Simplicity is a virtue

From Washington, DC

• The Wall Street Journal reports,
  • “Newly installed Centers for Disease Control and Prevention Director Dr. Erica Schwartz said she wants to change a culture of “paternalism” at her agency.
  • “Americans need to be better informed about how and why the CDC makes its recommendations, and the agency needs to be willing to listen to people’s concerns, she said. 
  • “There is a sense of paternalism that we have had at the CDC,” Schwartz said. “It shouldn’t be this black box that we say, ‘Verily thou shalt, and then that’s the answer.’”
  • Schwartz made the comments Wednesday at a Wall Street Journal Future of Health event in Washington, D.C.
  • “Schwartz said Wednesday that parents should prioritize receiving measles vaccines for their children amid current U.S. outbreaks, saying the shot is “absolutely safe, absolutely effective.” She defended the secretary, a skeptic of vaccines who has said they are a “personal decision,” saying he channels concerns from parents who are wary of the full slate of childhood immunizations.
  • “The secretary does represent the voices of a number of Americans who are asking questions about certain vaccines,” she said, adding that doctors shouldn’t approach vaccine-skeptical parents with “a paternalistic way of thinking.”

• Casey B. Mulligan, HHS chief economist and chief regulatory officer, writes in STAT News,
  • “Some Medicare patients owe more in coinsurance than the hospital paid for their drug. That arithmetic sounds impossible. It is a consequence of the 340B drug discount program and Medicare’s payment formula. Now the Department of Health and Human Services, where I work, is proposing to narrow that gap.
  • “Congress created the 340B drug discount program in 1992 to financially support safety net hospitals that serve low-income patients. Drug manufacturers must give them steep discounts. But Medicare, Medicaid, and commercial insurers generally reimburse them at the full amount, allowing these hospitals to keep the spread above the discounted purchasing costs.
  • “A new report from the Department of Health and Human Services shows other unintended consequences of this well-intended program. The spread grows with the price of the drug. It therefore rewards hospitals for using more and costlier drugs and makes physician practices and infusion clinics more valuable after a 340B hospital acquires them. The patient’s treatment needn’t change. The owner and billing site do.” * * *
  • “On April 18, 2025, President Trump directed HHS to obtain the cost information the statute requires. CMS surveyed hospitals from January through April 2026 and has proposed paying for affected 340B drugs at ASP minus 33.4% in 2027. CMS estimates that Medicare drug payments would fall by $4.55 billion in the first year and beneficiary drug copayments by $1.15 billion.
  • “For a drug with an ASP of $1,000, a beneficiary’s standard 20% coinsurance would fall from $212 to $133.20. The prescription hasn’t changed. The patient’s share of the hospital’s bill has. Narrowing the spread also weakens the incentive to steer patients toward costlier drugs and to acquire physician practices and infusion clinics — the very behaviors that have made care more expensive.” * * *
  • “Medicare patients should not pay coinsurance as though the discount did not exist.”
    
• Per an HHS news release,
  • “The U.S. Department of Health and Human Services (HHS) this week launched a series of actions to strengthen how the federal government identifies, documents, investigates, and responds to health problems reported following vaccination, with a focus on improving patient care and generating better evidence about potential vaccine-related injuries.
  • “To address health problems Americans report after vaccinations, HHS:
    • Opened a new National Institutes of Health (NIH) clinic dedicated to studying and caring for patients experiencing health problems following vaccination;
    • Proposed reimbursing physicians for reporting suspected vaccine-related injuries to the Vaccine Adverse Event Reporting System (VAERS) through a new Centers for Medicare & Medicaid Services (CMS) policy, bringing vaccine reporting in Medicare in line with typical Medicare reimbursement policies;
    • Will require electronic health records to capture vaccine-related adverse events so that information can follow patients across the health care system; and
    • Is modernizing the Centers for Disease Control and Prevention’s (CDC) VAERS to make reporting simpler and improve the tools available to researchers and medical professionals investigating potential safety signals.
  • “We must listen to patients and families who report vaccine injuries—not dismiss or gaslight them,” said HHS Secretary Robert F. Kennedy, Jr. “President Trump and I are building a health system that takes them seriously, follows the evidence, and uses what we learn to make vaccines safer. This is how we earn back trust in our public health institutions.”

