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Industry News Archive

  • Astellas' COVID-19 Pandemic Response

    Amidst the unprecedented public health challenge, Astellas and its employees continue to contribute to securing the safety of patients and alleviating strain on healthcare resources during this critical time. This includes financial assistance to support local and global communities; policies focused on the well-being of its employees, healthcare professionals, and partners; employee mobilizations, and company-matched donations to humanitarian organizations. Additionally, Astellas is ensuring that patients have access to its medicines through its Pharma Support Solutions, which offers support to patients needing access and reimbursement assistance. 

    Read Astellas' full statement on the coronovirus.

    Posted 5/13/2020



  • Merck's Response to COVID-19

    During this unprecedented time, Merck is committed to ensuring its medicines and vaccines reach its patients and customers. This includes supporting patients who might need more help today with their medications, including those who are unemployed or have lost insurance coverage due to the COVID-19 pandemic.

    To learn about what support 
    options may be available, visit Merck's Access and Patient Assistance information page.

    For more details about Merck’s response to the coronavirus, visit its COVID-19 information page.

    Posted 5/13/2020



  • FDA Approves Capmatinib Tablets for Metastatic NSCLC

    On May 6, 2020, the U.S. Food and Drug Administration (FDA) approved capmatinib (Tabrecta™, Novartis Pharmaceuticals Corporation) tablets for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.

    This indication is approved under accelerated approval based on overall response rate and duration of response.

    Read the corporate press release.

    Posted 5/12/2020



  • FDA Approves Darzalex Faspro™ for Multiple Myeloma

    On May 1, 2020, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro™, Janssen Biotech, Inc.) for adult patients with newly diagnosed or relapsed/refractory multiple myeloma. This new product allows for subcutaneous dosing of daratumumab.


    Read the FDA announcement.

    Posted 5/11/2020



  • FDA Approves Olaparib + Bevacizumab as Maintenance Treatment for Advanced Ovarian Cancer

    On May 8, 2020, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza) in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to 1st-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. Patients will be selected for therapy based on an FDA-approved companion diagnostic test.

    Read FDA announcement.

    Read the corporate press release. 

    Posted 5/11/2020



  • FDA Approves Selpercatinib for Lung & Thyroid Cancers with RET Mutations or Fusions

    On May 8, 2020, the U.S. Food and Drug Administration granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for the following indications:

    • Adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC);
    • Adult and pediatric patients ≥12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy;
    • Adult and pediatric patients ≥12 years of age with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
    Read the full FDA announcement here.
    Posted 5/11/2020


  • FDA Approves Capmatinib for Adults with Metastatic NSCLC

    On May 6, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to capmatinib (Tabrecta, Novartis) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.

    On the same day, the FDA also approved the FoundationOne CDx assay (Foundation Medicine, Inc.) as a companion diagnostic for capmatinib.

    Read FDA announcement

    Posted 5/6/2020



  • Sanofi Genzyme's CareASSIST Patient Assistance Program

    In response to COVID-19, Sanofi Genzyme is committed to helping patients. Through its CareASSIST Patient Assistance Program, eligible patients will receive assistance with access and support for their prescribed treatment. 

    Read the summary on the CareASSIST program

    Posted 4/30/2020



  • FDA Approves Niraparib for Frontine Maintenance of Advanced Ovarian Cancer

    On April 29, 2020, the U.S. Food and Drug Administration approved niraparib (Zejula, GlaxoSmithKline) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.

    Read the FDA announcement.

    Posted 4/29/2020


  • Merck Broadens Patient Support and Assistance Programs as Part of Overall COVID-19 Relief Efforts

    In response to the COVID-19 pandemic, Merck is focused on protecting the safety of its employees and their families, ensuring that its supply of medicines and vaccines reach its patients, contributing its scientific expertise to the development of antiviral approaches, and supporting healthcare providers and their communities. 

    Read the press release for more information on Merck's response to COVID-19.

    Posted 4/29/2020




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