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Monday, January 31, 2022

Trudeau Tests Positive For COVID While Hiding Out From Canadian Truckers

 Canadian Prime Minister was accused of hypocrisy when he suddenly was nowhere to be found late last week as a convoy of truckers rolled into Ottawa to protest the government's COVID mandates. Many scoffed at Trudeau's sudden disappearing act when confronted by a massive crowd of protesters, many carrying signs mocking his comment that the truckers and their supporters were part of a "tiny fringe minority".

Making matters worse for the PM, Canadian media reported Monday morning that Trudeau had been diagnosed with COVID, despite receiving a booster dose early this month on Jan. 4.

The truckers are protesting a new measure imposed by the Canadian government on Jan. 15 requiring unvaccinated cross-border truckers to quarantine upon returning home, making it virtually impossible for them to work. The convoy ended outside Parliament in Ottawa over the weekend, as thousands of protesters gathered.

Trudeau had reportedly decided to isolate due to one of his children testing positive for COVID. Now it appears he too has tested positive. Of maybe this is just another excuse for him to remain in hiding?

Former President Trump praised the Canadian truckers over the weekend, proclaiming that they were doing more to protect American freedoms than any lawmakers.

According to his own quarantine requirements, Trudeau now has an excuse to remain in hiding for up to 14 days.

https://www.zerohedge.com/political/coward-19-trudeau-tests-positive-covid-while-hiding-out-canadian-truckers

Biden Fed nominee Raskin opposed by 24 state financial officers on 'radical' economic views

 A coalition of Republican state financial officers is pushing back again Sarah Bloom Raskin, President Biden’s nominee to become the Federal Reserve's top Wall Street regulator, over concerns that her economic views on issues like climate change and the private banking sector are "radical."

In a Monday letter addressed to the White House, 24 state treasurers, auditors and financial officers urged Biden to withdraw his nomination of Raskin as the Fed's vice chair of supervision, warning that her past statements indicate she is "willing to place the growth and stability of the U.S. economy at risk to achieve her preferred social outcomes."

A major point of contention for the state financial officers is Raskin's stance on climate change and her view that it poses a systemic risk to the U.S. financial system. Raskin has previously argued that all financial institutions should re-evaluate their relationships with energy companies and has advocated for a push toward sustainable investments that do not depend on carbon and fossil fuels. If banks and other financial institutions do not take these steps to distance themselves from fossil-fuel companies, Raskin has said the Fed should penalize them.  

Sarah Bloom Raskin, governor of the U.S. Federal Reserve, listens during an open meeting of the Board of Governors of the Federal Reserve in Washington, D.C., on Tuesday, Dec. 10, 2013.  (Photographer: Andrew Harrer/Bloomberg via Getty Images / Getty Images)

"We oppose Ms. Raskin’s radical banking and economic views and are deeply concerned that she would use the supervisory authority as Vice-Chair for Supervision at the Federal Reserve Bank to disrupt the private banking sector, reliable energy supplies, and the U.S. economy," the state financial officers wrote. 

Signatories included the financial officers from Nebraska, Arkansas, Missouri, Utah, Louisiana, Arizona, Florida, Georgia, Idaho, Indiana, Kentucky, Mississippi, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, West Virginia and Wyoming. 

The letter comes just a few days before Raskin is scheduled to testify before the Senate Banking Committee on Thursday, along with two other academic economists that Biden tapped to join the central bank's board of governors: Lisa Cook and Philip Jefferson. The nominees need to be approved by a simple majority vote in the Senate. 

As vice chair for supervision, Raskin – a Duke University law professor who has held high-level jobs at both the Treasury Department and the Fed – would oversee annual stress tests that review bank safety and liquidity. Her nomination has been welcomed by progressive senators and advocacy groups, who think she will take a tougher stance against Wall Street than her predecessor, Randal Quarles, a Trump nominee who stepped down last month. 

