From Washington, DC,

White House News

• The President’s Executive Order No. 14192 creating a “Massive 10 to 1 deregulation initiative” was published in the Federal Register last Thursday, February 6.

• Regulatory Focus considers how this Executive Order may impact the Food and Drug Administration.

• The Regulatory Focus article notes that the Trump administration is in the process of updating the December 13, 2024, semi-annual regulatory agenda published by the Biden Administration.

Judicial News

• Federal News Network reports,
  • President Donald Trump’s plan to downsize the federal workforce remains on hold after a courtroom hearing on Monday afternoon.
  • It’s the latest example of how the Republican president’s ambitious plans have become ensnared in the judicial system.
  • U.S. District Judge George O’Toole Jr. had paused the deferred resignation program, commonly described as a buyout, last week.
  • On Monday, he said the stay would remain in place until he issues a ruling. It’s unclear when that could happen.
  • Trump wants to use financial incentives to encourage government employees to quit. According to the White House, 65,000 workers had taken the government up on its offer as of Friday.

FDA News

• Per MedTech Dive,
  • “The Food and Drug Administration published an early alert on Thursday about a BD device linked to 30 serious injuries and four deaths.
  • “The FDA issued the alert one day after BD wrote to customers to recommend actions to mitigate the risks posed by a system used to break up and remove clots from arteries. 
  • “Stress, wear, high temperatures, friction or localized pressure can cause part of BD’s Rotarex device to break, the FDA said, and result in vessel injuries and severe bleeding.”

• Reuters informs us,
  •  “AbbVie (ABBV.N) said on Friday that the U.S. Food and Drug Administration approved its drug for complicated intra-abdominal infections, including those caused by drug-resistant bacteria.
  • “AbbVie and co-developer Pfizer’s (PFE.N), opens new tab drug, Emblaveo, is approved in combination with an antibiotic medication for patients 18 years and older with such infections.
  • “Deaths from antibiotic-resistant bacteria, also known as superbugs, have been on the rise globally, and health regulators have called for the development of newer treatments as resistance to older antibiotics grows.”

From the public health and medical research front,

• The American Hospital Association News tells us,
  • “At least 24 million people have had seasonal flu this season, according to estimates  from the Centers for Disease Control and Prevention. Nearly 49,000 patients were admitted to hospitals with the flu for the week ending Feb. 1. Emergency department visits due to the flu remain classified as “very high” and “increasing,” the agency said. ED visits for COVID-19 are “low” and “decreasing,” while visits for respiratory syncytial virus are “moderate” and “decreasing.” Overall respiratory illness activity causing people to seek health care is “very high.” 

• The Washington Post reports,
  • “A Nevada dairy worker was infected with a version of bird flu that is known to have killed one person in the United States and severely sickened a teen in Canada, state and federal health authorities said Monday.
  • “This version of the virus was detected for the first time in dairy farms last month in Nevada. The Central Nevada Health District said Monday that an adult was exposed to infected dairy cattle while working at a farm in the northwestern part of the state. The Centers for Disease Control and Prevention said its genetic analysis confirmed that the virus in the Nevada person is the same as was detected in the Nevada dairy cows.
  • “The Nevada worker had conjunctivitis, commonly known as pink eye, but no other reported symptoms. The worker is recovering, the district said, and close contacts and other workers exposed at the farm are being contacted and monitored for symptoms. They are being offered personal protective equipment, testing and antiviral medication, the district said. No additional cases have been confirmed.”

• Cardiovascular Business lets us know,
  • “The virus responsible for COVID-19 is associated with several long-term heart risks, according to a new analysis published in Radiology.[1] This appears to be true regardless of the patient’s age or health at the time of infection.
  • “COVID-19, caused by SARS-CoV-2, is initially characterized by acute lung injury and respiratory failure,” senior author Junbo Ge, MD, director of the cardiology department at Zhongshan Hospital in Shanghai, China, said in a statement. “However, emerging evidence indicates COVID-19 also involves an extreme inflammatory response that can affect the cardiovascular system.”
  • “Ge et al. examined coronary CT angiography (CCTA) data from more than 800 patients with a mean age of nearly 64 years old. More than 67% of patients were men. While 41% of patients underwent CCTA prior to the COVID-19 pandemic, the remaining patients underwent CCTA during the pandemic. One in four of patients imaged during the pandemic presented with an active SARS-CoV-2 infection. All patients underwent baseline and follow-up measurements over time, allowing researchers to follow different trends over time.
  • “Overall, after reviewing more than 2,500 coronary artery lesions, the group determined that plaque volumes grew much faster in SARS-CoV-2 patients. High-risk plaques (20.1% vs. 15.8%), coronary inflammation (27% vs. 19.9%) and target lesion failure were also significantly more common in patients infected with SARS-CoV-2”

