• The Biden administration is spending $5 billion on a project to develop future coronavirus vaccines — called Project NextGen — despite the end of the COVID-19 public health emergency, mirroring the Trump-era Operation Warp Speed. (Axios) Meanwhile, Rep. Anna Eshoo (D-Calif.) is pressing the National Institutes of Health for not prioritizing efforts to research and address long COVID, writing in a letter to acting Director Lawrence Tabak that Congress “entrusted NIH with significant funding to provide relief to our constituents suffering from this life-altering disease, but so far, it hasn’t delivered that relief.” (Stat News)
• The Food and Drug Administration finalized a proposal to lift some restrictions on blood donations from men who have sex with men, allowing most gay or bisexual men in monogamous relationships with other men to donate blood. The policy will require all potential donors to take an individual risk-based questionnaire, regardless of gender or sexual orientation, and asks that people wait to donate blood if they had anal sex with new partners or more than one partner in the previous three months. (NBC News)
• The Senate Health, Education, Labor and Pensions Committee passed a slate of health bills aimed at boosting competition for generic drugs and increasing scrutiny of pharmacy benefit managers, though the committee did not pass as strict of PBM legislation as some may have hoped. The PBM legislation passed would ban spread pricing, where the groups charge insurers more for drugs than they pay pharmacies, and require the drug middlemen to disclose rebates, fees and payments they receive and pass them on to the insurers with whom they negotiate. (Stat News)
• Pfizer Inc. Chief Executive Albert Bourla called Medicare’s drug price negotiation program a “negotiation with a gun to your head” and said that he expects pharmaceutical companies to sue to block the program. (Reuters) Meanwhile, a GOP tax law has cut the average tax rate of top pharma companies by more than 40% since it took effect in 2017, according to a report from Senate Finance Committee Democrats. (CNBC)

Worth watching today:

• The FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee meeting to review Sarepta Therapeutics Inc.’s Biologics License Application for delandistrogene moxeparvovec with the requested indication for the treatment of ambulatory patients with Duchenne Muscular Dystrophy (DMD) with a confirmed mutation in the DMD gene.

As Emergency Ends, a Look at Covid’s U.S. Death Toll

The New York Times

As Covid Emergency Ends, Surveillance Shifts to the Sewers

Emily Anthes, The New York Times

With other virus tracking efforts winding down, wastewater data is likely to become increasingly important in the months ahead, scientists say.

U.S. Covid public health emergency ends, leaving behind battered health system

Spencer Kimball, CNBC

The end of the emergency will bring significant changes in how the U.S. responds to the virus. Hospitals will lose flexibility to rapidly add bed capacity if patient admissions surge, and the Centers for Disease Control and Prevention will scale back its efforts to track the virus.

Families of Those Lost to Covid Wrestle With Mixed Emotions as Emergency Ends

Julie Bosman, The New York Times

More than 1.1 million Americans have died of Covid. An official end to the health emergency has landed in complicated ways for those affected most acutely.

Covid Vaccine Administration Immunity Expanded as Pandemic Ends

Ian Lopez, Bloomberg Law

Covid-19 pandemic liability shields for health professionals administering vaccines will be extended as the Biden administration formally ends the federal public health emergency, the HHS announced Thursday.

The Latest COVID Variants Have a Surprising Feature in Common

Sarah Zhang, The Atlantic

Over and over again, genetic mutations are preventing a protein once thought to be key to the virus’s success from being expressed.

Mpox is no longer a global health emergency, WHO announces

Aria Bendix, NBC News

More than 87,000 mpox cases and 140 deaths have been reported across 111 countries since January 2022, according to the World Health Organization.

DeSantis signs “medical freedom” laws

Tina Reed, Axios

Florida Gov. Ron DeSantis on Thursday sought to draw a contrast with the expiring COVID-19 public health emergency, signing a set of “medical freedom” measures into law, including bans on mask and vaccine mandates, and new conscience protections for health providers.

Wegovy, other weight loss drugs ‘no silver bullet’, says WHO amid obesity review

Jennifer Rigby, Reuters

New highly-effective weight loss drugs such as Novo Nordisk’s Wegovy are not a “silver bullet” for addressing the rapid rise in global obesity rates, the World Health Organization’s nutrition chief told Reuters, as the agency conducts its first review of obesity management guidelines in more than 20 years.

Treatment-resistant ringworm infections seen in U.S. for first time

Kerry Breen, CBS News

Treatment-resistant illnesses have been diagnosed in Asia, Europe and Canada, but two cases in New York City mark the first time they have been diagnosed in the United States.

Youth mental health crisis may be improving, early ER data suggests

Alexander Tin, CBS News

America’s youth mental health crisis appears to have shown signs of improving last fall, the Centers for Disease Control and Prevention reported Thursday, based on slowdowns in emergency room visits compared to the year prior.

‘We never want to have this happen again,’ FDA official testifies about formula shortage

Jen Christensen, CNN

The hearing of the US House Oversight and Accountability Subcommittee on Health Care and Financial Services was one of several Congress has held to better understand what contributed to the recent formula shortage and to understand how to prevent more problems down the road.

Dueling Abortion Pill Rulings Ripe For Supreme Court Fight

Nisha Shetty, Bloomberg Law

Two federal judges with conflicting opinions on whether abortion pills can be sold through the mail are setting up a potential showdown at the US Supreme Court, legal analysts say.

Virginia could be key to abortion access in the South. Its laws could hinge on this Democratic primary.

