shares ticked up last week on third-quarter results that topped the consensus forecast.
The San Deigo-based sleep respiratory technology maker posted profits of $232.5 million. That amounts to $1.58 per share on sales of $1.12 billion for the three months ended March 31, 2023.
ResMed posted a 29.9% bottom-line gain on sales growth of 29.2%. ResMed’s continued growth reflects a ramp-up in production as a result of growing demand. The company grabbed a hold of the sleep respiratory market as a result of the ongoing Philips Respironics recall.
Adjusted to exclude one-time items, earnings per share totaled $1.68. That landed 9¢ ahead of expectations on Wall Street. Sales posted a beat, too, as analysts looked for revenues of $1.05 billion.
“During the third quarter, we significantly ramped up production and delivery of our cloud-connected flow generator devices to meet ongoing high demand from customers, resulting in strong device sales growth across our global markets,” said Mick Farrell, ResMed CEO. “We now have full global availability of our connected AirSense 10 platform, while we continue to ramp production and availability across more geographies of our AirSense 11 platform.
“The bottom line is this: We can now support global customer demand for CPAP and APAP devices to serve the entire sleep device market. This is great news for physicians, providers, and especially for patients. We also saw very strong growth in our mask and patient interfaces businesses globally, demonstrating a sustainable focus on patient adherence and resupply.”
ResMed did not provide financial guidance for the remainder of its 2023 fiscal year.
The Californian financial regulator has taken possession ofFirst Republic
, resulting in the third failure of an American bank since March, after a last-ditch effort to persuade rival lenders to keep the ailing bank afloat failed.
JPMorgan Chase Bank will assume all deposits, including uninsured deposits, and “substantially all assets” of the bank, according to a release early Monday.
The California Department of Financial Protection and Innovation said it had taken possession of the bank and appointed the Federal Deposit Insurance Corporation receiver of the bank. The FDIC accepted JPMorgan’s bid for the bank’s assets.
Since the sudden collapse of Silicon Valley Bank in March, attention has focused on First Republic as the weakest link in the U.S. banking system. Like SVB, which catered to the tech startup community, First Republic was also a California-based specialty lender of sorts. It focused on serving rich coastal Americans, enticing them with low-rate mortgages in exchange for leaving cash at the bank.
But that model unraveled in the wake of the SVB collapse, as First Republic clients withdrew more than $100 billion in deposits, the bank revealed in its earnings report April 24. Institutions with a high proportion of uninsured deposits like SVB and First Republic found themselves vulnerable because clients feared losing savings in a bank run.
Shares of First Republic are down 97% so far this year as of Friday’s close.
That deposit drain forced First Republic to borrow heavily from Federal Reserve facilities to maintain operations, which pressured the company’s margins because it’s cost of funding is far higher now. First Republic accounted for 72% of all borrowing from the Fed’s discount window recently, according to BCA Research chief strategist Doug Peta.
On April 24, First Republic CEO Michael Roffler sought to portray an image of stability after the events of March. Deposit outflows have slowed in recent weeks, he said. But the stock tanked after the company disavowed its previous financial guidance and Roffler opted not to take questions after an unusually brief conference call.
The bank’s advisors had hoped to persuade the biggest U.S. banks to help First Republic once again. One version of the plan circulated recently involved asking banks to pay above-market rates for bonds on First Republic’s balance sheet, which would enable it to raise capital from other sources.
But ultimately the banks, which had banded together in March to inject $30 billion of deposits into First Republic, couldn’t agree on the rescue plan and regulators took action, ending the bank’s 38-year run.
Study results of novel drug-eluting technology highlight potential durability of TAR-200 in patient population with high unmet need
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the first results from the open-label Phase 2 SunRISe-1 study evaluating the efficacy and safety of TAR-200 monotherapy (a novel investigational intravesical drug delivery system) and cetrelimab monotherapy (an investigational anti-PD-1 monoclonal antibody administered intravenously) in patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC), who are ineligible for, or decline, radical cystectomy. The study demonstrated that 72.7 percent of patients treated with TAR-200 alone (95 percent confidence interval [CI] 49.8-89.3) and 38.1 percent of patients treated with cetrelimab alone (CI 18.1-61.6) achieved the primary endpoint of a complete response (CR). These data were featured today in a Late Breaker Podium Presentation Session (Abstract #LBA02-03) at the American Urological Association Annual Meeting (AUA).
