Search This Blog

Monday, December 4, 2023

Alterity: Positive Efficacy Data for ATH434 in a Primate Model of Parkinson’s

 - ATH434 improved motor performance and general function –

- Webcast to be held this week to discuss new data and recent clinical progress –

Webcast details

AUSTRALIA PARTICIPANTS:
 Date:Wednesday, 6 December 2023
 Time:9:00 a.m. AEDT (Sydney/Melbourne)


UNITED STATES PARTICIPANTS:
 Date:Tuesday, 5 December 2023
 Time:2:00 p.m. Pacific Time
  5:00 p.m. Eastern Time

Register for the Zoom webcast:
https://us02web.zoom.us/webinar/register/WN_9Lv1OWMtSSSqdJrRsKRiTA#/registration
Registration is required and dial in details will be sent directly upon registration.

https://www.globenewswire.com/news-release/2023/12/04/2789905/0/en/Alterity-Therapeutics-Reports-Positive-Efficacy-Data-for-ATH434-in-a-Primate-Model-of-Parkinson-s-Disease.html

EyePoint: Phase 2 Trial in Wet AMD Achieving All Primary and Secondary Endpoints

 Both EYP-1901 cohorts demonstrated a statistically non-inferior change in BCVA versus aflibercept control with a numerical difference of only -0.3 and -0.4 letters, respectively for the 2 mg and 3 mg dose at blended six-month endpoint –

– Positive safety profile continues with no EYP-1901-related ocular or systemic SAEs –

– Key secondary endpoints were achieved with both EYP-1901 doses. These include an over 80% reduction in treatment burden, with nearly two-thirds of eyes supplement-free up to six-months –

– Strong anatomical control in both EYP-1901 cohorts documented by optical coherence tomography (OCT) –

– Conference call to discuss the results to be held today, December 4, 2023 at 8:00 a.m. ET –

EyePoint will host a conference call today, December 4, 2023 at 8:00 a.m. ET to discuss the results. To access the live conference call, please register at https://register.vevent.com/register/BI4c4d93355a394ea284131d7b537fd513. A live audio webcast of the event can be accessed via the Investors section of the Company website at www.eyepointpharma.com. A webcast replay will also be available on the corporate website at the conclusion of the call.

https://www.globenewswire.com/news-release/2023/12/04/2789884/0/en/EyePoint-Pharmaceuticals-Announces-Positive-Topline-Data-from-the-Phase-2-DAVIO-2-Trial-of-EYP-1901-in-Wet-AMD-Achieving-All-Primary-and-Secondary-Endpoints.html

Neuronetics: Expanded Regulatory Approval in Japan

 Neuronetics, Inc. (NASDAQ: STIM), a medical technology company focused on designing, developing, and marketing products that improve the quality of life for patients who suffer from neurohealth disorders, announced that the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has approved multiple proprietary innovations, which significantly advance the patient treatment experience with the NeuroStar TMS (transcranial magnetic stimulation) Therapy System for the treatment of major depressive disorder (MDD) in Japan. The features covered in this approval include the NeuroStar 3.7 platform, MT Cap, D-Tect™ MT Accessory, and the Dash treatment protocol.

The Dash treatment protocol reduces the daily TMS treatment time from 38 minutes to under 19 minutes. MT Cap and D-Tect optimize efficiency for providers and patients by shortening the time and simplifying the steps to determine a patient’s motor threshold (MT), which is a critical step to establishing the patient’s prescription prior to starting treatment. The NeuroStar 3.7 platform continues Neuronetics’ strategy to standardize the NeuroStar hardware globally and includes advancements designed to streamline a clinician’s workflow, including 60% more computing power and a touchscreen display with a biometric fingerprint reader.

https://www.globenewswire.com/news-release/2023/12/04/2790056/0/en/NeuroStar-TMS-Receives-Expanded-Regulatory-Approval-in-Japan.html

COP28: UAE signs deal with Bill Gates' nuclear company on advanced reactors

 Bill Gates' advanced nuclear reactor company TerraPower LLC and the United Arab Emirates’ state owned nuclear company ENEC said on Monday they have agreed to study the potential development of advanced reactors in the UAE and abroad.

