• The Centers for Medicare and Medicaid Services proposed two new rules that would make a list of changes to Medicaid and the Children’s Health Insurance Program to increase access to care and implement stronger monitoring and reporting requirements. The proposals include measures to implement a national wait-time standard of two weeks for routine primary care, stronger state monitoring and reporting requirements and a requirement for states to disclose provider payment rates for fee-for-service and Medicaid managed care plans that would be compared with Medicare fee-for-service rates. (Fierce Healthcare)
• Pharmacy benefit managers have become Congress’s most recent health care target as both the House and Senate are crafting legislation to lower drug costs that include provisions to increase oversight of the pharmaceutical industry middlemen. (Roll Call) Meanwhile, a bipartisan coalition of representatives and senators introduced legislation that would pay drug manufacturers to develop antibiotics and antifungal drugs to treat drug-resistant bacteria and fungi, as many companies stopped making the medications because the business was not highly profitable. (The Wall Street Journal)
• Washington Gov. Jay Inslee (D) signed into law major health privacy protections that restrict companies that run platforms like telehealth services or period-tracking applications from gathering or sharing patient data without consent, including protections for location data that could show if someone traveled to an abortion clinic or a specific health facility. (Bloomberg Law) As many states have recently implemented abortion restrictions, conservative-controlled legislatures in South Carolina and Nebraska shot down efforts to advance stricter abortion bans, a potential sign to the GOP that abortion limits could face backlash in certain states across the country. (The Washington Post)
• The United States has reported no new mpox cases for more than a week for the first time since the outbreak began last May, according to data published by the Centers for Disease Control and Prevention. More than 30,000 mpox cases have been reported in the United States, including 42 deaths, with Black men making up 87% of people who have died as of March, per federal health data. (CBS News)

Worth watching today:

• The Food and Drug Administration’s Oncologic Drugs Advisory Committee meeting to review AstraZeneca PLC’s new drug application to use Lynparza in combination with abiraterone and prednisone or prednisolone to treat a form of prostate cancer.
• The final day of the Medical Device Manufacturers Association’s annual meeting, featuring a CMS update from Center for Clinical Standards and Quality Director Lee Fleisher.

Map of gun deaths across the U.S. shows cities have lower rates than rural counties

NBC News

CDC eases COVID vaccination rule on international travelers, as expiration looms

Alexander Tin, CBS News

The Centers for Disease Control and Prevention moved Thursday to formally loosen its COVID-19 vaccination requirement on foreign visitors, which will now allow some to board flights into the U.S. with only a single dose of a COVID-19 vaccine from Pfizer or Moderna.

A new portrait of American teenagers in crisis

Krista Mahr, Politico

A sweeping series of surveys of U.S. high school students released Thursday by the Centers for Disease Control and Prevention have an urgent message for parents and policymakers: America’s kids are in crisis.

NIH Deadly Pathogen Research Funds at Risk, Key Republican Says

Jeannie Baumann, Bloomberg Law

The top Republican on a House oversight panel hinted he wants to end NIH funding for high-level biocontainment research, repeating his party’s criticisms of the way the agency handled coronavirus research grants in Wuhan, China.

Shortage of penicillin limits access to the go-to drug for syphilis

Aria Bendix, NBC News

The drug joins a growing list of medications facing supply shortages in the U.S. Liquid amoxicillin, another antibiotic used to treat strep, has been in short supply since October, according to the FDA.

Over 1 in 5 skip health care due to transportation barriers

Adriel Bettelheim, Axios

More than 1 in 5 U.S adults without access to a vehicle or public transportation missed or skipped a medical appointment in the previous year, according to a new study that sheds light on a key social driver of health equity.

US cigarette smoking rate falls to historic low, but e-cigarette use keeps climbing

Jen Christensen, CNN

About 11% of adults told the CDC last year that they were current cigarette smokers, according to the latest preliminary data from the National Health Interview Survey, a biannual survey that provides general information about health-related topics. The survey includes responses from 27,000 people age 18 and older. In 2020 and 2021, about 12.5% of adults said they smoked cigarettes.