This month Prothenaannounceda partnership with Walgreens to boost patient enrollment in an Alzheimer’s clinical trial, aiming to hasten the approval process for its anti-amyloid antibody. In partnership with the pharmacy, Prothena said it hopes to wrap up the first stage of the Phase I trial and release topline data at the end of 2023.
It’s the latest in a string of collaborations between biotech companies and U.S. pharmacy giants in recent years. The pharmacies say their infrastructure and vast troves of patient data can reach larger, more diverse patient cohorts, helping biotech and pharmaceutical companies to fill trials faster, avoid costly delays and right the pronounced inequities in clinical trial enrollment.
“The industry’s current clinical trials model is antiquated and in crisis,” Walgreens Chief Clinical Trials Officer Ramita Tandon told BioSpace via email, citing an “urgent need to diversify patient populations.”
Diversifying Patient Pools
CVS was the first pharmacy to enter the clinical trials space when it launched its Clinical Trial Services in 2021. Walgreens followed, announcing its Health Research Initiative in the summer of 2022. Rival Walmart launched the Walmart Healthcare Research Institute in October of the same year, and most recently, Kroger opened a clinical trial site network in January 2023.
These pharmacy chains can access more extensive and distributed patient prescription and diagnostic data pools than a typical healthcare provider such as a hospital or clinic. CVS Health, for example, has access to health data from 100 million patients, including claims data from insurance company Aetna. These data can, in turn, serve as the basis for targeted recruitment campaigns, the pharmacies note.
“If a patient has a prescription history or if you are an Aetna member and have claims data, we would access that information in order to outreach to you,” Omar Abdelsamad, executive director of CVS Health Clinical Trial Services, told BioSpace.
Carri Chan, a healthcare operations management professor at Columbia University, agreed.
“Pharmacies certainly have a strategic advantage relative to how clinical trials have historically been run,” she told BioSpace. “Pharmaceutical companies are happy to partner with them to be able to reach a broader population.”
Retail pharmacies charge partners for clinical trial services, but it’s unclear how much. Walgreens Communications Manager Steven Cohen told Biospace the company is “not currently sharing specific revenue information on our partners.” CVS has also not disclosed the profit model for its clinical trial services.
Such services can be invaluable for biotech and pharma companies needing to fill trials promptly. According to a 2020 study, 80% of clinical trials fail to meet the enrollment target and timeline, resulting in a loss of revenue of up to $8 million per day across the industry. A 2018 analysis showed that the single highest reason for trial termination, at 55% of total trials, is low patient enrollment and retention.
Pictured: A CVS pharmacy in Sunnyvale, CA, located inside a Target store / Adobe Stock, Sundry Photography
Pharmacy partnerships could also help companies diversify their historically biased trial populations. A 2021 study found that 5% of Americans participate in clinical trials, and as recently as 2020, 75% of clinical trial participants were white. Starting last December, the passage of the 2023 Omnibus spending bill’s DEPICT Act now requires that entities running clinical trials have a plan to recruit diverse participants.
In addition to aligning with federal regulations, Hideki Garren, chief medical officer at Prothena, told BioSpace that “what’s really important for both Walgreens and us . . . is to make sure that patients enrolled in Alzheimer’s studies are representative of the diverse population of Alzheimer’s patients.”
Retail pharmacies have emphasized their access to rural communities and communities of color as part of their services. Almost half of Walgreens’ pharmacies are located in “socially disadvantaged communities,” Tandon said, making Walgreens well-positioned to diversify enrollment. In October 2022, Walmart announced similar goals.
