Gilead Inhaled Remdesivir Needs More Testing Before Regulatory OK

 Foster City-based Gilead Sciences says its inhaled version of remdesivir, which has been increasingly used in research and practice to combat COVID-19 in hospitalized patients, won’t be available any time soon as it needs more testing in clinical research.

The inhaled remdesivir formulation is slowly undergoing investigation in a Phase I trial, but Gilead Sciences’ Chief Medical officer, Merdad Parsey, MD, says this trial has not reached adequacy to support a rapid regulatory approval.

Remdesivir, sold under the brand name Veklury, has been used in around half of hospitalized patients with COVID-19 in the U.S. The drug, which ranges in price from $2,340 to $3,120 for a five-day treatment course, brought in approximately $1.9 billion in sales for Gilead in the fourth quarter of 2020. This was above analyst estimates of around $1.34 billion. Sales of Veklury contributed to a 26% rise in quarterly revenue overall, and the announcement of this rise was swiftly followed by a 2.5% increase in Gilead shares. In contrast, product sales from Gilead have been down 3% to $21.5 billion in 2020 compared with 2019.

Gilead hopes that the inhaled formulation of Veklury could increase its earnings on the drug, especially if the indication is expanded to non-hospitalized patients. The inhaled formulation could be used after patients have been infected but before hospitalization is needed. Currently, inhaled remdesivir is drudging along in a Phase I trial and still needs further testing before it can receive approval or emergency authorization.

The inhaled version of remdesivir is formulated as a drug-device combination. The drug is delivered into the lungs, acting differently than the infused version used in hospital settings. The formulation’s different mode of action poses a different clinical efficacy question to researchers.

Officials at Gilead have suggested that sales of Veklury have offset sales of other drugs, primarily because many patients with HIV, cancer and hepatitis C have been hesitant to expose themselves to COVID-19. Additionally, following generic competitors flooding the market, Gilead’s HIV drugs Truvada and Atripla lost patient exclusivity last year. Despite this loss, sales of Gilead’s HIV drug Biktarvy rose to $6.1 billion in 2020, which was up year-on-year from $4.2 billion. Also, sales of the company’s HIV prevention drug, Descovy, saw an increase in sales to $1.5 billion versus $1.1 billion in 2019.

Just four days ago, Gilead inked a collaborative deal with Gritstone Oncology to develop a new vaccine-based immunotherapy with curative potential for HIV. This would mark the first “cure” for HIV, a disease which is typically managed and controlled with antiviral drug cocktails. The deal will see Gilead paying Gritstone $30 million in upfront cash as well as a $30 million equity investment. Gilead will also manage a Phase I trial for the vaccine.

And last year, Gilead also announced it planned to dive deeper into an oncology focus, following the $21 billion acquisition of Immunomedics, which has developed breast cancer treatment Trodelvy. Gilead is acquiring the company as it was seeking regulatory approval of this therapy, which previously received accelerated approval in April for adult patients with metastatic triple-negative breast cancer who have been treated with two or more prior treatments.

https://www.biospace.com/article/gilead-s-inhaled-covid-19-treatment-remdesivir-requires-more-adequate-testing-before-regulatory-approval/

CGM, insulin pump players look to 2021 as watershed for diabetes wearables

 The coronavirus pandemic has spurred an explosion in telehealth and digital health as patients stayed out of hospitals and doctors' offices to slow the spread of the virus turned to virtual care.

As a result, the healthcare landscape has significantly changed over the past 10-11 months and companies are making moves to capitalize on the rise of tech-driven services and wearable devices.

Patients embraced devices like continuous glucose monitors and insulin pumps in recent years before the pandemic, and companies in these markets like Dexcom and Insulet or Medtronic and Abbott Laboratories have remained successful despite the economic volatility throughout 2020.

Now, Wall Street and industry see 2021 as a watershed moment for diabetes technology. Along with plans to expand into new markets, nearly every major player in the CGM and insulin pump space have product launches this year, one of which J.P. Morgan said could be the year's biggest for industry.