But Republicans are already gearing up to fight Raskin's nomination as the Fed's top regulatory czar: A senior GOP aide told FOX Business that the party has "serious concerns" about her push to develop financial regulatory policies for cryptocurrencies and fighting climate change. Raskin's husband, Rep. Jamie Raskin, D-Md., also led the second impeachment trial of former President Donald Trump.

Raskin previously served on the Fed's board from 2010 to 2014 and was tapped by former President Barack Obama to serve as assistant Treasury secretary. 

Sen. Pat Toomey, the ranking member of the Senate Banking Committee, is expected to press Raskin over her view that federal policymakers take "bold actions" in order to avoid an "economic catastrophe" brought on by climate change. He also plans to question her calls for the Fed to allocate credit to businesses and deny credit to disfavored ones, such as oil and gas companies. 

"I have serious concerns that she would abuse the Fed’s narrow statutory mandates on monetary policy and banking supervision to have the central bank actively engaged in capital allocation. Such actions not only threaten both the Fed’s independence and effectiveness, but would also weaken economic growth," Toomey, R-Pa., said in a statement. 

Late last year, Biden nominated Chairman Jerome Powell to a second four-year term at the helm of the central bank, and picked current Fed Governor Lael Brainard as the Fed's second-in-command.  

https://www.foxbusiness.com/politics/biden-federal-reserve-nominee-opposition-state-treasurers

U.S. grants full approval to Moderna's COVID vaccine in adults

 The U.S. Food and Drug Administration on Monday gave full approval to Moderna Inc's COVID-19 vaccine for people age 18 and older, making it the second fully approved vaccine for the virus.

The Moderna vaccine has been authorized for emergency use in the United States since December 2020, and will now be sold under the brand name Spikevax. Pfizer and BioNTech's COVID-19 shot using similar technology received full approval in the United States last year for people aged 16 and older after also first gaining emergency authorization.

Nearly 75 million people have already received Moderna's two-dose vaccine in the United States, according to data from the U.S. Centers for Disease Control and Prevention.

"The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States," Acting FDA Commissioner Dr. Janet Woodcock said in a statement.

Moderna's vaccine is cleared for use in more than 70 countries, including Canada and the European Union.

https://finance.yahoo.com/news/1-moderna-receives-full-u-162107677.html

EU Digital COVID Certificate

 On 21 December, the European Commission adopted rules relating to the EU Digital COVID Certificate, establishing a binding acceptance period of 9 months (precisely 270 days) of vaccination certificates, following a primary 2-dose vaccination series or 1-dose series for the Johnson and Johnson vaccine, for the purposes of intra-EU travel. A clear and uniform acceptance period for vaccination certificates will guarantee that travel measures among the EU countries continue to be coordinated.

The validity period of 9 months takes into account the guidance of the European Centre for Disease Prevention and Control, according to which booster doses are recommended at the latest six months after the completion of the first vaccination cycle. The Certificate will remain valid for a grace period of an additional three months beyond those six months to ensure that national vaccination campaigns can adjust and citizens will have access to booster doses.

These new rules will apply from 1 February 2022.

The Commission has earlier proposed to update the rules on coordination of safe and free movement in the EU. Updates pertaining to the EU Digital COVID certificate are:

  • Focus on a ‘person-based approach': A person who has a valid EU Digital COVID Certificate should in principle not be subject to additional restrictions, such as tests or quarantine, regardless of their place of departure in the EU. Persons without an EU Digital COVID Certificate could be required to undergo a test carried out prior to or after arrival.
  • Booster shots: As of yet, there are no studies expressly addressing the effectiveness of boosters on the transmission of COVID-19 and therefore it is not possible to determine an acceptance period for boosters. However, given the emerging data, it can be expected that protection from booster vaccinations may last longer than that resulting from the primary vaccination series. On the basis of new scientific evidence on this issue, the Commission may, if needed, propose an appropriate acceptance period also for vaccination certificates issued following a booster.

The Commission also proposed an updated framework for travel from outside the EU, prioritising vaccinated travellers, with strong safeguards.

