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Wednesday, September 30, 2020

One Medical collaborates to enter Houston

1Life Healthcare's (NASDAQ:ONEM) One Medical partners with Houston Methodist hospital to deliver seamless coordinated care.

The partnership, which comes as a part of One Medical’s planned target to enter Houston, Texas, will provide Houston area residents access to its membership-based primary care model that offers on-demand telehealth services as well as in-person care.

"Working with one of the nation’s premier health systems in one of the nation’s largest cities further advances One Medical’s mission of transforming health care for all through a human-centered and technology-powered model," says Amir Dan Rubin, Chair & CEO at One Medical.

See the company's Q3 outlook, here.

https://seekingalpha.com/news/3618601-one-medical-collaborates-to-enter-houston

Provention Bio advances U.S. marketing application for Type 1 diabetes med

Provention Bio (NASDAQ:PRVB) reports that it has filed the clinical module of its rolling U.S. marketing application for teplizumab (PRV-031) for the delay or prevention of type 1 diabetes (T1D) in at-risk people.

It initiated the process in April with the submission of the nonclinical module. It expects to file the chemistry, manufacturing and controls (CMC) module in Q4.

A Phase 3 study, PROTECT, launched in April. Its objective is to assess teplizumab's effect on slowing the loss/preserving the function of beta cells in children and adolescents recently diagnosed (in the previous eight weeks) with T1D.

Teplizumab is a CD3-targeted monoclonal antibody designed to slow the loss of insulin-producing beta cells in the pancreas while preserving beta cell function as measured by C-peptide.

https://seekingalpha.com/news/3618602-provention-bio-advances-u-s-marketing-application-for-t1d-med-teplizumab

Moderna CEO Says Vaccine Won't Be Ready Before Election Day

In an interview with the FT, Moderna CEO Stephane Bancel acknowledged that his company wouldn't be able to apply for emergency authorization of its vaccine candidate before election day. The news - Bancel had left open the possibility that the vaccine would be ready by the end of October - deals another blow to Trump's hopes of producing a vaccine before the election, something that was on display during last night's debate.

Bancel said the company wouldn't be ready to apply for FDA approval until Nov. 25 at the earliest. Approval to distribute the vaccine to all segments of the population, beyond just health care workers and the most vulnerable, may not arrive until the spring.

"November 25 is the time we will have enough safety data to be able to put into an EUA [emergency use authorisation] file that we would send to the FDA — assuming that the safety data is good, ie a vaccine is deemed to be safe," Bancel said at a US Pharma and Biotech conference hosted by the FT.

Here's some more on the timeline for the Moderna vaccine (which, remember, was subsidized by nearly $1 billion in federal taxpayer dollars).

Mr Bancel said Moderna would not be ready to file an application to serve the whole population until at least late January, making March the earliest he thought it could be approved. “I think a late [first quarter], early [second quarter] approval, is a reasonable timeline, based on what we know from our vaccine.” He added it would not be possible for Moderna to file for a limited emergency authorisation before November 1, due to guidelines agreed with the FDA that require at least half of trial participants to have undergone two months of screening following their final injection. Moderna injected the 15,000th participant in its 30,000-person trial last Friday, he said, making November 25 the earliest it could complete the two-month screening.

The FT noted that President Trump's best hope for a pre-election day announcement will most likely come from Pfizer. CEO Albert Bourla has said the company will have "an answer" on the vaccine it's developing with Germany's BioNTech by the end of October.

https://www.zerohedge.com/geopolitical/new-research-hints-lower-herd-immunity-threshold-eu-approves-new-rapid-covid-19-test

Pandemic Drives Demand for Self-managed Abortions

Requests for self-managed abortion via a telemedicine service increased by 27% from March 20, 2020, to April 11, 2020, in the United States in the wake of widespread lockdowns and shelter-in-place directives because of the COVID-19 pandemic, based on data from a provider of such services.

Access to abortion care is challenging in many areas under ordinary circumstances, but the disruption of the COVID-19 pandemic led to many states suspending or limiting in-clinic services, wrote Abigail R.A. Aiken, MD, PhD, of the University of Texas at Austin and colleagues.

"As a result, people may increasingly be seeking self-managed abortion outside the formal health care system," they said.

In a research letter published in Obstetrics & Gynecology, the investigators reviewed request data from Aid Access, a telemedicine service that provides medication for abortion at up to 10 weeks' gestation for users who complete an online consultation form. They also collected data on the implementation and scope of COVID-19–related abortion restrictions by state.

The analysis included all 49,935 requests made between January 1, 2019, and April 11, 2020.

Overall, the rate of requests for self-managed medical abortions increased significantly, by 27%, during the period from March 20, 2020, to April 11, 2020, which reflected the average period after clinic restrictions or closures at the state level. A total of 11 states showed individually significant increases in requests for self-managed medical abortions, with the highest of 94% in Texas and the lowest of 22% in Ohio. In these 11 states, the median time spent at home was 5% higher than in states without significant increases in requests for self-managed medical abortions during the same period. These states also had "particularly high COVID-19 rates or more severe COVID-19–related restrictions on in-clinic abortion access," the researchers noted.

