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Monday, April 19, 2021

Interpace Biosciences Raises Full Year 2021 Revenue Guidance

 Interpace Biosciences, Inc. (“Interpace” or the “Company”) (OTCQX: IDXG) today announced an update to its full year 2021 revenue guidance originally provided on March 31, 2021.

"We saw increased and sustained clinical volume activity during the first quarter, which, coupled with our improved reimbursement rates translated into higher revenues overall for Interpace than initially forecasted,” said Thomas W. Burnell, CEO and President. “We now expect 2021full year revenue to be in the range of $42 to $44 million as compared to our prior guidance of $38 to $40 million provided at the time of our full year and fourth quarter 2020 earning’s announcement. This represents an approximate 30% to 36% improvement over our 2020 full year revenue.” Burnell added, “With the revenue growth and restructuring progressing as planned, expectations remain to achieve our goal of EBITDA break-even by the end of 2021. We will provide additional detail when we report the Company’s first quarter results in May.”

https://finance.yahoo.com/news/interpace-biosciences-raises-full-2021-110500873.html

XBiotech To Test New Med With Approved Pancreatic Cancer Treatment

 

  • The FDA has signed off Phase 1/2 clinical study to evaluate XBiotech Inc's (NASDAQ: XBIT) XB2001 when added to the ONIVYDE/5-FU combination therapy for treating patients with pancreatic cancer.
  • The Phase 1 portion of the study will examine increasing doses of XBiotech's new drug and assess the tolerability of the combination at escalating doses.
  • Once a safe dose has been determined, the phase 2 portion will begin, enrolling 60 patients. The trial will be randomized to receive treatment with ONIVYDE/5-FU or ONIVYDE/5-FU combined with XB2001.
  • Clinical endpoints in the study are safety, overall survival, objective response rate, progression-free survival, time to treatment failure, clinical benefit response, number of severe adverse advents, and biological measures of experimental drug activity.
  • XB2001 specifically targets a process potentially involved in the growth and spread of malignant tumors. The drug also blocks inflammation associated with tissue injury, which may reduce toxicity associated with the chemotherapy and allow these drugs to be better tolerated and more effective.
  • ONIVYDE (irinotecan liposome injection) is indicated, in combination with fluorouracil (5-FU) and leucovorin (LV), for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.

Sunday, April 18, 2021

New UK challenge trial studies if people can catch coronavirus again

 British scientists on Monday launched a trial which will deliberately expose participants who have already had COVID-19 to the coronavirus again to examine immune responses and see if people get reinfected.

https://www.reuters.com/world/uk/new-uk-challenge-trial-studies-if-people-can-catch-coronavirus-again-2021-04-18/

China trials mixing of COVID-19 vaccines from CanSinoBIO and Zhifei Longcom

 Chinese researchers are testing mixing two COVID-19 vaccines developed by CanSino Biologics (6185.HK) and a unit of Chongqing Zhifei Biological Products (300122.SZ) respectively, according to clinical trial registration data.

https://www.reuters.com/business/healthcare-pharmaceuticals/china-trials-mixing-covid-19-vaccines-cansinobio-zhifei-longcom-data-2021-04-19/

What CDC VAERS Database Reveals About 'Adverse' Post-Vaccine Reactions

 By Megan Redshaw via ChildrensHealthDefense.org,

Data released today by the Centers for Disease Control and Prevention (CDC) on the number of injuries and deaths reported to the Vaccine Adverse Event Reporting System (VAERS) following COVID vaccines revealed reports of blood clots and other related blood disorders associated with all three vaccines approved for Emergency Use Authorization in the U.S. — PfizerModerna and Johnson & Johnson (J&J). So far, only the J&J vaccine has been paused because of blood clot concerns.

VAERS is the primary mechanism for reporting adverse vaccine reactions in the U.S. Reports submitted to VAERS require further investigation before a causal relationship can be confirmed.

Every Friday, VAERS makes public all vaccine injury reports received through a specified date, usually about a week prior to the release date. Today’s data show that between Dec. 14, 2020 and April 8, a total of 68,347 total adverse events were reported to VAERS, including 2,602 deaths — an increase of 260 over the previous week — and 8,285 serious injuries, up 314 since last week.

Of the 2,602 deaths reported as of April 8, 27% occurred within 48 hours of vaccination, 19% occurred within 24 hours and 41% occurred in people who became ill within 48 hours of being vaccinated.

In the U.S., 174.9 million COVID vaccine doses had been administered as of April 8. This includes 79.6 million doses of Moderna’s vaccine, 90.3 million doses of Pfizer and 4.9 million doses of the J&J COVID vaccine.

This week’s VAERS data show:

Reports of blood clotting disorders in VAERS

Children’s Health Defense queried the VAERS data for a series of adverse events associated with the formation of clotting disorders and other related conditions. VAERS yielded a total of 795 reports for all three vaccines from Dec. 14, 2020, through April 8.

