Senate GOP votes to strike Biden's vaccine rule for health care workers

 Senate Republicans on Wednesday voted to strike down President Biden’s vaccine mandate targeting health care workers, in a rebuke of the administration.

Senators voted 49-44 to approve the GOP effort to nix the rule — a vote they were able to force under the Congressional Review Act.

Though no Democratic senators voted with Republicans to eliminate the rule, GOP senators were able to get it through the evenly divided Senate because of Democratic absences. Six Democratic senators missed the vote. 

The mandate was rolled out by the Centers for Medicare and Medicaid Services, which sought to require the COVID-19 vaccine for health care workers at providers that participate in Medicare and Medicaid. 

But the effort to nix the rule is facing headwinds. The Congressional Review Act sets up a fast track process in the Senate, but it does not greenlight the same procedure in the House.

If it made it to Biden’s desk, Democrats expect that he would veto it.  

“If it passes this won’t go anywhere in the House, and President Biden would veto it,” a Democratic Senate aide said.

https://thehill.com/policy/healthcare/596594-senate-gop-votes-to-strike-bidens-vaccine-rule-for-healthcare-workers

Avoid clinical trial 'valley of death' with medical countermeasure program

 The COVID-19 pandemic has put us on notice. It is critical to health and national security for the U.S. to prepare for the inevitable future infectious disease emergencies that will occur. It is clear that vaccines, antivirals, monoclonal antibodies and diagnostics are key components of preparedness and response. And we cannot relent, assuming another coronavirus will ignite the next pandemic. There are other threats out there. The United States needs to launch a strategic effort to create the capability to proactively develop a robust pipeline of products targeted toward the high consequence viral families most likely to cause a pandemic.

While it is impossible to know precisely what the next pandemic pathogen will be — “Disease X” is likely to arise from one of several viral families that include efficiently spreading respiratory viruses some of which may be highly transmissible and lethal. Right now, the U.S. remains vulnerable to the next novel pathogen because there is no sustained federal funding, program or strategy dedicated to accelerating the advanced development of medical countermeasures for such a Disease X virus.

What is stopping government, academia and industry from commencing this important work? The answers are many — the absence of a coordinated government strategy; the scientific complexity of the mission; limited resources; and the lack of a clear commercial market that could drive investment. The list goes on.

There is now hope that Congress will address these impediments. The bipartisan PREVENT Pandemics Act, currently being considered by Congress, directs the National Institutes of Health (NIH) director to develop a ”multidisciplinary research program to advance the discovery and preclinical development of medical products for priority virus families and other viral pathogens with a significant potential to cause a pandemic, through support for research centers.” As part of this program, the NIH director is to partner and coordinate with other agency chiefs.

This is exactly what is needed for early-stage development of medical products for a future Disease X, but it is only one aspect of the multi-stage process. 

Stopping at preclinical development of promising products only gets us (almost) halfway there if our national goal is to be optimally prepared for the next threat. As the PREVENT Pandemics Act moves through the legislative process it is imperative that the act includes specific funding and a clear remit to the Biomedical Advanced Research and Development Agency (BARDA) to launch a “Disease X” medical countermeasure development program. Sen. Tammy Baldwin (D-Wis.) introduced a bill, the Disease X Act, last summer that calls for the creation of this program.

Medical countermeasure development is well known to be a high risk undertaking that typically requires significant investment at all stages of development. There are products that make it through preclinical development successfully but falter when it comes to clinical trials and late phase development. Some products and platforms are highly scalable for surge manufacturing, but many are not, and this also must be carefully addressed during this later stage. This chasm between preclinical and clinical development is colloquially referred to as the “valley of death” as products can easily die at this stage.

With biodefense — preparation against potential biological weapons such as anthrax and smallpox — it was quickly realized that unless products were pulled through the “valley of death” the U.S. would be left without any products that could be quickly deployed to mitigate the impacts of a biological attack. Preclinical development would never be enough and because many of these products had no commercial market (as the diseases they addressed are thankfully not everyday occurrences), a comprehensive solution was required.

In 2006, President George W. Bush signed the Pandemic and All Hazards Preparedness Act (PAHPA) which, among myriad other things, established BARDA. BARDA has a mission “to develop and procure medical countermeasures that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases.”

Specifically, BARDA is an advanced development agency  — emphasis on advanced — which bridges across the “valley of death.” As such they have ample experience working with small and large biotech and pharmaceutical companies with promising technologies. These are not early-stage development ideas or basic scientific research. BARDA works with commercial companies of various sizes in a more mature stage of development, while NIH typically works with university-based researchers doing cutting-edge basic science. 