• Beckers Hospital Review informs us,
  • “The Trump administration is preparing a stopgap that would allow certain previously restricted peptides to be sold temporarily while federal health officials write new regulations, according to an Oct. 7 Washington Post report citing two people familiar with the matter.
  • “The move would let some compounding pharmacies dispense peptides marketed as medical treatments and wellness products, even though the claims for what they treat have not been fully safety tested. The plan has not been announced, and the Post reported that its timing is unclear, it could still change and it is not known which peptides would be included. The sources said federal officials are seeking guardrails around the policy, and HHS did not comment.
  • “The FDA has been weighing whether to let compounding pharmacies produce seven peptides for conditions such as insomnia, obesity and wound healing. FDA scientists said there is not enough evidence on their safety and effectiveness, but the agency’s Pharmacy Compounding Advisory Committee, which was reshaped with wellness clinic physicians before the meeting, voted in July to recommend six of the seven. It voted against emideltide, a proposed treatment for opioid withdrawal and insomnia.
  • “The FDA is not required to follow the panel’s advice, and the Post said it is not clear when formal rulemaking will be released. Safety groups ECRI and ISMP warned after the vote that gaps in safety and efficacy data remain unresolved.”

• The American Hospital Association News points out,
  • “The Department of Homeland Security Oct. 8 issued a proposed rule that would establish new fees for foreign students seeking Optional Practical Training, a program that allows F-1 students to work in the U.S. in positions related to their field of study after graduation. Specifically, DHS proposes a fee of $70,000 for an initial OPT authorization and $30,000 for any subsequent OPT authorization, citing concerns about fraud, program integrity and protection of U.S. workers. The agency is accepting comments through Nov. 9.
  • “The proposal could have significant implications for hospitals and health systems that rely on international graduates, including nurses, physicians, pharmacists and other healthcare professionals, as OPT often serves as a pathway into the healthcare workforce. The AHA will review the proposed rule and evaluate its potential impact on workforce recruitment and retention.”
• and
  • “The Agency for Healthcare Research and Quality Oct. 7 announced the launch of the Super Intelligence for Healthcare Improvement Initiative, a two-part artificial intelligence competition focusing on medical evidence reviews and data. The first competition, called the Clinical Evidence Synthesis Transformation Challenge, aims to reduce analysis times from a year or longer to hours. This competition consists of two phases, where up to five finalists will receive $100,000 each after the first, and one winner will receive $5.35 million following the second. The challenge submission period will run from Jan. 11 to March 12, 2027.
  • “The next part of the initiative, called the SI Tech Sprint for Healthcare Research and Implementation Quality and Safety, aims to use AI to leverage AHRQ’s cost, utilization and quality databases to establish an AI-enabled ecosystem of applications for research, quality improvement and public access. The total prize pool is $2.1 million for selected winners. Submissions will be accepted from March 1 to Sept. 9, 2027. AHRQ’s webpage for the competition provides additional details, including information on registration, resources and an FAQ.”

From the U.S. Office of Personnel Management front,

• FedWeek reports,
  • “Federal employees who have been watching the government’s renewed focus on reductions in force (RIFs) should pay close attention to one development in particular: newly finalized changes that make performance ratings far more important in determining who stays and who goes.
  • “These regulations are now final law and apply to any agency issuing a specific RIF notice on or after September 2, 2026. As a result, many employees will find that their last several performance appraisals carry greater weight in whether they keep their jobs. That means the time to review your record is now, not after an RIF notice arrives.
  • “This article is not legal advice for any individual employee. But it outlines practical steps federal employees can take now to protect their retention standing, preserve appeal rights, and avoid being caught flat-footed under OPM’s finalized RIF framework.”

