Vaxxinity's Vaccine Candidate Shows Durable Cholesterol Lowering Activity In Animal Models

 

• Vaxxinity Inc 
  VAXX+14.6%+ Free Alerts
   announced data demonstrating durable lowering of low-density lipoprotein (LDL) cholesterol in non-human primates.
• The company also selected VXX-401 to pursue as its anti-PCSK9 vaccine candidate to treat hypercholesterolemia. 
• The company plans to start Phase 1 clinical trial in early 2023.
• VXX-401 is a synthetic peptide vaccine that targets proprotein convertase subtilisin/kexin type 9 serine protease (PCSK9) to lower low-density lipoprotein (LDL) cholesterol, a mechanism proven to reduce the risk of cardiovascular events. 
• The new data in non-human primates demonstrate that VXX-401 is well tolerated and provides long-lasting, significant LDL reduction versus placebo. 
• After a 6-week priming regimen with VXX-401, LDL cholesterol progressively dropped to 40-50% of placebo values in healthy monkeys. 
• A steady-state reduction of LDL cholesterol was observed for months. The magnitude of LDL reduction with VXX-401 was similar to that of a single dose of a monoclonal antibody comparator. 
• While LDL levels returned to baseline within 2-3 weeks after a single dose of a monoclonal antibody, a steady-state and long-lasting reduction of LDL levels was observed after the last dose of VXX-401. 
• Levels of "good" high-density lipoprotein (HDL) cholesterol were not affected by treatment and remained stable.

https://www.benzinga.com/general/biotech/22/08/28313546/vaxxinitys-vaccine-candidate-shows-durable-cholesterol-lowering-activity-in-animal-models

Rhythm Pharma Outlines Robust Start To Newly Approved Drug For Genetic Condition

 

• Rhythm Pharmaceuticals Inc 
  RYTM+13.8%+ Free Alerts
   announced that over 35 physicians have written 50+ prescriptions for Imcivree (setmelanotide) for Bardet-Biedl syndrome (BBS) in the first six weeks since FDA approval in June.
• The company reported Q2 Imcivree sales of $2.3 million compared to $0.3 million a year ago.
• EPS loss came in at $(0.89) compared to a loss of $(0.70) a year ago, beating the consensus of $(0.95).
• The company held a cash balance of approximately $235.6 million, sufficient to fund operations into 2024.
• Rhythm also said that the cash balance, together with the second investment tranche under the RIFA with HealthCare Royalty Partners expected in 2H of 2022, will be sufficient to fund its expenditure requirements into at least 2H of 2024.
• Wells Fargo raised Rhythm Pharma's price target to $35 from $22.

https://www.benzinga.com/general/biotech/22/08/28315809/rhythm-pharma-outlines-robust-start-to-newly-approved-drug-for-genetic-condition

Pfizer Board Member Predicts Monkeypox Will Become A 'Public Health Failure'

 by Jack Phillips via The Epoch Times (emphasis ours),

Pfizer board member Dr. Scott Gottlieb warned that the United States lacks a federal infrastructure capable of dealing with public health emergencies such as monkeypox.

“Now if monkeypox ‌gains a permanent foothold in the U‌nited States and becomes an endemic virus that joins our circulating repertoire of pathogens, it will be one of the worst public health failures in modern times not only because of the pain and peril of the disease but also because it was so avoidable,” the former Food and Drug Administration head wrote in and op-ed for the New York Times.

“Our lapses extend beyond political decision making to the agencies tasked with protecting us from these threats.”

Gottlieb claimed the United States did not test enough people for the virus, which is overwhelmingly spreading via homosexual men, in the early part of the outbreak while the U.S. Centers for Disease Control and Prevention (CDC) should have utilized commercial labs sooner. It wasn’t until June that the CDC expanded to using those labs, he noted.

Data released by the CDC shows monkeypox, which hasn’t caused any deaths outside Africa in the recent outbreak, has infected about 5,200 people in the United States as of Sunday. Wyoming, Montana, and Vermont are the only states that haven’t reported any cases so far.

Over the past several days, health departments in New York City and San Francisco declared the virus a public health emergency, allowing those municipalities to free up more funding and resources. Days before, the head of the World Health Organization declared monkeypox a global public health emergency.

