When will kids get COVID shots?

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Welcome to Insider Healthcare. I’m Lydia Ramsey Pflanzer, and today in healthcare news:

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children covid-19 vaccine

Vaccines may get authorized for young kids in October. Here are the drug companies’ most likely timelines.

Here’s what you need to know>>


An image of a webpage for Ro's mental health service Ro Mind on a desktop computer.
The webpage for Ro’s mental health service Ro Mind.

Startups are pioneering new ways to get therapy or depression meds. They’re betting it’s the future of healthcare, but they risk leaving out vulnerable people.

Get the full story>>


Simone Biles, of the United States, waits for her turn to perform during the artistic gymnastics women's final at the 2020 Summer Olympics, Tuesday, July 27, 2021, in Tokyo.
Simone Biles, of the United States, waits for her turn to perform during the artistic gymnastics women’s final at the 2020 Summer Olympics, Tuesday, July 27, 2021, in Tokyo.

Olympic athletes are being more open than ever about mental health and the pressures of competing

Find out more>>


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– Lydia

Read the original article on Business Insider

Israel will roll out a booster dose of the Pfizer-BioNTech COVID-19 vaccine to older people, citing a drop in protection against severe disease driven by the Delta variant

israel vaccine
A person receives a coronavirus vaccine in Tel Aviv, Israel, on January 6.

  • Israel will begin offering booster shots of Pfizer’s coronavirus vaccine this weekend.
  • The vaccine’s protection against severe illness waned over time from 97% to 81%, officials said.
  • With the rise of the Delta variant, many countries are considering booster doses.
  • See more stories on Insider’s business page.

Israel will start offering booster doses of the Pfizer-BioNTech coronavirus vaccine to its older citizens on Sunday, as health officials described new data showing a decline in the vaccine’s protection against severe disease over time.

A key unknown with the COVID-19 vaccine is how long protection will last. The emergence and spread of the Delta variant has intensified that uncertainty, with the variant showing the ability to partially evade the vaccine’s protection.

In response to the latest data, Israel is offering a third dose of the vaccine to its citizens who are 60 and older and at least five months removed from their second shot. Other countries are also considering if and when to roll out booster shots. Israel had already begun offering booster shots to some people with compromised immune systems, such as cancer patients.

There has been a trickle of studies in recent weeks suggesting protection from Pfizer’s vaccine starts to wane after several months. Israel’s decision was motivated by signals of decreased efficacy, The Wall Street Journal reported.

Read more: Pfizer doubles down on the case for COVID-19 vaccine booster shots

In particular, one Israeli scientist said the country had data showing the vaccine’s protection against severe illness among this 60-plus age group dropped from 97% in April to 81% in July. Those results have yet to be published in a peer-reviewed medical journal or posted on a preprint server.

Eric Topol, the director and founder of the Scripps Research Translational Institute, said on Twitter that if these results held up, they would be “the first sign of a significant dropdown of protection against hospitalizations and death for these vaccines.”

“I hope all of the data will be shared ASAP as the implications are big,” he tweeted.

Israel’s findings appear at odds with reports from the UK in June, with one large observational study finding Pfizer’s vaccine reduced the risk of hospitalization from the Delta variant by 96%. One difference between the two findings is that Israel’s results are specific to an older population.

Pfizer presented more results on Wednesday supporting the company’s stance that boosters would be needed six to 12 months after initial vaccination. Laboratory testing by Pfizer showed neutralizing antibodies, a key part of the immune response, significantly declined eight months after the second dose of its vaccine among all age groups.

The New York drugmaking giant also posted new, detailed results from its clinical trial that enrolled more than 40,000 volunteers. Longer-term follow-up showed the vaccine’s ability to prevent symptomatic COVID-19 cases, regardless of severity, dipped to 84% starting four months after the second dose, compared with 96% efficacy in the first two months.

The vaccine’s overall efficacy against severe disease in that study was 97%, with 30 cases occurring among people who received placebo shots and one case in a person who got the vaccine.

Pfizer’s findings have also yet to be published in a peer-reviewed medical journal, and the company said it would submit an application to US regulators in August to begin offering booster shots.