The memorandum of understanding comes amid a push by the UAE to expand its nuclear energy capacity, and a pledge by over 20 nations at the COP28 climate conference in Dubai to triple nuclear deployment this decade to fight climate change.

“For the UAE, we're looking for a future for the clean electrons and molecules that will be brought to reality by advanced reactors,” said Mohamed Al Hammadi, CEO of ENEC, during the signing ceremony.

"Bringing advanced nuclear technologies to market is critical to meeting global decarbonization targets," said TerraPower President and CEO Chris Levesque.

The UAE currently has one traditional nuclear power plant, near Abu Dhabi, which began producing electricity in 2020. TerraPower, meanwhile, has a demonstration project underway for its advanced Natrium reactor in the U.S. state of Wyoming that hopes to come online in 2030.

Advanced reactors are meant to be smaller, easier to build, and more dynamic than traditional plants, and are regarded by some as vital complement to intermittent power sources like wind and solar that are expanding rapidly.

The MOU between TerraPower and the UAE said they would explore uses for advanced nuclear reactors such storing power on the grid and providing the energy needed to produce hydrogen, and decarbonize coal, steel and aluminum plants.

One potential hitch, however, is that TerraPower's Natrium reactors require a fuel called high assay low enriched uranium or HALEU, the main producer of which currently is Russia.

TerraPower's Wyoming project has experienced delays over concerns about HALEU supply since the Russian invasion of Ukraine, but the company told Reuters it expects the United States to be able to produce the fuel in the coming decade.

The United States is seeking to start up HALEU production domestically and has contracted with a company called Centrus to develop a project to do so.

https://finance.yahoo.com/news/cop28-uae-signs-deal-bill-060000713.html

Roche joins race for obesity drugs with $2.7 billion Carmot deal

 Roche agreed to take over obesity drug developer Carmot Therapeutics for $2.7 billion, joining a list global contestants seeking to challenge the dominant makers of weight-loss drugs Novo Nordisk and Eli Lilly.

The U.S. takeover target's most promising drug candidate, a once-a-week injection called CT-388, belongs to a class known as a dual GLP-1/GIP receptor agonist, the same as Lilly's Mounjaro, or Zepbound.

After encouraging Phase I trial results, the drug is ready to be tested on humans in the second of three trial stages, Roche added in a statement on Monday.

Pioneer Novo is ahead in the market with obesity drug Wegovy, a single agonist of the GLP-1 gut hormone receptor, and is scrambling to boost production amid overwhelming demand in an obesity market that analysts estimate could reach as much as $100 billion in annual revenues.

Roche shares opened up 1.75%, hitting a six-week high on optimism that the weight-loss market will accommodate many rivals.

"Competition in the fast-growing obesity and diabetes markets should heat up quickly. The markets are large enough for 'me too' products, particularly when offered at the right price," Zuercher Kantonalbank analysts said in a note.

Roche said in its statement CT-388 could become the best in its class to treat obesity and its comorbidities.

Among recent deals to acquire obesity drug development projects, AstraZeneca last month agreed to pay up to $2 billion for the rights to an experimental pill from China's Eccogene.

New Roche CEO Thomas Schinecker has set a high deal pace since taking the helm in March to restore Roche's drug development pipeline, which was hit by major late-stage trial setbacks in Alzheimer's and cancer immunotherapy last year.

Roche in October agreed to pay an initial $7.1 billion to Roivant and Pfizer for rights to a new inflammatory bowel disease drug, eyeing new therapeutic fields to offset falling oncology sales.


DNA Sequence In Pfizer COVID-19 Vaccine Could Spur New Lawsuits: Lawyers

  by Zachary Stieber via The Epoch Times (emphasis ours),

Pfizer and its partner BioNTech could be open to lawsuits for including a DNA sequence in their COVID-19 vaccine.

The Public Readiness and Emergency Preparedness Act, known as the PREP Act, largely shields COVID-19 vaccine manufacturers from lawsuits, but companies can be sued for "willful misconduct," which includes acts taken "intentionally to achieve a wrongful purpose."

"I think what we have here is willful misconduct," Mat Staver, chairman of Liberty Counsel, told The Epoch Times.

The Pfizer-BioNTech, in testing by outside scientists, was discovered to contain a Simian Virus 40 (SV40) DNA sequence despite the public never being told about the sequence.

