Biotech and Pharmaceuticals – TheNewsHub

Merck says experimental RSV treatment protected infants in trial, paving way for potential approval

suimt — Thu, 17 Oct 2024 22:00:01 +0000

The logo for Merck is displayed on a screen at the New York Stock Exchange on Nov. 17, 2021.

Andrew Kelly | Reuters

Merck on Thursday said its experimental treatment designed to protect infants from respiratory syncytial virus showed positive results in a mid- to late-stage trial, bringing the company one step closer to filing for approval of the shot.

The pharmaceutical giant could emerge as a new competitor in the market for treatments against RSV, which causes thousands of deaths among older Americans and hundreds of deaths among infants each year. Complications from the virus are the leading cause of hospitalization among newborns, making Merck’s drug a valuable new treatment option if approved.

Merck plans to discuss the study data with regulators worldwide, with a goal of making the treatment available for infants as early as the 2025 to 2026 RSV season, according to a release.

The trial examined the safety and efficacy of a single dose of the treatment, clesrovimab, in healthy preterm and full-term infants entering their first RSV season. Merck presented the results at the medical conference IDWeek in Los Angeles.

The treatment reduced RSV-related hospitalizations by more than 84% and decreased hospitalizations due to lower respiratory infections by 90% compared with a placebo among infants through five months, according to Merck. Clesrovimab also reduced lower respiratory infections that required medical attention by more than 60% compared with a placebo through five months.

RSV is a common cause of lower respiratory tract infections such as pneumonia. Results were consistent through both the five-month and six-month time points in the trial, Merck said.

The rates of adverse and serious side effects were comparable between patients who received Merck’s shot and those who took placebos in the trial. There were no treatment or RSV-related deaths in the study, the company added.

“These promising results demonstrating decreased incidence of RSV disease, including hospitalizations, highlight the potential for clesrovimab to play an important role in helping to alleviate the continued burden of RSV on infants and their families,” Dr. Octavio Ramilo, chair of the Department of Infectious Diseases at St. Jude’s Children’s Research Hospital, said in Merck’s release. Ramilo is also an investigator working on the trials.

Merck’s clesrovimab could potentially compete against a similar treatment from Sanofi and AstraZeneca called Beyfortus, which was in short supply nationwide last RSV season due to unprecedented demand. Both are monoclonal antibodies, which deliver antibodies directly into the bloodstream to provide immediate protection.

But Merck’s treatment can be administered to infants regardless of their weight, which the company said may offer convenience in terms of dosing. Meanwhile, the recommended dosage of Beyfortus is based on an infant’s body weight.

Last year, Pfizer and GSK rolled out RSV vaccines that are administered to expectant mothers who can pass on protection to their fetuses.

Novavax says FDA put hold on combination Covid-flu shot and influenza vaccine; shares plunge

Harsh — Wed, 16 Oct 2024 14:21:51 +0000

A health worker prepares a dose of the Novavax vaccine as the Dutch Health Service Organization starts with the Novavax vaccination program on March 21, 2022 in The Hague, Netherlands.

Patrick Van Katwijk | Getty Images

Novavax on Wednesday said the Food and Drug Administration has put a hold on its application for a combination shot targeting Covid and influenza and a standalone flu vaccine, sending the company’s shares down sharply.

The biotech company’s stock fell nearly 20% on Wednesday. The so-called clinical hold is due to a single report of nerve damage in a patient who received the combination shot in a phase two trial that finished in July last year.

A clinical hold is an order issued by the FDA to a manufacturer to delay or suspend a proposed clinical investigation on a drug.

It is unclear if the pause will impact Novavax’s ability to start and release data on phase three trials on those vaccines. Still, it appears to be a setback for the biotech company, which is scrambling to bring new products to market as demand for its Covid vaccine plummets worldwide.

Novavax said it was working with the FDA to resolve the clinical hold on its combination shot and standalone flu vaccine. The company said other trials of its Covid and flu shots had not shown any safety concerns related to the type of nerve damage reported in the patient.

Novavax said it does not believe there’s an established connection that the vaccine had caused the nerve damage in the patient but said it is working to provide more information to the FDA.

“Our goal is to successfully resolve this matter and to start our Phase 3 trial as soon as possible,” Dr. Robert Walker, Novavax’s chief medical officer, said in a release.

Public health officials see Novavax’s protein-based Covid vaccine as a valuable alternative for people who don’t want to take mRNA shots from Pfizer and Moderna, which use a newer vaccine method to teach cells how to make proteins that trigger an immune response against Covid.

Novavax’s shot, meanwhile, fends off the virus with protein-based technology, a decades-old method used in routine vaccinations against hepatitis B and shingles.

Healthy Returns: Covering weight loss drugs could cost Medicare $35 billion through 2034

Harsh — Tue, 15 Oct 2024 20:25:36 +0000

A combination image shows an injection pen of Zepbound, Eli Lilly’s weight loss drug, and boxes of Wegovy, made by Novo Nordisk.

Reuters

A version of this article first appeared in CNBC’s Healthy Returns newsletter, which brings the latest health-care news straight to your inbox. Subscribe here to receive future editions.

Good afternoon and happy Tuesday! To no surprise, expanding Medicare coverage of costly weight loss drugs could come at a steep cost for the federal government.

Allowing Medicare to cover obesity medications would increase federal spending by about $35 billion from 2026 to 2034, according to an analysis released by the U.S. Congressional Budget Office last week.

The federal costs for covering those drugs would grow from $1.6 billion in 2026 to $7.1 billion in 2034, the CBO said.

The analysis is all hypothetical, and comes as drugmakers and advocacy groups push for the government to expand coverage of – and give more seniors access to – the highly popular treatments. Those include GLP-1s for obesity such as Novo Nordisk‘s Wegovy and Eli Lilly’s Zepbound, which both carry hefty price tags of roughly $1,000 per month before insurance and other rebates.

Right now, Medicare doesn’t cover weight loss treatments unless they are approved and prescribed for another health condition. For example, Medicare covers Wegovy for reducing the risk of serious cardiovascular complications in those with heart disease and obesity, but doesn’t cover the drug for weight loss.

The CBO expects that savings from improved health among patients – mainly by reducing the incidence of obesity-related conditions –

will grow over time. Still, it says those savings could be relatively small, totaling less than $50 million in 2026 and about $1 billion in 2034.

“Even though net federal savings per user are projected to be larger over the longer term, they would still be less than the cost of the medications,” the CBO said in the report.