Read the original article on Business Insider

Vaccinated people: Don’t panic about your odds of a ‘breakthrough’ infection

Hello,

Welcome to Insider Healthcare. I’m Lydia Ramsey Pflanzer, and today in healthcare news:

If you’re new to this newsletter, sign up here. Comments, tips? Email me at lramsey@insider.com or tweet @lydiaramsey125. Let’s get to it…


flaming lips bubble concert


Vaccinated people: Your odds of a COVID ‘breakthrough’ infection have gone up. That doesn’t mean you need to panic.

Get the full analysis>>


Cake's software is displayed on a laptop.
Cake’s website allows people to learn about and plan for death.

A startup that wants to be the Tripadvisor of death planning used this 10-slide presentation to raise $3.7 million

See the presentation>>


Truepill cofounders Umar Afridi and Sid Viswanathan
Truepill cofounders Umar Afridi and Sid Viswanathan

The biggest US health insurer has a $600 million VC arm that places bets on the future of healthcare. Here are Optum Ventures’ 18 biggest investments, including startups reinventing home care and pharmacies.

  • Optum Ventures is a $600 million venture fund associated with UnitedHealth Group.
  • The fund launched in 2017 and has a focus on digital health, a spokesman confirmed to Insider.

Here are the 18 biggest investments Optum Ventures has participated in over the last few years>>


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– Lydia

Read the original article on Business Insider

See the presentations that hot healthcare and biotech startups used to raise millions from top VCs

Arel and Florian_Cedar
Cedar’s president Arel Lidow and CEO Dr. Florian Otto.

  • Startups have raised billions on the promise of disrupting healthcare.
  • To win over investors, startups often present their businesses through a slide deck.
  • Here are the presentations obtained by Insider that healthcare startups have used to raise millions.
  • See more stories on Insider’s business page.

In the past few years, investors have bet billions on healthcare startups looking to disrupt the industry.

In 2020 alone, healthcare startups raised $17 billion, according to Silicon Valley Bank.

Winning over investors can be a long process, and it often involves a slide deck that lays out what the startup does, and where the company is heading.

Insider rounded up all the presentations we’ve published that healthcare startups have used to raise cash from investors.

Early on, startups sell investors on often newly-tested ideas

When startup founders pitch investors ahead of a seed or Series A round, they haven’t gotten far off the ground.

Presentations can be helpful at laying out the approach that startup is taking, or plans to take.

For instance, 100plus raised $25 million in seed funding from investors including two billionaires and Dr. Oz for its approach to remote patient monitoring.

And The Public Health Company raised $8 million from Verily and Venrock with this presentation laying out a new approach to fighting disease outbreaks.

Others can use the presentations to share their new approaches, like Vori, which raised $45 million for a former neurosurgeon’s approach to solving Americans’ back pain.

They can also show how a startup might stand out in a competitive field. Brightside used this presentation to break through a crowded field of mental health startups and convince VCs to invest $24 million.

You can see more presentations below.

Read more:

We got a look at the slide deck of Bind, a startup that’s raised $70 million to upend the way we pay for healthcare

We got an exclusive look at the presentation two ex-Aetna execs used to raise $40 million for a new healthcare AI startup

A San Francisco startup helps hospitals recruit nurses through automation. Here’s the pitch deck it used to raise $15 million.

See the presentation a serial entrepreneur used to raise $20 million from Bessemer and Founders Fund for his solution for Americans living with chronic pain

See the presentation microbiome startup Seed Health used to raise $40 million

By Series B, startups are looking for a chance to grow big

By their Series B rounds, startups are raising higher sums at higher valuations. They’re often still early into their existence and are looking for ways to get big.

For instance, Devoted Health raised $300 million at a $1.8 billion valuation in 2018 before it had signed on any customers.

Swift Medical, an imaging startup for wound care, used this presentation to raise $35 million in its Series B. The funding could help the startup expand into more areas of wound care.

Read more:

We got an exclusive look at the presentation BrightInsight used to convince investors to bet $40 million that it can help pharma giants go digital

We got a look at the pitch decks that buzzy $40 million startup HealthJoy used to snag early investors and then execute a huge strategic shift

Alphabet’s VC arm just sank $140 million into a startup that wants to unseat dialysis giants like DaVita. We got the pitch deck that convinced CapitalG to back Strive Health.

Late-stage rounds can give startups the fuel to scale or gear up for a public debut

The presentations used to secure later rounds of funding can be used to show investors how far the startup’s come, and what’s ahead.