  • Member States should reopen systematically to those vaccinated with vaccines having completed the WHO emergency use listing process, in addition to reopening to those vaccinated with EU-approved vaccines as is the case today. As an essential safeguard, proof of a negative PCR test will always be required for all travellers who have been vaccinated with a WHO-approved vaccine that is not approved by the European Medicines Agency, and for recovered travellers. The updates also introduce a time limit of 9 months for the acceptance of vaccination certificates after the primary vaccination series. The updates also include acceptance of vaccination certificates issued after an additional (“booster”) dose.
  • Member States should accept non-EU vaccination and recovery certificates deemed equivalent to the EU Digital COVID Certificate.

These updates are currently under discussion with Member States

How can citizens get the certificate?

National authorities are in charge of issuing the certificate. It could, for example, be issued by test centres or health authorities, or directly via an eHealth portal. 

  • Vaccination certificates are issued by the Member State where the vaccination has been administered.
  • Test certificates are issued by the Member State where the test has taken place.
  • Recovery certificates are issued by the Member State where the recovered person is located.

Information on how to get the certificate should be provided by the national health authorities. 

The digital version can be stored on a mobile device. Citizens can also request a paper version. Both will have a QR code that contains essential information, as well as a digital signature to make sure the certificate is authentic.

Member States have agreed on a common design that can be used for the electronic and paper versions to facilitate the recognition.

https://ec.europa.eu/info/live-work-travel-eu/coronavirus-response/safe-covid-19-vaccines-europeans/eu-digital-covid-certificate_en

Reata Starts FDA Rolling Submission for Friedreich’s Ataxia Med

 Reata Pharmaceuticals, Inc. (Nasdaq: RETA), ("Reata," the "Company," "our," "us," or "we"), a clinical-stage biopharmaceutical company, today announced that the company has initiated a rolling submission of a New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for omaveloxolone for the treatment of patients with Friedreich’s ataxia. The rolling submission allows Reata to submit portions of the regulatory application to the FDA for review on an ongoing basis. The company reiterates that it expects to complete the submission of the NDA by the end of the first quarter of 2022.

https://finance.yahoo.com/news/reata-pharmaceuticals-initiates-rolling-submission-114500457.html

Madrigal's drug candidate reduces fatty liver in late-stage NASH trial

 Madrigal Pharmaceuticals Inc said on Monday a late-stage trial showed that its experimental drug helped reduce liver fat and certain lipids in patients with non-alcoholic steatohepatitis (NASH), an inflammatory disease of the liver.

Shares of the company were 18% higher before the bell.

The drug resmetirom was found to be safe and well-tolerated when given in doses of 80 and 100 mg once a day in the 972-patient trial.

"These positive results ... support our conviction that resmetirom has the potential to be the first medication approved for the treatment of patients with NASH and liver fibrosis," Chief Executive Officer Paul Friedman said.

NASH is a chronic liver disease characterized by excess fat, inflammation and cell damage in liver that can cause fibrosis or scarring of the organ, ultimately leading to cirrhosis or liver cancer.

It is estimated that about 5% of adults in the United States have NASH, according to the Liver Fondation, but there is no approved treatment for the ailment.

https://finance.yahoo.com/news/1-madrigals-drug-candidate-reduces-125328359.html

Altimmune: FDA Clears Pemvidutide (ALT-801) IND for Obesity

 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for its Phase 2 clinical trial of pemvidutide for obesity. Pemvidutide is an investigational GLP-1/glucagon dual receptor agonist under development for the treatment of obesity and non-alcoholic steatohepatitis (NASH). Altimmune expects to initiate the Phase 2 trial in obesity in the first quarter of 2022. The Company previously received IND clearance for pemvidutide in NASH and is currently enrolling subjects with nonalcoholic fatty liver disease (NAFLD) in a Phase 1b trial.

https://finance.yahoo.com/news/altimmune-announces-fda-clearance-pemvidutide-120000469.html