• The Justice Department asked the U.S. 5th Circuit Court of Appeals to overturn the ruling from a federal judge in Texas that suspended the Food and Drug Administration’s 23-year-old approval of the abortion drug mifepristone, stating that “the district court swept the agency’s judgments aside by substituting its own lay understanding of purportedly contrary studies.” Oral arguments are scheduled for May 17, and the Texas judge’s suspension of the drug will be on hold after an emergency ruling from the Supreme Court. (The Hill)
• Shortly after Sen. Bill Cassidy (R-La.) was officially named the ranking member of the Senate Health, Education, Labor and Pensions Committee, campaign donations from top pharmaceutical executives poured in, including from Pfizer Inc. Chief Executive Albert Bourla, Eli Lilly & Co. CEO David Ricks and Biogen Inc. CEO Christopher Viehbacher. The donations came as the Senate HELP Committee made pharmaceutical policies some of its key priorities; however, Cassidy told Stat News that when “somebody donates to me, they sign up for my agenda item, I don’t sign up for them.” (Stat News)
• Centers for Medicare and Medicaid Services Administrator Chiquita Brooks-LaSure told members of Congress that Medicare would cover Biogen’s new Alzheimer’s treatment Leqembi for all eligible patients if the FDA fully approves the treatment in July. (CNBC) Meanwhile, CMS said it would impose stricter timelines on hospitals to comply with federal price transparency laws and issue fines more quickly if hospitals do not comply. (Modern Healthcare)
• Bristol Myers Squibb Co.’s first-quarter revenue declined to $11.34 billion, compared with $11.65 billion in the year-ago period, and the pharmaceutical company announced that CEO Giovanni Caforio would step down in November. (Reuters) Merck & Co. Inc.’s first-quarter sales dropped to $14.5 billion from $15.9 billion year over year, but sales for its blockbuster cancer drug Keytruda grew by 20% to $5.8 billion. (Reuters)

Worth watching today:

• The Medical Device Manufacturers Association’s annual meeting continues. Today’s speakers include FDA Commissioner Robert Califf, Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, and House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.).
• AbbVie Inc., Eli Lilly and Merck report their latest earnings.

Communities of color saw higher COVID death rates for younger adults

Axios

Second judge says US not liable in Moderna COVID-19 vaccine patent case

Blake Brittain, Reuters

Moderna Inc failed to persuade a Delaware federal judge on Wednesday to shift liability to the U.S. government for patent infringement allegations based on COVID-19 vaccines it provided for the government’s vaccination effort.

As Federal Emergency Declaration Expires, the Picture of the Pandemic Grows Fuzzier

Sam Whitehead, KFF Health News

The pandemic gave federal officials expanded power to access crucial data about the spread of covid-19, but that authority will change when the public health emergency sunsets in May. That, along with the end of popular covid trackers, will make it harder for policymakers and the public to keep an eye on covid and other threats.

What to know about XBB.1.16, the ‘Arcturus’ variant 

Akshay Syal and Sara G. Miller, NBC News

It was first detected in early January and the majority of cases have been seen in India so far. It’s been steadily rising in the U.S. in recent weeks, although it still made up slightly less than 10% of new confirmed Covid cases as of April 22, according to the Centers for Disease Control and Prevention.

A Century-Old Vaccine Fails to Protect Against Covid

Roni Caryn Rabin, The New York Times

Early in the pandemic, scientists began testing an old TB vaccine against the coronavirus. But the trial enrolled fewer participants than expected as new Covid vaccines were introduced, and no discernible effect was found.

Another powerful congressional committee is ready to take on PBMs

John Wilkerson, Stat News

House Oversight Committee Chairman James Comer plans to hold a hearing on the results of an investigation into the business practices of drug middlemen, he said Wednesday.

Senate GOP votes down bill calling on VA to study marijuana as PTSD, pain remedy

Al Weaver, The Hill

Senate Republicans on Wednesday defeated a bill calling on the Department of Veterans Affairs to research marijuana as a remedy for post-traumatic stress disorder and chronic pain. Senators voted 57 to 42 to invoke cloture on the motion to proceed to the bill, falling short of the 60 votes necessary for it to advance.