As the CGM and insulin pump markets gain momentum, companies like Dexcom and Insulet point to a large, under-penetrated patient population as the largest growth opportunity.

In 2018, about 34 million people in the U.S. had diabetes, or 10.5% of the population, and another approximately 88 million adults were estimated to be pre-diabetic, according to a 2020 report from the Centers for Disease Control and Prevention. Nearly 8 million more were estimated to have diabetes but were not diagnosed. 

The World Health Organization estimates that there are about 422 million people with diabetes across the globe. Much like other chronic illnesses, these numbers are expected to grow as the global population ages.

As both patients and providers rely more and more on virtual care, digitally-based diabetes management stands to gain further momentum.

Turning to tech

Traditionally, diabetes is managed with finger sticks to read blood glucose levels and insulin injections for patients who require them. But newer wearable devices like CGMs and insulin pumps are changing the diabetes market.

CGMs can automatically monitor blood glucose levels throughout the day and warn users when levels get too high or too low, and pumps can deliver insulin to patients without requiring the patient to administer an injection or multiple injections throughout the day.

Insulet CEO Shacey Petrovic contends the industry is at an "inflection point," where the tech has evolved and improved as patients have further embraced virtually-based services.

Because traditional pumps are more expensive and cumbersome, patients are not as willing to use them, according to Petrovic. The CEO said that recent smaller wearable pumps that have similar health outcomes to traditional care have helped fuel the change in patient behavior.

Because of this shift, the CEO does not view Insulet as competing in a defined insulin pump market but creating a market that may have not been there because the majority of users are dependent on injections, not pumps. Approximately 80% of the company's users are patients that inject insulin multiple times a day.

Petrovic said that the company has doubled its patient population to hundreds of thousands over the last five years.

Jake Leach, Dexcom's chief technology officer, outlined a similar story that fueled the company's success in recent years — the technology improved, costs dropped, and patients became more willing to use CGMs.

Petrovic and Leach said that while patient behavior was changing before the pandemic, the recent rise of virtual care has boosted CGM and pump adoption.

Both companies have remained successful in 2020 as others were harder hit by the pandemic. Dexcom's stock price increased from $238.54 to $366.89 over the last 12 months, and Insulet's grew from $193.51 to $275.03. Petrovic said during a November earnings call that Insulet should beat pre-pandemic expectations in 2020.

2021 product launches

The next step for diabetes care is connecting the CGMs and insulin pumps together through what is called a closed-loop system, which requires less direct involvement for patients in managing their diabetes. An algorithm, which companies have developed independently or license with partners, connects the devices and allows them to work together.

Tandem's Control-IQ technology was the first FDA-cleared algorithm for use with a fully interoperable, automated insulin dosing system. However, competitors in the space are now catching up.

Insulet has developed an algorithm of its own and will use it with its Omnipod 5 automated insulin pump to connect with CGMs like Dexcom's G6 system. Petrovic said that the company plans to receive FDA approval and launch the product in the first half of 2021.

To further ease of use for patients, the pump will transmit data to an application on patients' cell phones. Petrovic said that the product will be available first with Androids when launched and then, ultimately, iPhones.

J.P. Morgan analysts wrote that this product is one of the company's most important launches and one of the biggest for medtech this year. The pump may provide patients with a better option to Tandem's because it is tubeless and comes at a cheaper cost as it will be offered directly through a pharmacy as opposed to the durable medical equipment channel.

Meanwhile, after pushing back the product launch in 2020, Dexcom plans to launch its G7 CGM system at the end of 2021 with a further rollout in 2022, according to Leach. The product will be key for the company to hit its projection of doubling revenue by 2025.

Leach said that closed-loop systems are where the market is headed, and while it won't be needed by everyone with diabetes, about 50% of Dexcom's users will eventually be on the system.

Competing with medtech leaders

Analysts have been high on both Insulet and Dexcom, with J.P. Morgan analysts picking Insulet as a top small-cap company in a 2021 outlook and William Blair analysts writing that Dexcom should meet or beat expectations going forward.