‘We went from almost no lockdowns to daily lockdowns’: The mental health crisis inside California women’s prisons

Taylor Majewski, Stat News

In STAT’s interviews with more than a half-dozen women who are incarcerated in California, many described the post-pandemic era as their most difficult period of incarceration. Every single woman also said that these lockdowns haven’t let up in the three years since the pandemic started.

How One Patient’s Textured Hair Nearly Kept Her From a Needed EEG

Tarena Lofton, KFF Health News

An EEG can help diagnose conditions like epilepsy, sleep disorders, and brain tumors. But a design flaw and outdated Eurocentric practices make the test less effective on thicker, denser, and curly hair types, potentially excluding or deterring some people from getting screened.

A drug company abandoned a treatment for  ‘bubble boy disease.’ After a 5-year fight, this little girl is about to get it

Elizabeth Cohen and Lauren Mascarenhas, CNN

The treatment is for a particular type of severe combined immunodeficiency called ADA-SCID that’s extremely rare – in the US, eight babies a year are born with it. Currently, 26 children in the US and Canada are on the waiting list to get the therapy, according to Dr. Donald Kohn, a UCLA scientist who has been working on the treatment for nearly 40 years.

The future of ketamine therapy

Sabrina Moreno, Axios

Ketamine use is surging as veterans and people with persistent depression look for alternative treatments. But the industry that’s sprung up around that demand is showing signs of buckling, leaving some patients stranded without support.

Pennsylvania set to ban supervised drug use sites, in setback for harm reduction

Lev Facher, Stat News

A bill outlawing sites that “knowingly” provide a space for drug consumption passed a committee vote by a wide margin on Tuesday. It now advances to the full state senate, where it is also expected to pass. Gov. Josh Shapiro, a Democrat, has expressed strong opposition to supervised injection sites in the past, and is expected to sign the legislation.

Utah judge to consider challenge to new abortion clinic ban

Sam Metz, The Associated Press

Planned Parenthood argues a state law passed earlier this year will effectively end access to abortion throughout the state when clinics next week stop being able to apply for the licenses they’ve historically relied on to operate.

Molina expects half of Medicaid enrollees gained during COVID to lose eligibility due to redeterminations

Sydney Halleman, Healthcare Dive

Molina Healthcare expects that half of the about 800,000 Medicaid enrollees it gained since the start of the COVID-19 pandemic will lose eligibility due to redeterminations, which began earlier this month.

Race for rural care: Why retailers are moving into small communities

Caroline Hudson, Modern Healthcare

About 15% of consumers live in rural areas, where they tend to be more at risk for heart disease, stroke, cancer, chronic respiratory issues and unintentional injuries than their urban counterparts, according to the Centers for Disease Control and Prevention. People in rural areas also are typically older, sicker and more likely to be impoverished.

Pfizer pledge for more equal access to RSV shot faces hurdles

Jennifer Rigby and Maggie Fick, Reuters

Pfizer Inc has pledged to deliver critical new medicines more quickly in low-income nations, but its first such vaccine effort faces hurdles likely to delay distribution in poorer countries by several years, global health officials told Reuters. Pfizer made a commitment on more equitable access last year, following criticism that it prioritized wealthy nations for doses of its COVID-19 shot early in the pandemic.

Lilly drug Mounjaro succeeds in second weight loss study

Jonathan Gardner, BioPharma Dive

Eli Lilly’s new medicine Mounjaro helped overweight people with diabetes lose about 30 pounds on average over an 18-month clinical trial, a significant result that boosts the drug’s chances of winning approval as a weight loss treatment.

Eli Lilly will use a priority review voucher on Mounjaro to ‘remove any uncertainty’ around fast FDA review

Nicole DeFeudis, Endpoints News

Eli Lilly isn’t waiting around for the FDA’s fast-track pathway. The team is “feverishly” submitting its new Phase III data for Mounjaro in obesity, and will use a priority review voucher to cut four months off of the standard review time.

