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Monday, June 7, 2021
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Unvaccinated US Children Called ‘Vulnerable Host’ For Covid
Americans are finally getting a breath of fresh air, as this summer is beginning to look like a time for not only soaking in the sun but also celebrating reopenings from the pandemic. But as the adult population gets inoculated, experts continue to draw attention to children who are not yet vaccinated.
Dr. Richina Bicette, associate medical director at Baylor College of Medicine in Houston, told CNN that children are accounting for nearly 25 percent of total Covid-19 cases in the US.
The report revealed that while there were no deaths, nearly a third were admitted to intensive care units and roughly 5 percent required invasive mechanical ventilation.“As adults get vaccinated and become more protected and immune to this virus, the virus is still in the community looking for a vulnerable host and pediatric patients fit that description,” Bicette explained.
And severe infections are not limited to older Americans. A study by the US Centers for Disease Control and Prevention examined more than 200 adolescents between the ages of 12 and 17 who were likely hospitalized primarily for Covid-19 in the first three months of 2021.
Children 12 and older can receive the Pfizer/BioNTech vaccine, and outreach efforts have already started in the race to protect teens who are eligible.
“I wanted to come get my vaccine because it’s going to benefit me, because of the summertime and also because I have to go to school,” said 14-year-old Aaliyah Jennings, who told CNN she received her first vaccine dose on Friday in New York.
On June 10, vaccine advisers will meet with the US Federal Drug Administration to discuss allowing Covid-19 vaccines for children 11 and under.
Nearly 63 percent of adults in the US have received at least one dose of a Covid-19 vaccine as of Saturday morning, CDC data shows.
We aren’t there yet, but we’re getting closer
Despite that less than half of the total US population is fully vaccinated — at about 42 percent — there’s been progress in how people feel about the impact of the coronavirus pandemic on their lives.
Two-thirds, or 66 percent, of adults in America, say their lives are at least somewhat back to normalcy, according to a new Gallup survey
“Almost all demographic subgroups of the population show large shifts since last fall in reports that their lives are back to normal,” the survey says.
Meanwhile, Hawaii has moved to loosen some of its restrictions as it reaches a vaccine milestone. Gov. David Ige said Friday that he’s ending all restrictions for inter-county travel on June 15, touting that 52 percent of his state’s population is fully vaccinated.The US averaged about 14,300 new cases per day over the last week, down from nearly 71,300 daily in mid-April, according to Johns Hopkins University data. During the country’s peak of infections last winter, the daily average of new cases eclipsed 250,000.
States are noticing the progress. Mass vaccination sites in Massachusetts will begin closing this month, Gov. Charlie Baker said in a news release, touting that 79 percent of adult residents have received at least one dose of a Covid-19 vaccine. New Jersey passed a bill this week to end the public health emergency initiated by the Covid-19 pandemic, as limits on group gatherings across the state are lifted.
“The easing of travel restrictions is a direct result of our robust vaccination rate, and a community that sacrificed and did what it had to do over the past year and a half to stop the spread of Covid-19,” Ige said.
Companies push for return to normalcy
President Joe Biden’s goal of vaccinating 70 percent of adults with at least one dose of Covid-19 vaccine by July 4 has proven difficult, to say the least, and incentives ranging from scholarships to lotteries are being offered by states to drive demand for vaccines.
Now, enter free beer.
This week, Anheuser-Busch teamed up with the White House in promising a round of free beers to those 21 and older if the country reaches its goal.
“Anheuser-Busch will buy America’s next round of beer, seltzer, non-alcoholic beverage or other A-B product,” the company said in a news release.
Royal Caribbean International announced on Saturday that six of its ships will sail from major US ports in Florida and Texas beginning in July. The company is not requiring vaccines for passengers, but those who are not inoculated “will be required to undergo testing and follow other protocols,” according to a news release from the company.
“This is it. Vacationers can finally plan to take their precious time off this summer and truly get away after what has been a challenging time for everyone,” said Michael Bayley, president and CEO of Royal Caribbean International, in the release.
