Industry News Archive

  • 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


  • 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 



  • IMFINZI® ES-SCLC National Broadcast

    Tuesday, April 21
    7:30 PM ET or 9:30 PM ET

    This national broadcast program includes a 45-minute presentation followed by a Q & A session. Preregistration is required. Click here for details. 

    4/14/2020



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