Patients Want Alternatives to In-Person Care

"Our results may reflect two distinct phenomena," Aiken and associates wrote. "First, more people may be seeking abortion through all channels, whether due to COVID-19 risks during pregnancy, reduced access to prenatal care, or the pandemic-related economic downturn. Second, there may be shift in demand from in-clinic to self-managed abortion during the pandemic, possibly owing to fear of infection during in-person care or inability to get to a clinic because of childcare and transit disruptions," they explained.

The study findings were limited by the inability to measure all options for women to achieve self-managed abortions and a lack of power to detect changes in states with low request numbers or where restrictions were implemented at later dates, the researchers noted. However, the results suggest that telemedicine services for medication abortion should be a policy priority because patients may continue to seek alternatives while in-clinic services remain restricted, they said.

In fact, "the World Health Organization recommends telemedicine and self-management abortion-care models during the pandemic, and the United Kingdom has temporarily implemented fully remote provision of abortion medications," the researchers wrote. However, similar strategies in the United States "would depend on sustained changes to the U.S. Food and Drug Administration's Risk Evaluation and Mitigation Strategy, which requires patients to collect mifepristone at a hospital or medical facility, as well as changes to state-specific laws that prohibit remote provider consultation," Aiken and associates concluded.

Lift Barriers to Protect Patients

"This important and timely article assesses the association between the disruptions of the coronavirus pandemic and online requests for telemedicine abortion," Eve Espey, MD, of the University of New Mexico, Albuquerque, said in an interview.

"As background, state abortion restrictions have increased exponentially over the last decade, while research over the same time period has demonstrated the safety of telemedicine abortion – a form of self-managed abortion – with no in-person visit for appropriate candidates," she said.

"Enter the coronavirus pandemic with safety concerns related to in-person medical visits and certain states leveraging the opportunity to enact even more stringent abortion restrictions. Unsurprisingly, the result, as documented in this excellent research report, is a significant increase in requests for telemedicine abortion in many states, particularly the most restrictive, from the single online service in the United States, Aid Access," said Espey.

"Barriers to self-managed abortion include the [FDA] Risk Evaluation and Mitigation Strategy for mifepristone, a set of unnecessary restrictions requiring that providers meet certain qualifications and dispense the medication only in a clinic, office, or hospital," she said. "The REMS precludes the use of telemedicine abortion; Aid Access and the FDA are in legal proceedings," she noted.

"Most recently, the [American Civil Liberties Union] sued the FDA on behalf of a coalition of medical experts led by [American College of Obstetricians and Gynecologists] to suspend the REMS for mifepristone during the COVID public health emergency, to allow patients to receive the medications for early abortion without a visit to a health care provider," Espey said. "Fortunately, a federal district court required the temporary suspension of the in-person dispensing restriction. Although this is a great step to improve abortion access during the pandemic, a permanent removal of the REMS would pave the way for ongoing safe, effective, and patient-centered early abortion care," noted Espey, who was asked to comment on the research letter.

Aiken disclosed serving as a consultant for Agile Therapeutics, and a coauthor is the founder and director of Aid Access. Espey had no financial conflicts to disclose. She is a member of the Ob.Gyn. News Editorial Advisory Board.

SOURCE: Aiken ARA et al. Obstet Gynecol. 2020 Jul 21. doi: 10.1097/AOG.0000000000004081.

https://www.medscape.com/viewarticle/938328

Non-COVID Hospital Admissions Plunged, Still Down in Pandemic

Acute medical hospital admissions for non-COVID-19 patients fell sharply with the spread of COVID-19 in March and April 2020, according to an analysis of more than 1 million admissions in a nationally representative hospitalist group.

Specifically, non-COVID admissions were down 42.8% at the height of the pandemic (95% CI, −43.2 to −42.4), report John Birkmeyer, MD, chief clinical officer for Sound Physicians in Tacoma, Washington, and colleagues. Admissions increased in June and July, but were still down by 15.9% (95% CI, −16.5 to −15.4) relative to baseline.

As of a few weeks ago, non-COVID admissions remained down by 14%, Birkmeyer said in an interview with Medscape Medical News.

When extrapolated to all hospital admissions, the decline represents "about 2.5 million fewer Americans being admitted to the hospital for acute medical illness every year in the US," Birkmeyer said.

Birkmeyer and colleagues published their findings online September 24 in Health Affairs.

Declines Vary by Region, Population

Non-COVID-19 admissions were greatest among patients residing in Hispanic neighborhoods, with a 32% drop from baseline for all conditions.

When stratified by medical condition, the authors found that admissions remain well below normal levels for patients with pneumonia (−44.1%), chronic obstructive pulmonary disease/asthma (−40.1%), sepsis (−25.1%), urinary tract infection (−24.3%), and acute ST-elevation myocardial infarction, (−22.2%). By contrast, non-COVID admissions for alcohol-related conditions, pancreatitis, and diabetes had returned to baseline levels by June and July.

