Industry News

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

FDA Approves Ibrutinib in Combination with Rituximab for CLL or SLL

On April 21, 2020, the U.S. Food and Drug Administration (FDA) expanded the indication of ibrutinib (Imbruvica) to include its combination with rituximab for the initial treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence.

Read the FDA announcement.

Posted 4/21/2020

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 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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