• Walgreens Boots Alliance Inc.’s fiscal second-quarter profit declined year over year by more than 20% to $703 million, as sales from COVID-19 vaccines and tests plummeted compared to last winter during the omicron surge. Still, reported revenue increased year over year by 3.3% to $34.86 billion, beating Wall Street expectations. (CNBC)
• Frank Yiannas, former deputy commissioner of the Food and Drug Administration’s food policy and response division, said in submitted congressional testimony that the baby-formula industry remains just as at risk for safety and supply problems as it was during last year’s nationwide shortage following a recall by Abbott Laboratories. Yiannis, who is scheduled to testify today before the House Oversight Committee’s health care panel, wrote that the United States “remains one outbreak, tornado, flood, or cyberattack away from finding itself in a similar place to that of February 17, 2022,” adding that the FDA’s poor communication system prevented a quicker response to allegations of production issues at an Abbott plant. (The Wall Street Journal)
• Ohio’s attorney general filed a lawsuit alleging that the pharmacy benefit managers Cigna Group, Humana Inc. and Prime Therapeutics LLC shared drug price information collected by a Swiss subsidiary to gain an advantage in negotiations with drugmakers for rebates. The lawsuit adds to the recent scrutiny of PBM practices, including investigations from several states, the Federal Trade Commission and House Republicans. (The Wall Street Journal)
• Sen. Tammy Duckworth (D-Ill.) asked the FTC to investigate reports that AmerisourceBergen Corp. is refusing to distribute the abortion drug mifepristone to retail pharmacies in certain states but is willing to offer the drug to health care providers, writing in a letter to the agency that the company “may be using broader political disagreements and active legal debates as pretextual cover and justification for engaging in anticompetitive, unfair and deceptive practices that are primarily concerned with maximizing profit margins.” (The Hill) Meanwhile, Georgia’s Supreme Court will hear arguments today on the state’s six-week abortion ban after a lower court ruled in November that the law was unconstitutional. (Axios)

Worth watching today:

• The FDA’s Safety and Risk Management and Dermatologic and Ophthalmic Drugs committees joint meeting to discuss proposed changes to the iPLEDGE Risk Evaluation and Mitigation Strategy requirements to minimize the burden on patients, pharmacies, and prescribers while maintaining safe use of isotretinoin oral capsules for patients.

Four House meetings:

• Appropriations Committee hearing: “Fiscal Year 2024 Request for the Department of Health and Human Services.” Health and Human Services Secretary Xavier Becerra is scheduled to testify.
• Ways and Means Committee hearing: “Hearing on President Biden’s Fiscal Year 2024 Budget Request with Health and Human Services Secretary Becerra.”
• Oversight and Accountability Committee’s Health Care and Financial Services Subcommittee hearing: “FDA Oversight Part I: The Infant Formula Shortage.” Yiannis is scheduled to testify.
• Oversight and Accountability Committee’s Coronavirus Pandemic Select Subcommittee hearing: “The Consequences of School Closures: Intended and Unintended.”

‘Live free and die?’ The sad state of U.S. life expectancy

NPR News

BioNTech readies for plunge in Covid sales, will boost mRNA and oncology pipelines

Beth Snyder Bulik, Endpoints News

BioNTech is estimating €5 billion (nearly $5.4 billion) in Covid-19 vaccine sales this year, a marked drop from €17.1 billion ($18.5 billion) in 2022 — and way off analysts’ expectations of around €8 billion ($8.6 billion).

FDA details plan to end emergency use authorizations

Elise Reuter, MedTech Dive

The agency is providing a 180-day transition period for devices that were exempted during the pandemic, and said companies that currently have an EUA should start preparing.

HHS Secretary Becerra aims to keep ‘pushing the envelope’

Victoria Turner, Modern Healthcare

During a sit-down with Modern Healthcare Thursday, the second anniversary of Becerra taking his Cabinet post and the 13th anniversary of the Affordable Care Act, he said his style is “pushing the envelope” as far as possible.

How the drug industry uses fear of fentanyl to extract more profit from naloxone

Lev Facher, Stat News

At first glance, the race to create stronger, more advanced overdose-reversal tools seems like a win-win: a case study in American pharmaceutical companies saving countless lives and turning a profit along the way.

Senators to Seek Alternatives to ‘Civil Death’ of Guardianship

Ronnie Greene, Bloomberg Law

When the US Senate Special Committee on Aging gathers Thursday to examine the nation’s fractured guardianship system, one prime focus will be to find ways to eliminate unnecessary guardianships by turning to less onerous options.