Mel Leonor Barclay, The 19th

Lashrecse Aird is challenging incumbent state Sen. Joe Morrissey, a disbarred defense attorney who has faced a number of personal scandals and who has not been clear on what, if any, restrictions he would support or oppose.

Trans Patients’ Testosterone Access Eased by Online Prescribing

Parker Purifoy, Bloomberg Law

Transgender patients who are prescribed testosterone online are signaling cautious optimism after federal health officials decided controlled substances may be prescribed via telemedicine through late 2024.

Eisai, Biogen Alzheimer’s drug Leqembi would cost US Medicare up to $5 billion a year, study finds

Deena Beasley, Reuters

Wide coverage of Alzheimer’s drug Leqembi would raise future costs for the U.S. Medicare health plan by $2 billion to $5 billion a year, according to a study led by researchers at the University of California, Los Angeles.

Where Geisinger, Security Health Plan execs see promise in AI

Frank Diamond, Fierce Healthcare

When Kaiser Permanente announced earlier this month that it plans to purchase Geisinger Health Plan, industry observers noted that both companies believe artificial intelligence can make healthcare faster, smarter and less expensive.

Payers uniquely positioned to enhance health equity, United Hospital Fund report says

Anastassia Gliadkovskaya, Fierce Healthcare

Payers are uniquely positioned to address disparities as they are major employers, control vast resources through premiums and spend billions of dollars on goods and services, the report said. Besides reeling in massive profits, payers also pay an estimated $93 billion annually in excess direct medical costs attributed to disparities.

Employers Struggle on Mental Health Benefits, DOL Official Says

Sara Hansard and Austin R. Ramsey, Bloomberg Law

Employer health plans and insurers continue to fall short when when it comes to how they treat mental health coverage, the head of Department of Labor’s employee benefits division said Thursday.

The fight over nursing home staffing mandates

Arielle Dreher, Axios

A fight over nursing home staffing mandates is pitting an industry that was at the epicenter of the pandemic against organized labor and some senior lawmakers in Congress.

Federal government’s $1 billion effort to recruit next generation of doctors at risk

Amanda Seitz, The Associated Press

Over the last three years, millions of taxpayer dollars were pumped into the National Health Service Corps to hire thousands more doctors and nurses willing to serve the country’s most desperate regions during the COVID-19 pandemic in exchange for forgiving medical school debts. 

About 1 in 3 physicians report being sued at least once in their career, AMA finds

Dave Muoio, Fierce Healthcare

About 31% of U.S. physicians have received a medical liability claim during their careers, though the percentage of physicians reporting they had been sued in the previous year dipped slightly during the course of the pandemic, according to recently shared American Medical Association survey data.

Closing rural Iowa birthing units is hurting delivery outcomes

Linh Ta, Axios

Expectant mothers are less likely to access prenatal care in rural counties where birthing units have shut down, despite other prenatal providers still being available locally.

Cancer drugs among top 5 most affected by shortages in the US

Deidre McPhillips, CNN

There is an active shortage of about two dozen chemotherapy drugs, the fifth most of any drug category, according to data from the end of March from the University of Utah Drug Information Service.

Sanofi’s RSV antibody cuts hospitalizations by 83% in late-stage study, as $10B market battle heats up

Andrew Dunn, Endpoints News

Sanofi’s RSV antibody nirsevimab cut the rate of hospitalizations by 83% in a Phase IIIb trial, the French pharma giant said Friday.

Amylyx’s ALS drug again surpasses Wall Street expectations

Jacob Bell, BioPharma Dive

Revenue from the biotech’s ALS therapy Relyvrio totaled $71.4 million in the first quarter, well above analyst estimates and helping the company turn a profit only months into the drug’s launch.

AbbVie sues a behind-the-scenes company for exploiting its patient assistance program

Ed Silverman, Stat News

AbbVie has filed a lawsuit against a behind-the-scenes company that helps health plan sponsors take advantage of the assistance programs created by drug companies to provide specialty medicines to patients for free.

FDA adcomm votes in favor of ARS Pharmaceuticals’ EpiPen alternative

Zachary Brennan, Endpoints News

An advisory committee of outside experts to the FDA today voted 16-6 in favor of ARS Pharmaceuticals’ EpiPen alternative for adults (and 16-5 for children who weigh about 66 pounds or more) which, if approved, would be the first epinephrine nasal spray on the US market.

PBMs, the Brokers Who Control Drug Prices, Finally Get Washington’s Attention

Arthur Allen, KFF Health News

Drugmakers, pharmacies, and physicians blame pharmacy benefit managers for high drug prices. Congress is finally on board, too, but will it matter?

Scientists use ‘mini-brains’ to study microglia, the brain’s cleanup crew and key players in neurological disease

Jonathan Wosen, Stat News

Home to billions of cells that form trillions of connections, the human brain isn’t just the body’s most important organ, it’s also the hardest to study. But an international team of scientists using cutting-edge stem cell technology has devised a new way to better understand the brain’s cellular cleanup crew — and its connection to neurological disease.

How pharma’s rocky real estate market has changed — for better and worse

Karissa Waddick, PharmaVoice

Whether you’re looking to build a new site or expand lab space, here are the biggest trends impacting life sciences real estate.

Breach of Mental-Health Records Challenges Nation’s Court System

Catherine Stupp, The Wall Street Journal

Hacker, reaching a dead end in extorting clinic in Finland, targeted individual patients.

An ultrasound device may unlock brain cancer treatment, early study shows

Lizzy Lawrence, Stat News

The study, led by Northwestern University researchers, also reported no treatment-related deaths or worsening of neurological symptoms. Drug levels increased almost sixfold in the part of the brain activated by the device.