To date, BARDA has been integrally involved in the FDA licensure, approval and clearance of over five dozen medical countermeasures. This speaks to their vital role in bringing actual products — against pressing health and biosecurity threats — to fruition. It is the mission they were constituted to fulfill. 

BARDA should not be relegated to a junior partner role, cc’d on emails. To advance the national goal of having safe and effective medical products that are ready to be surge produced in the face of a future pandemic, Congress should ensure that BARDA is specifically tasked in the PREVENT Pandemics Act with executing an advanced development program for Disease X medical countermeasures so that they aren’t interminably mired in the “valley of death” when the next infectious disease emergency surfaces.

Amesh Adalja, M.D., is an infectious disease physician and a senior scholar at the Johns Hopkins Center for Health Security.

Anita Cicero, JD is deputy director at the Johns Hopkins Center for Health Security and a senior scientist at the Johns Hopkins Bloomberg School of Public Health.

https://thehill.com/opinion/healthcare/596546-avoid-clinical-trial-valley-of-death-with-medical-countermeasure-program

Urban Institute: Part D $2,000 out-of-pocket cost cap would benefit less than 1M seniors

 A proposal to cap Medicare Part D drug costs would benefit nearly 1 million seniors, according to a new study.

The study, released Tuesday by the Robert Wood Johnson Foundation, comes as Congress is attempting to salvage drug pricing reforms before the midterm elections. One of the proposals being floated has been a $2,000 cap on out-of-pocket prescription drug costs on Part D beneficiaries that don’t already qualify for cost-sharing protections.

If the cap is put in place, it would benefit more than 860,000 seniors, the study conducted by the think tank Urban Institute found. Medicare drug spending would also increase by less than 1%.

“Ultimately, a spending cap would enhance the overall benefit of the Medicare Part D program without substantially raising Medicare program spending,” said Anuj Gangopadhyaya, senior research associate at Urban Institute, in a statement.

Urban’s researchers used a simulation model to estimate Medicare and out-of-pocket spending on Part D in 2019. It estimated there were about 866,000 Part D enrollees that year who did not get low-income subsidies to help cover the costs of drugs.

It found Part D enrollees had average total drug expenditures of about $19,800, and $2,900 would be spent out-of-pocket by the beneficiary.

Certain enrollees would also benefit more from the cap based on their expenses. For instance, 40% of beneficiaries who had out-of-pocket costs above $2,000 spent up to $2,500. Another 30% spent between $2,500 and $3,000.

There were 18% that spent more than $3,500 in out-of-pocket costs.

The study comes as Congress is trying to figure out a path forward on drug price reform ahead of the 2022 midterms.

A $2,000 cap on out-of-pocket Part D costs was included in the Build Back Better Act, a major $1.75 trillion social spending package that passed the House earlier this year. The legislation, however, has stalled in the Senate due to objections from Sen. Joe Manchin, D-West Virginia.

However, Democrats are now trying to figure out which pieces of drug price reform could survive in a slimmed-down package this year.

“The cap and other drug provisions could remain in a potential slimmed-down budget reconciliation bill that might pass in both the House and the Senate,” Urban’s study said.

Another potential reform could be placing a cap on Part D drug costs that would prevent drug companies from hiking prices beyond the cost of inflation.

https://www.fiercehealthcare.com/payers/urban-institute-part-d-2000-out-pocket-cost-cap-could-benefit-nearly-1m-seniors

IsoRay therapy has favorable outcomes in prostate cancer

 Investigators from the University of Pittsburgh School of Medicine have published a clinical study demonstrating favorable outcomes for localized intermediate-risk prostate cancer patients treated with IsoRay Inc's 

ISR +4.44%

 (Get Free Alerts for ISR) Cesium-131 brachytherapy known as Cesium Blu.