Congress Moves to Add ‘Tranq’ to Controlled-Drugs List

Jon Kamp and Julie Wernau, The Wall Street Journal

Xylazine, known to some users as “tranq,” is approved only for use in animals such as horses and cattle. But dealers have been adding it to the fentanyl supply at an alarming pace, potentially to reduce their costs and lengthen the high for users.

Kansas high court signals continued abortion rights support

John Hanna, The Associated Press

Kansas’ highest court signaled Monday that it still considers access to abortion a “fundamental” right under the state constitution, as an attorney for the state argued that a decisive statewide vote last year affirming abortion rights “doesn’t matter.”

Drug combo may extend the lives of women with advanced endometrial cancer

Erika Edwards, NBC News

Women with advanced endometrial cancer may live longer before their tumors return if they receive immunotherapy and chemotherapy at the same time, according to two studies published Monday in the New England Journal of Medicine.

As Colorado Reels From Another School Shooting, Study Finds 1 in 4 Teens Have Quick Access to Guns

Markian Hawryluk, Kaiser Health News

The study analyzed Colorado kids’ responses to how quickly they could get their hands on a loaded gun without their parents’ knowledge. More than 1 in 10 said they could do so within 10 minutes.

Buyers of Abbott’s Recalled Baby Formula Cite Economic Harm

Julie Steinberg, Bloomberg Law

Parents who allege they overpaid for recalled Abbott Laboratories baby formula urged a federal court to allow their claims, saying they have standing to sue because they suffered economic injury from buying contaminated products.

Dem lieutenant governors form abortion rights alliance

Victoria Knight and Oriana González, Axios

The Reproductive Freedom Coalition — led by Connecticut Lt. Gov. Susan Bysiewicz — comes as a federal judge in Texas weighs a case that could end nationwide access to one of the most commonly used abortion pills in the U.S.

Financial incentives could prompt ERs to provide more addiction treatment

Sabrina Moreno, Axios

A Pennsylvania program that incorporates addiction treatment into emergency care for opioid use disorder could help limit the high risk of death patients who overdose face after they’re discharged, according to a study published in JAMA Health Forum.

Abortion puts New York Republicans on defense

Brittany Gibson, Politico

Democrats are betting that the road back to the House majority rests with voters who care about abortion access — especially in blue states like New York.

Volunteer pilots fly patients seeking abortions to states where it’s legal

Rose Conlon, KMUW Wichita

It can be a lifeline for patients who can’t afford the time or costs of driving or flying commercially. It’s an example of the unconventional tactics of abortion rights groups in a post-Roe America.

Washington lawmakers buck trend of anti-trans bills

Melissa Santos, Axios

This year, Washington lawmakers are trying to protect transgender patients — as well as doctors that practice here — from the reach of other states’ laws that restrict gender-affirming health care for minors.

Could a fight over cost-effectiveness upend Medicare drug price negotiation before it’s begun?

Sarah Owermohle, Stat News

As Medicare drug price negotiation looms, congressional Republicans are scrambling to push through a limit that Democrats argue could hobble the agency’s efforts before they have even begun.

The quiet privatization of government health insurance programs

Caitlin Owens, Axios

Although privately run Medicare and Medicaid plans are still highly regulated and funded by the government, the commercialization has complicated efforts to rein in medical spending and unleashed fierce partisan fights like the ongoing one over Medicare Advantage.

Former Aetna CEO to Take Helm of Health Insurer Oscar

Anna Wilde Mathews, The Wall Street Journal

Mark Bertolini, former chief executive of health insurance giant Aetna Inc. and hedge fund Bridgewater Associates, will take the helm of Oscar Health Inc. as it seeks to turn a profit and carve out a role as a technology supplier in the healthcare industry.

Congressman Seeks to Plug ‘Shocking Loophole’ Exposed by KHN Investigation

Sarah Jane Tribble, Kaiser Health News

A federal lawmaker has introduced a House bill that would close one of a laundry list of oversight gaps revealed in a recent KHN investigation of the system regulators use to ban fraudsters from billing government health programs, including Medicare and Medicaid.

Tennessee transgender bill threatens to upend Medicaid contracts

Kara Hartnett, Modern Healthcare

Tennessee Speaker of the House of Representatives Cameron Sexton (R) and Speaker of the Senate Randy McNally (R), who also is lieutenant governor, sponsored the Tennessee MCO Reform Act, which would prohibit the state Medicaid agency from contracting with insurers that cover gender-affirming treatment for anyone, anywhere in the country.

Medicare Panel Targets Rate-Setting Process for Private Plans

Tony Pugh, Bloomberg Law

A congressional advisory panel is exploring possible options to overhaul the way Medicare managed care plans are paid because their enrollment of less-costly beneficiaries is leading to excess payments.

