Biotech week ahead, March 7

 Biotech stocks reversed course in the week ending March 4, as the Ukrainian crisis weighed down on the broader market as well as the sector. The iShares Biotechnology ETF (NASDAQ: IBB) retreated in four out of five sessions of the week.

Clinical trial updates and FDA-related news moved stocks, while earnings news flow tapered off.

NuCana plc. (NASDAQ: NCNA) was among the worst decliners of the week, with the stock reacting to the stalling of the company's Phase 3 biliary tract cancer study.

SAB Biotherapeutics, Inc. (NASDAQ: SABS) shares also came under pressure after the National Institutes of Health pulled the plug on a Phase study of the company's SAB-185 in COVID-19 patients. Celayad Oncology SA (NASDAQ: CYAD) shares plunged after the company said it is pulling the plug on an early-stage biliary tract cancer study.

FDA decisions scheduled for the week were mixed, with Amryt Pharma plc (NASDAQ: AMYT) and Gilead Sciences, Inc. (NASDAQ: GILD) failing to get their investigational drugs across the finish line. On the other hand, Legend Biotech Corporation (NASDAQ: LEGN) and CTI BioPharma Corp. (NASDAQ: CTIC) received approvals for their treatments for multiple myeloma and myelofibrosis, respectively.

Here are the key catalysts that can impact trading in biopharma stocks in the unfolding week:

Conferences

Cowen 42nd Annual Health Care Conference (virtual): March 7-9

Earnings

The earnings list presented is not comprehensive. Click here to access Benzinga's earnings calendar for the complete schedule.

Monday

Eagle Pharmaceuticals, Inc. (NASDAQ: EGRX) (before the market open)

DURECT Corporation (NASDAQ: DRRX) (after the close)

Tuesday

Neuronetics, Inc. (NASDAQ: STIM) (before the market open)

InspireMD, Inc. (NASDAQ: NSPR) (before the market open)

Matinas BioPharma Holdings, Inc. (NYSE: MTNB) (before the market open)

Harvard Bioscience, Inc. (NASDAQ: HBIO) (before the market open)

Aquestive Therapeutics, Inc. (NASDAQ: AQST) (after the close)

Accelerate Diagnostics, Inc. (NASDAQ: AXDX) (after the close)

Anika Therapeutics, Inc. (NASDAQ: ANIK) (after the close)

Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) (after the close)

Evoke Pharma, Inc. (NASDAQ: EVOK) (after the close)

Wednesday

Selecta Biosciences, Inc. (NASDAQ: SELB) (before the market open)

Assertio Holdings, Inc. (NASDAQ: ASRT) (before the market open)

Acorda Therapeutics, Inc. (NASDAQ: ACOR) (after the close)

Histogen Inc. (NASDAQ: HSTO) (after the close)

Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) (after the close)

Thursday

Tecogen Inc. (NASDAQ: TGEN) (before the market open)

TherapeuticsMD, Inc. (NASDAQ: TXMD) (before the market open)

Lineage Cell Therapeutics, Inc. (NYSE: LCTX) (before the market open)

Genocea Biosciences, Inc. (NASDAQ: GNCA) (before the market open)

BioXcel Therapeutics, Inc. (NASDAQ: BTAI) (before the market open)

Autolus Therapeutics plc (NASDAQ: AUTL) (before the market open)

Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) (after the close)

Achieve Life Sciences, Inc. (NASDAQ: ACHV) (after the close)

Clearside Biomedical, Inc. (NASDAQ: CLSD) (after the close)

Eiger BioPharmaceuticals, Inc. (NASDAQ: EIGR) (after the close)

Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS) (after the close)

OncoCyte Corporation (NASDAQ: OCX) (after the close)

Geron Corporation (NASDAQ: GERN) (after the close)

Lantern Pharma Inc. (NASDAQ: LTRN) (after the close)

Zumiez Inc. (NASDAQ: ZUMZ) (after the close)

Viridian Therapeutics, Inc. (NASDAQ: VRDN) (after the close)

Neovasc Inc. (NASDAQ: NVCN) (after the close)

Regulus Therapeutics Inc. (NASDAQ: RGLS) (after the close)

