COVID-19 accelerates trend of hospitals acquiring ambulatory surgery centers

 At the end of 2020, Tenet Healthcare made a major pivot to enter the ambulatory surgery center business with a $1.1 billion deal to get up to 45 centers.

The deal, which Tenet made in part after selling off its urgent care business, comes after a rough 2020 for hospitals that saw outpatient revenue plummet due to COVID-19.

But Tenet is not alone in trying to snap up surgery centers, which specialize in elective or same-day outpatient surgical procedures. Community Health Systems, for instance, opened up three new ambulatory surgery centers in 2020.

And it's not just hospitals. Medical device company Stryker launched its own ambulatory surgery center business in July 2020, pointing to the potential to help provide more than $55 billion in healthcare savings per year.

The pandemic has accelerated a growing desire among providers and even some medical technology manufacturers to acquire or get into the surgery center business, experts say. One of the biggest drivers of this shift has been eroding patient volumes at hospitals due to fears of contracting COVID-19.

“Patients were more reluctant now than ever to go into a hospital setting when there is an alternative setting that is really focused on just what the patient is looking for,” said Jim Freund, senior partner at ASCs Inc., which represents more than 250 surgery facilities. “It is focused on strictly their surgical procedures and [patients] encounter a much cleaner and simpler process.”

Hospitals also have pushed more procedures to outpatient settings to preserve operating rooms and other space for treating COVID-19 cases and more emergency procedures.

“The priorities were given to emergency procedures where the health condition of the patient is critical,” according to a report from the firm ResearchandMarkets.com released late last month. “Many suitable procedures were referred to be performed in ambulatory surgical centers.”

The pandemic also had the side effect of opening greater opportunities for patients to accept going to a surgery center for care. The report notes the surgery market is projected to grow by 7.5% through 2029.

But COVID-19 isn’t the only driver of this shift. Commercial payers have generally been in favor of moving outpatient procedures to surgery centers because they involve less costs than a hospital setting.

“The payers are very supportive of this trend because the costs of the same procedure in an ambulatory surgery center might be half of what it might cost in a hospital setting,” said Jonathan Kanarek, vice president and senior credit officer for Moody’s Investor Services, in an interview.

Hospitals have a “gigantic infrastructure that accounts for that reimbursement,” he added. “When you think about the convenience and benefits of saving the healthcare system cost and in some cases ownership opportunities for physicians, those are some of the driving factors behind why ASCs are becoming more of an interest for large hospitals.”

The Centers for Medicare & Medicaid Services has also increased the number of procedures that can be performed at ambulatory surgery centers and get Medicare reimbursement. The agency’s latest outpatient payment rule added 267 additional surgical procedures eligible for reimbursement starting this year.

Freund anticipates the trend for ambulatory surgery center acquisitions is likely to continue well past things get back to normal after the pandemic recedes.

“You have got to have a platform that enables us as a country to significantly reduce our healthcare costs,” he said. “The only way of doing that is to create a much more efficient and viable way to address patient care. It is not feasible to pay two or three times for the same procedure in a setting no more conducive to a good outcome.”

https://www.fiercehealthcare.com/hospitals/covid-19-accelerates-trend-hospitals-acquiring-ambulatory-surgery-centers

3 FDA-approved drugs that combat COVID-19 in lung cells

 Ever since the COVID-19 pandemic was declared over a year ago, researchers around the world have been searching for existing drugs that might be repurposed to fight the virus. A team led by the University of Pennsylvania is adding three candidates to the growing list of potential anti-COVID-19 candidates—medicines they believe are particularly promising because they appear to inhibit the virus in respiratory cells.

Scientists at Penn’s Perelman School of Medicine screened existing drugs in several cell types, including those that line human airways, to see whether they could inhibit SARS-CoV-2, the virus that causes COVID-19.  Nine were particularly effective in respiratory cells, three of which are FDA-approved: Pfizer’s lung cancer drug Vizimpro (dacomitinib), the antibiotic salinomycin and cyclosporine, which is used to prevent rejection in patients receiving organ transplants. They published their findings in the journal Cell Reports.

The team started with 3,059 compounds, 1,000 of which are FDA-approved drugs. They tested them for their potential to inhibit SARS-CoV-2 without causing toxicity. The scientists first screened all of them in kidney cells from monkeys and liver cells from people, and found 23 that were effective.