The cost of drugs could also fall over time, according to the CBO.

Here’s why: It expects generic versions of popular weight loss injections to enter the market and reduce prices. The CBO also anticipates average net prices for obesity medications will fall in 2027 due to Medicare drug price negotiations with manufacturers.

Semaglutide, the active ingredient in Wegovy and Novo Nordisk’s diabetes drug Ozempic, could be among the 15 prescription drugs selected for the next round of price talks, which will begin in 2025 and go into effect in 2027.

But how could Medicare coverage of those treatments impact access?

If Medicare covers those medications, more than 12.5 million beneficiaries would newly qualify for weight loss drugs beginning in 2026, according to the CBO. The analysis said around 2% of those patients are expected to use the treatments in the first year.

More than two-thirds of Medicare beneficiaries are

classified as either obese or overweight, according to their

body mass index, the CBO said.

Notably, spending could look slightly different beyond 2034.

The CBO said Medicare spending on weight loss drugs would probably be lower on a per-user basis due to lower costs tied to the drugs and increasing savings. But Medicare coverage of those treatments would still increase net federal costs from 2034 to 2044, the CBO noted.

A Novo Nordisk spokesperson said in a statement Tuesday that the medical and societal costs of obesity are “significant,” with some estimates exceeding $1.7 trillion annually in the U.S.

“We know treatment of obesity is linked to better medical outcomes, even if bureaucrats haven’t figured out how to account for these savings,” the spokesperson said, adding that the company hopes Medicare will start to offer coverage for weight loss drugs.

Eli Lilly did not immediately respond to CNBC’s request for comment.

Feel free to send any tips, suggestions, story ideas and data to Annika at annikakim.constantino@nbcuni.com.

Abbott Laboratories‘ consumer-friendly continuous glucose monitor for the last few weeks, and it’s a slick new tool for people who want an in-depth view into how their metabolism works.

The device is called Lingo, and it’s a small sensor that pokes through the skin to measure real-time glucose levels. It’s very comfortable and easy to use. I’m wearing one on the back of my right arm, and I forget that it’s there most of the time.

I’ve tried continuous glucose monitors before, but this was my first time testing one from Abbott. The company launched Lingo in September, just after its competitor Dexcom announced its own consumer-facing monitor called Stelo in late August. I reviewed Stelo for CNBC ahead of that launch.

There are a lot of similarities between Lingo and Stelo, but Abbott’s app provides a much more comprehensive look into your glucose data over time than Dexcom’s does. If you’re interested in exploring your metabolism on a more granular level, Abbott’s system is probably the better product for you.

Glucose is a sugar molecule that comes from food, and it’s our bodies’ primary source of energy. Everyone’s glucose levels vary, but people can develop serious health problems like metabolic disease, insulin resistance and heart disease if their levels are consistently high. Lingo aims to help educate users about their habits and teach them to manage their glucose in healthier ways, according to Abbott.

Continuous glucose monitors have historically been prescribed to patients with diabetes, but Lingo is intended for adults like me who do not have the disease. It’s available without a prescription, so you can pay out of pocket and buy one sensor online for $49, two for $89 or six for $249.

Dexcom’s Stelo is also available over the counter, and an ongoing subscription for two sensors costs $89 a month. Stelo sensors last up to 15 days before they need to be replaced, and Lingo sensors last up to 14 days.

Once your Lingo sensors arrive, it’s pretty simple to start using them. I downloaded the Lingo app, entered some basic biological information and prepared to apply the sensor to my arm. The app walks you through each step, and it’s easy to follow.

I started by putting together my applicator, the tool that inserts the sensor into the upper arm. There’s a needle in the applicator, but a flexible filament ultimately sits under the skin below the sensor itself.

I’m not typically nervous about needles, but I had to hype myself up a bit to apply Lingo. You have to stamp the applicator firmly onto the back of your arm, so it was a little intimidating to do it myself. To apply Stelo with Dexcom’s applicator, I just had to click a button.

I eventually built up the courage to stamp on my sensor, and it really wasn’t anything to be nervous about. I did feel some pain, but it subsided after about 10 minutes. When my 14 days were up and it was time to replace my sensor, I felt much more comfortable the second time around.

Lingo is really easy to wear. I don’t notice the sensor while I’m sleeping, and I’m able to wear all my usual clothes with it on. I would just recommend a little caution while pulling on long sleeves so it doesn’t snag. To remove the sensor, you peel it off like a Band-Aid.

The sensor takes an hour to warm up, and then it begins transmitting your real-time glucose levels to the Lingo app. One of Abbott’s primary goals is to help users learn about glucose spikes, and this is where the app really shines.

Glucose spikes occur when the amount of sugar present in the bloodstream rapidly increases and then decreases. They commonly occur after eating, but they can also be caused by stress, exercise and other factors. Limiting spikes and improving glucose management can help users improve their sleep and mood, manage their weight and be proactive about their future health, according to Abbott.

To help users conceptualize the impact of their spikes, the company created a metric called the “Lingo Count.” It’s an algorithm that assigns a numeric value to each glucose spike, and it’s supposed to represent how significant the impact is.

Over each day, users have a target Lingo Count that they want to aim to stay below, and it adjusts to your body with time. My Lingo Count target was 60 initially, and now it’s 44.

It’s a really helpful way to conceptualize the impact that your diet has on your body. For instance, when I ate a vanilla greek yogurt, it added 5 points to my Lingo Count, and when I had a few pieces of candy, it added 14. It’s almost intuitive, but it really helps reinforce those healthy habits in my mind. I haven’t managed to stay below my target every day, but I do have a much better understanding of why that’s the case, and what I can work on.

I also liked that I could go deeper into my Lingo Count data. Users can look at their Lingo Count over the course of a week, a month or all time. It also shows you what time of day you tend to experience the biggest spikes, which is usually the evening in my case.

In order to get the most out of Lingo Count, you need to log your meals and exercise in the app. This is mostly straightforward, but the app does glitch from time to time. I often have to tap the entry boxes repeatedly before it will let me type or make a selection, but it always works for me eventually.

Lingo Count is the crown jewel of the Lingo experience, but there are also a lot of other nice features in the app. For instance, Abbott has a tab full of challenges to help educate users and keep them engaged as they go through their day.

The challenges are fun, and they usually involve small changes that you can make to help reduce glucose spikes. You can decide how many days each challenge lasts. One challenge I completed encouraged me to close down my kitchen after dinner to avoid late night snacks. This week, I’m challenging myself to drink three liters of water a day.