More Details

“Its cultural instinct is to take a deliberative approach, debating each decision,” Gottlieb said of the CDC’s response. “With COVID, the virus ‌‌gained ground quickly. With ‌‌monkeypox, which spreads more slowly, typically through very close contact, the shortcomings of CDC’s cultural approach haven’t been as acute yet. But the shortfalls are the same.”

https://www.zerohedge.com/medical/pfizer-board-member-predicts-monkeypox-will-become-public-health-failure

Biden DOJ Sues Idaho Over 'Near-Total Ban' On Abortion

 The Justice Department filed a lawsuit against Idaho on Tuesday, challenging the state's near-total abortion ban which will take effect on August 25.

The lawsuit - which marks the DOJ's 1st challenge since the Supreme Court overturned Roe v. Wade this summer, argues that Idaho's law would violate the Federal Emergency Medical Treatment and Labor Act, which says that hospitals receiving Medicare funds "must provide medical treatment necessary to stabilize that condition before transferring or discharging the patient," according to Tuesday's filing.

"The Idaho law would make it a criminal offense for doctors to comply with EMTALA's requirement to provide stabilizing treatment, even where a doctor determines that abortion is the medical treatment necessary to prevent a patient from suffering severe health risks or even death," it continues.

Idaho's law does allow for exceptions for rape or incest which has been reported to police prior to the abortion, and the state will not prosecute physicians who perform abortions in "good faith medical judgement and based on the facts known" to save a woman's life, Just the News reports.

The DOJ, however, decries the law as a "near-total ban" in their filing.

"Even in dire situations that might qualify for the Idaho law’s limited 'necessary to prevent the death of the pregnant woman' affirmative defense, some providers could withhold care based on a well-founded fear of criminal prosecution."

According to Attorney General Merrick Garland, "If a patient comes into the emergency room with a medical emergency jeopardizing the patient’s life or health, hospitals must provide the treatment necessary to stabilize that patient," adding "This includes abortion, and that is the necessary treatment."

Garland claims that the Idaho lawsuit has "nothing to do with going around" the Supreme Court's recent decision.

"The Supreme Court said that each state can make its own decisions with respect to abortion, but so too can the federal government," he said. "Nothing that the Supreme Court said, said that the statutes passed by Congress, such as EMTALA are in any way invalid. It's quite the opposite. The Supreme Court left it to the people's representatives. EMTALA was a decision made by the Congress of the United States. The supremacy clause is a decision made in the Constitution of the United States. Federal law invalidates state laws that are in direct contradiction."

Last month the DOJ created a task force aimed at protecting abortion rights in the wake of the Supreme Court's decision to terminate the federal right to abortion.

https://www.zerohedge.com/political/biden-doj-sues-idaho-over-near-total-ban-abortion

China halts Taiwanese snack imports ahead of Pelosi's arrival

 The People's Republic of China has halted imports from Taiwanese snack and confection manufacturers ahead of House Speaker Nancy Pelosi's planned visit to the island. 

China has suspended imports from Taiwanese companies producing pastries, baked goods and sweets in what appears to be a retaliatory policy meant to put pressure on the island.

"The Ministry of Economic Affairs and the Council of Agriculture are currently aware of [the import ban]," said the Taiwanese Bureau of Foreign Trade on Tuesday, according to the South China Morning Post.

Popcorn from Taiwan Smile Food sits on a table at the ISM confectionery fair, Jan. 25, 2019. (Oliver Berg/picture alliance via Getty Images)

The ban was implemented Monday night, according to Taiwanese news outlets, not long after Pelosi's arrival in Asia. 

The speaker is expected to arrive in Taiwan on Tuesday night.

China has previously used economic sanctions and import bans to put pressure on Taiwan for political purposes.

Previously, China has slashed imports of fish, fruit, vegetables and other produce – most often citing pest concerns and the possibility of invasive species, according to the South China Morning Post.

Russian President Vladimir Putin’s press secretary Dmitry Peskov accused the U.S. on Tuesday of "provoking" China amid speculation that Pelosi, D-Calif., would visit Taiwan during her trip to the region this week.

"We can now state unequivocally, whether she makes it there or not, everything about this tour and the possible visit to Taiwan has provocative character," Peskov told Russian reporters. "Russia has absolute solidarity with China."