• Federal News Network relates,
  • “There’s a new way to look at data about the federal workforce. The Office of Personnel Management has launched an AI chatbot to answer the public’s questions about workforce trends. The new feature has been added to OPM’s “federal workforce data” website, which details employment numbers and other information about the civil service. Users can enter questions and get AI-generated answers about government hires and separations, as well as workforce demographics like age, veteran status and education level. — Drew Friedman(FWD Chat – Office of Personnel Management)”

• Edward Zurndorfer, writing in My Federal Retirement, discusses “The Biggest Medicare Mistakes That Can Cost Federal Retirees.”

• Tammy Flanagan, writing in Govexec, advises “Don’t let 5% become your TSP retirement strategy.”
  • “Getting the full agency match is a good baseline, but if retirement is around the corner there’s more to consider before deciding what to do with the rest of your paycheck.”

From the U.S. Food and Drug Administration front,

• NBC News reports,
  • “The Food and Drug Administration expects to complete its safety review of the abortion pill mifepristone in March, according to a court document the Justice Department filed Wednesday.
  • “In the filing, the FDA said it plans to compare mifepristone’s safety to that of surgical abortions through 10 weeks’ gestation. Its review will measure the frequency of side effects among roughly 100,000 women who took mifepristone, it said. 
  • “Results of the FDA’s review are expected in mid-December. From there, the agency will analyze the data and draft a final report — a process it expects to wrap up in March.” * * *
  • “The update Wednesday is in response to an order by a federal judge in Louisiana for a progress report on the safety review.
  • “The FDA is a defendant in a Louisiana suit challenging its telehealth provision, which has largely been responsible for preserving nationwide access to abortion since the Supreme Court overturned Roe v. Wade in 2022. Louisiana filed the case on behalf of a woman who said her boyfriend had ordered abortion pills and forced her to take them.
  • “In May, a federal appeals court granted Louisiana’s request to reinstate a nationwide requirement that mifepristone be dispensed in person. But the Supreme Court quickly blocked the decision while the case plays out.”

• Food Safety relates,
  • “The U.S. Food and Drug Administration (FDA) has issued a draft guidance that, if finalized, will provide enforcement discretion from the requirements of the Food Traceability Rule, also known as Section 204(d) of the Food Safety Modernization Act (FSMA 204),  for certain smaller retail food establishments (RFEs) and restaurants that were not previously captured as part of the full exemption for small RFEs and restaurants offered as part of the rule. 
  • “FDA said it believes “this additional flexibility will maintain the intended public health benefits of the rule, as it would only impact a small percentage of total food sales, while also providing relief to numerous smaller RFEs and restaurants.”

• MedPage Today tells us,
  • “The FDA flagged a potential safety signal after four deaths were reported among patients with treatment-resistant schizophrenia who received investigational evenamide in clinical trials, Newron Pharmaceuticals said Thursday.
  • “The notice follows an announcement in April that the agency halted patient enrollment in the phase III ENIGMA-TRS 2 trial after the sudden death of a participant in an evenamide clinical trial. That hold remains in place at U.S. study centers but enrollment continues in other countries, and additional clinical sites are being added.

• Cardiovascular Business informs us,
  • “Houston-based Leader Formulas is recalling one lot of its Rapture Preworkout dietary supplement due to the presence of 1,3-dimethylamylamine (DMMA), an ingredient not listed on the product label. 
  • “DMMA, often referred to as “geranium extract,” has been linked to a heightened risk of high blood pressure. It is also known to lead to certain cardiovascular problems, including heart attack, shortness of breath and chest pain. Its presence was first identified by the U.S. Food and Drug Administration (FDA) during a routine test. 
  • ‘This voluntary recall includes three different products—Rainbow Twist, Electric Lemonade and Berry Mojito—that were all part of lot 260327-4.
  • “Consumers who have purchased the Rapture Preworkout products which are being recalled should stop using the products and return to the place of purchase for a full refund,” according to Leader Formulas statement.”