• Brachytherapy is a localized internal radiation therapy in which seeds, ribbons, or capsules containing a radiation source are placed in or near the tumor.
• The study analyzed the outcomes for 335 intermediate-risk prostate cancer patients treated with Cesium-131 brachytherapy.
• Study patients had significant follow-up time. 
• The study found that both the "favorable" (147 patients) and "unfavorable" (188 patients) intermediate-risk groups demonstrated excellent biochemical outcomes. 
• Those outcomes were 97.6% and 91.4%, respectively, at five years. For 135 "favorable" patients treated with Cesium-131 implant alone, the outcome was 98.1%.
• Investigators used Cesium-131 to decrease the duration of acute toxicity compared to other radioisotopes because of its shorter half-life.

https://www.benzinga.com/general/biotech/22/03/25940297/isorays-cesium-131-radiation-therapy-shows-favorable-outcomes-in-prostate-cancer

REGENXBIO 2021 Financial Results and Recent Operational Highlights

 

• Closed eye care collaboration agreement with AbbVie to develop and commercialize RGX-314

• Continue to advance RGX-314 program for the treatment of wet AMD and diabetic retinopathy

• Received IND clearance and Orphan Drug Designation for RGX-202 for the treatment of Duchenne

• Presented positive data from RGX-121 and RGX-111 clinical trials for the treatment of MPS II and MPS I

• $849 million current cash and cash equivalents of as of December 31, 2021; including upfront payment from closing of the AbbVie eye care collaboration agreement; operational runway into 2025

• Conference call Tuesday, March 1st at 4:30 p.m. ET

Financial Guidance

Based on its current operating plan, REGENXBIO expects its balance in cash, cash equivalents and marketable securities of $849.3 million as of December 31, 2021 to fund its operations, including the completion of its internal manufacturing capabilities and clinical advancement of its product candidates, into 2025.

Conference Call

In connection with this announcement, REGENXBIO will host a conference call and webcast today at 4:30 p.m. ET. To access the live call by phone, dial (855) 422-8964 (domestic) or (210) 229-8819 (international) and enter the passcode 7635958. To access a live or recorded webcast of the call, please visit the "Investors" section of the REGENXBIO website at www.regenxbio.com. The recorded webcast will be available for approximately 30 days following the call.

https://finance.yahoo.com/news/regenxbio-reports-fourth-quarter-full-210500073.html

Turtle Beach Reports Strong 2021 Results

 "Our full year revenue of $366 million was in line with our previously communicated guidance range, and we’re pleased to have delivered the highest full year revenue in our history following a record 2020," said Juergen Stark, CEO and Chairman, Turtle Beach Corporation. "This success is a testament to our team’s disciplined management and execution through supply chain and logistics headwinds, our active global coordination with retailers, and the consistent and robust demand for our products.

"Our brands, now spanning seven market categories, have enabled us to deliver strong results despite supply chain challenges and semiconductor constraints that complicated operations and held back full year sales. For example, we gained share with our ROCCAT PC accessories across our core PC accessory markets, outperforming the competition as we continued to rapidly grow our PC business. Per U.S. NPD retail data, we maintained our console gaming headset market share of 40% or more for the 12th consecutive year.

"In 2021, we continued our transformation into a diversified gaming accessories business positioning us to take advantage of a growing total addressable market of $8.8 billion. Our success was driven in part by our entry into new product categories like Xbox gaming controllers and flight simulation hardware, while continuing as the clear leader in console gaming headsets. Further, we delivered 20% of revenues outside our core console headset business and expect to deliver $100 million of non-console-headset revenue in 2022, demonstrating our progress in successfully adding attractive categories to our business. Our best-in-class product portfolio, combined with a proven ability to navigate market challenges and execute on our strategy, gives us confidence in our ability to continue to drive long term growth and attractive returns for our shareholders."

2022 Outlook

For the full year 2022, the Company expects revenue to be approximately flat, plus or minus 5%, from record 2021 revenues. The mid-point of the range anticipates growth in sell-through and share gains in all categories offset by a reduction in channel inventory and the expectation that console and PC markets may decline somewhat from 2021 primarily due to an exceptionally strong first half of 2021 driven by stimulus checks and stay-at-home orders.

Gross margins are expected to be roughly 2-3% below our mid 30’s target range, reflecting the impact of 3-4% in higher freight and component costs which we anticipate will abate somewhat over time, as well as the expected return to normal promotional levels, partially offset by factoring higher costs into new product pricing.

Given the impact of higher costs on gross margin this year, we expect our adjusted EBITDA margin to be within the range of approximately 9% to 11%, within or slightly below our 10+% target, due to the factors stated above. Net income per diluted share is expected to be within the range of $0.70 to $1.20 based upon 17.5 million diluted shares for 2022.

Conference Call Details

Turtle Beach Corporation will hold a conference call today, March 2, 2022, at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time) to discuss its fourth quarter and full year 2021 results.

Chairman and CEO Juergen Stark and CFO John Hanson will host the call, followed by a question-and-answer session.