Although Chan agreed that these partnerships are one way to reach a diverse cohort, she said there are additional important steps to increasing diversity in clinical research.
“We need education in communities so that . . . they know [clinical research] is an option for them,” she said. Patients also need to feel that their health “is the priority when they’re participating in these trials,” she continued, “so it is important to also partner with physicians that can help build that trust.”
Tandon added that Walgreens could leverage the trust between pharmacists and community members to facilitate enrollment. Walmart and CVS have also emphasized the importance of such trust in patient recruitment.
Because these companies have a daily presence in patients’ lives, there is likely truth to this, Chan said. However, clinical trials are often for people with severe diseases who have few other treatment options.
“I think the person who is going to be most important in building that trust is their local physician,” she said.
Although, in some cases, patients’ regular physicians will not always be critical in the clinical trial process, Tandon said, as retail pharmacies can directly collect clinical trial data in their clinics and via telehealth. Pharmacies are often more accessible to patients in some rural areas without access to a hospital or clinic, which can facilitate clinical trial retention, she noted.
A Booming Industry
Some clinical trials are not well suited for the retail pharmacy model. Retail pharmacies can only sometimes recruit for trials that need to be run in inpatient hospitals, for example. But there is the potential for significant financial gain for those that are.
The drug developer typically foots the bill for running the clinical trial, but faster enrollment can allow firms to bring their drugs to market faster—and start earning sooner.
“We’re hoping that this will accelerate enrollment,” Prothena’s Garren said. “Over time, we hope the partnership will evolve to allow us access to a more diverse pool of patients that can go on to our larger, next-stage study.”
As such, pharmacy partnerships have become increasingly common. Abdelsamad said CVS has partnered with “over 25 pharma organizations.” Walgreens announced in its fiscal 2023 fiscal year second-quarter earnings that it has signed its first five clinical trial contracts. And in a statement, Walmart disclosed that it has a wide range of study partners, including clinical research organizations and academic medical centers.
A judge in northern Mexico has ordered the head of the national migration authority charged over a fire late last month that killed 40 migrants at a holding center in the border city of Ciudad Juarez, authorities said on Sunday.
After a lengthy hearing, the court in Ciudad Juarez said there was sufficient evidence to charge Francisco Garduno, head of the National Migration Institute (INM), for unlawful exercise of public office, the Federal Judicial Council said.
Garduno, an ally of President Andres Manuel Lopez Obrador, is not under arrest, but must report to authorities every two weeks. The investigation is set to conclude within four months.
After the announcement, Garduno told reporters he could not comment on details of an ongoing case, and that he would be paying close attention to efforts to provide reparations.
The fire, which authorities say began after one or more of the migrants set alight mattresses as a protest, killed 40 male migrants, most of them from Central America.
A video published online after the incident, apparently of security footage from the holding center during the blaze, showed men kicking on the bars of a locked door as uniformed people walk past without trying to open the door.
The difficulty of obtaining U.S. visas and the economic aftershocks of China’s COVID lockdowns have led to a sharp increase in Chinese nationals presenting at the U.S.-Mexico border. Some of those arrivals have learned from social media websites and applications about how to make the long and dangerous journey, migrants, immigration experts, attorneys and current and former U.S. officials, told Reuters.
“Entering the United States at the southern border is an expensive and risky proposition. But if you have personal or economic reasons to do so, then it is a route is available to you,” said Erik Finch, director of immigration strategy at the Seattle, Washington-based legal tech startup Boundless Immigration and a former State Department official with experience in both China and Mexico. “And I think the fact that you're seeing an increasing number of people utilize that is a product of the general trend and also the fact that other routes have become even more impossible.”
Migrants try to stay warm outside the Sacred Heart Church in El Paso, Texas, Dec. 18, 2022.
Over the course of three weeks photographing and reporting from a remote border stretch in southeastern Texas, Reuters witnessed hundreds of Chinese migrants crossing into the United States and interviewed more than two dozen in Mandarin.
All of those interviewed said they got the idea to take the land route to the United States on social media and drew on influencers, private groups and comments to plan their trips.
