Health Care Down as Traders Doubt Defensive Plays

 Health-care companies fell sharply, as traders reversed bets that the sector would be able to weather inflation and rising interest rates better than the broad market.

It was inevitable that the bear market would enter a "phase when virtually nothing worked, even defensives," said strategists at brokerage Morgan Stanley, in a note to clients.

The Health Care Select Sector SPDR exchange-traded fund, which tracks the health-care industry group of the S&P 500, is now down by roughly 10% from its recent peak in April.

Online pharmacy company Truepill said it's temporarily halting prescriptions for Adderall and other controlled substances used to treat attention-deficit hyperactivity disorder and partner Cerebral told its clinicians to direct those orders to patients' local pharmacies.

The Food and Drug Administration rejected two proposed new cancer drugs that were developed in China, one from Chinese drugmaker Hutchmed and one from a partnership between Shanghai Junshi Biosciences and U.S. company Coherus Biosciences, underscoring a tougher U.S. regulatory stance toward such drugs.

https://www.marketscreener.com/news/latest/Health-Care-Down-as-Traders-Doubt-Defensive-Plays-Health-Care-Roundup--40249473/

Acadia: FDA to re-review Nuplazid for Alzheimer's symptoms

 Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that a virtual meeting of the U.S. Food and Drug Administration's Psychopharmacologic Drugs Advisory Committee to review the resubmitted supplemental New Drug Application (sNDA) for pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP) has been scheduled for June 17, 2022. The target action date for the application is August 4, 2022.

https://finance.yahoo.com/news/acadia-pharmaceuticals-announces-fda-advisory-200500805.html

Guardant debuts first cancer screening blood test for colorectal tumors

 The blood-testing company Guardant Health aims to offer a simpler option to people who may have missed their recommended appointments to be checked out for colorectal cancer—such as a colonoscopy—with the launch of its first cancer screening test.

Guardant estimates that one in three adults have not completed the recommended set of screening tests for colorectal cancer, which include colonoscopies every 10 years and annual stool-based tests starting at age 45. 

Though treatments are most effective if the disease is caught early, currently colorectal tumors rank as the second-highest cause of cancer deaths in the U.S., and more than 75% of people who die from colorectal cancer were not up-to-date with their screening, the company said. Additional barriers to care and underscreening for cancer contribute to high cancer death rates among underserved populations.

Current screening methods can be uncomfortable and time-consuming to say the least, and many types may require days of dietary restrictions and preparation in addition to arranging transportation to and from the procedure, according to recommendations by the U.S. Preventive Services Task Force.

Guardant’s Shield test, meanwhile, is intended for adults over age 45 who have an average risk for colorectal cancer and show no symptoms, with a single blood draw performed in a provider’s office. The company previously launched a surveillance blood test in early 2021 to help recurring cases of colorectal cancer.

“Colorectal cancer screening is the start of this journey,” Guardant co-CEO AmirAli Talasaz said in a statement. “We will soon expand into multi-cancer screening, including lung, pancreas and others, where we believe cancer screening can save lives.”

The test searches for early signs of colorectal cancer from pieces of tumor DNA found floating in the bloodstream. In a clinical study of about 300 samples, the assay showed 91% sensitivity in detecting positive cases, including 90% for people with early, stage I cancers, 97% for stage II and 86% for stage III. Shield also demonstrated a low rate of false positives, at 8%, but the company said that a negative result does not fully rule out the presence of cancer. 

People who have a signal detected by the test should be referred to a colonoscopy for confirmation, and Guardant said its blood test is intended to complement, not replace, current screening methods. Shield is available as a lab-developed test, by prescription only.

Later this year, Guardant plans to provide results from a much larger clinical study of the Shield colorectal cancer test that gathered samples from more than 12,750 U.S. patients. It will use its findings to support a premarket approval application at the FDA.

Meanwhile, the company is studying a multi-cancer version of its Shield test, which aims to screen for colorectal, lung, pancreatic and bladder tumors, among others. 

Early data from a small number of patients presented at the annual meeting of the American Association for Cancer Research in April demonstrated sensitivities of 87% in stage I and II lung cancer, 73% in stage I and II pancreatic cancer and 52% in stage I and II bladder cancer. The blood test was also able to accurately identify the tumor’s tissue of origin.

https://www.fiercebiotech.com/medtech/guardant-debuts-first-cancer-screening-blood-test-catching-colorectal-tumors

J&J Monarch surgical robot gets FDA urology nod

 Auris Health has added another jewel to its crown.

The Johnson & Johnson subsidiary earned a second FDA clearance for its Monarch robotic surgery system, it announced Monday, allowing the robot to be used in kidney stone removal procedures. According to Auris, housed under J&J’s Ethicon division, that makes Monarch “the first and only multispecialty, flexible robotic solution for use in both bronchoscopy and urology.”