• Beckers Hospital Review adds,
  • “The FDA has flagged patient safety risks tied to nine products sold through Amazon that the agency said are unapproved new drugs marketed to treat sexually transmitted infections or their symptoms.
  • ‘The agency identified the violations after reviewing labeling for products it purchased from Amazon in July 2026, according to an Oct. 1 warning letter. The FDA said the products were introduced or delivered for introduction into interstate commerce by Amazon through its Fulfillment by Amazon service.
  • “The FDA said no OTC drug product has been approved for the treatment, cure, mitigation or prevention of any STI. The agency said effective treatment requires diagnosis and supervision by a licensed healthcare professional.” * * *
  • “Amazon was directed to respond within 15 business days of receiving the letter with steps taken to correct the violations and prevent their recurrence.”

From the Medicare Advantage front,

• In a CMS fact sheet, CMS published 2027 Medicare Advantage and Part D Star Ratings.
  • “The information included in this Fact Sheet is based on the 2027 Medicare Advantage (MA) and Part D Star Ratings published on the Medicare Plan Finder on Oct. 8, 2026. For details on the methodology of the MA and Part D Star Ratings, please refer to the 2027 Part C & D Star Ratings Technical Notes available at http://go.cms.gov/partcanddstarratings.”

No Surprises Act News,

• Bloomberg Law reports,
  • “Insurers and providers share common concerns about ineligible claims under a federal surprise billing law, bolstering Senate HELP Committee Chair Bill Cassidy’s push for a legislative fix before he leaves Congress, Erin Durkin and Victoria Knight report.
  • “The No Surprises Act, a 2020 statute designed to protect patients from unexpectedly large bills from emergency rooms and other out-of-network providers, established an arbitration process for payment disputes between providers and insurers. A flood of ineligible claims is clogging that process — and closed-door meetings convened by Cassidy have put the issue on the table as a shared concern
  • “Cassidy says he’d like to put out legislation before he departs the Senate at the end of the year. While time is running short, the veteran legislator signaled the issue is gaining traction.
  • “Believe it or not, there’s common ground there,” Cassidy said.”

• STAT News adds,
  • “A new proposal in Congress to scrap a surprise billing ban’s controversial arbitration system will need to to survive an onslaught of attacks from provider groups, for whom arbitration has been a gold mine.
  • “After Rep. Frank Pallone (D-.N.J.) unveiled his Lower Premiums, Faster Payments Act on Thursday, it quickly garnered praise from academics and consumer advocates, as well as condemnation from provider groups. It would dismantle the problem-plagued process that’s currently used to resolve disputes between health insurers and out-of-network providers and replace it with a payment system based on median in-network rates.”
•  FEHBlog observation — Good luck, Rep. Pallone.

From the fraud, waste and abuse front,

• NextGov reports,
  • “The Centers for Medicare and Medicaid Services is exploring a new contract operating model and technologies so that the agency can more effectively prevent fraud, instead of chasing after money already in the hands of bad actors, according to documents posted on SAM.gov Monday.
  • “CMS has traditionally contracted with private companies to boost its investigative capabilities and support administrative actions, such as imposing payment suspensions, according to the listing. But under a draft operating model, CMS wants to take a greater role in leading the development, prioritization and direction of those investigations, the website adds.
  • “The old model “worked in the past but new technology and new techniques mean it is time to see if it still works as well,” Kimberly Brandt, a CMS Deputy Administrator, posted on LinkedIn.
  • “Under the draft model, CMS would assign fraud investigations to contractors whose primary role is to develop the investigation and administrative actions under the agency’s oversight, according to a draft Statement of Objectives posted on SAM.gov.”