Regulators in Canada and Europe have since acknowledged that the companies did not highlight the sequence and that they should have, although regulatory submissions did show the full DNA sequence of the vaccine plasmid.

The U.S. Food and Drug Administration (FDA) has refused to disclose whether the companies highlighted the sequence.

The FDA alleged no safety concerns have been identified from the residual DNA left behind by the SV40 sequence, though the agency provided no evidence on the matter.

"I can't imagine that the FDA knew about this. There's nothing in the FDA documents that would that I am aware of yet where they knew about this contaminant," Mr. Staver said.

Under a declaration by then-Health Secretary Alex Azar in 2020, COVID-19 vaccines fall under the PREP Act. That act is aimed at allowing a quicker response to a health emergency and grants widespread immunity to manufacturers of vaccines and treatments, as well as administrators of the drugs.

The protection remains in place to this day thanks to extensions through both the Trump and Biden administrations.

The PREP Act has largely prevented lawsuits concerning the COVID-19 vaccines, but several recent developments could change that.

In August, a Michigan judge ruled that the drug manufacturer Gilead Sciences was not protected by the act in the case of a man who needed his leg amputated after receiving Gilead's drug remdesivir, used as a treatment for COVID-19. The administered drug was said to be contaminated with glass particles.

The other is the revelation that Pfizer's shot contains the SV40 sequence.

That could help plaintiffs "pierce that legal immunity that's otherwise provided by the PREP Act," Mr. Staver said.

He said he's heard from personal injury firms and organizations who are exploring suits and that Liberty Counsel is considering bringing some as well in light of the developments.

Liberty Counsel has been involved in multiple major suits concerning COVID-19 vaccines, including some with military members who were denied in form letters requests for religious exemptions from the military's COVID-19 vaccine mandate. The firm helped win orders blocking the military from discharging those members.

Pfizer and BioNTech have not returned requests for comment.

Warner Mendenhall, another American lawyer, said on a recent call that lawyers are talking about taking a different approach.

"The latest conversation that we've been talking about ... is whether we have access right now, at least for some people, to prove battery," he said.

Informed consent requires having information, "and nobody knew about the SV40," he said.

Without such knowledge, vaccine recipients could not properly give consent, according to Mr. Mendenhall.

"And if you haven't consented, and somebody does something to you without being informed and given proper consent, it's called battery. So, there is some opening for battery cases. And we're in discussions right now, and those may be able to be brought as as what are called mass torts or mass cases. So we're working on that."

https://www.zerohedge.com/medical/dna-sequence-pfizer-covid-19-vaccine-could-spur-new-lawsuits-lawyers

Moderna Employs Former FBI Analyst, AI To Secretly Police COVID 'Vaccine Misinformation'

 by Megan Redshaw via The Epoch Times (emphasis ours),

Pharmaceutical giant Moderna is policing what it calls “vaccine misinformation” online through its disinformation department aimed at shutting down dissenting voices and anything that might undermine COVID-19-related policies, such as lockdowns, vaccine passports, and mass vaccination.

According to an exclusive report by investigative journalists Lee Fang and Jack Poulson published on Nov. 20 in UnHerd, Moderna isn’t just manufacturing COVID-19 vaccines; it has an entire team dedicated to monitoring a wide range of social media platforms, government agencies, and news websites in the name of addressing the “root cause of vaccine hesitancy” by identifying and “shutting down misinformation” that may negatively affect the vaccine debate.

The internal documents show a “sprawling effort to monitor basically everything said online, on social media, and in the news media about vaccine policy, COVID policy, about Moderna, and other vaccine companies,” Mr. Fang told The Hill.

Monitoring Team of Former FBI, Secret Service, and Pharma-Funded NGOs

Moderna’s monitoring team includes its Global Intelligence division, run by Nikki Rutman, who was involved in compiling internal company misinformation reports of “high-risk” celebrities critical of vaccine mandates, including unvaccinated tennis star Novak Djokovic, Elon Musk, and actor Russell Brand, according to the investigative report.

Before joining “Moderna’s corporate security team” in 2022, Ms. Rutman worked as an intelligence analyst in the U.S. intelligence community for nearly 19 years, most of which was spent with the Federal Bureau of Investigation (FBI). According to the report, Ms. Rutman was working from the FBI’s Boston office during the COVID-19 pandemic and “Operation Warp Speed,” which involved weekly cybersecurity meetings with Moderna, also headquartered in Boston.