They tested the 23 finalists in respiratory cells and found that nine were active in fighting the virus. This suggests that SARS-CoV-2 uses a variety of mechanisms to invade different types of cells, the researchers suggested. Some drugs may be able to interrupt that mechanism in kidney and liver cells, but not in lung cells.

The researchers went on to demonstrate that cyclosporine worked against COVID in all of the cell types tested by exploiting two different mechanisms. It inhibits cyclophilins, which are enzymes the virus needs to thrive, while also tamping down the inflammatory response that can be deadly in some patients.

The Penn results come close on the heels of another drug-repurposing study, this one from Sanford Burnham Prebys Medical Discovery Institute and the University of Hong Kong. Researchers from those institutions reported last month that the leprosy drug clofazimine was effective in hamster models of COVID-19. They launched a phase 2 study testing a combination of clofazimine and interferon beta in hospitalized patients.

Other candidates for repurposing that have been proposed by different research groups include chemotherapy drug pralatrexate, sleep aid melatonin and heart failure treatment Corlanor.

The potential benefits of cyclosporine in fighting COVID-19 have already led to clinical trials, including one at Penn. Researchers there are testing the drug in hospitalized patients to see whether it can prevent the immune overreaction known as cytokine release syndrome.

The Penn researchers included two drugs in their newly reported screening study that have attracted a lot of attention during the pandemic: anti-malarial treatment hydroxychloroquine, which former President Donald Trump hyped early on, and Gilead’s Veklury (remdesivir), approved last October to treat the virus.

The results? Veklury was effective in fighting the virus in respiratory cells. Hydroxychloroquine, on the other hand, was not.

https://www.fiercebiotech.com/research/pfizer-s-vizimpro-among-three-fda-approved-drugs-combat-covid-lung-cells-report

Rain Therapeutics tees up $100M IPO to push ex-Daiichi cancer drug into phase 3

 Rain Therapeutics catapulted itself toward pivotal development in September when it picked up a cancer drug from Daiichi Sankyo. Now, the California biotech aims to raise up to $100 million in its Wall Street debut, which will fuel a phase 3 study for the asset in liposarcoma, a cancer that occurs in the body’s fat cells, and a phase 2 study in solid tumors.

The company plans to start both trials in the second half of this year, according to a securities filing. The IPO proceeds will also support a phase 2 study of the drug in intimal sarcoma in early 2022.

The treatment, known as RAIN-32 or milademetan, inhibits MDM2, a gene that drives many cancers. Rain licensed the drug from Daiichi based on phase 1 data showing “meaningful antitumor activity” in a subtype of liposarcoma and other solid tumors in which the MDM2 gene is amplified. At the time, the company also revealed a $63 million series B round to fuel the drug's journey to a pivotal trial.

MDM2 is not a new target, but it has been an elusive one. In 1996, the publication of the structure of the MDM2-P53 interaction prompted researchers to seek new small molecules that could disrupt the interaction of the two proteins. Several companies, such as Amgen, Merck, Novartis, Roche and Sanofi, all started clinical trials in the space, but most of those efforts have withered over the years.

Some companies, including Daiichi, pressed on with their programs. The Japanese pharma sidestepped the side effects of RAIN-32, then called DS-3032, on platelets by switching from continuous to intermittent dosing.  

Besides its MDM2 inhibitor, Rain is also developing a synthetic lethality program licensed from Drexel University in July 2020. Synthetic lethality is the interaction between two genes that causes cell death when both are activated. In cancer cells, one of these genes is inactivated by mutation; the other will be inactivated by a drug. Rain’s treatment inhibits RAD52 to bring about synthetic lethality in the DNA damage repair pathway, an approach the company thinks could work in breast, ovarian and prostate cancers, according to the securities filing.

Rain hopes to pick a lead candidate for clinical development in 2022, with early data expected in the second half of that year, the company said in the filing.

https://www.fiercebiotech.com/biotech/rain-therapeutics-tees-up-100m-ipo-to-push-ex-daiichi-cancer-drug-into-phase-3

England pitches free, nationwide COVID-19 testing twice per week

 As it works to get more shots into arms across the country, the U.K. government announced that it would make routine, rapid COVID-19 testing available for free to everyone in England.

The plan includes two tests per week starting April 9, with results expected at home within 30 minutes, regardless of whether a person is showing symptoms. The plan is part of the country’s road map to lift wider lockdowns by the end of June, depending on the continuing rollout of vaccines and lower rates of infections and hospitalizations.

