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Industry News Archive

  • 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



  • 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



  • How Pfizer Oncology Together Is Addressing Patient Needs

    Pfizer recognizes the strain that the COVID-19 pandemic is placing on patients and healthcare providers around the world, and is working with governments, international NGOs, and U.S.-based not-for profit organizations to respond to this pandemic by donating much needed medications and vaccines and working to support front-line health workers.

    Read Pfizer's full response to COVID-19

    Posted 4/28/2020



  • COVID-19 Healthcare Professional Information Update

    As critical and valued partners in the healthcare community in the U.S., Pfizer wanted to share its approach to the COVID-19 pandemic and changes it is making to best address your needs and those of the patients you serve. Pfizer is taking steps to ensure supply of its medicines and help halt the spread of this disease by developing antiviral therapies and, through a partnership, a potential vaccine for the COVID-19 virus.

    Pfizer also recently announced a commitment of $40 million in medical and charitable cash grants to help address urgent needs of U.S. and global partners on the front lines of the pandemic.

    Read Pfizer's full response to COVID-19

    Posted 4/28/2020



  • BMS Patient Support Program Overview

    In light of the developing situation around COVID-19, Bristol Myers Squibb would like to share immediate action they are taking to support the health and well-being of patients, customers, and employees during this time.

    Bristol Myers Squibb is expanding its longstanding patient support programs to help eligible unemployed patients in the U.S. who have lost their health insurance due to the COVID-19 pandemic. The expanded program offers access to BMS medicine for free.

    Read the expanded patient support program overview.

    Posted 4/28/2020



  • BMS Patient Assistance Transportation Program

    The Community Oncology Alliance (COA) has partnered with CancerCare to provide free local transportation to patients during the COVID-19 national emergency. This program will provide free transportation for patients to and from their community oncology provider. Working with a nationwide transportation provider, practices will be able to organize free local transportation to and from appointments in clean vehicles.

    Community oncology practices must register to be part of this program. Simply fill out this form and COA will provide you with details on how to book travel for patients needing transportation.

    Posted 4/28/2020



  • CMS Re-evaluating Accelerated Payment Program; Halting Advance Payment Program

    On April 26, the Centers for Medicare & Medicaid Services (CMS) announced that it is reevaluating the amounts that will be paid under its Accelerated Payment Program and suspending its Advance Payment Program to Part B suppliers effective immediately. 

    CMS states that significant additional funding will continue to be available to hospitals and other healthcare providers through other programs such as the Coronavirus Aid, Relief, and Economic Security (CARES) Act (PL 116-136) and the Paycheck Protection Program and Health Care Enhancement Act (PL 116-139) for healthcare providers. The U.S. Department of Health and Human Services (HHS) is distributing these funds through the Provider Relief Fund, and these payments do not need to be repaid.

    View CMS' updated fact sheet on the Accelerated Payment Program and Advance Payment Program here.

    Posted 4/27/2020


  • Pfizer Oncology Announces Transition of IBRANCE® (palbociclib) from Capsules to Tablets

    Pfizer Oncology is pleased to announce that IBRANCE® (palbociclib) is transitioning from capsules to tablets. The new film-coated tablets will be dispensed in blister packs, whichh are designed to enable patients to track where they are in their treatment cycle. The tablet formulation is bioequivalent to the capsule formulation.

    IBRANCE® is indicated for the treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced, or metastatic breast cancer in combination with:

    • an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men; or

    • fulvestrant in patients with disease progression following endocrine therapy.

    Read the trade sheet for the tablet formulation. 

    Posted 4/24/2020



  • FDA Approves KOSELUGO™ for Neurofibromatosis-1 with Plexiform Neurofibromas

    On April 10, the U.S. Food and Drug Administration (FDA) approved KOSELUGO™(selumetinib) for the treatment of children two years of age and older with neurofibromatosis type 1 (NF1) who have plexiform neurofibromas (PN) that cannot be completely removed by surgery. 

    Read corporate announcement.

    Read product fact sheet.

    Posted 4/23/2020



  • CMS Launches COVID-19 Workforce Virtual Toolkit

    On April 22, the Centers for Medicare & Medicaid Services (CMS) released a new toolkit to help state and local healthcare decision-makers in managing healthcare workforce challenges in response to the COVID-19 emergency. The online toolkit, developed by the Healthcare Resilience Task Force, includes a full suite of available resources to aid in response based on state and local needs. 

    Access the COVID-19 Workforce Virtual Tookit.

    Posted 4/22/2020


  • FDA Approves Sacituzumab Govitecan-hziy in Previously-Treated Metastatic Triple Negative Breast Cancer

    On April 22, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sacituzumab govitecan-hziy (Trodelvy™) for the treatment of adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease.