Peskov’s comments came as Pelosi touched down in Malaysia for the second leg of her Asian tour after first visiting Singapore. 

https://www.foxbusiness.com/retail/china-halts-taiwanese-snack-imports-pelosi-arrival

CBO Projects That by 2043, Deaths Will Exceed Births

 Please consider the Congressional Budget Office Demographic Outlook: 2022 to 2052

• Population. In CBO’s projections, the population increases from 335 million people in 2022 to 369 million people in 2052, expanding by 0.3 percent per year, on average. (In this report, population refers to the Social Security area population—the relevant population for the calculation of Social Security payroll taxes and benefits. The population is also projected to become older, on average, as growth in the number of people age 65 or older outpaces that of younger age groups. 
• Components of Population Growth. Population growth is projected to slow over the next 30 years. As fertility rates remain below the replacement rate (the fertility rate required for a generation to exactly replace itself in the absence of immigration), population growth is increasingly driven by net immigration flows. 
• Civilian Noninstitutionalized Population. The civilian noninstitutionalized population grows, in CBO’s projections, from 264 million people in 2022 to 298 million people in 2052. (This measure of the population includes only people age 16 or older. The agency uses it to project the size of the labor force.) The prime working age population (ages 25 to 54) grows at an average annual rate of 0.2 percent over that period, slower than its average over the 1980–2021 period (1.0 percent). 
• Changes Since Last Year. In CBO’s current projections, the population is smaller and grows more slowly, on average, than CBO projected last year. Fertility rates are expected to be lower than the agency projected last year, reducing the size and growth of the population that is under 24 years old over the 30-year projection period. In addition, as a result of new information about the effects of COVID-19, CBO increased projected mortality rates for people age 65 or older, on average, in the first two decades of the projection period.  

Looking Ahead Demographically 

Aging persons tend to spend less and travel less as the years pass. But they need more health care and it's expensive.  

Yet, there will be fewer people working and paying taxes to support each retiree.

Neither Social Security nor Medicare was created to withstand the cliff event that's coming when all the boomers retire.

Once Boomers are gone from Congress It will be interesting to see what Millennials and Zoomers do with the mess they inherited. 

https://mishtalk.com/economics/the-cbo-projects-that-by-2043-deaths-will-exceed-births

Perkinelmer sells rather than spins

 While the trend for diversified healthcare companies to spin out various parts of their businesses has gained pace – and was recently added to by Labcorp – another pattern is also becoming apparent. Several groups have decided to streamline not by floating units on the public markets but by selling them to private equity. The latest such company is Perkinelmer, which has sold its analytical, food and enterprise services businesses to New Mountain Capital for $2.5bn. When the deal closes Perkinelmer will have a 60-40 split between diagnostics and life sciences, and will be capable of high growth and high margins, it says. It will also have a new name, yet to be announced – the Perkinelmer brand will belong to the group owned by New Mountain. The units that are to be divested are expected to generate around $1.3bn in revenue in 2022, whereas the life sciences and diagnostics units are set to bring in sales of around $3.3bn this year. But this top line could be boosted by M&A, Stifel analysts write, with the company’s immunodiagnostics segment a possible area of focus. 

Selected healthcare divestments to private equity, 2021-2023
Parent	Unit	Buyer	Date closed	Deal value ($bn)
Cardinal Health	Cordis (interventional cardiology)	Hellman & Friedman	Aug 2, 2021	1.0
Roper Technologies	Civco Radiotherapy	Blue Wolf Capital Partners	Expected Q4 2021 but close has not been announced	Undisclosed
Pfizer	Meridian Medical Technologies (autoinjectors)	Altaris Capital Partners	Jan 24, 2022	Undisclosed
Bayer	Environmental science professional business	Cinven	Expected H2 2022	2.6
Perkinelmer*	Applied, food and enterprise services businesses**	New Mountain Capital	Expected Q1 2023	2.5
*Perkinelmer will change its name once the divestment is complete. **To be renamed Perkinelmer. Source: Evaluate Medtech & company communications. https://www.evaluate.com/vantage/articles/news/deals-snippets/perkinelmer-sells-rather-spins