Before her role with the FBI, Ms. Rutman worked for the Director of National Intelligence as an “adviser on terrorism to a mission manager” and as a counterintelligence analyst with the Defense Intelligence Agency.

Ms. Rutman is only one of many former law enforcement agents working on Moderna’s monitoring team, along with a drug industry-funded NGO called the Public Good Projects (PGP) and Talkwalker, an artificial intelligence firm that uses its technology to monitor vaccine-related discussions across 150 million websites in nearly 200 countries.

According to Mr. Fang, PGP is an “anti-misinformation NGO” financed through a $1,275,000 donation from the Biotechnology and Innovation Organization—lobbyists representing Pfizer and Moderna—that works closely with social media platforms, government agencies, and news websites to classify and combat alleged vaccine misinformation.

"We know from a separate batch of documents—the Twitter files—that I reported earlier this year, that the same partners that are working with Moderna—PGP and some of these other NGOs—had a direct line to Twitter's executives, and they also worked with Google and Facebook to shape content moderation policies," Mr. Fang told The Hill.

These Moderna-funded NGOs were pressuring social media companies to change their content moderation policies and delete and “de-amplify” specific tweets critical of coercive vaccine policies, Mr. Fang said. "They were actually sending entire Excel documents with tweets they wanted censored," he added.

Talkwalker's website states it is a "social listening and consumer intelligence platform" that helps pharmaceutical businesses by providing an array of services, including "above brand monitoring" and "misinformation detection." Neither PGP nor Talkwalker has publically disclosed how they define "misinformation" or who determines that one's speech falls into this category. However, Mr. Fang and Mr. Poulson say these organizations, along with marketing executives and former FBI and Secret Service analysts, provide misinformation alerts to Moderna.

None of the reports that we have seen makes any attempt to dispute the claims made,” Mr. Fang and Mr. Poulson wrote. “Rather, the claims are automatically deemed “misinformation” if they encourage vaccine hesitancy.

Beyond identifying and attempting to censor subjectively determined vaccine misinformation, Moderna has provided talking points and advice to a network of 45,000 healthcare professionals—unbeknownst to their patients—on “how to respond when vaccine misinformation goes mainstream,” according to an email from Moderna.

Dr. Jay Bhattacharya, co-author of the Great Barrington Declaration and professor of medicine at Stanford University, said Mr. Fang and Mr. Poulson’s report is “absolute fire.”

“Moderna, thru the Public Goods Project, pays thousands of health professionals to attack and defame vaccine critics and push social media to censor anyone who says things, true or false, that reduce profits,” Dr. Bhattacharya posted on X.

Moderna Censors Legitimate Discussion About Vaccines

Moderna isn’t just flagging “misinformation” it considers a “danger to public health.” It’s flagging legitimate discussion of vaccine-related issues and mere criticism of vaccine companies, according to Mr. Fang and Mr. Poulson.

For example, Moderna’s misinformation reports rate news surrounding Novak Djokovic as “high risk.” Mr. Djokovic acquired natural immunity from SARS-CoV-2 infection and refused to get vaccinated, preventing him from competing in the 2022 US Open. He returned in 2023 when mandates had been lifted and won the Moderna-sponsored competition. Moderna said vaccine opponents were celebrating his win, and social media users were “mockingly” pointing out that Moderna was a US Open sponsor.

The Moderna internal report entitled “Djokovic Crowned Anti-vaccine Hero after US Open Win” stated the “optics of Djokovic” bolsters “anti-vaccine claims that vaccines—and mandates—are unnecessary.”

Mr. Musk, CEO of SpaceX, Tesla, Inc., and owner of “X,”  was also classified as “high risk” because he mocked the media and government officials who erroneously claimed COVID-19 vaccines were 100 percent effective against the virus. Moderna’s report didn’t identify any false statements. Still, it raised concerns that pointing out the “deception by health authorities and health care providers during the pandemic” would “lay the groundwork to sow distrust in credible sources on vaccine safety and effectiveness.” In other words, Moderna wasn’t flagging the video because it was wrong but because it negatively shaped public discourse around COVID-19 vaccines.