    Read FDA announcement.

    Read corporate press release.

    Posted 4/22/2020


  • CMS Issues Guidance for Some Facilities to Re-Start Non-Essential Services

    On April 19, the Centers for Medicare & Medicaid Services (CMS) released guidance for facilities in areas with a low, or relatively low and stable incidence of COVID-19, to resume providing non-emergent, non-COVID-19 healthcare services. Many non-essential surgeries and procedures have been curtailed since March 18 when the agency recommended that facilities limit non-essential care to preserve personal protective equipment (PPE) and prepare for potential surge areas.

    The CMS guidance references the White House plan for Opening Up America, released on Friday, April 17. The agency's guidance titled, Opening Up America Again, Centers for Medicare & Medicaid Services (CMS) Recommendations Re-opening Facilities to Provide Non-emergent Non-COVID-19 Healthcare: Phase I, notes that "if states or regions have passed the Gating Criteria (symptoms, cases, and hospitals) announced on April 16, 2020, then they may proceed to Phase I."

    Access the CMS guidance.

    Posted 4/20/2020
     


  • FDA Approves Pemigatinib for Certain Unresectable Advanced Cholangiocarcinomas

    On April 17, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pemigatinib (Pemazyre, Incyte Corporation) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

    The FDA also approved the FoundationOne® CDX (Foundation Medicine, Inc.)  as a companion diagnostic for patient selection.

    Read FDA announcement.

    Posted 4/20/2020



  • FDA Approves Tucatinib in Combination for Advanced HER2-Positive Breast Cancer

    On April 17, the U.S. Food and Drug Administration (FDA) approved Tukysa (tucatinib) in combination with chemotherapy (trastuzumab and capecitabine) for the treatment of adult patients with advanced forms of HER2-positive breast cancer that can’t be removed with surgery, or has spread to other parts of the body, including the brain, and who have received one or more prior treatments.

    Read FDA announcement.


    Posted 4/17/2020


  • White House Guidance Suggests Phased-In Approach for Easing COVID-19 Restrictions

    On Thursday, April 16, the White House released guidance for a phased-in approach for easing social distancing and stay-at-home restrictions instituted in response to the novel coronavirus-19. In a call with state governors on Thursday, President Trump said that each state can determine its own plan for reopening, and that the White House three-phase plan titled, "Guidelines: Opening Up America Again," was intended to serve as general guidance and was not a mandate.

    Some state governors are starting to lay out forward-looking scenarios. However, state governors remain concerned about relaxing stay-at-home restrictions too early, before there is the capacity to clearly identify who is sick and where.


    Posted 4/17/2020


  • BMS Expands Patient Support Programs for Newly Uninsured Patients in the U.S.

    Bristol Myers Squibb (BMS) is expanding its patient support programs to help unemployed patients in the U.S. who have lost their health insurance due to the COVID-19 pandemic. Patients will be able to immediately access their medicines through one single point of entry and all BMS-branded medicines will be free (see list). The program will be in effect for six months, after which, patients who are currently enrolled may continue on the program until they have insurance.

    Read the press release.


    4/17/2020


  • FDA Approves Eltrombopag 25-mg Powder for Suspension Package Size

    Novartis Pharmaceuticals Corporation has announced that the US Food and Drug Administration approved Promacta® (eltrombopag) 25-mg powder for suspension package size on March 23, 2020.

    Read corporate announcement.


    4/17/2020


  • COVID-19 Program on Vidscrip Platform

    Video Platform for COVID-19 Patient Communications is now available, sponsored by AstraZeneca.

    In an effort to support healthcare professionals during this unprecedented time and provide an efficient way, to address the overwhelming influx of calls and emails from patients with questions and concerns about COVID-19, AstraZeneca is sponsoring a healthcare technology company called Vidscrip, through June 30, 2020, or until such time as the COVID-19 virus is no longer a US public health emergency.

    This program enables healthcare professionals to use their own computer to record short videos that answer questions to common COVID-19 questions and then share those videos with their patients through their web page, or through direct links to their patient’s phone via a personalized email or text message.

    For more information visit www.vidscrip.com/COVID19 or text “COVIDAZUS” to 73771.


    4/16/2020


  • Trastuzumab-dttb, Biosimilar of Herceptin, Launches on U.S. Market

    On April 15, Merck announced the U.S. launch of Ontruzant (trastuzumab-dttb), as a biosimilar of the reference biologic medicine Herceptin. Ontruzant is available in both 150 mg single-dose vials and 420 mg multiple-dose vials, according to the company press release. 

    Read company announcement.

    4/15/2020 




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