• House Republicans are pursuing an investigation into the handling of last year’s nationwide baby-formula shortage by the Food and Drug Administration and the White House, which was a catalyst for the agency’s overhaul of the food program. House Oversight and Accountability Committee Chairman James Comer (R-Ky.) and Rep. Lisa McClain (R-Mich.), who leads its health panel, asked the FDA to provide all communications with the White House and the Department of Health and Human Services about the shortage by April 4, and the panel has scheduled a hearing next week on the issue. (The Wall Street Journal)
• The Oklahoma Supreme Court ruled 5-4 that the state’s 2022 abortion ban, which allows for exceptions only in the case of a medical emergency, interferes with the “inherent right to terminate a pregnancy to preserve the woman’s life.” (Axios) Sen. Catherine Cortez Masto (D-Nev.) criticized AmerisourceBergen Corp., one of the country’s largest pharmaceutical wholesalers, after she was informed by the company’s government affairs and legal team that it will supply physicians in her state with the abortion pill mifepristone but not pharmacies, saying in an interview that it is “outrageous that any one company would suppose upon themselves to interpret our laws in a manner that prevents women across this country from getting the appropriate medication they need when it comes to reproductive freedom.” (Politico)
• The FDA may authorize a second omicron-tailored COVID-19 booster vaccine for the elderly and people considered high risk for developing severe illness within the next couple of weeks, according to people familiar with the agency’s deliberations. After the FDA finalizes a decision, the Centers for Disease Control and Prevention would have to recommend the shots for them to become widely available. (The Wall Street Journal)
• Shortages of crucial drugs like children’s medications and antibiotics increased by nearly 30% between 2021 and 2022, reaching a peak of 295 individual medicines by the end of last year, according to a report from Democrats on the Senate Homeland Security and Governmental Affairs Committee. Committee Chairman Gary Peters (D-Mich.) said in prepared remarks for a hearing later today that causes of the shortage, such as reliance on foreign sources and lack of supply chain visibility, “not only present serious concerns about providing adequate care to patients, they also represent serious national security risks.” (NBC News)

Worth watching today:

Three Senate meetings:

• Health, Education, Labor and Pensions Committee hearing: “Taxpayers Paid Billions For It: So Why Would Moderna Consider Quadrupling the Price of the COVID Vaccine?” Moderna Inc. CEO Stéphane Bancel is scheduled to testify.
• Appropriations Committee’s Labor, Health and Human Services, Education, and Related Agencies Subcommittee hearing to review President Joe Biden’s fiscal year 2024 budget request for the HHS. Secretary Xavier Becerra is scheduled to testify.
• Homeland Security and Governmental Affairs Committee hearing: “Drug Shortage Health and National Security Risks: Underlying Causes and Needed Reforms.”

FDA’s Peripheral and Central Nervous System Drugs Advisory Committee meeting to review Biogen Inc.’s new drug application for tofersen intrathecal injection for the treatment of ALS.

Inequities in Health Insurance Coverage and Access for Black and Hispanic Adults

The Commonwealth Fund

Moderna Confronts ‘Poster Child’ Label as Price Crackdown Looms

Alex Ruoff, Bloomberg Law

Moderna’s chief executive Stéphane Bancel will go before the Senate Health, Education, Labor, and Pensions Committee that Sanders (I-Vt.) chairs to talk about the company’s pricing for its Covid-19 vaccine Wednesday. He’ll have a chance to make the opposite argument: that his company repaid the government for its investment and is setting a fair private market rate for its vaccine.

Republicans’ COVID vaccine tightrope

Caitlin Owens, Axios

Republicans itching to probe the pandemic response are already struggling to separate vaccine-related questions that could yield lessons learned from ones that echo theories experts say are debunked by reams of data.

A Major Clue to COVID’s Origins Is Just Out of Reach

Katherine J. Wu, The Atlantic

A key set of data could shore up the case for a purely animal origin. So why aren’t scientists sharing it?

If you had Covid before being vaccinated, you might have less immunity than you think, study says

Annika Kim Constantino, CNBC

People who caught Covid-19 before they were vaccinated had a weaker immune response to the shots than those who never had the virus, potentially leaving them less protected against reinfection, new research shows.

China Approves First Homegrown mRNA Covid-19 Vaccine

Clarence Leong, The Wall Street Journal

CSPC Pharmaceutical Group Ltd.’s messenger RNA vaccine, known as SYS6006, was given emergency-use clearance by regulators, the company said in a filing to the Hong Kong stock exchange Wednesday. The vaccine was designed to work against the latest variants of Covid-19, and also proved effective against older strains, it said.

Troubled U.S. organ transplant system targeted for overhaul

Lenny Bernstein, The Washington Post

The government will announce plans Wednesday to overhaul the troubled U.S. organ transplant system, including breaking up the monopoly power of the nonprofit organization that has run it for the past 37 years.