Often, the investors start to look different as well, and startups can find themselves pitching asset managers or industry incumbents, like health insurers.

For instance, Tiger Global and health insurer Humana backed at-home healthcare startup Dispatch Health in its Series D, while insurer Centene joined in on Hazel Health’s Series C.

Centene was also a backer of Vida Health. The upstart shared the presentation that helped it raise $110 million toward a new vision for the hardest kind of healthcare.

And Cedar used its Series C presentation to lay out the businesses it plans to tackle next.

The presentations at this stage can help land startups like Aledade high valuations, which raised $100 million in a round that valued the company at $2.1 billion.

The funding rounds, such as Moderna’s pitch to investors in 2017, can come shortly before plans to go public. Moderna made its public debut in 2018.

Read more:

We got an exclusive look at the presentation telehealth startup Hazel used to raise $33.5 million and convince a major health insurer to bet on upending the way kids get healthcare

This pitch deck helped telehealth startup Heal raise $100 million and win a major partnership with healthcare giant Humana. Here’s how the deal came to be.

See the 39-slide presentation that Moderna used to win over investors on its way to becoming the hottest company in biotech

Read the original article on Business Insider

The head of the FDA is calling for an investigation into her agency’s controversial decision to approve a new Alzheimer’s drug

Janet Woodcock
Interim FDA Commission Janet Woodcock.

  • Interim FDA Commissioner Janet Woodcock has asked for an outside investigation into an Alzheimer’s drug approval.
  • The agency approved the drug, Aduhelm, last month, despite a lack of evidence showing the drug slowed the disease.
  • Officials from Biogen and the FDA worked closely together to revive the drug, raising concerns.
  • See more stories on Insider’s business page.

The top leader at the US Food and Drug Administration is asking for an investigation into the agency’s controversial decision to approve an expensive new Alzheimer’s disease treatment.

Janet Woodcock, acting commissioner of the FDA, published a letter Friday asking the federal government’s top inspector to investigate if FDA staff worked inappropriately with biotech company Biogen to approve the new drug.

“To the extent these concerns could undermine the public’s confidence in FDA’s decision, I believe that it is critical that the events at issue be reviewed by an independent body such as the Office of the Inspector General, in order to determine whether any interactions that occurred between Biogen and FDA review staff were inconsistent with FDA policies and procedures,” she wrote in the open letter.

The drug in question, Aduhelm, was approved by the agency last month and has caused an uproar in the scientific community. Three of the agency’s scientific advisors resigned following the decision.

Documents released by the FDA last month show that people within the agency thought that the drug should not have been approved because human testing data didn’t show it worked, but their concerns were overridden by top staff.

Biogen officials used back channels to get the drug approved after a late-stage clinical trial failed in March 2019, according to a report from STAT News.

The interactions pre-dated Woodcock, who became interim commissioner in January when the Biden Administration took office. She has been with the FDA for more than two decades and is one of the top contenders to permanently take the role, according to biotech analysts.

After the FDA approved Aduhelm, Biogen set its price at about $56,000 a year. Analysts estimate the US Medicare program could pay anywhere from $6 billion to $29 billion per year for Aduhelm, according to a recent New York Times analysis.

Biogen’s stock, which surged when the FDA approved Aduhelm, declined 3.2% to $357.09 a share on Friday afternoon.

Read the original article on Business Insider

A new breed of health insurers is taking a page out of UnitedHealth’s book and providing care directly to patients, and it could reshape the US healthcare industry

Telemedicine online doctor appointment
A doctor sees a patient online.

  • Health insurer upstarts have made care delivery a core part of their business strategies.
  • Alignment, Bright, Clover, and Devoted all employ doctors and care for their directly.
  • They’re betting that doing so will help them lower costs and compete against industry giants.
  • This article is part of a series called “Future of Healthcare,” which explores how technology is driving innovation in the development of healthcare.

A new breed of health insurers is betting that providing care directly to patients will help them compete against industry giants and grow their footprints across the country.

These young insurers, like Alignment Healthcare, Bright Health, Clover Health, and Devoted Health have made employing doctors and delivering healthcare a core part of their strategies.