Lumos Pharma, Inc. (NASDAQ: LUMO) (after the close)

Salarius Pharmaceuticals, Inc. (NASDAQ: SLRX) (after the close)

Friday

PLx Pharma Inc. (NASDAQ: PLXP) (before the market open)

IPOs

IPO Quiet Period Expiry

TC Biopharm (Holdings) Plc (NASDAQ: TCBP)

https://www.msn.com/en-us/money/news/the-week-ahead-in-biotech-march-6-12-quiet-week-on-tap-with-earnings-season-reaching-it-final-leg/ar-AAUGXfV

Disinfecting COVID-19 with a plasma filter

 A research team led by Dr. Seunghun Lee of the Department of Nano-Bio Convergence at the Korea Institute of Materials Science (KIMS) developed a plasma air conditioning technology that can inactivate the SARS-CoV-2 in real time. The technology verified the real-time virus inactivation in an aerosol which is main infection vector of the COVID-19.

The plasma filter developed by the research team uses dielectric filter discharge technology to inactivate the coronavirus aerosol with reactive oxygen species. The research team confirmed that the coronavirus was inactivated by about 99.8% or more immediately after passing through the plasma filter. The plasma filter uses catalyst materials for ozone removal that can be applied to air purifiers and air conditioning equipment. In addition, the research team installed a catalyst at the rear end of the plasma filter to maintain the concentration of emitted ozone below 0.05 ppm. The catalyst solved the ozone emission problem, a weakness of plasma technology, and satisfied various standards related to ozone emission.

Previous experiments were conducted in a liquid form in a petri dish, not in the form of an aerosol. Due to the dangers of high-risk viral aerosol experiments, it has been difficult to directly verify the inactivation of aerosolized coronavirus.

The research team developed an experimental device that can directly evaluate the virus inactivation performance by spraying the aerosol of the coronavirus culture medium. The research on the evaluation of plasma filter performance has been submitted to international journals. If the technology is applied to air purifiers and air conditioning equipment of medical facilities and multi-use facilities, it could suppress the spread of infectious diseases.

Air sterilization device manufactured by a company received technology transfer. Credit: Korea Institute of Materials Science (KIMS)

Dr. Seunghun Lee, the lead researcher and a senior researcher at KIMS, said, "Developing various disinfection materials and parts is important, but there are insufficient empirical studies using aerosols of a highly pathogenic virus. By utilizing the inactivation data of the coronavirus aerosol obtained in this study and predicting the performance of bio-aerosol removal in a virtual space using digital twin, we plan to conduct follow-up studies to calculate the processing time and optimal arrangement required for disinfection of multi-use facilities."

https://medicalxpress.com/news/2022-03-disinfecting-covid-plasma-filter.html

'A question of time': experts fear Balkans measles outbreak

 Despite vaccinating her first child, Vanja drew a line when it came time to inoculate her second and decided he would not be receiving the measles shot.

The 44-year-old psychologist living in Montenegro's capital Podgorica gave a host of reasons why she changed her mind, all after binging on a deluge of information shared in an online group she belongs to.

"I don't trust the vaccination system. We lack information and education," Vanja told AFP, asking that her surname be withheld.

"I feel great responsibility and it wasn't a simple and easy decision to make."

Vanja's position is increasingly common in Montenegro which has the lowest measles vaccine uptake globally with just 23.8 percent of infants inoculated in 2020 with the first of two shots, according to World Health Organization data.

The dramatic decline in inoculation rates has public health experts bracing for an imminent measles outbreak in Montenegro and its nearby Balkan neighbours where vaccination uptake has also plummeted, largely due to a rise in misinformation, especially during the COVID-19 pandemic.

"The risk of a measles outbreak is high," Dragan Jankovic, an immunisation official with the WHO, told AFP.

"Importation of the measles virus is only a question of time... as soon as it is imported into a susceptible population, an outbreak will start."

In neighbouring North Macedonia, 63 percent of children were inoculated with the first shot of the combined measles, mumps and rubella (MMR) vaccine, while in Serbia 78 percent have had the jab.

