From Washington, DC

• The House of Representatives and the Senate are back in session on Capitol Hill this week for Committee business and floor voting.

• Per a Senate news release,
  • “The U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing Thursday [April 16 at 10 AM] on how Congress can lower the cost of prescription drugs for American families by increasing competition among generic and biosimilar manufacturers. U.S. Senator Bill Cassidy, M.D. (R-LA), Chairman of the HELP Committee, is spearheading President Trump’s mission to make health care affordable.”

• Hopefully, Congress will resolve the Department of Homeland Security shutdown this week. Federal News Network adds,
  • “Homeland Security Secretary Markwayne Mullin is recalling all furloughed Department of Homeland Security staff to report to their next scheduled shift, despite the ongoing partial government shutdown.
  • “In an official message sent to DHS employees late Friday afternoon, staff were told that “all DHS employees, excepted and non-excepted/non-exempt” are to be returned “to a work and paid status, effective on your next regularly scheduled duty day.”

• Here’s a link to Roll Call’s projected activities on Capitol Hill this week.

From the public health and medical / Rx research front,

• MedPage Today reports,
  • About one in five males older than 15 years is infected with a high-risk HPV type.
  • Among males ages 9 to 26 years, those who received the 9-valent HPV vaccine had a lower risk of a composite of HPV-related cancers compared with those who were unvaccinated.
  • These results indicate that HPV vaccination should be sex-neutral, researchers said.

• The New York Times asks whether you are confused about the new cholesterol guidelines? If so, here’s what to hnow.
  • “New recommendations suggest that some people should start trying to lower their cholesterol as early as age 30.”
• and
  • lets us know about “D.W.I.s, relationship problems, accusations of secret drinking: Auto-brewery syndrome can wreak havoc on people’s lives and reputations.”
    • “The Mystifying Syndrome That Makes People Spontaneously Drunk.”

• NPR Shots informs us
  • “Forty percent of Americans have their daily lives interrupted by uncomfortable bowel symptoms, according to the American Gastroenterological Association. That’s a lot of troubled guts.
  • “But Dr. Trisha Pasricha says at the other end of the spectrum, there are people who experience “poophoria.” That’s Pasricha’s term for a state of being where doing your business is painless and worry-free. “ I just want you to poop quickly, effortlessly, and then go live your best life,” she says.”
  • The article provides the Doctor’s advice.

From the U.S. healthcare business front,

• Modern Healthcare reports,
  • “The Affordable Care Act of 2010’s medical loss ratio provision, which requires insurers to spend 80-85% of premium dollars on medical care, likely accelerated revenue diversification through venture capital arms, said Rachel Sachs, a law professor and co-director at The Cordell Institute at Washington University School of Law. Insurers are incentivized to find other profit generators that are not capped by federal legislation.
  • “Acquiring a stake in a company can lead to long-term financial gain if they exit their position or acquire the business. Cigna, for example, purchased telehealth provider MDLive in 2021 after Cigna Ventures invested in its Series E round in 2018.
  • “An insurer also may see value in the emerging company’s product and encourage the parent company to deploy it.” * * *

• Fierce Pharma relates,
  • “Novartis is launching a three-front push to close healthcare gaps in heart disease and cancer, expanding initiatives to roughly triple its footprint by 2030. 
  • “The three initiatives include the new Inclusive Health Accelerators (IHA) program. Launched in five U.S. cities this week, IHAs are designed to support early detection of prostate and breast cancer and address care gaps in underserved populations. Novartis will use the community-driven IHA model to support access to education, free screenings, diagnosis and follow‑up care.
  • ‘Basel-based Novartis will collaborate with local groups in New York, Los Angeles, Detroit, Houston and Baltimore to deliver the services. The initiative builds on existing U.S. partnerships, such as the Health Assessments and Rapid Transformation program that Novartis launched last year.”
• and
  • “As geopolitics bring reshoring interest to a fever pitch, the United States Pharmacopeia (USP) is adding to the impetus for local drug production with a warning that homes in on the pharmaceutical building blocks known as key starting materials. 
  • “In its new supply chain vulnerabilities update (PDF), USP, a nonprofit that helps set quality standards for medicines, highlighted 100 acute and chronic medications that, while not necessarily all in current shortage, are at risk of supply gaps and other disruptions. This is due to bottlenecks in their production chains, especially in the upstream phase focused on activities like sourcing raw materials, according to USP. 
  • “Looking at the broad trends, some 30% of the drugs on USP’s updated list are currently in shortage, per the U.S. FDA. Many of the therapeutics that have made it into the lineup are deemed essential by the World Health Organization or FDA, including multiple hospital drugs, chemotherapies, steroids and anesthetics, as well as drugs for chronic conditions like ADHD, diabetes and cardiac diseases, among many others.
  • “Notably, 63% of the medicines identified for their supply chain vulnerabilities are injectables, which USP chalked up to the “inherent manufacturing complexity” of that dosage form. Oral solid meds like tablets and capsules represented the second-biggest group of vulnerable drugs, making up 22% of the list, according to USP. 
  • “In perhaps the biggest flag from the updated list, USP noted that nearly half (48%) of the drugs included have at least one of their key starting materials (KSMs) solely manufactured in one country, which the organization deemed a “potential point of failure.” 

• BioPharma Dive informs us,
  • “Chinese biotechnology company Oricell Therapeutics said Friday it banked more than $110 million in a “pre-IPO” venture funding that will help it advance a portfolio of cell therapies for tough-to-treat solid tumors. 
  • “Oricell’s lead program is being tested against advanced hepatocellular carcinoma, an aggressive liver cancer that most frequently occurs in people with chronic organ damage. That therapy, Ori-C101, has already completed early testing in humans and demonstrated what the company claims to be a “best-in-class efficacy and safety profile.” 

• The Wall Street Journal adds,
  • “Finding innovative ways to treat cancer is Pfizer’s biggest priority so to boost cutting-edge technologies, Pfizer executives went to Shenyang, China. There, last summer, Pfizer paid $1.25 billion to China’s 3SBio for rights to a cancer drug candidate.
  • “Not long ago, China was a backwater for drug research. Its companies made pharmaceutical ingredients or lower-cost generic drugs. Its patients offered an opportunity for big drugmakers to sell medicines developed in the West. 
  • “Now it’s a major player in biotechnology. Researchers and startups in China are racing to develop hot new medicines for cancer, weight-loss and other diseases. Many are on the cutting edge of molecular biology. 
  • “China is rallying their innovation to degrees that we haven’t seen before,” Pfizer Chief Executive Albert Bourla said. 
  • “Looking to tap in to the innovation, big drugmakers and investors are spending billions to lock up rights to promising Chinese-originated drug candidates like 3SBio’s.”