Merck reveals HIV combo trial is back in the running after FDA partial hold lifted 

Max Bayer, Fierce Biotech

The Big Pharma has resumed a phase 2 study of MK-8591D, an oral regimen of islatravir and Gilead’s Sunlenca, executives said on a call with analysts Thursday. Gilead’s drug was approved in December as a twice-yearly treatment for patients with multi-drug resistant HIV.

J&J to retain all talc-related liabilities from litigation in US, Canada

Reuters

Johnson & Johnson said on Thursday it has agreed to retain all talc-related liabilities arising from litigation in the United States and Canada and will “indemnify” newly formed consumer health unit Kenvue for all costs.

Gilead profit misses Wall Street expectations as COVID drug sales decline

Reuters

Gilead Sciences Inc on Thursday reported a lower-than-expected first-quarter profit as sales from COVID-19 antiviral Veklury declined more than anticipated, and its shares fell more than 2%.

‘Lots of ways for donanemab to win’ in Alzheimer’s, Lilly says. Now, it just needs the data

Annalee Armstrong, Fierce Biotech

Lilly executives remain bullish on donanemab’s market potential even with the first-to-market advantage likely taken by Biogen and Eisai.

FDA approves Pfizer’s Prevnar 20 for infants and children

Tyler Patchen, Endpoints News

Pfizer has secured approval from the FDA for its Prevnar 20 pneumococcal disease vaccine for infants, children and adolescents, the New York-based drugmaker announced Thursday.

As Humira biosims take hold, longtime AbbVie CEO Richard Gonzalez talks succession plans

Zoey Becker, Fierce Pharma

In his 10 years at the helm, the CEO has stayed relatively mum about when his tenure would end. But, internally, Gonzalez has had “many, many” discussions with the board about his succession, he said during the company’s first-quarter earnings conference call.

Vast sequencing project begins to unlock human genome’s secrets — by deciphering other mammals’ DNA

Jonathan Wosen, Stat News

The findings, reported in a set of 11 studies published on Thursday in the journal Science, come out of the Zoonomia Project, which compared the genomes of 240 mammalian species. The list of sequenced creatures reads a bit like the passenger manifest of Noah’s Ark: Amazon river dolphins, greater mouse-eared bats, fat-tailed dwarf lemurs, horses, humans, and more.

How biopharma dealmaking kicked back into action

Michael Gibney, PharmaVoice

The collective capacity for M&A in the biopharma industry is a result of complex market factors, but at the granular level, every company has its own reasons for dealmaking. Cash reserves, valuations, the state of the pipeline — so many factors determine whether a single company, not to mention a whole sector, is ready to come to the table.

Drugmakers scout for deals, ramp up research spending

Manas Mishra and Patrick Wingrove, Reuters

Drugmakers including Merck & Co, AstraZeneca Plc and AbbVie Inc said on Thursday they are open to acquisitions and reported a ramp up in research and development spending as the industry’s larger players look for new sources of future revenue.

Quest Diagnostics to pay $450M to buy liquid biopsy cancer test developer as Q1 revenue drops

Susan Kelly, MedTech Dive

The announcement came as Secaucus, N.J.-based Quest reported a 10.7% drop in first-quarter revenue to $2.33 billion, compared to a year ago, on a faster-than-expected decline in COVID-19 testing as the public health emergency approaches an end.

FDA warns of security vulnerability in Illumina’s DNA sequencing machines

Matthew Herper, Stat News

The news is an embarrassing development at a time when Illumina’s management team, including CEO Francis deSouza, is trying to fight off a proxy battle by Carl Icahn. The activist investor is seeking to add three new members to Illumina’s board and has said that he would like to remove deSouza as CEO.

New AI-driven long COVID app coming soon to individual, enterprise customers

Anastassia Gliadkovskaya, Fierce Healthcare

The app, MyAdvocate, was developed by RAIsonance, a startup focused on AI and machine learning that was founded in response to the pandemic. The app and the technology behind it is said to be the first of its kind. Users cough into a mobile device, and the app analyzes their cough to provide a unique respiratory wellness score.