Of the 795 cases reported, there were 400 reports attributed to Pfizer, 337 reports with Moderna and 56 reports with J&J — far more than the eight J&J cases under investigation, including the two additional cases added Wednesday.

As The Defender reported today, although the J&J and AstraZeneca COVID vaccines have been under the microscope for their potential to cause blood clots, mounting evidence suggests the Pfizer and Moderna vaccines also cause clots and related blood disorders. U.S. regulatory officials were alerted to the problem as far back as December 2020.

CDC ignores The Defender, no response after 39 days 

According to the CDC’s website, “the CDC follows up on any report of death to request additional information and learn more about what occurred and to determine whether the death was a result of the vaccine or unrelated.”

On March 8, The Defender contacted the CDC with a written list of questions about reported deaths and injuries related to COVID vaccines. We requested information about how the CDC conducts investigations into reported deaths, the status of ongoing investigations reported in the media, if autopsies are being done, the standard for determining whether an injury is causally connected to a vaccine, and education initiatives to encourage and facilitate proper and accurate reporting.

After many attempts to get a response from the CDC, 22 days after our initial outreach a representative from the CDC’s Vaccine Task Force responded, saying the agency had never received our questions — even though the employees we talked to several times said their press officers were working through the questions we sent.

We provided the questions again and set a new deadline of April 7. We’ve reached out multiple times since, but the representative has not answered our emails or returned our calls.

On April 15 we called the CDC’s general media line again and were told they had our list of questions and were unsure why the representative told us she never received them. We were told the COVID response team would be informed and that we should follow up in a few days.

It has been 39 days since we first reached out and have yet to receive answers to our questions.

Johnson & Johnson paused over reports of blood clot

On April 15, The Defender reported that a healthy 43-year old man in Mississippi suffered a stroke hours after being vaccinated with J&J’s COVID vaccine. Brad Malagarie, father of seven, had received the vaccine a little after Noon and was found unresponsive by co-workers at his desk.

Also on April 15, the  Cincinnati Enquirer reported that the Ohio Department of Health is monitoring the investigation into what may have caused a 21-year-old University of Cincinnati student to die suddenly last Sunday, about a day after he received the J&J vaccine.

Alicia Shoults, a spokeswoman for the state health department, said the agency is waiting for the completion of a Hamilton County coroner’s report, and “if necessary,” further guidance from the CDC.

The two news stories came just days after federal health officials paused the J&J vaccine.

As The Defender reported April 13, the CDC and U.S. Food and Drug Administration (FDA) called for a temporary but immediate halt to the use of J&J’s COVID vaccine while the agencies investigated the vaccine’s possible link to potentially dangerous blood clots.

In a joint statement, the agencies said the Advisory Committee on Immunization Practices (ACIP) was reviewing clinical data gathered on six women, one who died, between the ages of 18 and 48 years who developed blood clots after receiving the single-dose J&J vaccine.

On April 14, the ACIP held an emergency meeting to vote on whether to lift the pause on J&J’s vaccine or change recommendations for its use. As The Defender reported, the ACIP postponed the vote, extending the pause pending further analysis of data relating to blood clots. The ACIP said it would reconvene for a vote in one week to 10 days.

That same day, J&J revealed two more cases of blood clots — one that occurred in a 25-year-old man who suffered a cerebral hemorrhage during a clinical trial and another case of deep-vein-thrombosis in a 59-year-old woman.

In its review of J&J’s submission for Emergency Use Authorization in February, the FDA initially urged further surveillance of a slight “numerical imbalance” in blood clotting events after receiving the shot. At the time, it was concluded there was “insufficient” data to determine “a causal relationship” with the vaccine and the drugmaker resumed the trial.

As The Defender reported April 12, the rollout of J&J’s COVID vaccine has not been smooth. At the beginning of the month the vaccine maker had to throw out 15 million doses of its vaccine after they were contaminated with AstraZeneca vaccine ingredients at an unapproved manufacturing plant in Baltimore.

The vaccine maker also has been plagued with shutdowns of its vaccine sites prior to the vaccine being paused, multiple reports of COVID breakthrough cases and criticism over its CEO’s $30 million pay package while the company pays out billions for its role in the opioid epidemic.

CDC, multiple states report ‘breakthrough’ COVID cases among fully vaccinated

Cases of fully vaccinated people getting COVID, referred to as “breakthrough” cases, continue to make news.

Calling it a “really good scenario,” the CDC yesterday reported 5,800 cases of COVID in fully vaccinated people. Of the 5,800 cases, 396 required hospitalization and 74 people died, the CDC said.

The CDC said it was “keeping a close eye” on the cases, but that breakthrough cases are to be expected. Tara Smith, a professor of epidemiology at the Kent State University College of Public Health in Ohio, told NBC News:

“This is a really good scenario, even with almost 6,000 breakthrough infections. Most of those have been mildly symptomatic or asymptomatic. That’s exactly what we were hoping for.”