Abbott also has lots of articles, videos and recipes available to Lingo users in the discover tab. I recommend going through these, especially if you’re new to glucose management. I think the company does a nice job explaining glucose in plain language.

I’m not great at eating a balanced breakfast, so I tried some of Abbott’s recipes for omelets and overnight oats. I’ll definitely return to many of these in the future.

On the whole, I’ve really enjoyed my experience with Lingo, and it’s a tool that I’d definitely recommend to family and friends. It’s easy to use and wear, and Lingo Count has helped me better understand how my dietary choices impact my body over time.

Feel free to send any tips, suggestions, story ideas and data to Ashley at ashley.capoot@nbcuni.com.

Walgreens says it will close 1,200 stores by 2027, as earnings top estimates

Harsh — Tue, 15 Oct 2024 20:10:50 +0000

A sign sits in front of a Walgreens store on November 10, 2023 in Wheeling, Illinois.

Scott Olson | Getty Images

Walgreens on Tuesday reported fiscal fourth-quarter sales and adjusted profit that beat Wall Street’s expectations, as the company slashes costs in an attempt to steer itself out of a rough spot.

The retail drugstore chain also said it plans to close roughly 1,200 stores over the next three years, which includes 500 in fiscal 2025 alone. The company said those closures will be “immediately accretive” to its adjusted earnings and free cash flow.

Walgreens has around 8,700 locations in the U.S., a quarter of which it says are unprofitable.

Those closures will give Walgreens a “healthier store base” and “will enable us to respond to shifts in consumer behavior and buying preferences,” the company’s CEO Tim Wentworth said during an earnings call on Tuesday. He added that Walgreens aims to employ the majority of the workforce affected by the closures, though it is unclear how many employees stand to lose their jobs.

The company’s shares closed more than 15% higher on Tuesday.

The results cap a rocky fiscal 2024 for Walgreens, which is grappling with pharmacy reimbursement pressure, softer consumer spending and challenges related to its push into primary care, among other issues. The company on Tuesday said it surpassed its target of cutting $1 billion in costs during fiscal 2024, which included shuttering underperforming stores, laying off employees and using artificial intelligence to make its supply chain more efficient, among other efforts.

Most of the benefits of the cost cuts came in the company’s U.S. retail pharmacy segment, Walgreens CFO Manmohan Mahajan said during the call.

In June, Walgreens said it intends to close a “significant” number of its underperforming stores by 2027. Tuesday’s announcement appears to be the company’s first exact estimate of how many locations it will shutter.

Here’s what Walgreens reported for the three-month period ended Aug. 31 compared with what Wall Street was expecting, based on a survey of analysts by LSEG:

Earnings per share: 39 cents adjusted vs. 36 cents expected
Revenue: $37.55 billion vs. $35.76 billion expected

Walgreens booked sales of $37.55 billion for the quarter, up 6% from the same period a year ago.

The company reported a net loss of $3 billion, or $3.48 per share, for the fiscal fourth quarter. That reflects a so-called valuation allowance meant to reduce the company’s deferred tax assets mainly related to opioid settlements.

It compares with a net loss of $180 million, or 21 cents per share, for the year-earlier period.

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Excluding certain items, adjusted earnings were 39 cents per share for the quarter.

The fourth-quarter and full fiscal-year results “reflected our disciplined execution on cost management, working capital initiatives and capex reduction,” Wentworth, who stepped into the role nearly a year ago, said in a release.

The company’s guidance for fiscal 2025 was in line with analysts’ expectations. Walgreens expects growth in its U.S. health-care and international segments, which will be offset by a decline in its retail pharmacy segment.

The company is engaged in a “multi-year process of reframing our relationship” with pharmacy benefit managers, which negotiate drug rebates on behalf of health plans and reimburse pharmacies for prescription drugs, Wentworth said during the call. Walgreens hopes that will help improve margins in its pharmacy business.

Walgreens anticipates adjusted earnings per share of $1.40 to $1.80 in the coming fiscal year. Analysts project an adjusted profit of $1.75 per share, according to LSEG.

The company also sees revenue for the year at $147 billion to $151 billion. Wall Street analysts estimate sales of $147.3 billion.

Growth across all three business units

Walgreens reported growth across its three business divisions in the fiscal fourth quarter.

Sales from the company’s U.S. health-care unit jumped to $2.11 billion, up 7.1% compared with the same period a year ago.

Analysts had expected sales of $2.10 billion, according to estimates compiled by StreetAccount.

That partly reflects growth in primary-care provider VillageMD and specialty pharmacy company Shields Health Solutions. Shields sales jumped 27.8% during the period, which the company attributed to growth within existing partnerships.

Specialty pharmacies are designed to deliver medications with unique handling, storage and distribution requirements, often for patients with complex conditions such as cancer and rheumatoid arthritis.

Notably, Walgreens posted a steep net loss in the fiscal second quarter as it recorded a hefty nearly $6 billion charge related to the decline in value of its investment in VillageMD. In August, the company said in a securities filing it is considering a sale of the provider.

A sign advertises Covid vaccine shots at a Walgreens Pharmacy in Somerville, Massachusetts, on Aug. 14, 2023.

Brian Snyder | Reuters

Walgreens’ U.S. retail pharmacy segment generated $29.47 billion in sales in the fiscal fourth quarter, an increase of 6.5% from the same period last year. Analysts had expected sales of $28.09 billion, according to estimates compiled by StreetAccount.

That segment operates the company’s drugstores, which sell prescription and nonprescription drugs as well as health and wellness, beauty, personal care, and food products.

Walgreens said pharmacy sales for the quarter rose 9.6% and comparable pharmacy sales increased 11.7% compared with the year-earlier period due to price inflation in brand medications, among other factors.

Total prescriptions filled in the quarter including vaccines came to 302 million, a 1.7% increase from the same period a year ago. Notably, falling reimbursement rates for prescription drugs cut into pharmacy margins, the company said.

Retail sales fell 3.5% from the prior-year quarter, and comparable retail sales declined 1.7%. The company cited a “challenging” retail environment, among other factors.

Walgreens’ international unit, which operates more than 3,000 retail stores abroad, posted $5.97 billion in sales in the fiscal fourth quarter. That’s an increase of 3.2% from the year-ago period.

Analysts expected revenue of $5.81 billion for the period, according to StreetAccount.