• Per a Justice Department news release,
  • “Assistant Attorney General Colin M. McDonald of the Justice Department’s National Fraud Enforcement Division (the Fraud Division) today released Directive 26-13, outlining the Division’s comprehensive approach in the fight against fraud.
  • “Expanding on earlier guidance regarding the Division’s priorities (available here) and corporate enforcement policy (available here), Directive 26-13 sets out the Division’s prosecutorial methodology for investigating, disrupting, and prosecuting fraud. This directive marks a significant operational shift, requiring the Division’s prosecutors to attack fraud from all angles using the Division’s tax, securities fraud, consumer fraud, and cybercrime authorities.
  • ‘This directive also requires Division prosecutors to deploy early, pre‑indictment asset seizures and digital‑infrastructure takedowns to halt fraud schemes and freeze assets in real time. Finally, this directive urges Division prosecutors to develop practice cooperators, zealously prosecute corporate bad actors, seek arrest and detention in appropriate cases, and deliver fulsome advocacy at sentencing. This new, comprehensive approach will drive the Division forward in its mission to preempt, disrupt, and dismantle fraudulent networks before they can inflict widespread harm.
  • “Read the full memo here.”

From the public health and medical / Rx research front,

• The Wall Street Journal reports,
  • “Taylor Farms, the produce giant linked to last summer’s deadly cyclospora outbreak, is suspending sales of iceberg lettuce from central Mexico during the parasite’s peak season. 
  • “Chief Executive Bruce Taylor said the company won’t sell iceberg lettuce in the U.S. or Canada that was harvested or processed in the region between May 1 and Aug. 31, starting next year. The period covers central Mexico’s rainy season, Taylor said, and it matches the time when the Centers for Disease Control and Prevention sees an increase in illnesses caused by the cyclospora parasite. 
  • “The company hasn’t determined when the suspension will be lifted.”

• Reuters relates,
  • “Centers for Disease Control and Prevention Director ​Erica Schwartz said on Wednesday the risk to the US ‌from an unconfirmed pneumonic plague case in Siberia was extremely low, but the agency was prepared to monitor and screen travelers.
  • “We are working with Department of Homeland Security, ​working (with) Department of State, Department of War, and other agencies within ​the government to make sure that we know exactly if ⁠anyone from that area comes into the United States,” Schwartz said at ​the Wall Street Journal’s The Future of Health event in Washington.”
• and
  • “Using artificial intelligence, researchers may have found a way to make vaccines based ‌on mRNA technology, such as Moderna’s (MRNA.O) and Pfizer’s (PFE.N) COVID shots, storable at room temperature, which would lower costs and make them available in regions where ultra-cold storage is not possible.”
• and
  • “AI may improve doctors’ ability to detect heart transplant rejection without surgery and appeared to be more accurate than standard blood tests, according to a report in Journal of Heart and Lung Transplantation.”

• Fierce Healthcare adds,
  • “Utah is expanding the state’s AI regulatory sandbox program with new pilots to test AI-supported prescription renewals, dermatology and physical therapy, while stepping up physician oversight and adding independent third-party evaluators.
  • “Utah is bringing the Utah Department of Health and Human Services, Intermountain Health, University of Utah Health, medical licensing officials and outside experts into the state’s AI policy process. State officials and health systems leaders say the initiative is designed to test AI in real-world clinical settings, generate evidence on its benefits and risks and address key questions around liability, privacy and regulation.”

• The Washington Post tells us,
  • “Brandon Luu began thinking about the body’s circadian machinery as a teenager, when he was routinely unable to fall asleep until late, sometimes well past 2 a.m. The schedule made mornings miserable and school harder.
  • “But it also left him with a question: What happens when the body’s sense of time falls out of sync with the world around it?
  • “Fifteen years later, Luu is exploring that question through one of psychiatry’s most common disorders: attention-deficit/hyperactivity disorder (ADHD). Sleep problems have long been seen as a consequence of the condition. But now researchers are looking at the possibility that the relationship might run in reverse: that disruptions to circadian rhythms — the biological machinery governing when we sleep and wake — might be a cause.”