Both, however, have to compete in a market with larger medtechs like Medtronic and Abbott.

Abbott's FreeStyle Libre CGM system has been a continual bright spot for the company and remained successful last year. CEO Robert Ford said during a fourth-quarter earnings call that FreeStyle Libre sales grew 50% in the U.S. in 2020 and 40% outside of the U.S., with international sales alone eclipsing $2 billion.

For comparison, Dexcom CEO Kevin Sayer projected during the J.P. Morgan healthcare conference that 2021 revenue will land in a range between $2.21 billion to $2.31 billion, representing growth of 15% to 20%.

Medtronic, the only company in the space to own both a CGM and insulin pump, has also recently re-prioritized its diabetes portfolio and invested in the more tech-driven management approach.

In June, the company received a $337 million investment from the private investment firm Blackstone Life Sciences to develop four undisclosed diabetes products, and Medtronic in August bought up Companion Medical, which has the only FDA-cleared insulin pen that can combine with a management smartphone application.

Ali Dianaty, vice president of product innovation for Medtronic's diabetes portfolio, said that the company is looking to a more "consumer electronics" approach to the diabetes business, with products being released or updated on a more annualized basis.

The device giant also plans to have a product launch in 2021: the MiniMed 780G pump system. The system will also be able to connect with a CGM to determine when insulin injections are needed. While the product is available in Europe, Dianaty said Medtronic is waiting for FDA approval. He would not provide a specific timeline due to delays because the agency is prioritizing COVID-19 applications.

Once approved, he said the rollout should be rapid as users need to just update the pumps that they already own with the new management system.

Dianaty said that one benefit of having both a CGM and a pump is that the company owns the algorithm and all the data coming through on the backend. However, he acknowledged a hurdle of not partnering with other CGM companies if customers settle on one product, potentially limiting growth. For example, on the insulin pump side, Insulet is working with both Dexcom and Abbott. Meanwhile, on the CGM side, Dexcom is working with both Tandem and Insulet.

When it comes to competing among larger companies with deeper pockets, Leach said that Dexcom was not concerned and plans to focus specifically on CGM users.

"Our perspective is that there's a lot of opportunity," Leach said. "There's multiple players in the market, they all have a slightly different approach to the products, and I think our approach is to remain the technology leader and drive forward with solutions that are right for the user."

UBS analysts echoed a similar sentiment in a recent report, writing that Dexcom's G7 product will be able to compete with FreeStyle Libre despite Abbott's size and CGM success.

Patient & global expansion

One competitive advantage that analysts have called out is that both Insulet and Dexcom have targeted the pharmacy channels to reach more users. The strategy drops the price of their devices but allows for a more direct and faster connection to customers compared to the DME channel.

Dexcom has made the pharmacy a key strategy shift, with plans to eventually sell about 75% of CGMs through the channel by the end of this year. And J.P. Morgan analysts said that Omnipod 5 will be the only pump available at a pharmacy, dropping its price to $150-$200 per year versus multiple hundreds of dollars a year. The pump also eliminates the need to pay about $1,000 every four years for traditional hardware.

Dianaty said that Medtronic's CGMs and pumps are primarily sold through the DME channel, but the company is looking more towards pharmacies and will be "opportunistic" in the space.

Along with the Omnipod 5 launch, expanding into international markets is a priority for Insulet in 2021 as it will significantly grow the company's potential patient base.

Petrovic said that among their current markets — the U.S., Canada, Israel, about 12 countries in Europe and one or two in the Middle East — there are 10 million to 11 million potential patients. The CEO would not provide an estimate on how much of that population is Insulet's addressable market, but said the number is a small sample compared to where the international market can reach.

"Massive markets remain unscratched or untapped by us, [such as] all of Asia Pacific, all of Latin America," Petrovic said. "There's a lot of work underway at the company now to assess those markets ... because it's a big growth driver for us over the next several years."

There is still room for innovation amid all the growth in the diabetes space. Petrovic, Leach and Dianaty all said that with closed-loop systems or singular wearables, patients still need to notify when they have meals or input information, which can cause complications around how much insulin to deliver to patients as levels change while eating.