The company said sales from its U.K.-based drugstore chain, Boots, increased 2.3%.

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Eli Lilly to trial use of weight loss drugs to combat unemployment in UK

Harsh — Tue, 15 Oct 2024 13:21:19 +0000

LONDON — U.S. pharmaceutical giant Eli Lilly is exploring whether obesity drugs could be used to curb joblessness after signing a major investment deal with the U.K.

The weight-loss treatment firm and creator of Zepbound announced Monday that it would commit £279 million ($364 million) to help tackle Britain’s significant health challenges — including obesity.

The “strategic collaboration,” agreed with the U.K.’s Department of Health and Social Care (DHSC) and the Department for Science, Innovation and Technology (DSIT), came as part of a wider £63 billion package of investments announced at the close of the Labour government’s inaugural International Investment Summit on Monday.

The Eli Lilly deal will see the company launch a “real-world” study to understand how tirzepatide — the GLP-1 treatment behind its Zepbound and Mounjaro drugs — impacts weight loss, diabetes prevention, and prevention of obesity-related complications, to better inform the National Health Services’ treatment of obesity.

Within that, the five-year trial, conducted in collaboration with Health Innovation Manchester, will also explore how weight-loss drugs impact “participants’ employment status and sick days from work,” the company said in a press release.

“This collaboration will add to the evidence base on the real world impact of obesity treatments on the health of people with obesity, and will explore a broad range of outcomes including health-related quality of life and impact on individuals’ employment status,” professor Rachel Batterham, senior vice president for International Medical Affairs at Lilly, said.

The U.K.’s Health and Social Care Minister Wes Streeting said the partnership was “key to building a healthier society, healthier economy, and making the NHS fit for the future.”

The U.K. is battling a stubbornly high rate of “economic inactivity,” defined as those neither working nor looking for a job. Almost a third of claims are attributed to long-term sickness, including pre-existing health conditions, such as obesity, which has been exacerbated by Covid.

Writing in an article in the Telegraph on Monday, Streeting said “widening waistbands” had placed a “significant burden” on the NHS and the economy, and was costing the health service £11 billion a year.

“It’s holding back our economy,” he wrote. “Illness caused by obesity causes people to take an extra four sick days a year on average, while many others are forced out of work altogether.”

Streeting noted that the jabs could be “monumental” in tackling obesity and getting people back to work, but added that the “NHS can’t be expected to always pick up the tab for unhealthy lifestyles.”

CNBC reached out to the DHSC, who said the minister’s comments “fully reflect” the government’s position.

The use cases for obesity drugs have been growing over recent months, with several drug regulators expanding GLP-1 drug labels for use in treating obesity-related comorbidities and other illnesses.

Speaking to CNBC last week, Citi pharmaceuticals analyst Peter Verdault said the body of evidence to support increased use of weight-loss drugs “keeps coming.”

However, some medical professionals expressed concern over drawing an association between health treatments and economic outcomes.

“[There are] some serious ethical, financial and efficacy considerations with such an approach … Such as looking at people, or measuring people based on their potential economic value, rather than primarily based on their needs and their health needs,” Dr Dolly van Tulleken, a visiting researcher at the MRC epidemiology unit at the University of Cambridge and specialist in obesity policy, told BBC Radio 4’s Today program on Tuesday.

Eli Lilly’s investment will also see the company launch its first “Lilly Gateway Labs” innovation accelerator in Europe to support early-stage life sciences businesses to develop transformative medicines and technologies.

The company said it anticipates making an additional £279 million of new investment into the U.K. over the coming years.

Former Pfizer CEO, finance chief step back from Starboard's activist campaign

Harsh — Thu, 10 Oct 2024 02:39:01 +0000

Ian Read, chairman and chief executive officer of Pfizer, speaks as President Donald Trump, left, listens during an announcement on a new pharmaceutical glass packaging initiative in the Roosevelt Room of the White House in Washington, D.C., July 20, 2017.

Andrew Harrer | Bloomberg | Getty Images

Former Pfizer CEO Ian Read and ex-CFO Frank D’Amelio said Wednesday evening that they would step away from Starboard Value’s campaign at the struggling pharmaceutical giant, just days after news of the activist’s stake broke.

Read and D’Amelio said they were “fully supportive” of Pfizer CEO Albert Bourla in a joint statement made via an investment bank and confirmed to be authentic. The duo had been in contact with a number of directors shortly before news of Starboard’s stake broke Sunday evening, according to people familiar with the matter.

“We are confident that over time they will deliver shareholder value,” the two former executives said of Pfizer’s current board and management. The company’s shares are essentially flat for the year and are off by roughly 50% from their 2021 highs.

The statement was made through Guggenheim Securities, which has long advised Pfizer on dealmaking. A representative for the bank declined to comment beyond the release.

The about face comes as Pfizer’s board grapples with the activist’s efforts, and just days before Starboard’s Jeff Smith was slated to meet with CEO Bourla, said people familiar with the matter. For executives to join, and then walk away from an activist’s campaign is highly unusual.

It was also not immediately clear what impact, if any, the breakaway would have on Starboard’s campaign. A representative for the activist fund did not immediately return a request for comment. Starboard, one of the largest and most tenacious activist funds, has amassed a roughly $1 billion position in the pharmaceutical firm, CNBC previously reported.

Jeff Smith, the managing member at Starboard, has previously mounted campaigns at Autodesk and Salesforce in recent months. While it typically focuses on the technology sector, it also built stakes in Starbucks and Wall Street Journal parent News Corp this year.

Representatives for Pfizer did not return requests for comment.

CVS, UnitedHealth say FTC should take Lina Khan and two commissioners off drug middlemen case

Harsh — Wed, 09 Oct 2024 14:17:47 +0000

FTC Chairwoman Lina Khan testifies during the House Appropriations Subcommittee on Financial Services and General Government hearing titled “Fiscal Year 2025 Request for the Federal Trade Commission,” in Rayburn Building on Wednesday, May 15, 2024.

Tom Williams | Cq-roll Call, Inc. | Getty Images

CVS Health and UnitedHealth Group are demanding Federal Trade Commission Chair Lina Khan and two other commissioners recuse themselves from a suit accusing the companies and other drug middlemen of boosting their profits while inflating insulin costs for Americans.

In separate motions filed Tuesday night with the FTC, CVS and UnitedHealth argued that all three commissioners have an extensive track record of making public statements that indicate “serious bias” against the companies’ so-called pharmacy benefit managers.

