Latest Headlines

31. Dizal Submits New Drug Application To The U.S. FDA For Sunvozertinib In Treating Relapsed Or Refractory Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations 11/8/2024

    Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of sunvozertinib for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

32. Promising Cooperation Between Medac And Chiron For The Development Of Organ-On Chip Technology 11/7/2024

    Testing new substances in animals is a regulatory cornerstone of drug development. At the same time, the development of animal free testing methods is progressing.

33. Research Shows Caterpillar Fungus Can Slow Down Growth Of Cancer Cells 11/7/2024

    New research into a chemical produced by a caterpillar fungus that has shown promise as a possible cancer treatment has revealed how it interacts with genes to interrupt cell growth signals.

34. Leads Biolabs Receives Orphan Drug Designation From The US FDA For LBL-034, A Uniquely Designed, Highly Differentiated Anti-GPRC5D/CD3 Bispecific Antibody, For The Treatment Of Multiple Myeloma 11/6/2024

    On November 1, Nanjing Leads Biolabs Co., Ltd. (hereinafter referred to as "Leads Biolabs") announced that LBL-034, a humanized bispecific T-cell engaging antibody targeting both GPRC5D and CD3 which is independently developed by Leads Biolabs with global intellectual property rights for treatment of multiple myeloma (MM), has been granted the Orphan Drug Designation (ODD) by the US Food and Drug Administration (FDA).

35. Enzyme Engineering Has The Potential To Drive Green, More Efficient Drug Manufacturing 11/5/2024

    Researchers have found a new way to use biocatalysis to improve the production of critical raw materials required for essential drugs, making the process quicker, more efficient, and environmentally friendly.

36. Nxera Pharma And Antiverse Enter Collaboration To Design Novel GPCR-Targeted Antibody Therapeutics Using Generative AI 11/5/2024

    Nxera Pharma (“Nxera”; TSE 4565) – formerly known as Sosei Group or Sosei Heptares – and Antiverse, a techbio company designing antibodies for challenging targets, have today announced a multi-target partnership and licensing agreement to design antibodies for G-protein coupled receptors (GPCRs).

37. Ionis Announces FDA Acceptance Of New Drug Application For Donidalorsen For Prophylactic Treatment Of HAE 11/4/2024

    Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for donidalorsen, an investigational RNA-targeted medicine for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older.

38. Electra Therapeutics Receives FDA Fast Track Designation For ELA026 In Secondary Hemophagocytic Lymphohistiocytosis (sHLH) 11/4/2024

    Electra Therapeutics, Inc., a clinical stage biotechnology company developing antibody therapies against novel targets for immunological diseases and cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ELA026 for the treatment of secondary hemophagocytic lymphohistiocytosis (sHLH).

39. 858 Therapeutics And OpenBench Launch Small Molecule Drug Discovery Collaboration 11/4/2024

    858 Therapeutics and OpenBench today announced a collaboration to discover small molecule inhibitors using OpenBench’s structure-based machine learning platform.

40. Lonza's Synaffix Collaborates With BigHat Biosciences On The Development Of A Machine Learning-Designed ADC 11/4/2024

    Synaffix B.V. ("Synaffix"), a Lonza company (SWX: LONN) focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs) with best-in-class therapeutic index, today announced that it has licensed its ADC technology to BigHat Biosciences, Inc. ("BigHat").