About half said they had been small business owners in China, running online stores, a sheep farm and a movie production company.
Some wore crosses and carried Chinese-language bibles, saying they were Christians who felt they could not freely practice their religion at home. China’s constitution guarantees religious freedom, but in recent years critics, including the U.S. government, say Beijing has tightened restrictions on religions seen as a challenge to the authority of the ruling Communist party.
One migrant who asked after speaking with Reuters that their face not be shown said his route took them to Hong Kong, Thailand, Turkey before getting to Ecuador.
“I go to Hong Kong from Hubai first, then to Thailand from Hong Kong by plane, then Turkey from Thailand by plane, then Ecuador and up through South America to America here,” the migrant said.
Migrants heading from South America into Central America face a difficult trek through Panama’s Darien Gap. (VOA)
The migrant said they were relieved when they arrived in the U.S.
“I feel relaxed. And I can breathe more comfortably. It’s rare. The people here, the police here, are very kind. And that’s the America in my head. That’s it. It’s good. It’s great,” the migrant said.
The Chinese Embassy in Washington said in an email that the government opposes illegal migration, which “is an international issue that requires cooperation between countries,” but did not respond to a request for comment on the issue of religious freedom.
Short video app Douyin, owned by TikTok owner ByteDance, is one of the main sources of the Chinese tech giant’s revenue overall, Reuters previously reported. ByteDance, which also owns Xigua Video, didn’t immediately respond to requests for comments.
FILE - People walk past a logo of Bytedance, the China-based company which owns the short video app TikTok, or Douyin, at its office in Beijing, July 7, 2020.
Apprehensions of Chinese nationals at the U.S.-Mexican border reached more than 6,500 in the six months since October 2022, the highest on record and a more than 15-fold increase over the same period a year ago, according to U.S. Customs and Border Protection (CBP) data.
While just a sliver of the hundreds of thousands of migrants arriving at the southwest border, Chinese people were the fastest growing demographic in those six months, CBP data show.
In a March 16 tweet, CBP Chief Border Patrol Agent Gloria Chavez in the Rio Grande Valley sector that includes Fronton said the increase was “creating a strain on our workforce due to the complexities of the language barrier & lengthens the processing.”
Refusal rates among Chinese nationals for the most common U.S. visitor visas reached 80% in fiscal year 2021 and more than 30% in 2022, the two highest years on record, according to State Department data. While U.S. visa issuance globally has mostly recovered to pre-pandemic levels, the number of U.S. visas issued from China last year remained 90% below 2019’s pre-pandemic levels.
FILE - A woman opens her mouth for a swab sample during mass COVID-19 testing, in Beijing, May 3, 2022.
“Because of their zero-COVID policy, the actual impact of COVID extended past the point where a lot of the restrictions and things were more severe than in the rest of the world, and to the point where a lot of 2022 and late 2022 COVID, the COVID situation in China was at its most severe, and therefore that inhibited travel to and from China during that period, even after restrictions had been removed in most of the rest of the world,” said Finch, whose career at the State Department included overseeing various visa section services in China. “So I think just generally speaking, that impact was much amplified there. And it's stands to reason that they are experiencing issues like recovery and visa issuance is just one of the indicators of that.”
Visa holders and border crossers can request U.S. asylum on arrival if they fear persecution at home. Asylum seekers from China won in U.S. immigration court 58% of the time, according to U.S. Justice Department data.
The State Department in an emailed statement said 2021 and 2022 “were not standard years.” It said visa issuances were expected to increase as China “catches up on its passport backlog and air travel resumes after the end of the zero-COVID policy.”
Other Chinese nationals didn’t wait and chose to follow in the steps of others who learned via social media.
Scrolling through their social media feeds, one migrant came across “Baozai,” an internet personality who gained tens of thousands of followers on Douyin, Xigua Video, YouTube and Twitter by posting videos about his migration to the United States. Reuters was not able to independently confirm Baozai's identity and in messages to Reuters, he denied being an influencer and said he was just a migrant.