Insulet is advancing its algorithm to better adjust for meal times, and Medtronic's 780G system is designed to adjust for any complications that can come from users inputting inaccurate information. The company is also looking at technology from the 2019 acquisiton of the behavior monitoring company Klue, which can track hand movement to signify when people are taking bites.

All of the companies said that addressing this meal-time hurdle is the next step of where the technology is headed. 

"Our goal is to make diabetes go away … That's fundamentally what we're trying to do for our customers and our patients," Dianaty said. "In order to do that, you basically have to manage all aspects of diabetes, and the one place, the Holy Grail that's remaining is dealing with meals."

https://www.healthcaredive.com/news/cgm-insulin-pump-players-look-to-2021-as-watershed-year-for-diabetes-weara/594517/

Healthcare lost 30K jobs in January in first setback since pandemic hit

 

• The healthcare sector lost 30,000 jobs in January after posting consistent monthly gains since April’s significant losses when the pandemic hit, according to the latest jobs report from the Bureau of Labor Statistics.
• Nursing care facilities were the hardest hit, losing 19,000 jobs, followed by home health services and community care facilities for the elderly. Hospitals lost about 2,000 jobs from December to January based on the preliminary figures.
• Employment in the sector is still down by 542,000 jobs compared to February of last year. While the healthcare sector posted losses, overall, the U.S. added 49,000 jobs in January. The unemployment rate overall is now at 6.3%.

The healthcare sector lost a whopping 1.4 million jobs in April 2020 amid restrictions on non-essential medical services and lockdowns. Ambulatory service jobs were hard hit along with dentists and other doctor’s offices.

While a lot of those jobs bounced back in the following months, they slowed in the fall and winter months. January’s loss of 30,000 jobs is the first for the sector overall since the pandemic hit.

In the previous monthly report, healthcare added 39,000 jobs with the bulk of growth in hospitals and ambulatory healthcare services, though gains were slightly offset by declines in nursing care facilities, which have suffered grave employment losses throughout the pandemic.

Nursing homes have lost about 160,000 jobs since March, according to BLS data.

Home health services on the other hand have posted consistent monthly gains up until January, when jobs declined by 13,000.

Home healthcare services saw a surge in demand in wake of COVID-19 fears in nursing homes, though employment numbers in the sector are still slightly below where they were during the same time last year.

It’s unclear where a rapidly aging population will ultimately go to seek care, though jobs at nursing homes and home health services "could be substituted for by people leaving the workforce, by family members working fewer hours or not at all to take care of their loved ones," Erica Groshen, former BLS commissioner and senior labor economics advisor at Cornell's School of Industrial and Labor Relations, said.

The pandemic’s long-term impact on healthcare employment is still unclear. BLS projects employment in healthcare occupations to grow 15% from 2019 to 2029, much faster than the average for all other occupations, adding about 2.4 million new jobs.

That estimate was released in September though, using data predating the pandemic. The sector still has 542,000 jobs to recover before getting back to pre-pandemic levels.

https://www.healthcaredive.com/news/healthcare-lost-30K-jobs-in-January-BLS/594635/

Getting COVID-19 vaccines is a waiting game; one doctor who succeeded

 In a bayou community so isolated, it's actually called Cut Off, Louisana, Dr. Gary Birdsall has been singularly focused on getting his hands on the one thing his rural patients desperately need: doses of the COVID-19 vaccine.

Among the town’s 25,000 residents, many people still have concerns about the vaccine, but they've told Birdsall they would get the shot if he administered it. 

The only other option is for patients in that coastal area to drive up to two hours one-way to a vaccination site, Birdsall told Fierce Healthcare.

Through January, there was no word from Louisiana health officials about when practices would get the vaccine. “I’ve been contacting the state through emails. They never gave us phone numbers,” Birdsall said.

Almost 1,400 miles away in New York City, family physician Mark Horowitz, M.D. also hit a wall. He’s been lobbying city health officials and local politicians to quickly allocate vaccines to primary care doctors like himself to help get shots in arms.