• MedPage Today notes,
  • “Adults with ADHD had substantially higher risks of mild cognitive impairment or dementia.
  • “Genetic ADHD risk predicted cognitive impairment, supporting an association beyond clinical diagnoses.
  • “Findings do not prove a causal link; treatment effects and other variables require further study.”

• Beckers Clinical Leadership informs us,
  • “Suicide became the 10th-leading cause of death in the U.S. in 2024, up from No. 11 in 2023, according to final mortality data from the CDC’s National Center for Health Statistics. Suicide deaths fell 1% over the same period, from 49,316 in 2023 to 48,824 in 2024, and accounted for 1.6% of all deaths in both years. Suicide’s move into the top 10 happened as COVID-19 deaths declined 37%, dropping COVID-19 from 10th to 15th.
  • “Recent data show patterns that differ by method, age and geography. Gun suicides reached record levels for a fifth straight year even as the overall suicide rate trended down. Emergency department visits for suspected suicide attempts declined among adolescents but rose among adults 26 and older. In 2025, rates ranged from 5.3 per 100,000 in the District of Columbia to 31 in Alaska. At the same time, researchers, children’s hospitals and states are pursuing a range of prevention approaches, from smartphone-based risk forecasting and universal ED screening to firearm access laws.
  • [The article notes] seven things to know about the state of suicide in the U.S.

• The National Cancer Institute points out,
  • “Mutations in a family of genes called RAS, and the rogue proteins they produce, help drive roughly a third of all cancers, including more than 90% of pancreatic cancers. Yet RAS has long been one of the most elusive drug targets in cancer research. Unlike other proteins targeted by cancer drugs, RAS proteins have relatively smooth surfaces, with no obvious place for a drug molecule to bind. That made RAS notoriously “undruggable.” 
  • “Despite the long odds, federally funded research continued to push the field forward. Researchers eventually revealed the structure of RAS proteins and how they function, and those insights led to new approaches for blocking mutant RAS, particularly KRAS, which is involved in the vast majority of RAS-driven cancers.
  • “Today, three RAS inhibitors—sotorasib (Lumakras), adagrasib (Krazati), and, most recently, daraxonrasib (Rasonque)—are helping patients live longer, and many additional molecules that block mutant RAS are moving through the research pipeline.”
  • “These life-changing drugs would not have been possible without the sustained public investments that laid the groundwork for the field, said Harold E. Varmus, M.D., former Director of the National Cancer Institute (NCI) and the National Institutes of Health, who launched NCI’s RAS Initiative.”

From the U.S. healthcare business front,

• Healthcare Dive reports,
  • “Hospitals continue to shift care to outpatient settings, according to a new analysis of data from the first half of the year by Strata Decision Technology.
  • “As a result, hospitals are seeing sicker patients in their inpatient wards as they send lower-acuity patients to outpatient departments. 
  • “Patients in some service lines, like gynecology, had procedures done less in hospitals as minimally invasive surgery options in outpatient settings grew. However, other service lines like breast health saw more, sicker patients in the hospital, likely due to an increase in breast cancer testing and diagnoses, according to the data.”