In some ways, they’re following a playbook etched out years before them by incumbents like UnitedHealth Group, which has worked for more than a decade to assemble a fleet of 56,000 doctors and counting by acquiring medical groups.

Humana, which deals in health plans for elderly people, has been buying and building out primary-care clinics for years. And Blue Cross Blue Shield insurers in Florida, Tennessee, and Texas have stood up dozens of retail clinics.

But while the big players have waded into providing care over time, the new-age insurers, which bank on using sophisticated technology to improve care and lower costs, have it in their DNA. Unlike the dominant insurers, they’ve largely steered clear of physical clinics, focusing instead on providing care virtually or in people’s homes.

It’s an approach that requires less capital, but still arms the upstarts with the tools needed give their members more ways to get care, and better control how much they spend on care.

“It gives us the reliability of making sure we can bend that cost curve everywhere we go without having to go into each market with a bunch of bricks and mortar,” Alignment CEO John Kao said. Alignment employs about 150 clinicians that care for the sickest plan members virtually and at their homes.

Alignment and Devoted are seeing patients online and at home

Alignment, the California-based Medicare Advantage insurer with 83,000 members, uses its technology to find the sickest, most expensive plan members who have chronic illnesses and frequent the hospital.

Alignment’s group of employed doctors, nurses, case managers, social workers, and behavioral health coaches care for 4,000 of these members, in partnership with their regular primary-care doctors. Being able to provide care itself is just more efficient, Kao said, and it helps save Alignment some money, which it can put back into better health benefits and attract more customers.

Waltham, Massachusetts-based Devoted, which had a little more than 20,000 Medicare Advantage members at the end of 2020, has its own medical group of employed doctors and other clinicians who provide virtual care to plan members at home.

Its services “wrap around and complement” the health care providers that Devoted partners with, so members get the best care at the right place and time, a spokesman for the company said in an email.

Clover is expanding its in-house home healthcare program

Meanwhile, insurer Clover Health also built up a home-healthcare program mostly run by employed healthcare providers.

The insurer, which had 66,300 Medicare Advantage members in March, uses claims data and medical records to look for people with multiple chronic illnesses, who are frail or home-bound, or visit the emergency department often. Its technology will then tell an eligible patient’s primary-care doctor that they might benefit from home visits, which are conducted by Clover’s internal care teams, Dr. Kumar Dharmarajan, head of Clover Home Care, told Insider.

Dharmarajan said the program increases access to care for older adults who don’t leave the house. It also allows Clover to get a picture of non-medical factors that could lead to worse health, like disorganized medications or fall hazards like electrical cords on the floor. An office visit wouldn’t reveal that kind of information.

In New Jersey alone, Clover expects to have between 3,000 and 3,500 Medicare Advantage members in its home care program by the end of this year, compared with just 200 patients in 2017, Dharmarajan said. It’s set to expand further as Clover starts offering home care to traditional Medicare enrollees that it’s managing through a federal program.

Bright is buying up medical practices

Most young insurers aren’t building clinics, but Bright Health is the exception.

Its CEO Mike Mikan, a former UnitedHealth Group executive, is following his former employer’s blueprint and buying up medical practices.

Bright, which provides health coverage to 623,000 individuals, families, and seniors, is tucking these acquisitions into its new care delivery business called NeueHealth. The business owns or manages care for 61 clinics, but it also works closely with outside provider groups and arms them with analytics and other tools to they can provide better care.

In both cases, the goal is for the insurer and provider to get on the same page and partner to improve patients’ health and lower costs under a payment model where each side wins when it works.

That’s different the old insurance strategy of restricting care, Mikan said.

“What we really want to promote is the healthcare system to move to a value-based model where you’re really rewarding performance based on the quality of the care they provide, not just the quantity of care,” he said. “Every consumer is better served when they’re part of an aligned model.”

Read the original article on Business Insider

Tracking Delta in vaccinated people – What we know about mixing shots – Where Delta’s spreading

Hello,

Welcome to Insider Healthcare. I’m Lydia Ramsey Pflanzer, and today in healthcare news:

If you’re new to this newsletter, sign up here. Comments, tips? Email me at lramsey@insider.com or tweet @lydiaramsey125. Let’s get to it…


coronavirus testing
A nurse administers a COVID-19 test at a testing site in Suffolk County, New York, on December 18, 2020.