The system was previously cleared in 2018 to help surgeons get a better look at hard-to-reach and potentially cancerous nodules found in the deep recesses of the lungs.

“This latest FDA 510(k) clearance for Monarch delivers on our vision to extend the robotic platform’s capabilities across multiple specialties, enabling hospital systems to target two disease states using one device,” said Vladimir Makatsaria, Ethicon's company group chairman.

With the new urological clearance, doctors will be able to use the surgical robot to snake an endoscope into the kidney to break up and suction out kidney stones, with an attached camera providing a real-time view of the area the whole time.

Monarch has been proven especially useful in percutaneous nephrolithotomy procedures to remove kidney stones, or PNCL, which reach the stone through a small incision in the patient’s back. Though this method is highly effective at removing larger stones, it’s more difficult to perform than the widely used ureteroscopic method, which sends a scope through the urethra and bladder to reach the stone.

With Monarch’s help, however, surgeons can use a video-game-like controller to send the endoscope safely through the skin to the kidneys and remove the broken-up kidney stones and any additional fragments with greater precision. The system can also be used in ureteroscopic procedures to remove smaller stones.

“Monarch reduces the complexity of gaining high-quality percutaneous access and aids stone clearance efficiency through simultaneous fragmentation and suctioning of stones with robotic assistance,” said Mihir Desai, M.D., a professor of clinical urology at the University of Southern California and a paid Auris advisor. “With this platform, many urologists may be willing to expand their practice to include percutaneous access and PCNL procedures, thereby increasing patient access to more effective treatments closer to home.”

Now that FDA clearance has been secured for the indication, Auris said it plans to launch a first-in-human clinical study of the robotic surgery system’s endourological applications later this year.

The Monarch system joined J&J’s line of succession in early 2019. At the time, Ethicon put forth a deal worth up to $5.75 billion—split between $3.4 billion in upfront cash and another $2.35 billion in potential milestone payments.

Under the terms of the acquisition, Auris’ founder and CEO, Frederic Moll, M.D.—also the founder of robotics maven Intuitive Surgical—joined his tech at J&J, where he’s now chief development officer of robotics.

https://www.fiercebiotech.com/medtech/fda-crowns-monarch-surgical-robot-jjs-auris-health-urology-nod

Is Biogen Planning to Appeal CMS Aduhelm Reimbursement Decision?

 In early April, the U.S. Center for Medicare and Medicaid Services (CMS) implemented its guidance for Biogen's controversial Alzheimer's drug Aduhelm (aducanumab). The guidance significantly limited the drug's availability. CMS had issued the draft notice in January, providing several months of public responses.

The recommendation restricts Aduhelm to reimbursement only if used in a clinical trial, a very unusual move for a drug approved by the U.S. Food and Drug Administration. The agency also applied this guidance to an entire class of beta-amyloid-clearing medicines that have yet to be submitted for approval.

There is speculation that Biogen might appeal the decision. It was reported that the company hired William Clyburn Jr. of Clyburn Consulting, according to a federal lobbying disclosure. Clyburn's focus isn't usually healthcare. He was formerly commissioner of the U.S. Surface Transportation Board, having worked with former U.S. Senator Zell Miller on airport planning and infrastructure development projects. The company notes transportation and telecommunications as its primary areas of focus.

However, he is a relative of House Majority Whip Jim Clyburn, D-SC, which might be one of the reasons Biogen hired his firm. The filing indicated the specific lobbying issues Biogen was hiring him for were "Alzheimer's Disease treatment availability."

Biogen has also hired several other lobbyists to focus on Alzheimer's, including Federal Street Strategies and Capitol Counsel. It's not unusual for biopharma companies to employ lobbyists, but the timing does raise the question of whether the company will attempt to appeal the CMS decision.

In other news, Biogen's chief executive officer Michel Vounatos's bonus was chopped in half to "hold him accountable for the company's overall business performance in 2021," per a company filing. Vounatos received $1.5375 million in salary for 2021, up 2.5% from $1.5 million in 2020, which was consistent with other executives in the company except for Chirfi Guindo, the company's executive vice president, head of global product strategy & commercialization, whose base salary increased 10.2% from $567,100 in 2020 to $625,214 in 2021. The company reported the increase "reflects the annual merit increase and, in the case of Mr. Guindo, also includes a market adjustment based on our C&MD Committee's review of peer group and survey data."

The executives' non-salary compensation, i.e., bonuses, was based on company performance. As a result, Vounatos received a dividend of $1,153,125, about half of what he could potentially have earned. Biogen noted, "Notwithstanding Mr. Vountasos' essential individual contributions to Biogen in 2021, our Board of Directors believed it was important to hold him accountable for the Company's overall business performance in 2021. As a result, our Board of Directors approved an Individual Multiplier of 50% for Mr. Vountasos."