FILE - Migrants camp between the two border fences as they wait for authorities to request asylum in San Ysidro, California, as seen from Tijuana, Mexico, April 24, 2023.
Baozai’s original account “Baozai adventure the world alone” is shown as “blocked” on Douyin for violating “community self-discipline regulations.”
He is now posting under a new account with the same name on Douyin, sticking to content about his life in the United States.
Douyin did not respond to a request for comment on Baozai.
The travel guide presented on social media matched descriptions given by clients to U.S.-based immigration attorney Xiaosheng Huang, who says he has represented 15 Chinese nationals who have made the trip to the U.S. via Ecuador since last summer.
“They start talking about getting out of the country on the social media, such as Doiyin, the Chinese version of Tik Tok and also Kuaishou and some other platforms. So they exchange the information: how to get out of the country, how to go to Ecuador, from Europe or Macao, Hong Kong,” said Huang, who added that most of his clients were leaving to look for a better life.
At a clinic in Quito one migrant told Reuters they found a group of Chinese migrants who had contacted a local Colombian guide known only by his first name, “Carlos.”
FILE - Aerial view of La Penita indigenous village, Darien province, Panama, May 23, 2019. Migrants cross the border between Colombia and Panama through the Darien Gap on their way to the United States.
The migrant and several others said Carlos and his associates charged around $1,230 per adult and $700 per child to arrange travel and hotels from Ecuador to Panama including a guided trek through the Darien Gap.
Jungle tents and horses were also available for part of the trip for an extra fee, the migrants said.
Nineteen American in-flight refueling aircraft will be stationed at the Powidz Air Base in western Poland. According to the U.S. magazine Stars and Stripes, this is the latest sign that U.S. Armed Forces are shifting combat resources to strengthen NATO’s eastern flank.
The U.S. Air Force command in Europe confirmed that on March 10 of this year “American air tankers began working in their new main location in Poland.”
This was done as part of operation “Copper Arrow,” which demonstrated the efforts of the U.S. military command in Europe to “strengthen security on NATO’s eastern flank through forward deployed and stationed forces.”
“The cooperation of American air tankers with our NATO allies clearly shows how much we value our partnerships and how important it is to increase our interoperability,” said Colonel Timothy Foery, advisor to the U.S. Air Force Reserve Commander.
Foery noted that interoperability is evident when looking “at any photo of a KC-135 refueling a Polish F-16 or a KC-46 refueling a Finnish F/A-18.”
American air tankers KC-135 Stratotanker, KC-10 Extender and the newest in the U.S. Air Force fleet, KC-46 Pegasus, could all be sent to the Powidz Air Base.
The aircraft currently stationed at the Spangdahlem base in Germany, will be transferred to the Powidz air base as Unit 1. As emphasized by the U.S. Air Force leadership, this relocation also demonstrates “the ability of U.S. command to quickly deploy large, credible combat forces and equipment throughout Europe.”
The tankers stationed in Powidz can be used for refueling combat aircraft, including the world’s most advanced fighter jet, the F-35A Lightning II, which extends the range of NATO air missions. Stars and Stripes notes that eight F-35 aircraft of the Dutch Air Force have been stationed in the Malbork air base in Poland for several months.
Since the Russian invasion of Ukraine in February 2022, the presence of U.S. forces in Europe has increased, with the number of U.S. military personnel on the continent growing from 80,000 to 100,000.
U.S. Ambassador to Warsaw Mark Brzezinski recently stated that over 10,000 American soldiers are in Poland.
“The U.S. military’s shift to the east is another example of the United States’ efforts to create a permanent presence in the former Warsaw Pact country, an important member of NATO, which has over 300 miles of border with Ukraine,” said reporter Jennifer Svan in Stars and Stripes.
A month ago, the United States officially established its first permanent base in Poland. The U.S. Army garrison in Poznań, located about 100 kilometers from Powidz, will support the V Corps of the Army, which oversees NATO missions in the east.