Although some tweets flagged by Moderna’s disinformation team were legitimate misinformation, many were “genuine points of disagreement around coercive vaccine policy,” such as vaccine passports and mandates, Mr. Fang told The Hill.

Another Moderna report flagged an Oct. 5 post on X that expressed Mr. Musk's opposition to vaccine mandates. The report states: “Musk has one of the largest platforms in the world—literally and figuratively. He increasingly uses that platform to elevate fringe vaccine opponents and conspiracy theorists.”

“These mandates were not successful in increasing vaccination rates. It got tens of thousands of Americans fired or pushed out of their jobs. These were controversial policies that were eventually overturned by the Supreme Court,” Mr. Fang said.

“This is not an area of misinformation that needed to be censored. This was a legitimate area of public debate around the very controversial and novel application of public policy that benefited just a small number of corporations,” he added. “Basically, the government forcing you to buy a certain product and to use it in your body. This is a bodily autonomy issue—a public health area that deserved more scrutiny, not less.”

Russell Brand, a critic of pharmaceutical companies, was also flagged for his claim that Moderna and Pfizer made $1,000 of profit every second from the pandemic because his views are “circulated in anti-vaccine spaces where he is viewed as a truth-teller and threat to authority,” the report said.

“Where this is potentially problematic is that if you look closely at these misinformation reports, they are clearly blurring the line between fighting actual disinformation—intentional lies—and classifying legitimate points of discussion around vaccine policy as dangerous misinformation,” Fang told The Hill. “They’re taking kind of a broad brush and painting any kind of criticism of their company vaccines as dangerous misinformation.”

According to Moderna emails, other misinformation alerts have centered around drug industry profits, vaccine hesitancy, competitor issues, and discussions of Pfizer. Moderna also closely tracks elected officials against coercive vaccination policies and laws restricting vaccine mandates. “Politicians attempting to ban COVID-19 mandates—or at least claiming to—signals growing resistance to COVID-19 mitigations,” reads one of the Moderna alerts.

Moderna Ramps up Marking Efforts as Profit Dwindles

Now that demand for COVID-19 vaccines has dwindled, so have Moderna’s earnings. Unlike Pfizer, Moderna was a 2010 startup company without an approved product before the COVID-19 pandemic. With the creation of its COVID-19 vaccine, it transformed from a struggling biotech company to a “household name” valued in 2021 at over $100 billion. The pandemic also created five new billionaires at Moderna alone, Mr. Fang told The Hill.

According to company financial reports, Moderna made $18.5 billion in 2021 and $19.3 billion in total revenue in 2022. Through the third quarter of this year, it has only made $3.9 billion.

In addition to lost profits and reduced demand, Moderna must now make royalty payments to the National Institute of Allergy and Infectious Diseases (NIAID), formerly run by Dr. Anthony Fauci, because NIAID scientists collaborated with Moderna to develop its COVID-19 vaccine. As a result, Moderna raised the price of its vaccine from $15–$26 per dose to $130 per dose, the investigative report said.

The European Patent Office also recently invalidated one of Moderna’s European patents on mRNA vaccine technology. Moderna, in 2022 filed a patent infringement lawsuit in Germany, alleging Pfizer and BioNTech had copied its mRNA vaccine technology. The company requested a payout based on vaccine sales during the pandemic—sales of which topped $35 billion in 2022 alone. However, Pfizer and BioNTech countersued Moderna and won. Although Moderna intends to challenge the ruling, a payout would have been substantial.

With evaporating profits, Moderna is relying on a "flashy new marketing campaignhighlighting its mRNA technology and its ability to unlock cures for all sorts of diseases and efforts to rebrand its COVID-19 vaccine as a symbol of a healthy lifestyle.

"The most important thing for Moderna is that people keep having their jabs. Smart ads are part of that. But more important is to push back aggressively against any prevailing anti-vax narrative and engage where possible in any discussions around vaccine policy," wrote Mr. Fang and Mr. Poulson. "That’s where the Moderna disinformation department comes in."

The Epoch Times has reached out to Moderna for comment.

https://www.zerohedge.com/political/moderna-employs-former-fbi-analyst-ai-secretly-police-covid-vaccine-misinformation