This week, one of these doctors succeeded.

Birdsall received a shipment of Moderna COVID-19 vaccines on Monday. He’s been giving them to high-risk patients in groups of ten. His office also created a stand-by list so if someone doesn’t show up for an appointment, another patient can come in on a moment’s notice, he said.

He’s one of the few independent primary care practices to receive the COVID vaccine, according to Aledade, a network of 750 practices across the country, of which Birdsall is a member.

“Because we’re in a linear community, people have to travel 50 to 60 miles to get the vaccine. Having it available here is going to be a great asset to my patients,” he said.

His advice to other primary care doctors: Be persistent.

“Don’t give up. I think that’s what happened with us. We never had feedback but I just kept sending emails out. It’s like that Bible verse—knock on the door for a loaf of bread and they will finally give it to you just to get rid of you.”

In Manhattan, Horowitz doesn’t know when he will get doses of the vaccine for his 4,000 patients. After being approved for the vaccination program, he bought a compliant vaccine freezer, which is still sitting in the box waiting to be used.

“Last month the Department of Health informed me I’d get vaccines in early February. And then we went through that shortage in the last two weeks. It’s clear I’m not getting the vaccine any time soon,” he said. In the meantime, Horowitz is keeping his patients informed about vaccination sites throughout New York City that are open for walk-ins.

Across the country, there’s growing frustration among independent practices and medical groups about being shut out of the vaccine distribution process.

Some primary care doctors are concerned that powerful hospital lobbying groups and big corporate pharmacy chains like CVS and Walgreens have influenced the direction of the vaccine rollout process. There needs to be stronger advocacy for getting vaccines to smaller medical practices, doctors say.

Leaving primary care doctors out of the initial vaccine rollout is a crucial missed opportunity to help save lives during the pandemic, physicians say.

“We have long-standing relationships with our patients, who have a tremendous amount of trust in us. We also can provide vaccines for people who may not have the technical capabilities to go on websites to make reservations. Even tech-savvy people are finding the reservation process rather daunting,” Horowitz said.

He added, “We can reduce the bottleneck at the various vaccination centers, improve vaccine equity, and help overcome vaccine hesitancy if they gave us 5% or 10% of the vaccine allocation that the city gets.”

Birdsall also believes primary care doctors are in a position to help push more people to get the vaccine.

“I had three patients this morning who said they were not going to take it and then agreed to get it if I administered it. That’s how I can make a difference,” he said.

But many smaller practices will face obstacles to administer the COVID-19 vaccine. Ultra-cold refrigeration is required, and few office-based practices have or can afford to purchase the specialized equipment required, some doctors say.

For many practices, especially in rural areas, vaccine management will largely be a time-consuming, manual process.

At Birdsall’s practice, staff are calling patients to verify whether they have received the vaccine and to book appointments.

“Through our electronic health record system, we can also send emails and texts. Bear in mind, with our patients aged 70 and above in this community, probably around 50% only have a landline or they have a flip phone, so a text or email does not go through.”

But in a year marked by triumphs and heart-wrenching defeats, getting the vaccine was a major victory, Birdsall said.

Thirty patients in his practice died of COVID-19 since the pandemic started.

“My patients are my neighbors and my friends. This has been very difficult,” he said.

He added,"[Getting the vaccine] has put some degree of power back in my hands to prevent some of the illness I’m seeing.”

https://www.fiercehealthcare.com/practices/from-louisiana-bayou-country-to-manhattan-doctors-say-getting-covid-19-vaccines-a-waiting

Telehealth's cybersecurity risk an industrywide issue

 Experts have repeatedly predicted that telehealth would present a major challenge for healthcare cybersecurity in the coming year.  

But it's not enough to know telehealth is likely to be an issue. The real task is working collaboratively to address those dangers.  

At the second installment of the American Telemedicine Association's EDGE policy conference on Tuesday, leaders in the healthcare space reiterated the importance of cybersecurity as a patient safety issue.  