The companies accused Khan, as well as Commissioners Alvaro Bedoya and Rebecca Kelly Slaughter, of incorrectly asserting that PBMs are “price gougers” that hold significant control over the pricing and access to drugs like insulin. CVS said those statements demonstrate that the commissioners have “prejudged this matter,” so their participation in the case “violates due process.”

“If the opposite of ‘complete fairness’ is ‘blatant bias,’ the Three Commissioners would easily satisfy even that standard,” CVS wrote in a 23-page motion.

Meanwhile, UnitedHealth’s 17-page motion said, “Any judge who made these remarks about a litigant at the outset of a lawsuit would immediately need to recuse for blatant bias.”

The FTC on Wednesday declined CNBC’s request for comment on the motion.

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Other corporate giants, including Amazon and Meta, have unsuccessfully pushed for Khan to be disqualified from previous cases or investigations, citing concerns about her objectivity. Khan has resisted those calls, saying she has never prejudged any case or set of facts.

The FTC filed the suit last month against the three largest PBMs, CVS Health’s Caremark, UnitedHealth Group‘s Optum Rx and Cigna‘s Express Scripts. All are owned by or connected to health insurers and collectively administer about 80% of the nation’s prescriptions, according to the FTC.

The FTC filed its complaint through its so-called administrative process, which initiates a proceeding before an administrative judge who would hear the case.

PBMs sit at the center of the drug supply chain in the U.S., negotiating medication rebates with manufacturers on behalf of insurers, creating lists of preferred medications covered by health plans and reimbursing pharmacies for prescriptions. The FTC has been investigating PBMs and their role in insulin prices since 2022.

The agency’s lawsuit argues that the three PBMs have created a “perverse” system that prioritizes high rebates from manufacturers, which leads to “artificially inflated insulin list prices.” The suit also alleges that PBMs favor high-list-price insulins even when insulins with lower list prices become available.

The lawsuit also includes each PBM’s affiliated group purchasing organization, or GPO, which brokers drug purchases for hospitals and other health-care providers. Zinc Health Services operates as the GPO for Caremark, while Emisar Pharma acts as the GPO for OptumRx. Ascent Health Services is the GPO for Cigna.

The lawsuit is just one of several headwinds CVS is facing. Shares of the company are down more than 20% this year as it grapples with runaway medical costs in its insurance segment and pharmacy reimbursement pressure.

CVS has engaged advisors in a strategic review of its business, which could potentially involve splitting the company’s insurer from its retail pharmacies. It’s unclear where Caremark would fall in the case of a breakup.

A general view shows a sign of CVS Health Customer Support Center in CVS headquarters of CVS Health Corp in Woonsocket, Rhode Island, U.S. October 30, 2023.

Faith Ninivaggi | Reuters

In the motion Tuesday, CVS alleged that Khan has vilified PBMs during her entire professional career. For example, the company cited a 2022 statement in which Khan said PBMs “practically determine which medicines are prescribed, which pharmacies patients can use, and the amount patients will pay at the pharmacy counter.”

CVS similarly pointed to Slaughter’s previous comments about the allegedly “disturbing,” “unacceptable” and “rotten” rebating practices of PBMs, and how she believes they create “competitive distortions in pharmaceutical markets.” Meanwhile, the company cited Bedoya’s suggestions that “a significant part of the blame” for insulin price increases rests on rebates demanded by PBMs.

CVS called the prior statements of the three commissioners “incorrect assertions” about Caremark and other PBMs.

The health-care giant also alleged that during the FTC probe, the three commissioners attended closed events to help fundraise for anti-PBM lobbying groups. Organizers of those events vilified PBMs as “bloodsuckers” and “vampires,” CVS argued in the motion.

The Biden administration and lawmakers on both sides of the aisle have escalated pressure on PBMs, seeking to increase transparency into their business practices as many patients struggle to afford prescription drugs. Americans pay two to three times more than patients in other developed nations for prescription drugs on average, according to a fact sheet from the White House.

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Healthy Returns: What activist Starboard's $1 billion stake means for Pfizer

Harsh — Tue, 08 Oct 2024 20:46:17 +0000

Jakub Porzycki | Nurphoto | Getty Images

A version of this article first appeared in CNBC’s Healthy Returns newsletter, which brings the latest health-care news straight to your inbox. Subscribe here to receive future editions.

Happy Tuesday! Pfizer‘s troubles may finally be coming to a head.

Former executives of the pharmaceutical giant are backing a push by activist investor Starboard Value to turn around the struggling company, according to recent reports.

Starboard has a roughly $1 billion stake in the drugmaker and approached former Pfizer CEO Ian Read and ex-CFO Frank D’Amelio, both of whom expressed interest in supporting the activist investor’s efforts to shake up the company, CNBC previously reported. As of late Tuesday, Pfizer has a market cap of roughly $165 billion.

Read and D’Amelio relayed proposals from Starboard to several members of the company’s board on Sunday, the Financial Times reported on Monday, citing sources familiar with the conversations. Still, the details of the turnaround plan are scant.

Read was Pfizer’s CEO from 2010 through 2018, while D’Amelio was Pfizer’s chief financial officer from 2007 to 2021.

Here’s why it matters: Read and D’Amelio’s reported involvement is a rare instance of former executives engaging in what could be an activist fight for the future of one of the largest pharmaceutical companies in the world.

Investors have been clamoring for change at Pfizer, whose shares are down more than 30% over the past two years. The company has struggled to recover from the rapid decline of its Covid business, which raked in record-breaking revenue during the peak of the pandemic.

Pfizer CEO Albert Bourla is facing mounting pressure to improve the company’s performance after several commercial missteps over the past two years – including disappointing data on an experimental obesity pill and a slower-than-expected launch of a respiratory syncytial virus vaccine – along with a costly M&A strategy that has yet to yield significant returns.

Pfizer is betting big on oncology, and particularly its whopping $43 billion acquisition of cancer drug developer Seagen, to regain its footing. But that deal may take years to pay off. Meanwhile, Pfizer last month pulled a key sickle cell disease drug from global markets – the centerpiece of its roughly $5 billion buyout of Global Blood Therapeutics in 2022.

Starboard’s turnaround push raises questions about Bourla’s fate at the company.

“We’ve sensed investor frustration with CEO Albert Bourla since at least the beginning of 2023,” BMO Capital Markets analyst Evan Seigerman wrote in a research note Monday.