'Perfect storm'

Experts say a uptake of at least 95 percent of the two-dose jab is needed to avoid the spread of measles, a highly contagious airborne disease that can be fatal.

The virus can cause complications that include blindness, brain swelling and pneumonia, and unvaccinated children are at the highest risk of developing serious cases—including death.

But for decades, there has been an aversion to the MMR shot, rooted in rampant misinformation tied to a widely debunked 1998 study that suggested a link between autism and the vaccine.

The United Nations has repeatedly warned that a "perfect storm" was brewing for new outbreaks of preventable diseases, with the pandemic disrupting routine vaccinations.

And even after the measles killed over 207,000 people worldwide in 2019, vaccination rates still dropped in many parts of the globe.

The first-dose vaccination rate dropped from 86 to 84 percent globally between 2019 and 2020, while only 70 percent received a second dose during the same period, according to WHO data.

In the Balkans, epidemiologists chalk up the growing anti-vax sentiment to several factors, including distrust in the government, a lack of serious enforcement measures, and a deluge of misinformation that overwhelmed social media during the pandemic.

In Montenegro, doctors have called on the government to take the issue more seriously, saying small fines on parents who refuse mandatory vaccine mandates have done little to reverse the country's anti-vax shift.

"The MMR vaccine is currently not a condition for enrolment in schools and kindergartens," Milena Popovic Samardzic, an epidemiologist from Montenegro's Institute of Public Health, told AFP.

Almost one-third of Montenegrins believe a conspiracy theory that alleges doctors and government seek to vaccinate children with shots that cause autism, according to an Ipsos survey published in 2021.

The same report also found that over half of the country's population are convinced that "global elites" created the coronavirus in order to slash the planet's population.

'Fed up'

In Serbia, the vaccine is mandatory for student enrolment but experts say officials often turn a blind eye to the problem until an outbreak forces their hand.

"The state only needs to follow the rules they set out," said Georgios Konstantinidis, the head of Serbia's paediatrics association.

"But nobody does—neither the parents nor the people in kindergartens who enrol kids through 'connections'."

Serbia was last hit by a measles outbreak in 2017, resulting in 3,800 recorded cases and 12 deaths, including two children.

In wake of the outbreak, state prosecutors launched proceedings against 43 prominent anti-vaxers for "causing panic", but none were convicted, according to Vladimir Cimerman, a Belgrade doctor who helped bring a lawsuit.

Doctors in Serbia are increasingly frustrated that warnings go ignored.

"We lack social responsibility. I'm fed up with everything," said Konstantinidis.

"Basic humanity has vanished from this society, and the whole world for that matter."

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Explore further

WHO, CDC warn of measles threat after 22 million infants miss shots during pandemic

https://medicalxpress.com/news/2022-03-experts-balkans-measles-outbreak.html

Key COVID-19 metrics decline, but some say it's far from over

 COVID-19 cases, deaths, and hospitalizations across the United States continued to decline this week, spurring roll backs of protective measures such as masking and prompting discussion about when the pandemic will end.

The United States reported nearly 533,300 cases for the week ending Feb. 24, a 36% decline over the previous week that has cascaded through every state in the nation, according to an analysis by Emily Pond, a research data analyst for the Johns Hopkins Coronavirus Resource Center and Center for Health Security.

The nation reported 12,194 deaths over the same time period, a 22% decline nationally, according to Pond's analysis. Yet a dozen states still experienced an increase in fatalities, pushing the cumulative number of U.S. deaths to more than 945,000.

"This is a very much welcomed trend," said Jennifer Nuzzo, epidemiology lead for the Coronavirus Resource Center, during the CRC's Friday expert briefing. "But we still have a way to go to get back to where we were in June 2021 with 11,000 cases per day."

Hospitalizations have also been trending lower to 53,000 over the past week, a 22% decline. Although there were far fewer cases at the same time last year, hospitalizations were higher, closer to 57,000.

"Even if we shift away from mask mandates, we can still focus on encouraging mask usage in areas where it is most needed," said Nuzzo, a senior scholar at the Johns Hopkins Center for Health Security.

Vaccinations in the United States remain stagnant, said William Moss, the CRC vaccinology lead and executive director of the International Vaccine Access Center. Slightly more than 215 million people in the United States have been fully vaccinated, just below 66% of the total population.

