About healthcare regulation
U.S. health agency mandates review of regulations every 10 years: “The outgoing Trump administration has finalized a rule that will require all new regulations by agencies under the Department of Health and Human Services to be reviewed for relevance every 10 years or face automatic expiration. The department, however, will now have five years to review all existing regulations, instead of the two-year timeline proposed earlier.”
About pharma
Fujifilm Pays $2 Billion to Establish U.S. Cell-Culture Manufacturing Plant: “Fujifilm is investing $2 billion in a high-output U.S. cell-culture manufacturing plant to speed the expansion of its biopharmaceutical contract development and manufacturing organization business.
Scheduled to be operational in 2025, the facility will produce antibodies, recombinant proteins, gene therapies and vaccines, and it will have automated fill-finish and assembly, packing and labeling capabilities.”
Lilly's donanemab slows clinical decline in Alzheimer's disease study: “Eli Lilly said Monday that donanemab, an experimental antibody targeting N3pG-amyloid beta, significantly slowed decline on a composite measure of cognition and daily function in patients with early symptomatic Alzheimer's disease compared to placebo, meeting the primary endpoint of the Phase II TRAILBLAZER-ALZ trial…
Top-line results demonstrated that donanemab slowed decline on the iADRS by 32% relative to placebo. Eli Lilly also noted that the drug led to "consistent improvements" on all pre-specified secondary goals measuring cognition and function compared to placebo, although statistical significance was not achieved on every measure. Key secondary measures included change from baseline to week 76 on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13), ADCS-iADL, Mini Mental State Examination (MMSE) score, and Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) scores, as well as brain amyloid and tau deposition.”
Miller School Leads Groundbreaking Trial Treating Severe COVID-19 with Mesenchymal Stem Cells: “The paper describes findings from 24 patients hospitalized at UHealth Tower or UM/Jackson Memorial Hospital with COVID-19 who developed severe acute respiratory distress syndrome. Each received two infusions given days apart of either mesenchymal stem cells or a placebo.
It was a double-blind study…
Researchers found the treatment was safe, with no infusion-related serious adverse events.
Patient survival at one month was 91% in the stem cell treated group versus 42% in the control group. Among patients younger than 85 years old, 100% of those treated with mesenchymal stem cells survived at one month.”
Sanofi acquires immunotherapy biotech Kymab: “French drugmaker Sanofi has announced a deal of up to $1.45bn to buy UK biotech Kymab and confirmed it is studying the possibility of helping manufacture rival Covid-19 vaccines after delays in developing its own jab…
Cambridge-based Kymab is studying the use of a new monoclonal antibody drug known as KY1005 for the treatment of eczema, a skin condition.”
About diagnostics
Abbott Earns FDA OK for Handheld Concussion Blood Test: “Abbott Laboratories has received the FDA’s 510(k) marketing clearance for a test that helps evaluate mild traumatic brain injuries, also known as concussions, using a handheld device.
The blood test is run on the company’s handheld i-STAT Alinity device, producing a result within 15 minutes after the patient’s blood plasma sample is inserted.
The diagnostic assesses plasma samples for biomarkers UCH-L1 and GFAP, two proteins that are seen after a concussion or head trauma.”
This device could be a blockbuster for use on the sports field. But it would be better to prevent injuries in the first place.
About the public’s health
Trump administration reverses stance, will no longer hold back second shots of coronavirus vaccine: “The Trump administration will announce sweeping changes to its vaccination rollout on Tuesday, including making many more doses of the coronavirus vaccine available and urging states to provide shots to anyone 65 and older. The steps are an effort to speed up a delayed and disjointed rollout.
The changes are a sharp departure from the administration’s previous strategy, and they come just days after President-elect Joe Biden announced plans to release nearly all the vaccine supply. Biden is expected to provide a detailed blueprint on reinvigorating the rollout later this week.”
Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine — United States, December 14–23, 2020: “During December 14–23, 2020, monitoring by the Vaccine Adverse Event Reporting System detected 21 cases of anaphylaxis after administration of a reported 1,893,360 first doses of the Pfizer-BioNTech COVID-19 vaccine (11.1 cases per million doses); 71% of these occurred within 15 minutes of vaccination.”
Record low flu cases show how COVID-19 is more contagious and 'less forgiving,' experts say: “As COVID-19 raged last year, the seasonal flu all but vanished, according to data from the U.S. Centers for Disease Control and Prevention.
During the 2019 flu season from Sept. 29 to Dec. 28, the CDC reported more than 65,000 cases of influenza nationwide. During the same period this flu season, the agency reported 1,016 cases.
Health experts said that high vaccination rates against the flu – combined with social distancing, mask-wearing and hand-washing employed to stop the spread of the coronavirus – played a huge role in preventing influenza transmission.”
Trial of COVID-19 blood plasma finds no benefit in severely ill patients: “The decision by the REMAP-CAP trial leaders came after an initial analysis of more than 900 severely ill trial participants in intensive care showed that treatment with the product - an antibody-rich plasma taken from people who have recovered from the pandemic disease - did not improve outcomes.”