US challenges Tennessee ban on healthcare for transgender youth

Kanishka Singh, Reuters

The U.S. Justice Department on Wednesday filed a complaint challenging a new Tennessee law that bans doctors from providing gender-affirming medical treatment such as puberty blockers, hormone therapy and surgery to transgender minors.

Amphetamines often prescribed along with depression and anxiety medications

Berkeley Lovelace Jr., NBC News

A large number of U.S. adults are being prescribed drugs like amphetamines, which have a risk for misuse, along with medications for depression and anxiety, a new study has found. The practice, the authors say, could lead to higher rates of misuse and addiction, and cause unknown side effects.

First pill for fecal transplants wins FDA approval

Matthew Perrone, The Associated Press

The new treatment from Seres Therapeutics provides a simpler, rigorously tested version of stool-based procedures that some medical specialists have used for more than a decade to help hard-to-treat patients.

Promising new malaria vaccine has been approved in two countries, with others likely to follow

Aria Bendix, NBC News

Ghana and Nigeria each approved a new malaria vaccine this month — an important step in the fight against a disease that kills more than 600,000 people annually. At least 10 other African countries are reviewing trial data for the shot, according to the World Health Organization, so more approvals are expected in the coming weeks.

Texas woman denied an abortion tells senators she ‘nearly died on their watch’

Jacqueline Howard and Tierney Sneed, CNN

A woman who is suing the state of Texas after being denied an abortion told lawmakers Wednesday that not receiving abortion care harmed her mental health and might prevent her from having children in the future.

Kansas abortion providers face new rule after veto overriden

John Hanna, The Associated Press

Kansas health care providers could face criminal charges over accusations about their care of newborns delivered during certain abortion procedures after the Republican-controlled Legislature on Wednesday overrode Democratic Gov. Laura Kelly’s veto of their legislation.

Post-Roe, abortion access has dropped in the US, but support has not, survey finds

Deidre McPhillips, CNN

About a year after the court’s Dobbs decision, 80% of US adults say that their views on abortion have not changed. More than 6 in 10 say that abortion should be legal in all or most cases, while about a third say that it should be illegal in all or most cases.

Menopause symptoms cost billions in medical expenses and lost days of work, study suggests

Carma Hassan, CNN

Researchers surveyed about 5,000 women ages 45 to 60 who are primary care patients at the Mayo Clinic; 4,440 of the women were employed at the time of the study.

As US Life Expectancy Falls, Experts Cite the Health Impacts of Incarceration

Fred Clasen-Kelly, KFF Health News

In a nation with one of the highest incarceration rates in the world, imprisonment speeds the aging process, research shows. Some experts complain the federal government isn’t collecting or releasing data that could identify disease patterns and prevent deaths.

Health insurance CEOs set another record for pay in 2022

Bob Herman, Stat News

In 2022, the CEOs of the seven major publicly traded health insurance and services conglomerates — CVS Health, UnitedHealth Group, Cigna, Elevance Health, Centene, Humana, and Molina Healthcare — combined to make more than $335 million, according to a STAT analysis of annual financial disclosures.

Hospitals put on defensive over site-neutral payments

Tina Reed, Axios

Momentum is building in Congress to address the way hospitals charge more for the same services private doctors deliver in their offices — a sign of broader lawmaker frustration with the industry.

OIG audit reveals lack of data sharing led to $128M in duplicate payments by Medicare, VA

Annie Burky, Fierce Healthcare

Medicare paid for medical services that the Veterans Health Administration had also paid for, resulting in duplicate payments of up to $128 million over five years, revealed an audit performed by the Office of Inspector General.

Humana boosts 2023 expectations for Medicare Advantage growth

Shannon Muchmore, Healthcare Dive

Humana said Wednesday it expects 2023 Medicare Advantage membership to increase 17% from the prior year, representing metrics that are “meaningfully higher than industry growth,” as it also reported favorable MA inpatient utilization trends for the first quarter.

Work Rules in Debt Bill Risk Patchwork Impact on Most Vulnerable

Maeve Sheehey and Alex Ruoff, Bloomberg Law

House legislation to change work rules for social and health care safety net programs would hit red and blue states in different ways, broadening existing inequalities nationwide.