"We're not seeing a sustained increase in vaccinations," Moss said Friday. "Even with booster doses—fewer than half of adults in the United States have received boosters."

Many viewers of the CRC Friday Live Briefing asked the experts when the pandemic will become an endemic, or regularly recurring, virus like a seasonal influenza.

"We know that the SARS-CoV-2 virus is not going to disappear, that we are going to continue to encounter it in our lives," Nuzzo said. "That's why it's important to get vaccinated. It's not yet endemic. We're still at very high levels of case numbers even though they're falling."

The scientific community does not yet know what an endemic level of infections for COVID-19 looks like, she added.

"We don't know if it will fall on a seasonal pattern, although there is increasing belief that it will," she said. "But we don't know what that season will look like and when it will start and when it will end. We're not there. But we are having a conversation given that this virus is not going away."

https://medicalxpress.com/news/2022-03-key-covid-metrics-decline-experts.html

U.S. working to secure release of basketball star detained by Russia

 Diplomats had been working to make sure the release of seven-time WNBA All-Star participant Brittney Griner after Russia stated it had detained the participant final month for possession of vape cartridges containing hash oil, U.S. Secretary of State Antony Blinken stated on Sunday.

The Russian Customs Service, with out naming Griner, stated on Saturday that it had detained an athlete in February after the participant arrived at Moscow’s Sheremetyevo airport on a flight from New York.

Russian information company TASS recognized the participant as Griner, citing a supply. Griner’s WNBA group, the Phoenix Mercury, stated: “We are conscious of and are intently monitoring the state of affairs with Brittney Griner in Russia.”

A scan of the participant’s baggage revealed cartridges containing “liquid with cannabis oil”, and a prison case has been opened carrying a doable sentence of 5 to 10 years in jail, the customs service stated.

It was not clear when in February Griner, who performs in Russia throughout the WNBA’s winter low season, was detained. The participant continues to be in custody and an investigation is underway, the Russian Customs Service stated.

Griner, who gained Olympic gold medals with the U.S. nationwide groups in 2016 and 2021, “has all the time dealt with herself with the utmost professionalism throughout her lengthy tenure with USA Basketball,” USA Basketball stated on Twitter.

At a joint press convention with Moldova President Maia Sandu on Sunday, Blinken stated the Biden administration had assigned an embassy group to work on Griner’s case.

“There’s solely a lot I can say given the privateness issues at this level,” Blinken stated of Griner. “Whenever an American is detained anyplace on this planet, we of course stand prepared to present each doable help, and that features in Russia.”

He added, “We have an embassy group that’s working on the circumstances of different Americans who’re detained in Russia. We’re doing every little thing we will to see to it that their rights are upheld and revered.”

Following Russia’s invasion of Ukraine on Feb. 24 and Western nations’ sweeping sanctions geared toward isolating Moscow, the United States on Saturday warned in opposition to journey to Russia and stated its embassy there had restricted potential to help residents.

LGBTQ rights advocates expressed specific concern for Griner in mild of the truth that she is an brazenly homosexual lady being detained in a rustic that has a document of proscribing LGBTQ rights.

“Our ideas are with Brittney Griner, her family members, and her teammates throughout this terrifying ordeal,” a spokesperson for Athlete Ally, a company that advocates for LGBTQ rights in sports activities, stated on Sunday. “Brittney has long been a powerful voice for LGBTQ+ equality. It’s critical that now we use our collective voice to call for her safe and swift return to her family.”

Griner’s spouse, Cherelle Griner, posted on Instagram on Saturday that she appreciated the prayers and assist she had acquired following Brittney’s detention. “This message comes throughout one of the weakest moments of my life,” she wrote. “Please honor our privateness as we proceed to work on getting my spouse house safely.”

https://mywinet.com/u-s-working-to-secure-release-of-basketball-star-detained-by-russia/

Hospital margins plummeted in January amid omicron

 

• Hospitals' margins, outpatient volumes and revenues all dropped while expenses rose in January, as the highly contagious omicron variant spread and COVID-19 cases and hospitalizations peaked, according to Kaufman Hall's National Hospital Flash Report.
• Ongoing expense increases and abrupt volume shifts led the median change in operating margin without accounting for relief funds to drop more than 70% from December to January, according to the report.
• Outpatient care delays from December to January led outpatient revenue to drop 7.5% while inpatient revenue rose 2.7%, according to the report.