The CDC stopped tracking most COVID-19 cases in vaccinated people. That makes it hard to know how dangerous Delta really is.

Find out more>>


johnson & johnson covid vaccine

Some experts say J&J vaccine recipients should get an mRNA booster. Here’s what we know about mixing shots.

Here’s what we know>>


Spc. Demetrie Barnett of the Nevada National Guard administers a COVID-19 test to Josiah Smith, 12, of Nevada, during a preview of a free drive-thru COVID-19 testing site in the parking garage of the Texas Station Gambling Hall & Hotel on November 12, 2020 in North Las Vegas, Nevada.
Spc. Demetrie Barnett of the Nevada National Guard administers a COVID-19 test.

The Delta variant is causing more than 80% of new COVID-19 infections in 4 US states, including 96% of new cases in Missouri

Get the full story>>


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– Lydia

Read the original article on Business Insider

What it takes to keep up with the digital health boom

Hello,

Welcome to Insider Healthcare. I’m Lydia Ramsey Pflanzer, and this week in healthcare news:

If you’re new to this newsletter, sign up here. Tips, comments? Email me at lramsey@insider.com or tweet @lydiaramsey125. Let’s get to it…


We’ll be off next Monday for the holiday! Hope you all have a great weekend, and we’ll see you again on Tuesday.


A check with the words "paid to the order of digital health" written on it surrounded by dollar signs on a blue background.

Keeping up with the digital health boom

Dealmaking is heating up in healthcare.

Case in point: Ro on Wednesday made its third acquisition in the last year, buying at-home diagnostics startup Kit.

Megan Hernbroth spoke to some of the folks involved in inking digital health deals. They’ve been working overtime amid the boom – pulling all-nighters and working seven days a week.

The boom has led to a new crop of healthcare startups.

With the help of the VC team here at Insider, we pulled together a list of 23 of the most promising healthcare startups of 2021.

Read the full list here>>

Blake Dodge meanwhile has spent the past few weeks searching out the bankers that every digital health company should know.

They shared with her predictions for the future of the industry.

Meet digital health’s go-to bankers>>

12 top bankers break down how tech is driving record deals and the next generation of giants


mental health illness depression anxiety headache migraine therapy

The cost of inequity

Over the last few months, the Insider newsroom has been busy reporting on a series that quantifies the cost of inequity in the US.

The healthcare team contributed some articles:

Find the whole project here>>

How inequity persists in America


Tia Office

What’s fueling women’s-health startups

It’s Patricia Kelly Yeo’s last week with us here on Insider’s healthcare team! In her final few weeks, she went deep on what’s happening in women’s health.

On the heels of Ro’s announced deal to buy Modern Fertility, we started wondering what the future of women’s health looks like: Is it possible to grow a startup focused on something like fertility, or contraception? Or is the fate ultimately to become an acquisition target?

Kelly spoke to experts in the field to understand how women’s-health startups could benefit from all the dealmaking.

Meanwhile, Kindbody last Friday raised $62 million, valuing the fertility clinic startup at $612 million.

That puts Kindbody as one of the top-funded women’s-health startups.

Get the full list here>>

From birth-control delivery to online pregnancy care, here are the 9 highest-funded women’s-health startups


More stories we covered this week:


– Lydia

Read the original article on Business Insider

CureVac’s COVID-19 shot just failed in a large trial, a major setback for the Gates-backed biotech

Employee Philipp Hoffmann, of German biopharmaceutical company CureVac, demonstrates research workflow on a vaccine for the coronavirus (COVID-19) disease at a laboratory in Tuebingen, Germany, March 12, 2020. Picture taken on March 12, 2020. REUTERS/Andreas Gebert
An employee of German biopharmaceutical company CureVac.

  • CureVac’s experimental COVID-19 vaccine failed in a pivotal clinical study, the biotech said Wednesday.
  • It’s the first late-stage study to flop, with CureVac’s vaccine showing 47% effectiveness.
  • The German biotech saw its stock price drop by more than 50% in post-market trading.
  • See more stories on Insider’s business page.

A COVID-19 vaccine candidate developed by the German biotech CureVac failed in a critical late-stage study, the company said Wednesday.

It’s the first failure of a major vaccine candidate in a final-stage trial. CureVac said an interim analysis showed the shot was 47% effective, falling short of the study’s goals and the minimum bar for what US regulators find approvable.