• Per Beckers Hospital Review,
  • “Patients aren’t the only ones turning to obesity drugs to manage health. More physicians are using GLP-1s too, The New York Times reported Feb. 10.
  • “While there are no studies documenting the number of physicians taking GLP-1s, a number of physicians told the Times that they’ve noticed many colleagues growing thinner and sharing similar eating habits.
  • “Physicians “are a good litmus test for drugs that are highly effective,” Robert Califf, MD, the former FDA chief, told the Times.” 

• Per National Institutes of Health press releases,
  • “Eating gradually increasing doses of store-bought, home-measured peanut butter for about 18 months enabled 100% of children with peanut allergy who initially could tolerate the equivalent of at least half a peanut to consume three tablespoons of peanut butter without an allergic reaction, researchers report. This easy-to-implement treatment strategy could potentially fulfill an unmet need for about half of children with peanut allergy, who already can tolerate the equivalent of at least half a peanut, considered a high threshold. The findings come from a trial sponsored and funded by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) and published today in the journal NEJM Evidence.
  • “Children with high-threshold peanut allergy couldn’t participate in previous food allergy treatment trials, leaving them without opportunities to explore treatment options,” said NIAID Director Jeanne Marrazzo, M.D., M.P.H. “Today’s report focuses on this population and shows that a very safe and accessible form of therapy could be liberating for many of these children and their families.”
• and
  • “Influenza A virus particles strategically adapt their shape—to become either spheres or larger filaments—to favor their ability to infect cells depending on environmental conditions, according to a new study from National Institutes of Health (NIH) scientists. This previously unrecognized response could help explain how influenza A and other viruses persist in populations, evade immune responses, and acquire adaptive mutations, the researchers explain in a new study published in Nature Microbiology.”

From the U.S. healthcare business front,

• BioPharma Dive tells us,
  • “Axsome Therapeutics gained more than $1 billion in market value Monday, after the brain drug developer disclosed a patent settlement with Teva Pharmaceuticals that will keep a generic copy of Axsome’s top drug at bay in the U.S. until at least 2038.
  • “Axsome had sued Teva for patent infringement when the generic drugmaker filed for approval of a knock-off version of Auvelity, a medicine for major depressive disorder that last year earned Axsome some $290 million in net sales.
  • “Per the settlement struck by the two companies, Teva will gain a license to sell generic Auvelity on or after March 31, 2039, should Axsome gain regulatory exclusivity for pediatric use of the drug. If Axsome doesn’t, Teva can enter the U.S. market with its copy on Sept. 30, 2038.”

• Fierce Pharma adds,
  • “Incyte’s ruxolitinib franchise, made up of blockbuster JAK inhibitor Jakafi and its topical counterpart Opzelura, have been the company’s driving focus for years. Now, with Jakafi approaching a 2028 patent cliff, Opzelura is gaining momentum as several expansion opportunities take shape.
  • “The 2021-approved Opzelura grew sales by 50% during 2024, reaching $508 million on the back of its two approved indications in atopic dermatitis and vitiligo. Included in the fourth quarter’s $162 million revenue haul is $24 million from sales outside of the U.S., where Opzelura’s European launch is seeing positive momentum, Incyte said on its earnings presentation Monday. 
  • “Opzelura remains the only marketed topical JAK inhibitor, although Leo Pharma’s delgocitinib is vying for a nod in chronic hand eczema. Besides studies in prurigo nodularis and mild to moderate hidradenitis suppurativa, Incyte’s next move for Opzelura is an expected approval in pediatric atopic dermatitis in the second half of this year.”

• Beckers Hospital Review relates
  • “As of September, there were 284,626 licensed nurse practitioners practicing in the U.S., though NP availability per capita varies significantly across states.
  • “The total number of practicing NPs has remained relatively unchanged since January 2024, according to KFF data. 
  • “To compare NP availability across states, Becker’s analyzed KFF data on the number of practicing NPs alongside U.S. Census Bureau population estimates to calculate the number of NPs per 100,000 residents in each state.”
  • FEHBlog note — The article provides lists the states from highest to lowest NP availability per capita. Tennessee is on top.