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Wednesday, January 4, 2023

Xi and Marcos Agree to Boost Ties, Consult on Maritime Issues

  • China willing to restart talks on oil and gas exploration: Xi
  • Philippines’ president visiting Beijing after recent tension

 The presidents of China and the Philippines agreed to strengthen cooperation and discuss maritime differences amicably after meeting in Beijing on Wednesday, according to Chinese state media. 

“China is willing to properly handle maritime issues with the Philippines side through friendly consultation, and restart negotiations on oil and gas exploration,” China Central Television quoted President Xi Jinping as saying. 

https://www.bloomberg.com/news/articles/2023-01-04/xi-and-marcos-agree-to-boost-ties-consult-on-maritime-issues

The Real COVID Infection Fatality Rate

 by Naveen Athrappully via The Epoch Times (emphasis ours),

A study that looked into the age-stratified infection fatality rate (IFR) of COVID-19 among the non-elderly population has found that the rate was extremely low among young people.

The median IFR was 0.0003 percent at 0–19 years, 0.002 percent at 20–29 years, 0.011 percent at 30–39 years, 0.035 percent at 40–49 years, 0.123 percent at 50–59 years, and 0.506 percent at 60–69 years,” the study conducted across 29 countries stated. “At a global level, pre-vaccination IFR may have been as low as 0.03 percent and 0.07 percent for 0–59 and 0–69-year-old people, respectively.”

The study aimed to accurately estimate the IFR of COVID-19 among non-elderly populations in the absence of vaccination or prior infection.

For every additional 10 years in age, the IFR was observed to increase by roughly four times. After including data from nine more nations, the median IFR for 0–59 years came in at 0.025 to 0.032 percent and for 0–69 years was at 0.063 to 0.082 percent.

According to the study, the analysis suggests a “much lower” pre-vaccination IFR in the non-elderly population than had been suggested previously. The large differences found between nations were pegged to differences in factors like comorbidities.

Vaccination Dangers Among Youth

A recent study that analyzed children between the ages of 5 and 17 who had received Pfizer COVID-19 shots found an elevated risk of heart inflammation among children as young as 12 years old.

Myocarditis and pericarditis met the threshold for a safety signal for children aged between 12 and 17 following the second and third doses. These heart conditions can cause long-term issues and even death.

“The signal detected for myocarditis/pericarditis is consistent with published peer-reviewed publications demonstrating an elevated risk of myocarditis/pericarditis following mRNA vaccines, especially among younger males aged 12-29 years,” the researchers said.

In an interview with Fox News back in January, MIT researcher Stephanie Seneff had said that it was “outrageous” to give COVID-19 vaccines to young people as they have a “very, very low risk” of dying from the infection.

When looking at the potential harms of these vaccines for children, they don’t make “any sense,” she added. With repeated boosters, such treatment will be “devastating” in the long term.

Parents should do “absolutely everything they can” to avoid getting their children vaccinated against COVID-19, the research scientist advised.

Vaccinating Children

Some countries have stopped their COVID-19 vaccine programs for children. In October, the Swedish Public Health authority ceased recommending vaccination for 12- to 17-year-olds except under special circumstances. The agency acknowledged that very few healthy children have been affected seriously by the virus.

“Overall, we see that the need for care as a result of COVID-19 has been low among children and young people during the pandemic, and has also decreased since the virus variant omicron began to spread,” Soren Andersson, head of a unit at the Public Health Authority, told broadcaster SVT at the time. “In this phase of the pandemic, we do not see that there is a continued need for vaccination in this group.”

Read more here...

Meanwhile, here's what Dr. Fauci said about it (as noted by Jeffrey A. Tucker via the Brownstone Institute).

https://www.zerohedge.com/covid-19/lets-discuss-real-covid-infection-fatality-rate

Vivos: FDA OKs Treatment of Obstructive Sleep Apnea

 Vivos Therapeutics, Inc. (“Vivos” or the “Company'') (NASDAQ: VVOS), a medical technology company focused on developing innovative treatments for patients suffering from dentofacial abnormalities and/or mild-to-moderate obstructive sleep apnea (OSA) and snoring in adults, today announced a brand new clearance from the U.S. Food and Drug Administration (FDA) for its proprietary DNA appliance (daytime-nighttime appliance).

The FDA 510(k) clearance for the DNA appliance as a Class II device gives rise to a completely new treatment regimen for mild-to-moderate OSA. Making this development even more meaningful is that the DNA device for palatal expansion is Vivos’ longest standing appliance with the widest use among Vivos-trained dentists, which Vivos anticipates will now increase the ease of adoption of the DNA for treating OSA.

https://finance.yahoo.com/news/vivos-therapeutics-receives-fda-510-123000600.html

Astellas loses bid to block Lexiscan generics in US

 It looks like Astellas has been unsuccessful in its attempt to block Pfizer’s generic medicines unit Hospira from launching a copycat version of big-selling pharmacologic stress agent Lexiscan in the US.