"We've been measuring the risks and the threat for telemedicine-type services for many years," said Christopher Logan, director of healthcare industry strategy at VMWare.

Even before the COVID-19 pandemic, "healthcare already had a cyber target on its back," said Logan.

Now, with the explosion of connected devices in conjunction with the rising value of digital medical records and an increasingly remote workforce, Logan said maintaining seamless cybersecurity will be more important than ever. 

This is particularly important, he said, given that patient safety can be on the line – as we've seen with the fallout and continued disruption from high-profile ransomware cases over the last year. Ransomware attacks have even been linked to a patient's death in Germany.  

"At the end of the day, 'adequate security' is not enough when you think about what we're trying to accomplish," said Logan.  

Of course, taking precautionary steps in terms of security-as-a-service and planning for a worst-case scenario will be paramount in developing a robust security profile. But Logan noted that "the most important aspect of any security program … is always going to be the people that are involved."   

Mark Jarrett, chief quality officer and deputy chief medical officer at Northwell Health, agreed: "What we're trying to [do] … is look at it from the patient viewpoint and the provider's viewpoint."  

It's not a matter of computer literacy, he said, but rather whether there are basic security measures in place. Providers who are associated with larger hospitals, said Jarrett, may have the privilege of an additional, institutionalized layer of security, while smaller or medium-sized providers "are basically on their own."  

And again, this is magnified by the increasing reliance on telehealth, which frequently relies on patients' own network security – especially when it comes to remote patient monitoring devices. Jarrett noted that this could be a good opportunity for the government to intervene. 

"I don't love overregulation, but this is an area where we have to be careful, because patients will be hurt," he said. "Cybersecurity is a patient safety issue."

Still, said Jessica Wilkerson, a cyber policy advisor with the All Hazards Readiness, Response and Cybersecurity team at the Center for Devices and Radiological Health within the Food and Drug Administration, cybersecurity is a shared responsibility.

"FDA does not regulate telemedicine," she reminded co-panelists. But "if there's one thing FDA has really learned … it's that everybody has to be doing their part."  

Even for medical device manufacturers, she said, that device will still go into a hospital system or someone's home, where it needs to be kept secure. "You have to be doing your part and talking to the other person about what they're doing and adjust on a constantly evolving basis," she said.   

"Telemedicine is the epitome of cybersecurity issues," she continued, in that there are varying levels of security expertise at play. "The whole ecosystem approach to cybersecurity is so critical."

"At the end of the day, we all know technology is going to fail," added Logan. "We have to be running a little faster than the bad guy.

"The key here is going to be people. That's going to help reduce the risks associated with telemedicine," he continued. "We're going to be able to reduce that risk only if we work in harmony together."

https://www.healthcareitnews.com/news/addressing-telehealths-cybersecurity-risk-will-be-industry-wide-problem

Biden: 'challenging for U.S.' to reach herd immunity by summer's end

 President Joe Biden said that it will be difficult for the United States to reach herd immunity, at least 75% of the population inoculated against the coronavirus, by the end of this summer.

“The idea that this can be done and we can get to herd immunity much before the end of next -- this summer, is -- is very difficult,” Biden told CBS news in an interview.

As of Sunday morning the United States has administered 41,210,937 doses of COVID-19 vaccines and distributed 59,307,800 doses, the Centers for Disease Control and Prevention said.

https://www.reuters.com/article/us-health-coronavirus-usa-biden/biden-says-challenging-for-u-s-to-reach-herd-immunity-by-summers-end-idUSKBN2A70RL

S.Africa suspends use of AstraZeneca vax as trial showing limited protection

 South Africa will suspend use of the AstraZeneca vaccine in its immunisation programme while scientists advise on the best way to proceed, Health Minister Zweli Mkhize said on Sunday.

Mkhize was speaking after trial data showed the AstraZeneca vaccine offered only limited protection against mild disease caused by the 501Y.V2 coronavirus variant first identified in South Africa.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/S-Africa-suspends-use-of-AstraZeneca-vaccine-after-trial-showing-limited-protection-32380735/