Halozyme Therapeutics Announced US FDA Approval for Janssen Biotech's DARZALEX FASPRO® Halozyme Therapeutics (HALO) announced that Janssen Biotech, Inc. (Janssen) received U.S. FDA approval of DARZALEX FASPRO® (daratumumab + hyaluronidase-fihj) in combination with pomalidomide and dexamethasone (Pd) for adult patients with multiple myeloma who have received at least one prior line of therapy, including . . . This content is for paid subscribers. Please click here to …
IVERIC bio GATHER2 Trial of Zimura® for Geographic Atrophy IVERIC Bio (ISEE) announced that it received written agreement from the U.S. FDA under a Special Protocol Assessment (SPA) for the overall design of GATHER2, the pivotal clinical trial of IVERIC product Zimura® (avacincaptad pegol) for the treatment of . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
Vir Biotechnology Announced Positive Safety Findings from its Ongoing Trials for Chronic HBV Vir Biotechnology (VIR) announced new data from its ongoing Phase 2 clinical trials of VIR-2218 and ongoing Phase 1 studies of VIR-3434 in patients with chronic hepatitis B virus (HBV) infection. The results comprised positive safety findings in addition to a reduction in hepatitis . . . This content is for paid …
Halozyme Therapeutics Approvals for DARZALEX®SC Halozyme Therapeutics (HALO) announced that the European Commission (EC) has granted Janssen Pharmaceutical Companies of Johnson & Johnson two marketing authorizations for the subcutaneous formulation of daratumumab, known as DARZALEX® SC in the European Union. The first authorization relates to the use of DARZALEX® SC in combination with bortezomib . . . This content is for paid subscribers. Please click here to …
Blackstone Life Sciences, Intellia Therapeutics and Cellex Cell Professionals New Company Blackstone (BX) announced that funds managed by Blackstone Life Sciences have committed $250 million towards the launch of a new autologous and allogeneic universal chimeric antigen receptor (CAR) T-cell therapy company with Intellia Therapeutics (
Jounce Therapeutics Inc: US FDA Cleared IND Application for JTX-1811 Targeting CCR8 Jounce Therapeutics Inc (JNCE) - a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application for its product JTX-1811, an anti-CCR8 antibody.
Veracyte Inc Decipher® Prostate Test Veracyte Inc (VCYT): New data that demonstrated the prognostic utility of its Decipher® Prostate genomic classifier in men with non-metastatic castration-resistant prostate cancer (nmCRPC) has been published online in
Vertex Pharmaceuticals Receives FDA Approval for TRIKAFTA® Vertex Pharmaceuticals (VRTX) announced the U.S. FDA approved the expanded use of TRIKAFTA® to include children with cystic fibrosis (CF) ages 6 through 11 years who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive . . . This content is for paid subscribers. Please click here to …
Clinical Holds on bluebird bio Gene Therapies were Lifted by the FDA The U.S. FDA has lifted the clinical holds on the bluebird bio (BLUE) Phase 1/2 HGB-206 and Phase 3 HGB-210 studies of LentiGlobin for sickle cell disease (SCD) gene therapy (bb1111) for adult and . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
Focus on Intellia Therapeutics Upcoming Presentation for NTLA-2001 Data to offer insight into safety and pharmacodynamics of NTLA-2001, the first-ever systemically administered in vivo CRISPR therapy candidate Late-breaking abstract selected for oral presentation on June 26 Intellia Therapeutics NTLA-2001 for People Living with hATTR-PN Intellia Therapeutics (NTLA) announced that Phase 1 . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
BridgeBio Pharma Granted Fast Track Designation for Encaleret BridgeBio Pharma (BBIO) announced the U.S. FDA granted Fast Track designation for Encaleret – a treatment of autosomal dominant hypocalcemia (ADH1), on World Hypoparathyroidism Awareness Day, an annual global awareness event meant to support people who are living with ADH1 and with other types of hypoparathyroidism. ADH1 is a rare, genetic form of . . . This …
Annovis Bio Inc and Neurodegenerative Diseases Annovis Bio Inc (ANVS), a clinical-stage drug platform company. This firm's focus is the treatment of neurodegenerative diseases. Annovis Bio Inc announced today new results from a double-blind, placebo-controlled study of its product ANVS401, the Company's lead . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
Compugen Updated Trial Data Updated data from COM701 Phase 1 combination and monotherapy studies to be presented at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting Milestone rich 2021 to include data readouts from ongoing COM701 triple combination study and COM902 monotherapy study in Q4 2021 Initiation of Phase 1b cohort expansion study of COM701 with Opdivo® in Q2 2021 and Phase 1 …
Editas Medicine Reporting Editas Medicine (EDIT) reported business highlights and financial results for the first quarter of 2021. The reporting started with James C. Mullen, Chairman, President and Chief Executive Officer, Editas Medicine stating that Editas’ team is making tremendous progress towards discovering, developing, and manufacturing novel genome editing medicines, including excellent forward momentum this quarter for the firm’s two . . . This content …
Gilead Sciences and Eisai Pharmaceutical Co Submitted an Application to Japan's PMDA for Filgotinib Galapagos NV (GLPG) announced that Gilead Sciences (
European Authorities Recommended Additional Approval of Bristol-Myers Squibb Product Onureg® for AML Bristol-Myers Squibb (BMY): The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of Onureg® (azacitidine tablets; CC-486) as maintenance therapy in adult patients with acute myeloid leukemia (AML). The approval is for the AML . . . This content is for paid subscribers. Please click here …
Cassava Sciences Guidance and Financial Results Cassava Sciences (SAVA) announced financial results for the first quarter ended March 31, 2021 as well as its guidance regarding the release of new clinical data with simufilam, the Company’s lead drug candidate to treat Alzheimer’s disease. Investors and shareholders of this firm are impatiently waiting for more news about the firm’s . . . This content is for …
Inovio Pharmaceuticals Promising Results for INO-4800 for COVID-19 Inovio Pharmaceuticals (INO) announces promising results of a study focusing on the human immune responses induced by Inovio DNA vaccine candidate, INO-4800, against COVID-19, and variants of concern. The results demonstrated that INO-4800 induced a robust T . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
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