The development is a setback to the world’s immunization efforts, as European officials had previously reached deals to acquire up to 405 million doses of the shot.

Despite the disappointing result, CureVac CEO Franz-Werner Haas said the company plans to go “full speed for the final readout.” The trial is still ongoing and the final vaccine efficacy figure may vary as more COVID-19 cases are tallied.

“We are still planning for filing for approval,” Haas told The New York Times’ Carl Zimmer.

CureVac, which is backed by The Bill & Melinda Gates Foundation, saw its stock price plummet following Wednesday’s announcement. Shares were down more than 50% in post-market trading. The foundation owns about 3.1 million shares of CureVac, or 1.7% of the company, according to data compiled by Bloomberg.

An independent biostatistics expert said it will be nearly impossible for CureVac’s study to still produce success. The 47% estimate of efficacy is based on 134 COVID-19 cases among study participants. “It’s not going to change dramatically,” Natalie Dean, a University of Florida biostatistician, told The Times.

CureVac blames variants, even as other vaccines hold up against different strains

In a statement, CureVac leaders said that the abundance of virus variants played a role in the result. Only one of the 134 analyzed cases resulted from the original strain of the SARS-CoV-2 virus, the company said.

“While we were hoping for a stronger interim outcome, we recognize that demonstrating high efficacy in this unprecedented broad diversity of variants is challenging,” CureVac CEO Franz-Werner Haas said in a statement.

The disappointing result is surprising given some of the similarities CureVac’s experimental vaccine candidate had with other, highly effective immunizations. CureVac’s shot is a messenger RNA vaccine, a new technology platform that’s also used by Moderna and Pfizer-BioNTech.

Those shots proved to be more than 90% effective in late-stage trials last year. They also appear to protect people against some major virus variants.

Other vaccines have also shown success against variants. Novavax, for instance, announced earlier this week its two-dose shot was 90% effective in a late-stage study. What’s more, Novavax’s vaccine was about 93% effective in preventing illnesses caused by variants of concern or variants of interest, the company said.

A quiet existence, until the pandemic

Since its founding in 2000, CureVac had a largely quiet existence until the pandemic. As one of the first companies trying to develop a COVID-19 vaccine, CureVac’s CEO was invited to the White House in March 2020. Shortly after, reports circulated that the US had offered a “large sum” for access to its vaccine program. CureVac disputed the reports. The company also cycled through three CEOs in the span of a week.

Tesla CEO Elon Musk has also drawn attention to CureVac with his tweets. A Tesla subsidiary is working with CureVac in building a “prototype of an automated manufacturing unit,” Insider reported in July.

In its Wednesday press release, CureVac focused attention on its second-generation coronavirus vaccine. Pharma giant GlaxoSmithKline has partnered with CureVac on that research, paying the company roughly $235 million upfront and investing an additional $180 million in multiple deals over the past year.

CureVac said it hopes this next-generation program could start human testing by the end of September, with the goal of launching in 2022.

Dr. Catherine Schuster-Bruce contributed reporting.

Read the original article on Business Insider

Novavax says its coronavirus shot is 90% effective

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Welcome to Insider Healthcare. I’m Lydia Ramsey Pflanzer, and today in healthcare news:

If you’re new to this newsletter, sign up here. Comments, tips? Email me at lramsey@insider.com or tweet @lydiaramsey125. Let’s get to it…


Vaccine distribution

Novavax says its coronavirus vaccine was 90% effective in a large trial, moving the shot a step closer to widespread use

More from the results>>


pfizer vaccine us
Pfizer BioNTech’s COVID-19 vaccine at Desert Valley Hospital on Thursday, December 17, 2020 in Victorville, California.


Young people are experiencing rare cases of heart inflammation after getting coronavirus vaccines, but doctors say the risk of COVID-19 is far greater

Find out more>>


Diana Flores, Amelia, and husband and father Dr. Ali Ebneshahidi.
From left to right: Diana Flores, Amelia, and husband and father Dr. Ali Ebneshahidi.

Biden’s plan to send $400 billion to help families caring for loved ones with disabilities is in jeopardy as infrastructure talks falter

Here’s what’s at stake>>


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– Lydia

Read the original article on Business Insider