Kaiser Permanente to acquire Geisinger, form company to operate other nonprofit systems

Shannon Muchmore and Rebecca Pifer, Healthcare Dive

Kaiser Permanente is acquiring Geisinger Health and forming a new nonprofit to buy and operate other value-oriented nonprofit systems, the organizations announced Wednesday. The new nonprofit, Risant Health, will operate separately from Kaiser Permanente.

Bipartisan bill would subject nonprofit hospitals to FTC

Arielle Dreher, Axios

The nonprofits comprise nearly half of all facilities in the U.S. but fall outside the purview of the Federal Trade Commission. There’s been growing concern in Congress over secret contracting practices and other behavior that some lawmakers contend justifies more oversight.

Nonprofit Hospital Community Benefit Needs Clarity, GAO Says

Nisha Shetty, Bloomberg Law

The community benefit standard that nonprofit hospitals must meet is too loosely defined by Congress and the Internal Revenue System, the chairman of a House Ways and Means Oversight Subcommittee said at a Wednesday hearing.

How a 2019 Florida Law Catalyzed a Hospital-Building Boom

Phil Galewitz et al., KFF Health News

In Wesley Chapel, Fla., near Tampa, residents will soon have three general hospitals within a five-minute drive. The new construction is part of a hospital-building boom across Florida unleashed almost four years ago, when the state dropped a requirement that companies obtain government approval to open new hospitals.

Early findings in gene therapy death suggest CRISPR was not the cause

Jason Mast, Stat News

In February, four months after the first patient in the trial of a designer CRISPR therapy suddenly died, around 100 researchers gathered in a Tucson, Ariz., conference hall to hear investigators in the study walk through the results of an autopsy.

Eli Lilly raises annual profit forecast on strength of diabetes drug

Reuters

Eli Lilly and Co raised its full-year profit forecast on Thursday, betting on the approval of its diabetes drug, tirzepatide, for the treatment of obesity expected later this year.

Sanofi Q1 profit buoyed by better-than-expected Dupixent sales

Ludwig Burger, Reuters

French drugmaker Sanofi on Thursday posted better-than-expected earnings for the first quarter as continued gains from anti-inflammatory drug Dupixent more than offset declining sales from an established multiple sclerosis drug.

AstraZeneca beats estimates on strong emerging market sales as COVID wanes

Natalie Grover and Maggie Fick, Reuters

AstraZeneca on Thursday beat expectations for first-quarter profit and revenue, as buoyant sales of cancer drug Imfinzi and strong demand for its roster of drugs in emerging markets helped to offset dwindling COVID product sales.

Lilly’s Mounjaro leads to 16% weight loss for obese diabetics in trial

Deena Beasley, Reuters

A large trial showed that a high dose of Eli Lilly and Co’s Mounjaro helped people with type 2 diabetes who were also obese or overweight to lose nearly 16% of their body weight, or over 34 pounds (15kg) on average, the company said on Thursday.

EU publishes proposed drug laws overhaul, seting up tussle with industry

Maggie Fick, Reuters

Brussels on Wednesday published a long-awaited draft of its proposed overhaul of laws governing the European Union’s pharmaceuticals industry, setting up a tussle with drugmakers which warn they will invest and innovate elsewhere.

Early results from Alzheimer’s study set stage for Alnylam’s expansion into brain diseases

Ryan Cross, Endpoints News

Alnylam Pharmaceuticals unveiled the first evidence that its RNA interference technology can dramatically reduce levels of proteins linked to Alzheimer’s disease, an early but intriguing result that could prompt new approaches to treating the memory-robbing condition.

A research team airs the messy truth about AI in medicine — and gives hospitals a guide to fix it

Casey Ross, Stat News

Caregivers complain AI models are unreliable and of limited value. Tools designed to warn of impending illnesses are inconsistent and sometimes difficult to interpret. Even evaluating them for accuracy, and susceptibility to bias, is still an unsettled science.

5 takeaways from Teladoc’s Q1 financials

Gabriel Perna, Modern Healthcare

The Purchase, New York-based telehealth company posted a first-quarter net loss of $69.2 million, or 42 cents per share, compared with a net loss of $6.6 billion, or $41.58 per share, in the year-ago period. Revenue increased 11% year-over-year to $629.2 million, from $565.4 million.