Biden administration rejects “march-in” request to lower drug price

Peter Sullivan, Axios

The Biden administration on Tuesday rejected a request to use march-in rights to break the patent of the prostate cancer drug Xtandi as a way to lower the price. The move is sure to lead to progressive pushback on the Hill.

Abortion pill mifepristone ruling in Texas case could hinge on 1873 Comstock Act

Spencer Kimball, CNBC

The central aim of the Alliance for Hippocratic Medicine, the antiabortion group that filed the lawsuit, is to pull mifepristone from the U.S. market. But Kacsmaryk could stop short of blocking sales and instead order the FDA to impose tougher restrictions on how the pill is distributed, legal experts said.

Lawsuit seeks to block abortion pill ban in Wyoming

Mead Gruver, The Associated Press

A group hoping to open what would be the state’s second clinic offering abortions filed the amended lawsuit days after Republican Gov. Mark Gordon signed what is the nation’s first explicit ban on abortion pills. Absent court intervention, that ban would take effect July 1.

Some people who seek abortions can face prison time in more than 120 countries, analysis shows

Julianne McShane, NBC News

More than 90 countries have maximum penalties of up to five years of prison time for certain abortion-seekers, while 25 have sentences of between five and 10 years, according to the research, which relied on a World Health Organization database of abortion policies.

Minnesota moving to fortify state status as abortion refuge

Steve Karnowski, The Associated Press

The state House on Monday passed a bill by a 68-62 vote to prohibit enforcement in Minnesota of laws, subpoenas, judgements or extradition requests from other states against people who get, perform or assist with abortions in Minnesota. The Senate version passed its first committee test last week.

Rite Aid Investor Sues Over Stock Drop After DOJ Opioid Action

Martina Barash, Bloomberg Law

Rite Aid and several of its executives failed to disclose to investors that it “filled at least hundreds of thousands of unlawful prescriptions for controlled substances that lacked a legitimate medical purpose, including for potentially lethal opioids such as oxycodone and fentanyl,” stockholder David Holland says.

For many insulin users, new price cuts will be a ‘lifeline’

Berkeley Lovelace Jr., NBC News

Three major insulin makers said this month they will lower the cost of the medication. Many insulin users are breathing a sigh of a relief.

Men with advanced prostate cancer ‘missing months of therapy’ amid medication shortage

Jen Christensen, CNN

Pluvicto, a drug to treat metastatic castration-resistant prostate cancer, also known as mCRPC, is in such short supply that its maker, Novartis, said it cannot allow further supply until it can produce more of the drug. It has also had to reschedule people who were about to get their first doses.

Birth control methods that use one hormone raise breast cancer risk as much as those with a combo, study finds

Aria Bendix, NBC News

Studies have suggested for decades that birth control pills containing both estrogen and progestogen — synthetic versions of female hormones — may slightly elevate one’s risk of breast cancer. But less research has focused on the risk associated with progestogen-only contraceptives like intrauterine devices or the so-called mini pill.

Georgia senators send gender care restrictions to governor

Jeff Amy, The Associated Press

Senators voted 31-21 along party lines with Republicans pushing through Senate Bill 140, despite impassioned pleas from Democrats and LGBTQ advocates against what has become the most fiercely contested bill of Georgia’s 2023 legislative session.

The Surgeon General’s New Mission: Adolescent Mental Health

Matt Richtel, The New York Times

In an interview with The Times, Dr. Vivek Murthy ascribed the mental health challenges among young people in part to “hustle culture” values.

Feds, states end fight over $13B UnitedHealth-Change Healthcare deal

Nona Tepper, Modern Healthcare

The agency and attorneys general in New York and Minnesota on Monday filed paperwork in the Court of Appeals for the District Court of Columbia to voluntarily dismiss their appeal. The document did not disclose why the agencies and attorneys general abandoned their call for a review of Judge Carl Nichols’ ruling, which he handed down in the District Court for the District of Columbia last September. 

More Than a Third of US Military Vets Worry About Health Bills

Ilena Peng and Tanaz Meghjani, Bloomberg Law

About 13% of veterans had problems paying medical bills and over 8% had forgone medical care altogether, according to the report from the National Center for Health Statistics. Those covered by private insurance were more likely to be worried about health costs than people who got care through the US Department of Veterans Affairs or the Department of Defense’s Tricare program, the report found.

Health systems bet on employee mental health initiatives

Lauren Berryman, Modern Healthcare

With greater attention on employee satisfaction and mental health, health system leaders are ramping up programs that existed before the pandemic, investing in new initiatives and making organizational changes to destigmatize mental illness. Executives said they rely on employee feedback to determine what strategies work best.

How nurses are making inroads in hospital boardrooms

Alex Kacik, Modern Healthcare

Amid the nursing labor shortage, providers’ financial pressures, the increasing prominence of quality measures and the tension between nurse unions and systems, it’s imperative that nurses have a seat at the table, industry observers said.

