eupraxia” or the “Company”) (NASDAQ:EPRX) (TSX:EPRX), a clinical-stage biotechnology company leveraging its proprietary Diffusphere™ technology designed to optimize local, controlled drug delivery for applications with significant unmet need, today announced positive 12-week and 36-week tissue health data from its ongoing Phase 1b/2a part...
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EMERYVILLE, Calif. – Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T-cell therapies to treat solid tumors, today announced the initiation of ARYA-2, a Phase I/II open-label, dose escalation clinical trial of ET140203 ARTEMIS® T-cell therapy in pediatric patients with relapsed or refractory hepatoblastoma (HB), hepatocellular neoplasm not otherwise specified (HCN-NOS),...
EMERYVILLE, Calif. – Eureka Therapeutics, Inc. announced today that Eureka and Memorial Sloan Kettering Cancer Center (MSK) entered into a license agreement with Sanofi for the non-CAR use of a novel, human binding domain targeting GPRC5D (G Protein-Coupled Receptor Family C Group 5 Member D). The GPRC5D binding domain was discovered using...
BRIDGEWATER, N.J. — Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that the European Commission has approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in...
Beerse, Belgium — Janssen-Cilag International NV, a Johnson & Johnson company, today announced that the European Commission (EC) has approved a new indication for DARZALEX® (daratumumab) subcutaneous (SC) formulation as monotherapy for the treatment of adult patients with smouldering multiple myeloma (SMM) at high-risk of developing multiple myeloma.3 SMM is an...
SAN DIEGO, Calif. — Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the European Commission (EC) has granted marketing authorization for DAYBU (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older, making it the first and only treatment approved...
PRINCETON, N.J. — Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has granted approval to Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy...
LONDON, UK – Vertex Pharmaceuticals Inc. (Nasdaq: VRTX) announced today that the European Commission has granted conditional marketing authorization to CASGEVY™ (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited therapy. CASGEVY is approved for the treatment of patients who are 12 years of age and older with severe sickle cell disease (SCD)...
BEERSE, BELGIUM — Janssen-Cilag International NV, a Johnson & Johnson company, today announced that the European Commission (EC) has approved an indication extension of IMBRUVICA® (ibrutinib) in frontline mantle cell lymphoma (MCL).1 The approval is for ibrutinib in combination with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone (ibrutinib + R-CHOP) alternating with R-DHAP...
WILMINGTON, Del. — Incyte (Nasdaq:INCY) today announced that the European Commission (EC) has approved Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC). “The EC approval of Zynyz...