Conference Call Details:
Date: Wednesday, March 2, 2022
Time: 5:00 p.m. ET / 2:00 p.m. PT
Toll-Free Dial-in Number: (877) 303-9855
International Dial-in Number: (408) 337-0154
Conference ID: 8270996

For the conference call, please dial-in 5-10 minutes prior to the start time and an operator will register your name and organization. If you have any difficulty with the conference call, please contact Gateway Investor Relations at (949) 574-3860.

The conference call will be broadcast live and available for replay here and via the investor relations section of the Company’s website at www.turtlebeachcorp.com.

https://finance.yahoo.com/news/turtle-beach-reports-strong-full-210500631.html

Ukrainian Maternity Hospital Treats Wounded Soldiers

I n spite of the conflict surrounding them, Valery Zukin, MD, PhD, CEO of a private maternity hospital in western Kyiv -- just 5 to 10 kilometers from the "zone of fire" -- said staff have no choice but to continue to work.

Over the prior 4 days, doctors, nurses, midwives, and cooks have stayed overnight at the hospital. Some doctors and nurses have brought their children as well. "And for this moment, we must stay like big family," Zukin told MedPage Today in a phone call Saturday evening.

Life has changed dramatically for Ukrainians in only a few days, he said.

"We could not imag[ine] for example that few days ago ... we live by another life," he told MedPage Today. "If for example you must stay in your working place without change. You could not go at home [without] special permission. You couldn't go in the shop because all [of] the shop[s] are closed. You could not move by the car ... and you must go according to some signal in the shelter and you never could imag[ine] it will happen during the day or during the night. You understand that it is a very stress[ful] situation."

Because moving around Kyiv is "absolutely forbidden," the hospital must work with police to inform different posts throughout the city when a patient needs to be moved into or out of the hospital.

Zukin compares life in the hospital underground to working on a Navy boat. To maintain a sense of structure and calm, "all the [crew] they stay on the ship all the time but they have some working hours and some ... sleeping, resting hours," he said. A psychologist is available to do Skype consultations to help staff cope with the new stressors.

As of Saturday, Zukin said there were around 60 doctors, nurses, and midwives and around 25 patients and 17 babies in the hospital.

"We have a lot of Ukrainian patient[s] from [other] cities, and for this moment, we must care for all of these people, for all of these babies," he said.

Zukin spoke with a man whose wife had just given birth in the hospital a few days earlier. He is Italian, she is Ukrainian, and they have an apartment in Kiev, but it's on the 21st floor. Until he finds a way to leave Ukraine, the husband wants his wife to stay in the hospital.

"She has no good place to go," Zukin said.

The hospital is not only serving pregnant women and mothers, but also wounded patients.

"Everyday we have eight, ten of our soldiers," he said, clarifying that these aren't members of the Ukrainian military but volunteers for the territorial defense, who arrive with head wounds, chest wounds, and injuries to their hands and legs.

Because the hospital has something known as GCI certification, all of the doctors are trained to provide basic life support, which is akin to military medicine. So, a patient with a brain injury can be sent to the neurological hospital, but the staff there can help with the initial primary medical care.

"We have very qualified anesthesiologist and very qualified anesthesiologist nurses," and can provide the necessary care, he said.

Last week, Zukin said his staff shared a post on Facebook calling for help with supplies, and strangers brought them food, water, and medications.

A car came and delivered their dinner the other night. He initially thought the delivery was from an organized charity group but it was actually a private restaurant.

"You understand that is not safe to come now in our part of Kyiv," he said, moved by the gesture.

President Putin's "big mistake" Zukin said, has been to underestimate Ukrainians' commitment to freedom.

"I promise [the driver] that we will celebrate our win in this restaurant [with] the staff who stay now in the hospital," he said.

This was a light and hopeful moment for Zukin, but everyone is struggling.

"I think that everyday [we are] waiting, it is a problem for Ukraine," he said, and each day more soldiers are killed.

"I think that this war must be killed in the embryonic stage," he said, comparing it to fire, as it grows "more and more it will be more difficult to stop." If the West continues to ignore Putin, WWII will repeat itself, he said.

"We hope that all of this movement against Russia it will be very quick. ... Ukraine is not so powerful country but in spite of this, the general feeling of all the people is to defend their country, their democracy," he said.

"We hope for the support of United States and Western Europe," Zukin added. "Without support we could not survive and we could not win."

https://www.medpagetoday.com/special-reports/exclusives/97407