Still, he said, “While placing blame on one person may seem easy, rarely will it result in a quick turn-around.”

Other analysts similarly said there may be no quick fix by an activist investor.

“We await future developments, but we do not see low-hanging fruit to boost shareholder value,” Leerink Partners analyst David Risinger wrote in a research note on Monday.

Risinger said that’s because the company faces “revenue growth constraints” over the next five years, driven by patent expirations for top-selling drugs and pressure from competitors. Pfizer has also pursued significant cost-cutting efforts, he added. The company last fall announced that it would cut $4 billion in costs and in May disclosed another multi-year plan to slash roughly $1.5 billion in expenses by 2027.

Pfizer’s debt levels are also relatively high, Risinger noted, with $57.5 billion in debt as of June 30. He said that may only be partially reduced by selling more shares from its assets, such as the consumer health business Haleon.

We’ll continue to follow Starboard’s turnaround push, so stay tuned for our coverage.

Feel free to send any tips, suggestions, story ideas and data to Annika at annikakim.constantino@nbcuni.com.

Hims & Hers Health, a direct-to-consumer health-care company, closed 10% higher on Monday following the announcement that the stock is being added to the S&P SmallCap 600.

The S&P Dow Jones Indices said Hims & Hers will replace Vector Group ahead of the opening bell on Oct. 9, according to a release Friday. Japan Tobacco completed its acquisition of Vector Group, which operates tobacco and real estate businesses, on Monday.

Hims & Hers offers treatments for weight loss, sexual health, hair loss and other conditions, and the stock is up nearly 120% year to date as of Monday’s close. However, shares of the company tumbled last week after the U.S. Food and Drug Administration announced tirzepatide injections are no longer in shortage.

Tirzepatide is the active ingredient in Eli Lilly’s GLP-1 weight loss drug Zepbound and diabetes drug Mounjaro. Hims & Hers doesn’t offer these medications through its platform, but CEO Andrew Dudum told investors in August that the company was looking to introduce access to compounded versions in the near future, as well as the branded versions when supply allowed.

Compounded medications are custom-made alternatives to the brand drugs, and they can be produced when brand-name treatments are in shortage. Hims & Hers has been offering customers compounded versions of semaglutide, the active ingredient in Novo Nordisk’s GLP-1s called Wegovy and Ozempic.

“We don’t offer access to tirzepatide at this time,” a Hims & Hers spokesperson told CNBC in a statement Monday. “Whenever we bring a treatment to our platform, our first consideration is how accessible it will be for the large majority of customers and accessible means consistently available at a reasonable price.”

Hims & Hers is one of several digital health companies selling compounded GLP-1 medications as a cheaper alternative for consumers while demand for the weight loss and diabetes drugs spikes. But they’re not a foolproof way to carve out a piece of the anti-obesity drug market, which some analysts estimate could generate $100 billion in annual revenue by 2030.

Both Zepbound and Mounjaro are under patent protection in the U.S., and Eli Lilly does not supply the active ingredient of those two drugs to outside groups. The FDA warned last week that outsourcing facilities are generally restricted from compounding copies of an approved drug unless it’s on the shortage list.

“When a drug shortage is resolved, FDA generally considers the drug to be commercially available,” the agency said on its website. “Certain amounts are permissible under the law as long as the compounding is not done ‘regularly or in inordinate amounts.'”

Though Hims & Hers does not offer compounded tirzepatide, the FDA’s announcement was enough to spook investors. Shares of Hims & Hers closed down nearly 10% on Thursday.

Analysts at Citi said that Hims & Hers will not be directly impacted by the tirzepatide news, but it does limit the company’s total addressable market. It also suggests that shortages could resolve faster than anticipated, they added.

“HIMS has maintained that it will be able to continue to compound GLP-1s after shortages abate by changing the form factor/formulation/dosage for the clinical benefit of an individual,” the analysts wrote in a Thursday note. “In our view, this sets HIMS up for a legal battle in the coming months.”

Feel free to send any tips, suggestions, story ideas and data to Ashley at ashley.capoot@nbcuni.com.

CVS is under pressure and considering a breakup. Here's why that could be risky

Harsh — Fri, 04 Oct 2024 15:30:17 +0000

A sign outside of a CVS pharmacy store on February 07, 2024 in Miami, Florida.

Joe Raedle | Getty Images

It’s time for a wellness check at CVS Health.

Shares of the company are down more than 20% this year as it grapples with higher-than-expected medical costs in its insurance unit and pharmacy reimbursement pressure, among other issues.

As it seeks to claw back faith with Wall Street, the company is considering breaking itself up.

CVS has engaged advisors in a strategic review of its business, CNBC reported Monday. One option being weighed is splitting up its retail pharmacy and insurance units. It would be a stunning reversal for the company, which has spent tens of billions of dollars on acquisitions over the last two decades to turn itself into a one-stop health destination for patients.

Some analysts contend that a breakup of CVS would be challenging and unlikely.

CVS risks losing customers and revenue if it splits up its vertically integrated business segments, which includes health insurer Aetna and the major pharmacy benefits manager Caremark. That could translate to more lost profits for a health-care giant that has slashed its full-year 2024 earnings guidance for three consecutive quarters.

“There really is no perfect option for a split,” said eMarketer senior analyst Rajiv Leventhal, who believes a breakup is still a possibility. “If that does happen, one side of the split becomes really successful and prosperous, and the other would significantly struggle.”

Notably, CVS executives on Monday met with major shareholder Glenview Capital to discuss how to fix the flailing business and recover its stock, CNBC previously reported. But Glenview on Tuesday denied rumors that it is pushing to break up the company.

If CVS stays intact, CEO Karen Lynch and the rest of the management team will have to execute major changes to address what industry experts say are glaring issues battering its bottom line and stock price.

The company has already undertaken a $2 billion cost-cutting plan, announced in August, to help shore up profits. CVS on Monday said that plan involves laying off nearly 3,000 employees.

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Some analysts said the health-care giant must prioritize recovering the margins in its insurance business, which they believe is the main issue weighing on its stock price and financial guidance for the year. That pressure drove a leadership change earlier this year, with Lynch assuming direct oversight of the company’s insurance unit in August, displacing then-President Brian Kane.

CVS’ management team and board of directors “are continually exploring ways to create shareholder value,” a company spokesperson told CNBC, declining to comment on the rumors of a breakup.