Novartis: Tabrecta® first published overall survival, updated overall response data in lung cancer
Novartis today announced the first published mature overall survival (OS) and updated overall response rate (ORR) data following treatment with Tabrecta® (capmatinib) in adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to MET exon 14 skipping (METex14)1-3. Data from the ongoing, pivotal, multi-cohort Phase II GEOMETRY mono-1 study will be presented today during the 2021 Annual American Society of Clinical Oncology (ASCO) Virtual Scientific Meeting (Poster Discussion Session, Lung Cancer—Non-Small Cell Metastatic; June 4, 2021, 9:00 AM-10:00 AM CT; abstract 9020).
"This new analysis further supports Tabrecta as a cornerstone targeted treatment for METex14 NSCLC patients and highlights the importance of biomarker testing," said Juergen Wolf, MD, from the Center for Integrated Oncology, University Hospital Cologne, and lead investigator of the GEOMETRY study. "The impressive overall survival outcome and confirmed outstanding response in the first-line setting will help oncologists decide upon a therapeutic option for patients."
AstraZeneca: Positive Results From Trial for Leukemia Drug Calquence
AstraZeneca PLC said Monday that the Calquence drug-inhibitor showed improvements in atrial fibrillation when compared with ibrutinib in previously treated adult patients with chronic lymphocytic leukemia.
The pharmaceutical giant said Calquence also proved to give favorable tolerability at four years.
The company said these final results of Calquence come from the head-to-head elevate-rr phase 3 trial.
FDA set to rule on controversial Biogen Alzheimer's drug
The U.S. FDA on Monday is expected to give its thumbs up or down on Biogen Inc's aducanumab, a decision that will affect the future of Alzheimer's disease research and treatment and show the agency's willingness to approve badly needed medicines based on less than definitive data.
Aducanumab has been at the center of a divisive public battle. The Food and Drug Administration is under enormous pressure from patient advocacy groups and some doctors to approve the first major drug for the mind-wasting condition, while many experts say huge amounts of money will be spent despite a lack of compelling evidence aducanumab can provide meaningful benefit.
Approval could reinvigorate a failure-laden field that has been abandoned by many large drugmakers and give Biogen a new multibillion-dollar seller. Its shares rose 5% on Friday ahead of the expected decision.
A rejection would likely spell the end of aducanumab and possibly sound the final death knell for similar experimental Alzheimer's drugs in development. The FDA decision could also have wider ramifications, analysts said.
It is "likely to reverberate throughout the biopharma sector, influencing overall sentiment on the space, perceptions on regulatory flexibility, and business development dynamics," RBC Capital Markets analyst Brian Abrahams said in a recent research note.
Alzheimer’s disease is the sixth leading cause of death in the United States. There is "a profound and enormous unmet medical need" for new treatments, Billy Dunn, director of neurology products evaluation for the FDA, said at a November advisory committee meeting.
Aducanumab aims to remove sticky deposits of a protein called amyloid beta from the brains of patients in earlier stages of Alzheimer's to stave off the ravages of memory loss.
The amyloid theory has been at the center of Alzheimer's research for many years with a long list of failures to show for it, and seemed on life support until Biogen revived its aducanumab program.
Biogen's drug has been hailed by patient groups and some neurologists eager for an effective option to treat the lethal disease, but trial results have been inconsistent.
One Phase III aducanumab study resulted in a statistically significant 23% benefit at slowing declines in cognition and daily function compared to a placebo.
However, a second large study failed to show that benefit, leading Biogen and partner Eisai Co to scrap development in March 2019.
They reversed course in October, saying a more detailed company analysis of the failed study showed that some patients with very early forms of the disease benefited from taking higher doses over an extended period of time.
That was enough for some advocates desperate for anything that might help. Opponents say the FDA risks setting a precedent for lowering its standards, opening a path to expensive, potentially ineffective drugs by not requiring truly compelling evidence for approval.
The waters were further muddied when FDA staff concluded that the successful trial offered enough persuasive evidence, only to have a panel of outside advisers to the agency vote in November that data did not prove aducanumab could slow Alzheimer's progression.
Advocates have been marshalling support since.
'MEANINGFUL EFFICACY'
"We believe that the perspective of the panel was too narrow ... We conclude that aducanumab achieves the standard of meaningful efficacy with adequate safety," six prominent Alzheimer's experts, including lead author Dr. Jeffrey Cummings, director of the University of Nevada Las Vegas Chambers-Grundy Center for Transformative Neuroscience, wrote last month in Alzheimer's Research & Therapy.
