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Drug Discovery & Development
Vertex gains US FDA approval for expanded use of Casgevy in children from two years old with sickle cell disease or transfusion-dependent beta thalassemia
The US Food and Drug Administration (FDA) has approved expanded use of Casgevy (exagamglogene autotemcel) for the treatment of people ages two years and older with either...
Vertex Pharmaceuticals and Crinetics Pharmaceuticals, a global pharmaceutical company focused on the discovery, development and commercialisation of novel therapeutics for endocrine diseases, have entered into...
Finance, mergers and appointments
Cumberland Pharmaceuticals closes strategic transaction with Apotex
Cumberland Pharmaceuticals has made an agreement with a subsidiary of Apotex Health, a Canadian-based pharmaceutical company, to integrate their branded US businesses. Under the...
Drug Discovery & Development
Sanyou Bio and Baiyunshan Xihe join forces to advance innovative radiopharmaceuticals and radiodiagnostics
Sanyou Biopharmaceutical and Guangzhou Baiyunshan Xihe have signed a strategic cooperation agreement.
The partnership will focus on the co-development of novel radiopharmaceuticals and radiodiagnostic products,...
Finance, mergers and appointments
Codis to acquire Catalent’s Nottingham (UK) facility to create Europe’s leading end-to-end spray dry capability
Codis, a global contract development and manufacturing organisation (CDMO) specialising in spray drying, amorphous solid dispersions and advanced particle engineering solutions, has entered an...
Pharma Delivery and Supply Chain
Vector Science & Therapeutics announces cGMP manufacturing agreement with LyoGenesis Plus for its proprietary peptide portfolio
Vector Science & Therapeutics Chas entered an exclusive licensing and manufacturing agreement with LyoGenesis Plus, a cGMP lyophilisation and manufacturing partner based in Mequon,...
Finance, mergers and appointments
Helix announces long-term agreement with AstraZeneca to support genomic research for drug discovery and development
Helix, a leading enterprise genomics company, has announced a multi-year relationship with AstraZeneca, a global biopharmaceutical company. Under this agreement AstraZeneca will gain access...
Clinical Trials Insights
Keenova announces positive phase 3 results in clinical trial of Xiaflex (collagenase clostridium histolyticum) for treating plantar fibromatosis
Keenova Therapeutics has announced positive results from its phase 3 clinical trial of Xiaflex (collagenase clostridium histolyticum) for the treatment of plantar fibromatosis, a chronic...
Clinical Trials Insights
Mighty Therapeutics announces first patient dosed in phase 4 confirmatory study of Elamipretide in Barth Syndrome
Mighty Therapeutics, a commercial-stage biotechnology company pioneering a new class of medicines that directly target mitochondrial dysfunction in rare and age-related diseases, has dosed...
Clinical Trials Insights
Octapharma USA announces expanded FDA approval of Wilate for von Willebrand disease prophylaxis in children under six years
The US Food and Drug Administration (FDA) has approved the use of Wilate (von Willebrand Factor/Coagulation Factor VIII Complex ) for routine prophylaxis to reduce...
Clinical Trials Insights
Northwest Biotherapeutics presents updated survival data from phase 3 trial of DCVax-L for Glioblastoma using individual patient level data in multiple independent analyses
Northwest Biotherapeutics, a biotechnology company developing DCVax personalised immune therapies for solid tumour cancers, has presented updated survival data from the phase 3 trial of...
Clinical Trials Insights
Lynk Pharmaceuticals announces first patient dosed in phase 2 clinical trial of LNK01004 ointment for vitiligo
Lynk Pharmaceuticals, a clinical-stage innovative drug development company focused on immune and inflammatory diseases, has successfully dosed the first patient in the phase 2 clinical trial...
Drug Discovery & Development
WuXi Biologics’ MFG8 drug substance facility secures FDA PLI approval, advancing commercial supply of a potential blockbuster autoimmune therapy
WuXi Biologics, a leading global contract research, development and manufacturing organisation (CRDMO), has announced that its MFG8 drug substance manufacturing facility located in Hebei...
Clinical Trials Insights
Blue Earth Therapeutics announces first participant dosed in phase 1 clinical trial investigating actinium injection in metastatic castration-resistant prostate cancer
Blue Earth Therapeutics, a clinical-stage radiopharmaceutical company and University College London (UCL) has announced initiation of a phase 1 clinical trial (NCT07414940) evaluating actinium...
Drug Discovery & Development
FDA approves Ennumo, Accord BioPharma’s second pegfilgrastim biosimilar to Neulasta
Accord BioPharma, the US specialty division of Intas Pharmaceuticals, focused on the development of oncology, immunology and central nervous system (CNS) therapies, has announced...
Drug Discovery & Development
Priority review granted to bispecific antibody Opamtistomig, accelerating commercialisation and addressing unmet need in EP-NEC
Nanjing Leads Biolabs has announced that the biologics license application (BLA) for Opamtistomig (a bispecific antibody) as monotherapy for the treatment of advanced extrapulmonary...
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