• Beckers Hospital Review relates
  • “In early January, Tamar Goldblatt was named vice president of payer revenue strategy and contracting at St. Louis-based Ascension. 
  • “Since then, Ms. Goldblatt has worked closely with system and ministry leaders to understand the distinct needs of each market and align them with Ascension’s broader payer strategy. Her work comes at a time where Medicare Advantage instability, rising denial rates and growing administrative burden have turned once-routine payer discussions into high-stakes negotiations. 
  • “Becker’s connected with Ms. Goldblatt to discuss her top priorities nearly one year into the role, the trends that are reshaping payer partnerships and how she approaches payer collaboration.”
• and
  • “CVS Health unveiled its first pharmacy-focused CVS Pharmacy in the Boston area Oct. 7. The site is meant to expand access to medications, immunizations and other pharmacist-provided services in the community.
  • “Nearly 20 pharmacy-focused locations will open in select communities across the country in 2026. The sites average about 3,000 square feet and include a full-service pharmacy with a limited selection of over-the-counter products.
  • “CVS has already opened pharmacy-focused locations in Birmingham, Ala., Chicago, Detroit, Houston and Washington, D.C. The company also plans to open more than 40 new CVS Pharmacy locations this year, including traditional stores and pharmacies inside Target stores. CVS cited its 2025 Rx Report, which found 80% of patients prefer face-to-face pharmacy care and 48% would switch pharmacies if limited to digital-only options.”

• The Wall Street Journal tells us,
  • “Viatris VTRS has agreed to buy pain-drug maker Pacira BioSciences PCRX for $1.65 billion in a deal that expands the healthcare company’s medicines portfolio.
  • “Viatris on Thursday said it would pay $36.50 a share in cash for Pacira, a roughly 45% premium to Wednesday’s closing price of $25.20 for the Brisbane, Calif., company.
  • “The deal is slated to close by the end of the year.
  • “Shares of Pacira were recently up 44% at $36.33 in premarket trading, while shares of Viatris edged down 0.1% to $17.47.
  • “Viatris said the addition of Pacira’s Exparel and Zilretta products to its proposed meloxicam treatment for moderate-to-severe acute pain, positions the Canonsburg, Pa., company as a leader in non-opioid pain-management therapies.”
• and
  • Argenx ARGX shares fell sharply after the biotech company stopped a late-stage clinical trial of its Vyvgart drug due to lack of efficacy for the treatment of autoimmune condition Sjogren’s disease.
  • “Shares in Argenx were down 18% in European morning trading Thursday, wiping out the stock’s gains in the year to date. If sustained until close, this would be the stock’s biggest one-day percentage drop since December 2023.
  • “The Amsterdam-based company said it would discontinue the study following the recommendation from an independent data-monitoring committee, which concluded that the trial would fall short of its primary goal.
  • “The study evaluated the effects of Vyvgart in subcutaneous formulation in adults with moderate-to-severe Sjogren’s disease, a chronic autoimmune disorder that can cause symptoms including dry eyes and mouth, fatigue and joint pain. No new safety signals were identified in the trial, and safety data were consistent with the drug’s known profile, Argenx said.”

• BioPharma Dive adds,
  • “On Wall Street, a major search is underway to find struggling public companies that can serve as the raw materials for a niche but booming business. A promising candidate may have just emerged.
  • “This business revolves around “reverse mergers,” a type of deal where a private company combines with a public counterpart, often as a quick way to access the broad and deep-pocketed array of investors found on marketplaces like the Nasdaq. While previously disparaged, reverse mergers have recently become so popular that some deal experts question whether there are enough quality “shell” companies to meet the demand.
  • “Shell hunters could have another option following a Tuesday announcement from Caribou Biosciences, the once high-flying biotechnology startup co-founded by CRISPR gene editing pioneer Jennifer Doudna. In a statement, Caribou CEO Rachel Haurwitz said the current financing environment has made it “increasingly challenging” to secure the money needed to advance the company’s two main research programs, which focus on a hard-to-make form of medicine known as “off-the-shelf” cell therapy.” * * *
  • “To Daina Graybosch, an analyst at Leerink Partners who covers Caribou, the natural end for the company now is either a reverse merger or an acquisition by Tang Capital, a San Diego-based investment firm that made a name for itself by buying up cash-rich biotechs and returning much of their value to shareholders. Caribou ended the second quarter with $114 million worth of cash, cash equivalents and marketable securities.”