“We remain focused on driving performance and delivering high quality healthcare products and services enabled by our unmatched scale and integrated model,” the spokesperson said in a statement.

Investors may get more clarity on the path forward for the company during its upcoming earnings call in November.

UnitedHealth Group, Cigna and Humana, also have their own PBMs, said eMarketer’s Leventhal.

But Caremark, in some cases, also funnels drug prescriptions to CVS retail pharmacies, he said. That has helped the company’s drugstores gain meaningful prescription market share over its chief rival, Walgreens, which has been struggling to operate as a largely stand-alone pharmacy business.

CVS is the top U.S. pharmacy in terms of prescription drug revenue, holding more than 25% of the market share in 2023, according to Statista data released in March. Walgreens trailed behind with nearly 15% of that share last year.

Now, CVS drugstores must maintain an edge over competitors at a time when the broader retail pharmacy industry faces profitability issues, largely due to falling reimbursement rates for prescription drugs. Increased competition from Amazon and other retailers, inflation, and softer consumer spending are making it more difficult to turn a profit at the front of the store. Meanwhile, burnout among pharmacy staff is also putting pressure on the industry.

CVS’ operating margin for its pharmacy and consumer wellness business was 4.6% last year, up from 3.3% in 2022 but down from 8.5% in 2019 and 9.9% in 2015.

CVS and Walgreens have both pivoted from years of endless retail drugstore store expansions to shuttering hundreds of locations across the U.S. CVS is wrapping up a three-year plan to close 900 of its stores, with 851 locations shuttered as of August.

The rocky outlook for retail pharmacies could make it difficult for CVS to find a buyer for its drugstores in the event of a split, according to Tanquilut. He said a spinoff of CVS’ retail pharmacies would be more likely.

“There’s a reason they’re cutting down stores. Why break it up when the relationship between Caremark and CVS retail is what keeps it outperforming the rest of the pharmacy peer group?” Tanquilut said.

$10.6 billion last year, and Signify Health, an in-home health-care company that CVS bought for about $8 billion in 2022. Those deals aimed to build on CVS’ major push into health care – a strategy that Walgreens and other retailers have also pursued over the last few years.

Oak Street Health could theoretically be spun out with Aetna in the case of a split, Mizuho managing director Ann Hynes wrote in a research note Tuesday.

An Oak Street Health clinic stands in a Brooklyn neighborhood on February 08, 2023 in New York City.

Spencer Platt | Getty Images

The primary care clinic operator complements Aetna’s Medicare business because it takes care of older adults, offering routine health screenings and diagnoses, among other services. CVS also sells Aetna health plans that offer discounts when patients use the company’s medical care providers.

But CVS has also started to integrate Oak Street Health with its retail pharmacies. The company has opened those primary care clinics side by side with some drugstore locations in Texas and Illinois, with plans to introduce around two dozen more in the U.S. by the end of the year.

Several companies, including Amazon, Walmart, CVS and Walgreens, are feeling the pain from bets on primary care. That’s because building clinics requires a lot of capital, and the locations typically lose money for several years before becoming profitable, according to Tanquilut.

Walgreens could potentially exit that market altogether. The company said in a securities filing in August it is considering a sale of its primary care provider VillageMD.

But Tanquilut said it may not make sense for CVS to sell Oak Street Health or Signify Health because “they’re actually hitting their numbers.”

Signify saw 27% year-over-year revenue growth in the second quarter, while Oak Street sales grew roughly 32% compared with the same period last year, reflecting strong patient membership, CVS executives said in an earnings call in August.

Oak Street ended the quarter with 207 centers, an increase of 30 from last year, executives added.

“Why get rid of them when they’re still strategic in nature?” Tanquilut told CNBC, adding that it would be difficult to find a buyer for Oak Street given the challenging market for primary care centers.

jumped over the last year for insurers as more seniors return to hospitals to undergo procedures they had delayed during the Covid-19 pandemic, such as hip and joint replacements.

Medicare Advantage, a privately run health insurance plan contracted by Medicare, has long been a key source of growth and profits for the broader insurance industry. More than half of Medicare beneficiaries are enrolled in those plans as of 2024, enticed by lower monthly premiums and extra benefits not covered by traditional Medicare, according to health policy research organization KFF.

But investors are now concerned about the skyrocketing costs from Medicare Advantage plans, which insurers warn may not come down anytime soon.

A general view shows a sign of CVS Health Customer Support Center in CVS headquarters of CVS Health Corp in Woonsocket, Rhode Island, U.S. October 30, 2023.

Faith Ninivaggi | Reuters

Cherny said CVS faced a “double whammy” in Medicare Advantage this year, grappling with excess membership growth at a time when many seniors are using more benefits.

In August, CVS also said its lowered full-year outlook reflected a decline in the company’s Medicare Advantage star ratings for the 2024 payment year.

Those crucial ratings help patients compare the quality of Medicare health and drug plans and determine how much an insurer receives in bonus payments from the Centers for Medicare & Medicaid Services. Plans that receive four stars or above get a 5% bonus for the following year and have their benchmark increased, giving them a competitive advantage in their markets.

Last year, CVS projected it would lose up to $1 billion in 2024 due to lower star ratings, the company disclosed in a securities filing.

But things may start to look up in 2025.

For example, one of the company’s large Medicare Advantage contracts regained its four-star rating, which will “create an incremental tailwind” in 2025, CVS executives said in August.

“We’re giving them the benefit of the doubt because we know that the stars rating bonus payments will come back in 2025,” Tanquilut said.

During a conference In May, CVS said it would pursue a “margin over membership” strategy: CVS CFO Tom Cowhey said the company is prepared to lose up to 10% of its existing Medicare members next year in an effort to get its margins “back on track.”

The company will make significant changes to its Medicare Advantage plans for 2025, such as increasing copays and premiums and cutting back certain health benefits. That will eliminate the expenses tied to those benefits and drive away patients who need or want to use them.

Those actions will help the company achieve its target of 100- to 200-basis-points margin improvement in its Medicare Advantage business, CVS executives said in August.

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Healthy Returns: Pfizer pulls sickle cell disease drug from markets – here’s why it matters

Harsh — Tue, 01 Oct 2024 18:32:35 +0000

Kena Betancur | Corbis News | Getty Images

A version of this article first appeared in CNBC’s Healthy Returns newsletter, which brings the latest health-care news straight to your inbox. Subscribe here to receive future editions.

Hello and happy Tuesday! Today, we’re unpacking a shocking move from Pfizer.