On April 12, the Houston Health Department reported 142 breakthrough cases of COVID that occurred in fully vaccinated people since January, according to ABC 13 News. Vaccine recipients received either two doses of Moderna or Pfizer, or one dose of J&J. The report ruled out those who were said to have contracted the virus 45 days before their second scheduled shot date.

Houston Health Department said there were 2.46 positive cases out of every 10,000 fully-vaccinated people and it was unclear if those who tested positive contracted the original strand of COVID or a newer variant.

Last month, The Defender reported on breakthrough cases in Washington, Florida, South Carolina, Texas, New York, California and Minnesota. On April 6, The Defender reported on 246 breakthrough cases in Michigan, which included three people who died.

Children’s Health Defense asks anyone who has experienced an adverse reaction, to any vaccine, to file a report following these three steps.

https://www.zerohedge.com/covid-19/what-cdcs-vaers-database-reveals-about-adverse-post-vaccine-reactions

Ontario to expand use of AstraZeneca COVID vaccine as epidemic rages

 The Canadian province of Ontario will begin offering AstraZeneca's (AZN.L) COVID-19 vaccine on Tuesday to people turning 40 or older this year, according to a government source.

https://www.reuters.com/world/americas/exclusive-canadas-ontario-expand-use-astrazeneca-covid-vaccine-epidemic-rages-2021-04-18/

Latest COVID-19 surge hitting Ram truck production at Stellantis

 Michigan's worst-in-the-nation COVID-19 surge could be affecting auto production at the plant where the popular Ram 1500 pickup is built.

A published report put the number of absent production workers who either tested positive or were in quarantine on Tuesday at 630, up from about 200 from a week prior.

Bloomberg, citing unnamed sources, said Stellantis' Sterling Heights Assembly Plant, known as SHAP, "fell short of its daily build number by between 200 and 300 vehicles this week."

More than 7,800 workers are employed at SHAP, according to the company, but that total includes other types of workers beyond production, such as skilled trades. 

Spokespeople for Stellantis, the company formed from the merger of Fiat Chrysler Automobiles and Peugeot-maker PSA Group earlier this year, responded with a company statement when asked about the accuracy of the report.

"Stellantis continues to be vigilant in enforcing our comprehensive, multilayered program of health and safety measures that was put in place last year to protect our employees. As COVID cases are increasing in communities across Michigan, we also have had employees test positive. We continue to be aggressive in following recommended guidelines for contact tracing," according to the statement provided by spokeswoman Jodi Tinson. "We also continue to strongly encourage our employees to follow the same health and safety measures whenever they are out and about."

The company said employees are urged to get vaccinated and that it has been facilitating employee vaccinations in metro Detroit.

The UAW said cases are up, although it did not confirm the specific numbers.

“While the numbers change by shift, we can say that there is an recent increase in cases, as there is throughout Michigan," according to a statement from UAW Vice President Cindy Estrada. "Based on our daily calls with the company we know many of the absences are not positive cases, but rather absences due to close contact quarantine, waiting on test results or other COVID-related absences to be as cautious as possible and keep the plants and our UAW members and families safe.”

The union noted that its protocols call for self-reporting and quarantine for exposures in and out of the plant.

The situation puts extra stress on a company already dealing with extensive production issues connected to the global chip shortage. Five Stellantis plants in North America are currently shut down:

  • Warren Truck, north of Detroit — Ram 1500 Classic pickup
  • Belvidere Assembly in Illinois — Jeep Cherokee SUV
  • Brampton Assembly, northwest of Toronto in Ontario — Chrysler Charger, Challenger and 300 sedans
  • Windsor Assembly, in Ontario but near Detroit — Chrysler Pacifica and Pacifica Hybrid minivans
  • Toluca Assembly, west of Mexico City — Jeep Compass

The shutdown has now been extended for several plants. Belvidere, Windsor and Toluca are now scheduled to be down until the end of April. Warren Truck is to be down until the end of May, although the company said it "remains on track for the launch of the all new Grand Wagoneer." Only Brampton is to restart this month, on Monday.

The strategy has left other, high-margin plants operating.

Spokeswoman Shawn Morgan noted that the company continues "to prioritize key products as we work to get through the situation."

Stellantis is far from alone in feeling the effects of the chip shortage. Automakers, including Ford and General Motors, have also been forced to grapple with the fallout, and have had their own production disruptions.

But with COVID-19 cases once again adding to the woes, Stellantis is facing new pressure because any production losses at SHAP affect one of the company's most profitable vehicles, the newer version of the Ram 1500.

https://www.freep.com/story/money/cars/chrysler/2021/04/16/ram-truck-plant-sterling-heights-covid-19-surge-production/7255441002/