On a positive note, Biogen and partner Sage Therapeutics initiated a rolling submission of a New Drug Application (NDA) to the FDA for zuranolone for the treatment of major depressive disorder (MDD). The drug is a once-daily oral treatment for MDD and postpartum depression (PPD). They have submitted the nonclinical portion to the NDA and expect to submit the rest in the second half of this year.

"Zuranolone has the potential to help address a significant unmet medical need in depression as an innovative option in a therapeutic area where little has changed in the past 30 years," said Dr. Priya Singhal, M.D., M.P.H., Head of Global Safety and Regulatory Sciences and Interim head of R&D at Biogen. "We are committed to advancing the science and developing new approaches to treating mental health, a major public health challenge that was exacerbated by the COVID-19 pandemic."

The drug has been granted Fast Track and Breakthrough Therapy Designation for MDD as well as Fast Track Designation for PPD. It is being studied in the LANDSCAPE and NEST clinical development programs.

https://www.biospace.com/article/is-biogen-planning-an-appeal-to-cms-decision-on-alzheimer-s-drug-/

Russian TV: UK Can Be 'Drowned In Radioactive Tsunami’ By Single Nuke Sub Strike

A recent Russian state TV program has stirred outrage and made headlines across the United Kingdom after a television presenter featured a simulated demonstration of how the Russian navy's nuclear submarines would take out the UK with ease.

The segment aired late last week on public broadcaster "Channel One" and featured the chairman of the nationalist Rodina political party, Aleksey Zhuravlyov, who declared that "one Sarmat missile and the British Isles will be no more." 

Specifically under discussion was the UK's military support to Ukraine. London was earliest out of the gate to publicize it's repeat planeloads of weapons, including anti-tank systems and munitions, flown into Ukraine.

That's when the segment transitioned to news anchor Dmitry Kiselyov describing the following as a graphic of a submarine played behind him:

"It approaches its target at a depth of 1km at a speed of 200km/h. There's no way of stopping this underwater drone. The warhead on it has a yield of up to 100 megatons."

"The explosion of this thermonuclear torpedo by Britain's coastline will cause a gigantic tsunami wave up to 500m high."

The clip from the segment, which is now being widely shared in the West...

He then said the UK could be turned into "a radioactive desert" in the most provocative moment of the program: 

"Such a barrage alone also carries extreme doses of radiation. Having passed over the British Isles, it will turn what might be left of them into a radioactive desert.”

The panel had started off by reacting to recent comments by UK’s Armed Forces Minister, who appeared to earlier give approval for Ukraine striking Russian soil utilizing UK-provided weapons if need be.

British Defence Secretary Ben Wallace issued the remarks last Thursday while describing Ukraine's right to defend itself.

"Part of defending itself in this type of invasion is obviously where Ukraine will go after the supply lines of the Russian army because without fuel and food and ammunition, the Russian army grinds to a halt and can no longer continue its invasion," he told BBC TV.

But he did note the caveat that it remains unlikely. "They currently don't have British weapons that could do that, so it's unlikely that it is our weapons," he said, and added: "We're very unlikely to supply that to anyone simply because of the technology and also the scarcity we have of those capabilities. So it is very unlikely."

https://www.zerohedge.com/geopolitical/russian-tv-warns-britain-can-be-drowned-radioactive-tsunami-single-nuclear-sub-strike

Amazon workers lose paid COVID leave

 Amazon will no longer offer paid time off for employees with COVID-19, according to multiple reports.

The online retail giant announced the change, which went into effect on Monday after the Centers for Disease Control and Prevention changed its guidance surrounding its handling of the virus and the widespread availability of vaccines in the U.S., Reuters noted, adding that employees who contract COVID-19 will be given five days of excused, unpaid leave.

Workers are also still allowed to use their sick time if needed, according to CNBC.

The Hill has reached out to Amazon for comment.

Amazon has been slowly dialing back its COVID-19 leave policies since the start of the year.

In January, it shortened its paid leave policy for employees from 10 days to seven days. That change was fueled largely by labor shortages caused by the rapid spread of the omicron variant.

At the start of the pandemic, the company initially offered up to two weeks of paid time off for any employee who had COVID-19 and needed to quarantine.

The development comes shortly after Amazon was granted a hearing over its claims that a Staten Island facility’s successful vote to unionize, the first location in the U.S. to do so, was improperly carried out.

“We’ve always said that we want our employees to have their voices heard, and in this case, that didn’t happen — fewer than a third of the employees at the site voted for the union, and overall turnout was unusually low,” Amazon spokesperson Kelly Nantel said of the vote.

https://thehill.com/policy/healthcare/3473633-amazon-workers-lose-paid-covid-leave/