The pharmaceutical giant last week announced it would voluntarily withdraw its sickle cell disease therapy, Oxbryta, from worldwide markets — to the surprise of doctors, patients and investors.

Here’s why the drug is important: Oxbryta is one of at least six treatments for the inherited blood disorder. The drug first won accelerated approval from the U.S. Food and Drug Administration in 2019, which requires further trials to confirm its benefits to patients.

Oxbryta was one of the centerpieces of Pfizer’s $5.4 billion acquisition of Global Blood Therapeutics in 2022.

Sickle cell disease causes red blood cells to become misshapen half-moons that get stuck inside blood vessels, which can restrict blood flow and cause what are known as pain crises. It impacts roughly 100,000 people in the U.S., many of whom are Black, according to data from the Centers for Disease Control and Prevention.

The company on Wednesday said the decision to withdraw Oxbryta was based on data showing a higher risk of deaths and complications in patients treated with the once-daily pill. In a release, Pfizer said the “totality of clinical data” on Oxbryta now indicates that its overall benefit “no longer outweighs the risk” in the patient population for which the drug is approved.

As part of that move, Pfizer is also discontinuing all studies and access programs related to the treatment.

The FDA on Saturday urged healthcare professionals to stop prescribing Oxbryta. The agency also said patients and caregivers should contact their healthcare professional about stopping the drug and starting another treatment option.

European regulators on Thursday also said patients in trials had higher rates of pain crises after they started treatment with Oxbryta than they did before taking it. Those regulators recommended suspending the drug’s marketing authorization.

That all may sound cut and dry. But Oxbryta’s withdrawal is raising concerns.

Its sudden absence from the market leaves doctors, sickle cell disease patients and patient advocates scrambling for more information on the decision and guidance on what they should do next, STAT reported on Friday. And while taking Oxbryta could put patients at risk, it is not entirely clear what they may experience if they abruptly stop treatment with the drug.

In a statement last week, the National Alliance of Sickle Cell Centers urged patients not to abruptly stop taking Oxbryta. The group, which supports health centers that administer treatments for the disorder, urged all patients currently taking Oxbryta to make an appointment with their doctor and develop a plan for gradually tapering off the medication.

Oxbryta’s withdrawal will be a “significant blow” to patients with sickle cell disease “who have been historically underserved,” BMO Capital Markets analyst Evan Seigerman wrote in a research note last week.

The FDA last year approved two gene therapies to treat sickle cell disease, a landmark decision that gave hope to patients who suffer from the debilitating disease. But health officials have so far struggled to find a way to provide equitable access to the costly treatments.

Vertex Pharmaceuticals‘ gene therapy Casgevy costs $2.2 million per patient, and Bluebird Bio‘s treatment Lyfgenia lists for $3.1 million per patient.

Other companies such as Agios Pharmaceuticals and Fulcrum Therapeutics are developing new experimental treatments for sickle disease. Notably, some Wall Street analysts said Pfizer’s withdrawal of Oxbryta could accelerate the timeline for clinical trials on those rival drugs.

If Agios’ experimental drug, mitapivat, shows a benefit in reducing pain crises in clinical trials, “We anticipate this will enable an easier regulatory review, especially now considering the greater demands from patients who can no longer access Pfizer’s drug,” Piper Sandler analyst Christopher Raymond said in a research note last week.

Meanwhile, the financial impact of the Oxbryta withdrawal is “somewhat modest for a company of Pfizer’s size,” Guggenheim analysts said in a note last week.

They said Oxbryta sales have been relatively modest for the company, amounting to $328 million last year. But the analysts noted that Oxbryta sales were expected to increase to around $750 million by the end of the decade, citing FactSet consensus estimates.

Pfizer’s decision will likely raise questions around the company’s ability to grow through the end of the decade when it faces several drug patent expirations and “other challenges to their current growth drivers,” according to Guggenheim. The analysts also said the Oxbryta withdrawal raises questions about what will happen to Pfizer’s other sickle cell disease treatment in development, GBT-601.

That oral drug, which Pfizer also acquired through the Global Blood Therapeutics deal, is seen as a successor to Oxbryta.

Feel free to send any tips, suggestions, story ideas and data to Annika at annikakim.constantino@nbcuni.com.

introduced a bill that aims to establish “tough” new cybersecurity standards within the health-care sector.

Under the proposed legislation, the Department of Health and Human Services would be responsible for developing and enforcing new standards for health plans, providers, business associates and clearinghouses. The bill is called the “Health Infrastructure Security and Accountability Act,” according to a release.

Patient data is inherently sensitive and valuable, which can make it an enticing – and often lucrative – target for bad actors. The number of health-care cyberattacks has been trending upward over the last 14 years, with a record 725 data breaches reported last year, according to The HIPAA Journal.

As of August 31, the journal said 491 data breaches of more than 500 health records had been reported in 2024. This includes the massive ransomware attack against the clearinghouse Change Healthcare that shook the health-care industry this spring.

Change Healthcare is owned by UnitedHealth Group, and it offers payment and revenue cycle management tools as well as other solutions like electronic prescription software. The company processes more than 15 billion billing transactions annually, and 1 in 3 patient records passes through its systems, according to its website.

On February 21, UnitedHealth discovered that hackers compromised part of Change Healthcare’s information technology systems. UnitedHealth shut down the impacted systems, leaving many doctors without a way to fill prescriptions or get paid for their services. Many providers took thousands of dollars out of their personal savings to keep their practices afloat.

UnitedHealth CEO Andrew Witty testified in front of the Senate Finance Committee about the attack in May, where he apologized to the people impacted. In a subsequent hearing that afternoon, Witty estimated that data from around one-third of Americans could have been compromised.

“Megacorporations like UnitedHealth are flunking Cybersecurity 101, and American families are suffering as a result,” Wyden said in a release Thursday announcing the proposed legislation.

Patient data is protected by the Health Insurance Portability and Accountability Act, or HIPAA, and organizations can be fined for violations. As part of the new bill, Wyden and Warner said they would remove the existing cap on HIPAA fines so that regulators can actually compel big companies to adhere to the new cybersecurity standards.

There’s still a long road ahead before this piece of legislation could become a reality. It needs to pass through both chambers of Congress and get approved by the president before it can be signed into law.

You can read a full copy of the legislative text here.

Feel free to send any tips, suggestions, story ideas and data to Ashley at ashley.capoot@nbcuni.com.