Previous clinical studies of Alzheimer's drugs had largely targeted patients in later stages of the disease, while many experts now believe attacking it as early as possible may be the key to success.
Aducanumab was studied in patients with early disease who test positive for a component of amyloid brain plaques. Some trial patients experienced potentially dangerous brain swelling.
Biogen has estimated that around 1.5 million Americans would be eligible for treatment with aducanumab, which is given by monthly infusion, raising concerns about costs to the healthcare system for both diagnostics and treatment.
If approved, the drug could reap billions of dollars in sales, mostly at a cost to the U.S. government's Medicare health insurance program for seniors.
The Institute for Clinical and Economic Review, an influential drug pricing research group, in a May report cited "insufficient" evidence that aducanumab provides a net health benefit. It said data so far indicate a cost-effective price of no more than $8,300 per year. Looking only at favorable trial results, that price rises as high as $23,100, ICER said.
The research group put the fair price for any drug proven to halt progression of Alzheimer’s-related dementia at $50,000 to $70,000 per year.
Addex, Janssen Start Phase 2 Clinical Study of ADX71149 for Epilepsy
Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, today announced that the first patients have been enrolled into a Phase 2 clinical study evaluating JNJ-40411813 (ADX71149) in patients with epilepsy. JNJ-40411813 (ADX71149) is a selective metabotropic glutamate type 2 (mGlu2) receptor positive allosteric modulator (PAM). The trial is being conducted in collaboration with Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
“Addex is anticipating multiple clinical study catalysts during 2021. The first, starting with this epilepsy study, illustrates the continued commitment of our long-time collaboration partner Janssen Pharmaceuticals, Inc. to this program and to pioneering novel ways to help epilepsy patients. Data from the study are expected in Q3 2022,” said Tim Dyer, CEO of Addex. “The start of additional clinical trials, including our pivotal study for our lead program dipraglurant in Parkinson’s disease patients suffering from dyskinesia remains on track for this quarter.”
The multi-center study (ClinicalTrials.gov Identifier: NCT04836559) will assess the efficacy, safety, tolerability and pharmacokinetics of adjunctive JNJ-40411813 (ADX71149) administration in patients with focal onset seizures with suboptimal response to levetiracetam. The primary objective of the study is to evaluate the efficacy of JNJ-40411813 (ADX71149) in combination with levetiracetam using a time-to-event endpoint.
China To Build 25-30 More Bio-Labs Like In Wuhan Over Next 5 Years
by James Anthony via The Post Millennial,
In the next few years, the world could see almost 60 maximum security Level 4 virology labs in operation. The Guangdong province announced in May that it was planning to build between 25 to 30 biosafety labs in the next five years.
"What could go wrong?" questioned Human Events senior editor Jack Posobiec:
The facilities will be flung all over the globe, spanning 23 countries including the United Kingdom, the United States, India, Gabon, and Côte d’Ivoire.
The current Wuhan Institute of Virology is now at the center of an investigation by US authorities into whether COVID-19 could have leaked from its lab.
About 75 percent of these facilities are or will be built in urban areas, which has experts around the world worried about the possibility of further "lab leaks."
"Reporting is getting better certainly in some countries such as the UK and US where there has been media coverage of this, but we’re not yet where we want to be. The more work that is going on, the more accidents will happen," commented Filippa Lentzos of King's College in London, the Financial Times reported.
Richard Ebright, a professor of chemical biology at Rutgers University, concurred:
"The larger the number of institutions and the larger the number of individuals with access to these dangerous agents, the greater the risk."
Ebright said that accidents and leaks have happened in large numbers in places that have weaker biosafety standards.
"We need to strengthen biosafety and biosecurity rules around the world," the scholar urged.
Such laboratories used to carry out the most dangerous biological research have proliferated in the past decade with scientists now warning that lax controls at several locations could lead to another pandemic. Many experts have said the probe into the origins of COVID-19 has shown the problems of running high-risk experiments in the country. In March, 13 countries criticized China for not allowing full access to data and samples relating to the start of the pandemic.
https://www.zerohedge.com/covid-19/china-build-25-30-more-bio-labs-wuhan-over-next-5-years
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