A billing dispute means a mom must pay nearly $1,000 a month for her son’s diabetes care

Ken Alltucker, USA Today

A New York family’s struggle to get medical care for their 12-year-old son is an example of how difficult it can be for people to afford the cost of diabetes supplies.

‘We’re Going Away’: A State’s Choice to Forgo Medicaid Funds Is Killing Hospitals

Sharon LaFraniere, The New York Times

Mississippi is one of 10 states, all with Republican-led legislatures, that continue to reject federal funding to expand health insurance for the poor, intensifying financial pressure on hospitals.

Heated oral arguments at SCOTUS hint at Sanofi-Regeneron edge over Amgen in patent spat

Zachary Brennan, Endpoints News

Lawyers for Sanofi-Regeneron, Amgen, and the federal government took the stage at the Supreme Court on Monday, arguing a complicated patent case over the two sides’ competing, blockbuster PCSK9 inhibitors with justices’ questions hinting at a decision that will likely be a win for Sanofi and Regeneron.

Novartis data set up multibillion-dollar battle over breast cancer drugs

Matthew Herper, Stat News

At issue is the market for medicines called CDK 4/6 inhibitors. The first of these drugs, Pfizer’s Ibrance, is a $5-billion-a-year product and one of that company’s top sellers. But it has been losing market share to Eli Lilly’s Verzenio.

In new PD-1 showdown, GSK’s Jemperli loses initial edge on Merck’s Keytruda

Angus Liu, Fierce Pharma

Both drugs showed that their addition to chemotherapy can significantly improve patient outcomes over chemo alone. But the results once again suggested that for GSK, challenging the world’s best-selling immunotherapy won’t be an easy task.

Truly Random Drug Testing: ADHD Patients Face Uneven Urine Screens and, Sometimes, Stigma

Arielle Zionts, Kaiser Health News

Doctors have no national standards on when to order urine tests to check whether adult ADHD patients are properly taking their prescription stimulants. Some patients are subjected to much more frequent testing than others.

ALS drugmakers, encouraged by recent FDA feedback, set their sights on a key protein

Jacob Bell, BioPharma Dive

A protein that’s become increasingly important to ALS drugmakers is likely to get even more attention after a recent regulatory meeting signaled it could be used to support the approval of some experimental treatments.

BrainStorm files ALS drug application over FDA protest

Ned Pagliarulo, BioPharma Dive

On Monday, BrainStorm Cell Therapeutics said the agency will convene a panel of outside experts to review its medicine, a personalized stem cell treatment called NurOwn. The planned meeting, which has not yet been scheduled, is the result of BrainStorm taking the rare step of requesting its approval application be filed over the FDA’s protest.

Look out, Lilly. Novartis touts ‘consistent benefit’ for Kisqali in broad early-stage breast cancer

Angus Liu, Fierce Pharma, Fierce Pharma

Kisqali, used on top of endocrine therapy after surgery, significantly reduced the risk of invasive disease recurrence compared with endocrine therapy alone in HR-positive, HER2-negative early breast cancer, Novartis said in a Monday press release.

Cutting the cord — why streaming is a new frontier for pharma advertising

Karissa Waddick, PharmaVoice

Television is king in pharma marketing — at least it used to be. After a long reign at the top, linear TV advertising spending dropped in 2022 as a proportion of pharma’s total ad budget to just 43%, surpassed by digital communication streams.

Vertex pays CRISPR to use its gene editing tech for diabetes drugs

Christopher Newman, BioPharma Dive

Under an agreement announced Monday, CRISPR will get $100 million upfront and is eligible to receive an additional $230 million for research and development milestones. Vertex and CRISPR are already partnered on a possible cure for the blood disorders sickle cell disease and beta thalassemia.

Labcorp to pay $2.1 million to settle DOJ lawsuit for allegedly overbilling Defense Department

Annika Kim Constantino, CNBC

A former LabCorp employee turned whistleblower, Donna Hecker-Gross, sued the diagnostic testing company in 2018 on behalf of the federal government under the False Claims Act. The civil lawsuit was filed in the U.S. District Court for the District of Maryland.

As AI promises to revolutionize medical note-taking, concerns mount about accuracy and harm

Brittany Trang, Stat News

In the doctor’s offices of the future, artificial intelligence will be a fly on the wall, listening in and logging the sensitive conversations that happen every day between patients and their doctors. Gone will be the distracted doctor hunched over a keyboard, tapping, clicking, constantly playing catch-up with hours of extra work.

Google investor describes troubling rumors heard before Outcome Health fell

John Pletz, Crain’s Chicago Business

Laela Sturdy, who led Google’s investment in Outcome Health, said she was “shocked and surprised” five years ago when allegations of fraud at the healthcare advertising company made headlines. She also had an inkling such a story might be coming.