Intellia Therapeutics Announcement Intellia Therapeutics (NTLA) announced the initiation of HAELO, a pivotal Phase 3 study of NTLA-2002 for the treatment of hereditary angioedema (HAE). NTLA-2002 is a wholly owned investigational in vivo CRISPR-based gene editing therapy developed as a single-dose treatment for life-threatening diseases. Patient screening is active following Intellia’s successful end-of . . . This content is for paid subscribers. Please click here to …

AstraZeneca Agreement with CSPC Pharmaceutical Group Yesterday, October 7, 2024, AstraZeneca (AZN) announced it entered into an exclusive license agreement with CSPC Pharmaceutical Group Ltd (CSPC) to advance . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Johnson & Johnson New TECNIS Odyssey On September 30, 2024, Johnson & Johnson (JNJ) announced expanding the roll-out of its latest advancement in presbyopia-correcting intraocular lenses (PC - IOL), TECNIS Odyssey, in the U.S. TECNIS Odyssey IOL is built on the TECNIS platform, providing two . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Aligos Therapeutics in the NEWS Yesterday, Sept. 19, 2024, Aligos Therapeutics (ALGS) - a small clinical-stage company, announced positive topline results from the Phase 2a HERALD study of ALG-055009, a thyroid hormone receptor beta (THR-β) agonist, in metabolic-dysfunction associated steatohepatitis (MASH) subjects. Aligos Therapeutics is a clinical-stage biopharmaceutical company founded with the mission to improve patient outcomes by . . . This content is for …

AstaZeneca Fasenra Approval AstraZeneca (AZN) product Fasenra (bevacizumab) has been approved in the US for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) - a rare, immune-mediated vasculitis that can result in damage to multiple organs, and without treatment, can be fatal. The approval in the United States FDA was based on positive results from the MANDARA Phase III trial published in . …

Novartis FDA Approval Yesterday, September 17, 2024, Novartis (NVS) announced that the United States FDA has approved Kisqali®(ribociclib) in combination with an aromatase inhibitor (AI) for adjuvant treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early breast cancer (EBC) at high risk of recurrence, including those . . . This content is for paid subscribers. Please click here …

AstraZeneca Imfinzi + Imjudo Updated results from the HIMALAYA Phase III trial have demonstrated that AstraZeneca (AZN) Imfinzi (durvalumab) plus Imjudo (tremelimumab) showed a sustained clinically meaningful overall survival (OS) benefit at five years for patients with unresectable hepatocellular carcinoma (HCC) who had not received prior systemic therapy and were not eligible for localized treatment. The results from HIMALAYA were presented at . . . …

Halozyme Therapeutics in the NEWS Halozyme Therapeutics, Inc. (HALO) announced that Roche received U.S. Food and Drug Administration (FDA) approval for Tecentriq Hybreza™ (atezolizumab and hyaluronidase-tqjs) with Halozyme's ENHANZE® drug delivery technology. Tecentriq Hybreza™ can be injected subcutaneously in approximately 7 minutes compared to 30-60 minutes for standard intravenous (IV) infusion of . . . This content is for paid subscribers. Please click here to subscribe …

Johnson & Johnson FDA Approval Yesterday, September 11, 2024,  Johnson & Johnson (JNJ) announced that the FDA has approved TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC) - a chronic disease of the large intestine in which the lining of the colon becomes inflamed.  About Ulcerative Colitis Ulcerative colitis is a form of inflammatory bowel . . . This …

Travere Therapeutics Approval Travere Therapeutics, Inc., (TVTX) announced that the U.S. FDA has granted full approval to FILSPARI® (sparsentan) to slow kidney function decline in adults with primary IgAN who are at risk of disease progression. In February 2023, based on the surrogate marker of proteinuria, FILSPARI was granted accelerated approval. Now, full approval has been granted based on positive long-term confirmatory results . . . This …

Regenxbio Positive Results Regenxbio (RGNX) announced positive results from the Phase I/II/III CAMPSIITE® trial of RGX-121 for patients with Mucopolysaccharidosis Type 2 (MPS II), also known as Hunter syndrome. The results were presented at the Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium 2024. The totality of evidence from the CAMPSIITE trial continues to . . . This content is for …

Vertex Announces CASGEVY™ Reimbursement Agreement with NHS England Vertex Pharmaceuticals (VRTX) announced a reimbursement agreement with NHS England for eligible transfusion-dependent beta-thalassemia (TDT) patients to access the CRISPR/Cas9 gene-edited therapy, CASGEVY™ (exagamglogene autotemcel).  The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) granted CASGEVY the first authorization in the world for a CRISPR-based . . . This content is for paid subscribers. Please click here …

Cytokinetics Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing, and commercializing muscle biology-directed drug candidates as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. The company is developing small-molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. Cytokinetics is preparing for regulatory submissions for aficamten, its next-in-class cardiac myosin inhibitor, following positive results from SEQUOIA-HCM, …

Exelixis Q2 Results and Corporate Update Yesterday, Aug. 6, 2024, Exelixis, (EXEL) reported financial results for the second quarter of 2024, provided an update on progress toward achieving key corporate objectives, and detailed its recent and anticipated commercial, clinical, and . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Adaptimmune Therapeutics Adaptimmune Therapeutics plc (ADAP) announced that the U.S. FDA has accelerated the approval of TECELRA® for the treatment of adults with unresectable or metastatic synovial sarcoma who received prior chemotherapy, and are  HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Anaves Life Sciences Trial Results of Blarcamesine Anavex Life Sciences (AVXL) presented comprehensive results from a Phase IIb/III study showing that blarcamesine (ANAVEX®2-73), once daily orally, significantly slowed clinical decline in people with early Alzheimer's disease (AD). The data presentation was made by Marwan Noel Sabbagh, MD, Professor of Neurology at Barrow Neurological Institute and Chairman . . . This content is for paid subscribers. …

Viking Therapeutics Viking Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders, with three compounds currently in clinical trials.  Viking's research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients' lives. The firm’s clinical programs include VK2735, a novel dual agonist of the glucagon-like …

Ionis Pharmaceuticals in the NEWS Yesterday,  July 22, 2024, Ionis Pharmaceuticals (IONS) announced positive results from the completed multiple ascending dose (MAD) portion of the Phase 1/2 open-label study of ION582 in people with Angelman . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Pliant Therapeutics Pliant Therapeutics is a late-stage biopharmaceutical company focusing on the discovery and development of novel therapeutics for the treatment of fibrotic diseases. Pliant's lead product candidate, bexotegrast (PLN-74809), is an oral, small molecule, dual selective inhibitor of αvß6 and αvß1 integrins that is in development in the lead indications for the treatment of idiopathic pulmonary fibrosis, or IPF, and primary sclerosing cholangitis, or …

Kazia Therapeutics in the NEWS  Sydney, July 10, 2024, Kazia Therapeutics Limited (KZIA) - an oncology-focused drug development company, is pleased to announce results from GBM-AGILE, a phase II/III study that included an evaluation of paxalisib versus standard of care (SOC) for patients with the life-threatening brain cancer glioblastoma.  GBM AGILE STUDY GBM AGILE is an adaptive phase . . . This content is for …