Admissions declined in all patient groups defined by age, race and ethnicity, Medicaid and self-pay status, and income, according to the study.

The authors suggest three plausible explanations for the declines. First, people are too afraid to come in for care. While Birkmeyer acknowledged that certainly was the case at the beginning of the pandemic, he said that wouldn't completely explain the persistence of the low numbers now.

A second possibility is that hospitals have found much of the care can be done outside the hospital with telemedicine, for example.

But Birkmeyer says he believes the main driver is fewer people are getting sick.

He explains that air quality is better with fewer people traveling, which may reduce non-COVID admissions, especially respiratory admissions; social distancing, stay-at home directives, and mask wearing may be containing spread of many diseases beyond COVID-19; and a slower pace of life may be reducing inflammation from stress that has been associated with cardiovascular events.

Birkmeyer said their study is consistent with data coming from the southern hemisphere, where hospitals have already experienced a pandemic winter.

"For the first time ever, there was essentially no flu season," Birkmeyer said, "which basically is consistent with the idea that measures put in place to battle COVID are having a salutary effect in preventing patients from getting flu and other illnesses."

However, Birkmeyer said, "There's no doubt there are pockets of patients who likely need to be in the hospital but aren't."

Andrew Oseran, MD, a cardiology fellow at Massachusetts General Hospital in Boston who published a study in July on trends of urgent hospital admissions in the COVID-19 era, told Medscape Medical News he's not convinced the main driver of reduced admissions is that people are less sick, but thinks it is part of the equation.

He points out the study also shows a decline in admissions for urinary tract infections and heart attacks and stroke, conditions for which care would not be less necessary during the pandemic.

Oseran also said he believes the fear of coming into a hospital remains substantial.

"This pandemic is surging in different parts of the country at different times, so we may see behaviors changing depending on where the pandemic is taking place," he said.

Particularly concerning, Oseran said, are the differences in how the decrease affected people in several demographics, primarily Black and Hispanic populations.

"The folks most at risk for getting COVID-19 and getting sick are also the ones who suffer the collateral effects," such as not coming to the hospital for non-COVID care, he said.

For his part, Birkmeyer said an interesting aspect of their findings is what was not found. For example, the drop in admissions did not seem to be dependent on whether specific hospitals had heavy COVID-19 caseloads.

Even hospitals minimally affected by COVID-19 saw a drop of 39.5% in non-COVID admissions. Those most affected by COVID-19 saw a decrease of 50% in non-COVID admissions.

Inpatient Mortality Rates Largely Unchanged

In addition, Birkmeyer notes that the findings did not uphold the researchers' hypothesis on how the non-COVID inpatients fared in the hospital.

The team had originally hypothesized that mortality would be increased for non-COVID patients for two reasons: that hospitals' attention would be taken up with COVID-19 patients and thus care would suffer elsewhere, and that it would be the sicker patients who came in, thus raising odds of mortality.

Neither scenario proved true, with a couple of exceptions, he said. Higher mortality rates were seen among non-COVID Hispanic patients and the poor at the height of the pandemic.

Birkmeyer said, "Public health authorities should continue to monitor for subgroups that are being undertreated, but we shouldn't assume that all of the 'missing' hospitalized patients are patients who need to be there."

This study was supported by a grant from the National Institute on Aging. Birkmeyer has an equity interest as an officer for Sound Physicians. Oseran has disclosed no relevant financial relationships.

Health Aff. Published online September 24, 2020. Full text

https://www.medscape.com/viewarticle/938327

Bayer to cut more than 1.5 billion euros in costs

German drugs company Bayer AG BAYGn.DE announced plans on Wednesday for more than 1.5 billion euros ($1.76 billion)of cost cuts as of 2024, on top of savings announced in 2018, as it battles with a slowdown in the agricultural market.

The cash flow freed up would be allocated for investments in further innovation, profitable growth opportunities and debt reduction. It said the restructuring, which may also lead to extra job cuts, is in the early stages of planning.

Bayer said it expects 2021 sales to be about the same as in 2020, despite significant headwinds from COVID-19, especially in the agricultural market, and said it expects core earnings per share to be slightly lower at constant exchange rates.

https://www.reuters.com/article/us-bayer-restructuring/bayer-to-cut-more-than-1-5-billion-euros-in-costs-idUSKBN26L3D8

Vesper Healthcare Acquisition prices $400M IPO

Vesper Healthcare Acquisition (VSPR) has priced its initial public offering of 40M units at $10/unit.

The units kicks-off trading today on the Nasdaq Capital Market.

Each unit consists of one share of the Company's Class A common stock and one-third of one redeemable warrant, each whole warrant exercisable to purchase one share of Class A common stock at $11.50.

The company to target pharmaceutical and healthcare sectors.

Underwriters over-allotment is an additional 6M units.

Press release

https://seekingalpha.com/news/3618517-vesper-healthcare-acquisition-prices-400m-ipo