As systems finish reporting their financial earnings for the fourth quarter and full year of 2021, the findings paint a fuller picture of the omicron variant's impact during the first month of 2022.

Kaufman Hall's report, which draws on data from more than 900 hospitals across the country, found providers and patients again delayed nonurgent care, including outpatient care, either to mitigate the spread of the virus or preserve resources for patients with more urgent needs.

In January, actual hospital margins were negative for the first time in 11 months as a result of the omicron headwinds.

The median Kaufman Hall Operating Margin Index was -3.68% for the month, and when including federal relief funds, it was still -3.3%.

Volumes shifted elsewhere during the period as outpatient care revenue fell and inpatient care revenue rose. Meanwhile, operating room minutes fell nearly 16% from December to January and more than 20% compared to January of 2020.

Sicker patients also required longer hospital stays, with patient days up 1.7% and average length of stay up 8.6% from December to January.

At the same time, heightened expenses have been an ongoing challenge for operators amid labor shortages and supply chain issues.

Total expense per adjusted discharge rose 11.6% from December to January, in large part due to a 14.6% jump in labor expense per adjusted discharge, Kaufman Hall found.

Non-labor expense per adjusted discharge also rose 7.8% during the period.

"While COVID-19 cases have swiftly declined since peaking in mid-January, the effects of the sudden and sizable margin and outpatient volume declines will be felt throughout 2022," said Erik Swanson, senior vice president of data and analytics with Kaufman Hall.

https://www.healthcaredive.com/news/hospital-margins-plummeted-january-omicron-kaufman-hall/619556/

Primary care physician turnover costs payers almost $1B every year: study

 

• Turnover among primary care physicians cost public and private payers $979 million annually, according to a new American Medical Association-backed study published in Mayo Clinic Proceedings.
• About $260 million of those excess costs are attributable to burnout spurring physicians to leave the field, the study, which is based on pre-pandemic data, found.
• The costs are incurred when primary care physicians leave and patients lose continuity of care. For example, Medicare beneficiaries spend an additional $189 within the first year of losing a primary care provider due to greater use of specialty, urgent and emergency care services, according to the study.

Studies have shown that patients receiving continuous care from their primary care provider results in better outcomes like more accurate diagnoses, fewer emergency department visits, fewer hospital admissions and ultimately lower costs.

The flipside is also true. Primary care physician turnover was a costly issue even before the COVID-19 pandemic began in the U.S. two years ago, according to the study.

While past research has focused on how physician burnout impacts productivity or recruitment and replacement costs, this is the first study looking at the excess spend associated with disruptions in care continuity between primary care physicians and their patients, according to the its authors.

Researchers used data from a survey of more than 5,000 U.S. physicians conducted between October 2017 and March 2018 focusing on questions around burnout and intentions to leave one's current practice within two years.

They estimate that 11,339 primary care physicians are expected to leave their current practices each year, with 3,006 departing due to burnout.

Public and private payers in turn spend almost $1 billion a year on expenses related to patients losing their primary care providers, the study found.

Burnout is a key driver of turnover. While it has long been an issue in the healthcare field, the pandemic has greatly exacerbated burnout, according to numerous surveys among nurses, physicians and other healthcare workers.

A December report from Doximity found more than 73% of physicians reported feeling overworked and 50% are consequently considering a career change.

Doximity also identified a spike in retirements during the first few months of the pandemic that never fully recovered, resulting in roughly 1% of the entire physician workforce retiring earlier than expected based on pre-pandemic trends.

Burnout can have a number of adverse effects beyond increased physician turnover, including more frequent errors leading to higher medical malpractice claims, reduction in clinical hours and other organizational costs, according to the AMA study.

https://www.healthcaredive.com/news/primary-care-physician-burnout-costs-payers-annually-AMA/619712/