In an update on the litigation posted this morning, Astellas confirmed that the Court of Appeals for the Federal Circuit (CAFC) had upheld a lower court ruling that Hospira’s generic does not infringe any of the patents that are protecting Lexiscan (regadenoson injection) from competition.

The Japanese pharma and Gilead Sciences – which licensed US rights to Lexiscan to the Japanese company – won a temporary reprieve against the launch of the generic back in the autumn, winning a temporary stay on launch until 6th December.

They sought another temporary injunction, but that was rejected along with the decision on patent infringement on 30th December, and Astellas said it is now “evaluating its legal options” and reviewing the financial impact of the outcome.

The long-running dispute dates back to 2018, when Hospira filed for approval of its generic of Lexiscan, an A2A adenosine receptor agonist used alongside radionuclide, myocardial perfusion imaging (MPI) in patients being assessed for cardiovascular disease who are not physically able to carry out standard exercise stress testing on a treadmill or stationary bike.

In May, the lower court sided with Hospira and ruled that three patents Astellas is relying on for Lexiscan market exclusivity in the US – 8,106,183; 8, 524,883; and RE47301 – are not infringed by Hospira’s generic.

According to IQVIA figures, US sales of Lexiscan were approximately $650 million for the 12 months that ended 31st March 2022, making it one of Astellas’ top products.

The drug was originally developed by CV Therapeutics – bought by Gilead in 2009 – and first launched in the US in 2008. It is sold as Rapiscan in Europe by GE Healthcare.

There’s no word yet from Hospira on its launch plans for the generic, but it looks likely to do so quickly now that the CAFC has ruled against Astellas.

Hospira isn’t the only generics company trying to bring a version of regadenoson to the US market. AmphaStar and Glenmark Pharma also claimed FDA approval for versions of the drug earlier this year.

https://pharmaphorum.com/news/astellas-loses-bid-to-block-lexiscan-generics-in-us/

Cingulate Kickstarts Pivotal Trial For ADHD Candidate, Data Expected In First Half

 Cingulate Inc 

 has initiated the first Phase 3 clinical trial of its lead candidate CTx-1301, an extended-release tablet formulation of dexmethylphenidate, a compound approved by the FDA for attention-deficit/hyperactivity disorder (ADHD). 

What Happened: The Phase 3 trial is an adult dose-optimization study to assess the onset and duration of efficacy and the safety of CTx-1301 in adults with ADHD compared to a placebo.

The trial is expected to take three months to complete, and initial results are expected in the first half of 2023. 

The company says that CTx-1301 is the first medication aiming to achieve fast onset of action (in 30 minutes or less) and efficacy that lasts up to 16 hours. 

Why It Is Important: Cingulate’s proprietary PTR platform unlocks the opportunity to provide once-daily, multi-dose delivery tablets in large addressable markets, including the $18 billion U.S. ADHD market. 

The PTR platform can deliver medications in other large markets, including anxiety (CTx-2103 in development), insomnia, depression, bipolar disorder, Parkinson’s disease, xerostomia (dry mouth), migraine, and hypothyroidism. 

https://www.benzinga.com/general/biotech/23/01/30269779/cingulate-kickstarts-pivotal-trial-for-adhd-candidate-data-expected-in-first-half-2023

Sanofi Forecasts Foreign Exchange, Record Flu Vaccine Sales To Boost Q4

 

  • As Sanofi SA  schedules to report Q4 FY22 earnings early next month, it expects a positive currency impact in Q4 2022.
  • The company expects growth driven by Dupixent, while Neurology & Immunology be slightly down. It also expects record flu season sales.
  • Sanofi said its preliminary estimate of currency movements be approximately +4.5% and +5.5% on Q4 sales and a positive impact of +6% and +7% on its Q4 business EPS.
  • Sanofi expects a positive impact of +6.5% and +7.5% for FY22 sales and +8% and +9% for EPS. Previously, Sanofi forecasted a currency impact of +9.5% and +10.5% on FY22 EPS.
  • The company also said that an arbitration award concerning the U.S. litigation about the heartburn drug Zantac was expected to be rendered sometime in 2023 and at the end of the first quarter at the earliest.
  • Sanofi "remains confident in its legal defenses" regarding the litigation.
  • In December, the federal Multi-District Litigation court determined insufficient evidence that ranitidine can cause plaintiffs' alleged cancers
  • This ruling significantly decreased the litigation scope and substantiated Sanofi's scientific defenses to the claims being asserted. In mid-December, Sanofi reached a favorable agreement to resolve Mr. Goetz's claims against it (California court case). With this settlement, Sanofi is not a defendant in any of the other California cases set for trial in 2023