The announcement also comes as the country considers implementing COVID-19 passports as a requirement for entering large public gatherings, such as soccer matches and concerts, according to the Associated Press. Information on the passport would include testing status and whether the holder has received the vaccine or whether they’ve recovered after a coronavirus infection in the previous six months.

“Around one in three people who have COVID-19 show no symptoms, and as we reopen society and resume parts of life we have all dearly missed, regular rapid testing is going to be fundamental in helping us quickly spot positive cases and squash any outbreaks,” Matt Hancock, secretary for health and social care, said in a government release. 

However, the accuracy of lateral flow diagnostic tests has been called into question.

A recent Cochrane review found that rapid, point-of-care tests, including antigen diagnostics, can vary in sensitivity over time and potentially be the most accurate during the first few days of an infection while viral loads are highest.

Because of that variability, the tests could be useful as a way to confirm active cases where molecular lab tests are unavailable, according to the researchers, but they said they could find virtually no evidence confirming their effectiveness at screening large numbers of people on a regular basis.

Meanwhile, across 64 studies encompassing more than 24,000 samples, antigen tests only correctly identified 58% of hidden COVID-19 infections among people who showed no symptoms.

“The effectiveness of mass screening using these tests will only be established through outcome studies, such as cluster‐randomized community trials,” the researchers wrote.

In addition, while the U.K. government said its tests had a rate of less than one false-positive result among every 1,000 performed, when multiplied at twice per week across England’s population of more than 55 million people, incorrect readings could still number in the tens of thousands.

"Mass testing is a scandalous waste of money," Allyson Pollock, professor of public health at Newcastle University, told the BBC. "When the prevalence rate of coronavirus falls as low as it is at the moment, then an increasing proportion of cases are likely to be false positives meaning that cases and contacts will self isolate unnecessarily."

The U.K. has previously spent more than £800 million, or more than $1.1 billion, to help set up rapid testing programs capable of screening millions of people per day, including through a pilot project in the city of Liverpool—but the tests themselves could give high rates of wrong results, according to a January report from the Guardian.

That money includes the purchase of more than 380 million rapid, lateral flow tests from Innova Medical Group. An analysis by researchers at the University of Oxford found those tests were more accurate depending on who was using them. 

When testing was performed by laboratory specialists, an average of 79.2% of positive cases were correctly identified—but that number dropped when tests were used by healthcare workers in real-world settings and among people swabbing themselves at home, down to 73% and 57.5%, respectively.

Writing in the British Medical Journal, contributor Ingrid Torjesen said lateral flow tests such as Innova’s should be used under strict parameters—including for people who cannot work from home, such as healthcare providers, teachers and students. The tests should not be used to clear people who have been exposed to a confirmed case or to shorten the amount of time spent in quarantine, unless used alongside a gold-standard PCR diagnostic, Torjesen said.

https://www.fiercebiotech.com/medtech/england-pitches-free-nationwide-covid-19-testing-twice-per-week

Acadia takes shot at FDA, alleging sudden about-face in costly Nuplazid rejection

 “Very disappointing” and “strongly disagree.” Those are the words Acadia Pharmaceuticals had for an FDA rejection of its label expansion for Nuplazid, criticizing the agency for suddenly changing its mind despite a prior agreement that was repeatedly reinforced over four years of communication.

The FDA issued a complete response letter over Nuplazid for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP), the California company said Monday. Its stock price slid roughly 17% on the news Monday morning.

The rejection came after the FDA surprisingly called for a halt to an expected discussion of labeling and post-marketing requirements around a potential approval merely a month before the decision date, citing deficiencies in Acadia’s filing. At that point, industry watchers were simply expecting a delay in review.

With the rebuff, now we know just how irreconcilable the company’s and the FDA’s positions are. And by Acadia CEO Steve Davis’ account, the FDA’s stance is very new and represents a clear shift in its thinking around not only Nuplazid itself, but also the DRP indication.

The FDA’s division of psychiatry took issue with the design of the pivotal phase 3 Harmony trial Acadia used to support Nuplazid’s new application. Specifically, it said the trial wasn’t enough to prove the drug’s effectiveness because of a lack of statistical significance in some patient subgroups—including those with Alzheimer’s disease—and the small numbers of patients with certain less common dementia subtypes.

But Davis said the trial was never designed to detect differences in individual patient subgroups and was not powered for statistical analysis for different disease subtypes. Basically, to hear him tell it, the FDA previously agreed that the company could use the big DRP umbrellas to include different dementia patients in a single analysis. DRP refers to behavioral changes, namely symptoms, while various dementia types may have different underlying pathological changes.

