About Covid-19
Coronavirus (COVID-19) Update: FDA Approves First COVID-19 Treatment for Young Children “Today, the U.S. Food and Drug Administration expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct SARS-CoV-2 viral testing, who are:
Hospitalized, or
Not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
This action makes Veklury the first approved COVID-19 treatment for children less than 12 years of age. As a result of today’s approval action, the agency also revoked the emergency use authorization for Veklury that previously covered this pediatric population.”
Oral Antiviral Medications for COVID-19 A good, easy to understand review of the topic
Biden admin to promote availability of COVID antiviral pill “First approved in December, supply of the Pfizer regimen was initially very limited, but as COVID-19 cases across the country have fallen and manufacturing has increased it is now far more abundant. The White House is now moving to raise awareness of the pill and taking steps to make it easier to access.
Paxlovid, when administered within five days of symptoms appearing, has been proven to bring about 90% reduction in hospitalizations and deaths among patients most likely to get severe disease…
The U.S. has ordered enough supply of the pills for 20 million people, which is estimated to last for several more months. The administration has warned that subsequent deliveries are dependent on Congress approving additional COVID-19 response funding.”
In a related story: WHO recommends highly successful COVID-19 therapy and calls for wide geographical distribution and transparency from originator “WHO made a strong recommendation for nirmatrelvir and ritonavir, sold under the name Paxlovid, for mild and moderate COVID-19 patients at highest risk of hospital admission, calling it the best therapeutic choice for high-risk patients to date. However, availability, lack of price transparency in bilateral deals made by the producer, and the need for prompt and accurate testing before administering it, are turning this life-saving medicine into a major challenge for low- and middle-income countries.”
Quarter of US COVID-19 deaths could have been prevented by vaccination: analysis “The analysis from the Peterson Center on Healthcare and the Kaiser Family Foundation underscores the importance of vaccination, and indicates a significant portion of the heavy toll from the virus could have been prevented.
The 234,000 preventable deaths translates to about one quarter of the nearly 1 million U.S. deaths from the virus since the pandemic began, and 60 percent of the deaths since June 2021, when vaccines became widely available.”
COVID-19 third leading cause of death for 2nd year straight: 4 updates “About 415,000 Americans died of COVID-19 in 2021, making it the third leading cause of death in the U.S. for the second consecutive year, according to provisional data from the CDC.
The two leading causes of deaths last year were heart disease and cancer, respectively, with provisional death tolls of about 693,000 and 605,000, respectively, according to the data published April 22.
About health insurance
Biden administration says it won’t keep messing with Texas' Trump-era Medicaid waiver “The Biden administration is dropping out of litigation against a Texas Medicaid waiver that the Trump administration approved during its final week in office, saying the yearlong court fight has overtaxed the federal government’s resources.
Last spring, the Centers for Medicare and Medicaid Services revoked a 10-year waiver for Texas’ Medicaid program that the Trump administration approved on Jan. 15, 2021, without going through a required public comment period. The provision, which extended the state’s waiver for a decade, included significant money for health providers to cover the cost of caring for uninsured patients. Texas sued the Biden administration, and in August a federal district court judge reinstated the waiver. With CMS’ decision not to challenge that judge’s ruling, the provision will continue through 2030.”
CMS Proposes Updates to Reduce Barriers to Coverage, Simplify Medicare Enrollment and Expand Access “CMS) issued a proposed rule to update Medicare enrollment and eligibility rules that would expand coverage for people with Medicare and advance health equity. This proposed rule would provide Medicare coverage the month immediately after enrollment, thereby reducing the uninsured period and expand access through Medicare special enrollment periods (SEPs). It would also allow eligible beneficiaries to receive Medicare Part B coverage without a late enrollment penalty. This proposed rule would make it easier for people to enroll in Medicare and eliminate delays in coverage.”
About pharma
The top advertisers in Big Pharma FYI. The list is by drug.
Pfizer recalls some batches of blood pressure drug over carcinogen presence “Pfizer said on Friday it was voluntarily recalling five batches of its Accupril blood pressure tablets after finding elevated levels of a potential cancer-causing agent in the medicine.
The drugmaker said it was not aware of any reports of adverse events related to the recalled batches, which were distributed in the United States and Puerto Rico from December 2019 to April 2022.”
This problem has recently occurred with a number of other medications.
British Regulatory Watchdog Lambasts Seven Pharmaceutical Companies for Code of Practice Breaches “The UK’s self-regulatory industry watchdog, the Association of the British Pharmaceutical Industry (ABPI) has cited seven drugmakers for violations of its code of practice — LEO Pharma, Janssen, Teva Pharmaceuticals, Lundbeck, Otsuka Europe, Daiichi-Sankyo and Roche.
LEO Pharma, for example, was dinged for promoting its psoriasis drug Enstilar (betamethasone dipropionate/calcipotriol monohydrate) before it was given marketing authorization and for its failure to disclose payments made to patient organizations in 2019.”
About the public’s health
HHS Launches Pledge Initiative to Mobilize Health Care Sector to Reduce Emissions “The voluntary pledge asks signees to, at a minimum, commit to: (1) reducing their organization’s emissions (by 50% by 2030 and to net zero by 2050) and publicly reporting on their progress; (2) completing an inventory of Scope 3 (supply chain) emissions; and (3) developing climate resilience plans for their facilities and communities. It also asks them to designate an executive lead for this work.
Showa Group Receives FDA’s 510(k) Approval for Biodegradable Nitrile Glove “Fayette, Ala.-based Showa Group’s single-use nitrile gloves have been granted the FDA’s 510(k) marketing clearance.
The company claims to be the only U.S. domestic manufacturer of FDA-cleared, Berry Amendment-compliant medical gloves. The Berry Amendment requires the Department of Defense to give preference in procurement to domestically manufactured products.”
About healthcare IT
SAS and Microsoft Drive Toward Health Care Interoperability “Global analytics leader SAS and Microsoft are working together to build deep technology integrations, making advanced health analytics more accessible to health care and life science organizations. The collaboration boosts health care interoperability by enabling the use of Fast Healthcare Interoperability Resources (FHIR®) standards and through integration from Azure Health Data Services to SAS® Health on Azure.
Microsoft recently announced the availability of Azure Health Data Services, a platform as a service (PaaS) offering designed to support Protected Health Information (PHI) in the cloud. By connecting to Azure Health Data Services, the embedded AI capabilities of SAS Health are more efficient and secure, expanding the possibilities of patient-centric innovation and trusted collaboration across the health landscape.”
About health technology
Labcorp beefs up at-home testing options with Getlabs’ on-demand blood draw service “Only a few months after launching its Labcorp OnDemand direct-to-consumer testing service, allowing individuals to order tests straight to their doorsteps, the diagnostics giant has inked a deal with Getlabs allowing them to schedule their own sample collection services, too.
Getlabs offers a staff of full-time phlebotomists who are authorized to collect blood, saliva, stool, urine and breath samples. Patients can book a sample collection appointment online, arranging for the Getlabs staffer to meet them at either their home or workplace. Prices start at $25.”