Hospitals say syringes supplied by feds waste vaccine doses: “Pharmacists discovered early in the U.S. vaccination push that the standard five-dose vials of the vaccine from Pfizer and its German partner BioNTech often contained enough material for six or even seven shots…
But some syringes distributed by Operation Warp Speed, the federal Covid-19 vaccine program, aren’t efficient enough to extract a sixth dose, according to hospital lobbyists. They say the issue appears to stem from supply chain problems that have troubled the nation’s pandemic response from the start.”
2021 Global Mayors Challenge: “Bloomberg Philanthropies has launched an innovation competition that will identify and accelerate the most ambitious ideas developed by cities in response to COVID-19. The competition will select 50 finalists that represent the world’s leading urban innovations to emerge from the pandemic. Fifteen grand-prize winners will receive $1 million each and robust multi-year support to implement and spread their breakthrough ideas.”
Health Workers’ Antibody Levels Wane After SARS-CoV-2 Infection: Another reason to vaccinate those who had the infection. “Most people who are infected with SARS-CoV-2 develop antibodies to the virus within 2 to 3 weeks. But how long those antibodies last is unclear. To learn more, the Influenza Vaccine Effectiveness in the Critically Ill Network, a group of academic centers studying both influenza and coronavirus disease 2019 (COVID-19), enrolled 3248 health care workers in a seroprevalence study. All worked directly with patients who had COVID-19 at 13 medical centers throughout the US.
Six percent, or 194, of participants had detectable antibodies to SARS-CoV-2 based on enzyme-linked immunosorbent assay test results. About 80% of these antibody-positive health care workers returned for a second antibody test 2 months later.
At the second test, SARS-CoV-2 antibodies had declined in about 94% of those who initially were seropositive. About 28% no longer tested positive for antibodies. Roughly 1 in 5 individuals who had COVID-19 symptoms fell below the threshold for seropositivity at the second test, as did nearly half of participants who were asymptomatic. Older adults and those with lower antibody levels on the initial test were more likely to seroconvert by the second test.
The results suggest that studies using seropositivity as a proxy for previous infection are likely to underestimate the true prevalence of infections, the authors cautioned. They also suggested that the window for collecting convalescent plasma to use as a potential treatment for COVID-19 is narrow.”
About healthcare IT
VA, Fitbit help support Veteran health and wellness during COVID-19 pandemic: “The U.S. Department of Veterans Affairs (VA) announced today a new initiative with Fitbit that will provide eligible Veterans, caregivers and VA staff with access to Fitbit programs and services to help manage stress, improve sleep and increase physical activity during the COVID-19 pandemic.
The initiative will be focused on participants who currently use Fitbit devices.
VA has contracted with Fitbit to initially provide 10,000 eligible Veterans, caregivers and VA staff a one-year free membership to Fitbit Premium. This includes access to guided programs, hundreds of workouts, mindfulness content, a wellness report and a health metrics dashboard. Participants will also have access to Fitbit Health Coaching, one-on-one coaching and guidance from a certified health coach or licensed health professional.”
At all-virtual CES, the spotlight is on touchless tech, robot companions — and smart bathrooms: The annual consumer tech conference is coincident with the JPM conference. This article explains some interesting healthcare applications presented at this virtual show.
About healthcare devices
HHS Moves to End Oversight of Some Gloves, Masks, Ventilators:”Seven types of surgical and examination gloves won’t require FDA oversight anymore, the HHS said Monday in a move to permanently cut regulatory requirements that were initially curtailed during the pandemic.
These gloves are considered class one medical devices, the lowest risk label for medical products the Food and Drug Administration oversees. They’ll now be permanently excluded from the FDA’s medical device regulatory scheme.
In addition, the Department of Health and Human Services is proposing that certain sterilizers, digital imaging software, face masks, and ventilators be excluded from FDA review.”
About health insurance
Atrius Health, state's largest independent physician group, is in acquisition talks: “The nation’s largest employer of primary-care physicians is in talks to acquire the largest independent doctor group in Massachusetts, a decision that would further cement the national group’s presence in the Bay State.
Optum, the for-profit health provider arm of UnitedHealth Group, has signed a memorandum of understanding to acquire Atrius Health, a nonprofit that counts 715 physicians across 30 locations in Massachusetts, sources tell the Boston Business Journal.”
Payers Kick Off 2021 Investments in Social Determinants of Health: The article gives many examples of payer partnerships with local organizations.
About healthcare systems
2020 M&A in Review: COVID-19 as Catalyst for Transformation: From Kaufman, Hall & Associates: “In the face of these pressures, it is remarkable that M&A activity for the year stayed within the historic range of activity seen over the past 10 years…”
The anticipated trends for 2021 will compell “healthcare organizations to:
Focus on core business strengths and assess the long-term viability of non-core assets, aligning as needed with partners that offer complementary, innovative, or otherwise unrepresented capabilities Build partnerships to address gaps in the healthcare infrastructure exposed or intensified by the virus, including collaborative partnerships with non-traditional partners
Strengthen intellectual capital resources to be nimbler and more flexible in dealing with the current crisis and in pivoting to new modes of providing care more efficiently, effectively, or uniquely relative to other legacy providers and potential new market entrants”