The company and the FDA reviewers agreed to the phase 3 trial design at different points during the process, Davis said, including at the end of the phase 2 meeting, at the Harmony trial protocol submission, at the pre-sNDA meeting and at the time of the application submission.

Davis repeated “they did not say” five times during a Monday conference call to stress that Nuplazid met all prespecified standards agreed upon by the FDA, and that the current rejection was only the result of the FDA abruptly changing its standards. When Nuplazid posted that phase 3 win in December 2019, SVB Leerink analyst Marc Goodman put the DRP indication’s peak sales at $2.5 billion.

While the company “strongly” disagrees with the FDA review process, it considers the FDA’s understanding of DRP, as reflected in the CRL, even more troublesome.

“The subtypes of dementia are often mixed and can be very difficult to distinguish in the clinical setting,” Acadia President Serge Stankovic explained on the call. “Furthermore, these diseases are overlapped pathologically, and the rates of overlapping pathology increases with age.”

Translation? It could be difficult to group patients according to disease subgroups anyway. The Harmony trial enrolled different subtypes in line with the actual prevalence of those in the real world, according to Stankovi.

While DRP may be caused by different diseases, the symptoms are treated similarly, he said. “Therefore, the approach to look at the measure broadly when developing a symptom-based treatment makes sense,” he added.

Stankovi noted that there have been significant changes in leadership at the division of psychiatry and the FDA office of neuroscience, but also said the team the company’s been working with regarding this application has been the same through the review process.

Acadia will now request a Type A meeting with the FDA, which will allow the company to better understand the agency's rationale for the decision and bring its argument forward, Stankovi said.

Because the Harmony trial is simply not powered to analyze subgroup performance, the company will be forced to conduct another trial if the agency insists on its stance. But Davis appeared to be averse to that idea, saying the drugmaker remains confident in Harmony supporting a DRP indication.

https://www.fiercepharma.com/marketing/furious-acadia-takes-shot-at-fda-s-sudden-about-face-pricey-nuplazid-rejection

AstraZeneca COVID vax production move from Emergent plant won't hurt dose output: Feds

 The U.S. government’s removal of AstraZeneca PLC’s COVID-19 shot production from Emergent BioSolutions Inc’s Baltimore manufacturing facility does not suggest it has any concerns about the vaccine’s safety or effectiveness and will not impact its output of doses, a White House official said on Monday.

The U.S. Department of Health and Human Services ordered Johnson & Johnson to take charge of production at Emergent and for Emergent to stop making AstraZeneca’s shots after the contract manufacturer made an error that ruined 15 million J&J COVID-19 vaccine doses.

“This is a decision that HHS made with Johnson & Johnson and AstraZeneca in complete collaboration,” White House COVID-19 adviser Andy Slavitt told reporters during a press conference.

https://www.reuters.com/article/us-health-coronavirus-usa-whitehouse/white-houses-removal-of-astrazeneca-covid-19-shot-production-from-emergent-plant-wont-affect-its-dose-output-official-idUSKBN2BS1GA

Why Nanox Stock Is Skyrocketing

 Shares of Nano-X Imaging (NASDAQ:NNOX) (Nanox) were skyrocketing 28.7% higher as of 10:34 a.m. EDT on Monday. The huge jump came after the company announced that the U.S. Food and Drug Administration (FDA) awarded 510(k) clearance to its single-source Nanox.ARC digital X-ray technology.

FDA clearance means that Nanox has a green light to market its game-changing X-ray system. Nanox CEO Ran Poliakine said that this was "a significant step forward" for his company.

Nanox's X-ray devices are fully digital and eliminate the need for conventional X-ray tubes. This means that the company's systems are smaller and require much less energy to operate. They're also a lot less expensive than current X-ray devices.

These advantages could be huge as Nanox begins to market its technology. Poliakine said, "We believe we are well positioned to achieve our goal of democratizing medical imaging and expanding the market to the roughly two-thirds of the world's population who currently have limited or no meaningful access to imaging or the preventative screening that it offers."

Nanox expects to begin shipping its single-source systems in the fourth quarter of 2021 and the first quarter of 2022. The company thinks that it will be able to place 15,000 initial systems by the end of 2024. Another key catalyst for the life sciences stock could also be on the way: Nanox hopes to submit for FDA clearance for its multisource Nanox.ARC system this year.

https://www.fool.com/investing/2021/04/05/why-nanox-stock-is-skyrocketing-today/