Big Pharma lobbies for ‘Chips Act’ style tax breaks

Jamie Smyth, Financial Times

Companies want incentives to create jobs and stave off competition from China.

Despite CMS snub, Eisai is ‘not so nervous’ about Leqembi’s long-term coverage prospects: US CEO

Fraiser Kansteiner, Fierce Pharma

Ultimately, when it comes to Medicare access for Leqembi, “we do not believe this has any impact,” Ivan Cheung, Eisai’s U.S. CEO and global Alzheimer’s disease officer, said during a recent sit-down interview at Eisai’s U.S. headquarters.

Roche teams up with Lilly to validate Alzheimer’s blood test

Ludwig Burger and Julie Steenhuysen, Reuters

Roche and Eli Lilly and Co. are joining forces to develop a blood test for Alzheimer’s disease, and plan to kick off a two-year clinical trial involving hundreds of volunteers with the aim of winning U.S. regulatory approval.

Patient groups balk at former AstraZeneca official negotiating U.K.-India free trade deal

Ed Silverman, Stat News

More than 200 civil society and patient advocacy groups are urging the U.K. government to remove the key negotiator working on a free trade agreement with the Indian government because of his previous ties to a major pharmaceutical company. A leaked version of the agreement already sparked concerns last year that the proposed deal would impede the supply of affordable generic medicines in poor countries around the world.

Gilead’s Yescarta extends survival in lymphoma study

Ben Fidler, BioPharma Dive

A cell therapy from Gilead Sciences helped patients with an aggressive form of lymphoma live longer than standard treatment in a major clinical trial, adding to evidence supporting its use earlier in a patient’s disease course.

Altimmune’s obesity drug fails to stand out from blockbuster treatments in early data

Allison DeAngelis, Stat News

Interim data released Tuesday from 160 of the participants in Altimmune’s Phase 2 study showed that pemvidutide could also have blockbuster potential: Trial participants who took the drug for 24 weeks saw an average 9.7% reduction in weight, when adjusted for the placebo group. That’s in line with Wegovy and Mounjaro, which are associated with between 8% and 12% weight loss, according to Jefferies analysts.

Novo Nordisk remains under UK scrutiny as MHRA conducts its own review in ‘incredibly rare’ case

Beth Snyder Bulik, Endpoints News

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

Roche unveils long-term data from pivotal spinal muscular atrophy trial

Paul Schloesser, Endpoints News

Presenting at the Muscular Dystrophy Association Clinical and Scientific Conference, the pharma giant’s subsidiary Genentech unveiled positive data Monday in patients ages 2 to 25 from the SUNFISH pivotal study that had either type 2 or type 3 SMA. In short, Genentech said that its spinal muscular atrophy drug showed continued efficacy in patients four years after starting the therapy.

As approvals roll in, Takeda details pricing strategy for dengue vaccine launch

Zoey Becker, Fierce Pharma

Brazil’s National Health Surveillance Agency has signed off on Qdenga, making the country the first in Latin America to approve the shot. Last year, Brazil reported more than 1.4 million cases of dengue and more than 1,000 deaths from the disease.

Cerebral and other telehealth startups face new legal and regulatory challenges over ad models

Mohana Ravindranath and Casey Ross, Stat News

A potential class-action lawsuit against troubled digital prescribing startup Cerebral raises crucial questions about whether standard online marketing methods violate legal and ethical standards — an issue with important implications for dozens of other telehealth companies doing largely the same thing, experts tell STAT.

Generative AI Makes Headway in Healthcare

Belle Lin, The Wall Street Journal

Healthcare startups such as Pittsburgh-based Abridge AI Inc., whose product helps doctors write notes after seeing their patients, and San Francisco-based Syntegra Inc., which uses generative AI to create realistic copies of patient data for research, say they have applied generative artificial intelligence for the safest and most accurate current uses in healthcare.

Google asks London court to throw out lawsuit over medical records

Reuters

Google asked London’s High Court on Tuesday to throw out a lawsuit brought on behalf of 1.6 million people over medical records provided to the tech giant by a British hospital trust. The Royal Free London NHS Trust transferred patient data to Google’s artificial intelligence firm DeepMind Technologies in 2015 in relation to the development of a mobile app designed to analyse medical records and detect acute kidney injuries.

A new Medicare ruling could give virtual reality companies an easier path to payment

Lizzy Lawrence, Stat News

CMS granted AppliedVR a unique code for its flagship product, RelieVRx, and placed it in an existing benefit category: durable medical equipment. The device, which consists of a headset and software guiding patients in pain management exercises, received Food and Drug Administration authorization to treat chronic lower back pain in 2021.

IBM installs quantum computer on-site at Cleveland Clinic

Rebecca Pifer, Healthcare Dive

Hospitals looking to leverage their reams of patient data for research and development have increasingly inked deals with technology companies. Cleveland Clinic and IBM signed their deal two years ago, which revolves in part around quantum computing, a faster and futuristic way of processing data.