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Takeda Group Begins Manufacturing COVID-19 Plasma Treatment Ahead of Approval | Top News

NEW YORK (Reuters) – The Takeda Pharmaceutical Co-led group that is developing a blood plasma treatment for COVID-19 has started manufacturing while the late-stage trial to determine whether it works is ongoing, Takeda Chief Executive Christophe Weber said on Monday.

The group, known as the CoVIg Plasma Alliance, enrolled its first patient in the Phase III trial on Friday after months of delays. It aims to enroll 500 adult patients from the United States, Mexico and 16 other countries and hope to have results by the end of the year.

“The likelihood it works is very high,” Weber said in an interview. “And that’s why we have launched a campaign in order to accelerate the donation of convalescent plasma to manufacture and produce this product.”

The alliance, which includes CSL Behring, Germany’s Biotest AG and other companies, is testing a hyperimmune globulin therapy, which is derived from blood plasma of people who have recovered from COVID-19. Hyperimmune globulin therapy offers a standardized dose of antibodies and does not need to be limited to patients with matching blood types.

That makes it more advanced and convenient than treatment with convalescent plasma drawn from recovered patients.

The manufacturing process is expensive.

Weber said the treatment could be slightly more costly to make than monoclonal antibody treatments like the ones Regeneron Pharmaceuticals Inc and Eli Lilly and Co have developed. The alliance does not intend to profit from the treatment, Weber said.

The Takeda CEO said he does not know how many doses of the treatment the group will be able to produce by the end of the year. That will depend on donations as well as the dosage size they decide to test in the clinical trial.

The trial will test the hyperimmune globulin therapy in combination with Gilead Sciences Inc’s antiviral drug remdesivir compared with patients who get remdesivir alone, he said.

(Reporting by Michael Erman; Editing by Bill Berkrot)

Copyright 2020 Thomson Reuters.

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Michigan Medicine begins recruitment for phase 3 of Janssen COVID-19 vaccine trial

ANN ARBOR, Mich. (WXYZ) — The University of Michigan announced Monday that Michigan Medicine has begun recruiting for phase 3 of the Janssen COVID-19 clinical trial.

The trial, known as the ENSEMBLE study, will evaluate a vaccine for the prevention of COVID-19 as part of a double-blind phase 3 clinical trial.

U-M is one of several sites across the world supporting the trial, which hopes to enroll up to 60,000 people worldwide.

“Michigan Medicine is committed to supporting the continued study of the investigational Janssen vaccine and other vaccine candidates. These trials are crucial to moving us toward an effective vaccine,” says Marschall Runge, M.D., Ph.D., Dean, U-M Medical School, Executive Vice President, Medical Affairs and CEO, Michigan Medicine.

This is the second trial being done on COVID-19 vaccines at U-M. They are also doing an AstraZeneca trial.

Enrollment is open for both trials now, and you can apply to be part of it by visiting uofmhealth.org/covid19-vaccine

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Week of Nobel Prize announcement begins with medicine award

STOCKHOLM (AP) — The 2020 Nobel Prizes kick off Monday with the naming of the winner, or winners, in the field of physiology and medicine.

A panel at the Karolinska Institute in Stockholm will announce the recipient some time after 11:30 a.m. (0930 GMT).

The medicine prize carries particular significance this year due to the coronavirus pandemic, which has highlighted the importance that medical research has for societies and economies around the world. However, it is unlikely that the winners will have been directly involved in researching the new virus, as the prize usually goes to discoveries made many years or even decades ago.

Often the Nobel Assembly recognizes basic science that has laid the foundations for practical applications in common use today.

It is common for several scientists who worked in the same field to share the prize. Last year, British scientist Peter Ratcliffe and Americans William Kaelin and Gregg Semenza received the award for discovering details of how the body’s cells sense and react to low oxygen levels.


The prestigious award comes with a gold medal and prize money of 10 million Swedish kronor (over $1,118,000), courtesy of a bequest left 124 years ago by the prize’s creator, Swedish inventor Alfred Nobel. The amount was increased recently to adjust for inflation.

The other prizes are physics, chemists, literature, peace and economics.

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Read more stories about Nobel Prizes past and present by The Associated Press at https://www.apnews.com/NobelPrizes

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Remote-learning begins in virus-hit Philippines

MANILA, Philippines (AP) — Grade and high school students in the Philippines began classes at home Monday after the coronavirus pandemic forced remote-learning onto an educational system already struggling to fund schools.

The shift to distance-learning has been a logistical nightmare for the poverty-stricken Southeast Asian country that has long lacked enough classrooms, teachers and educational equipment. Nearly 25 million students enrolled this year in mostly 47,000 public schools nationwide that would have to be replicated in homes and enlist the help of parents and guardians as co-teachers.

A majority of families, especially from poor and rural communities, opted to use government-provided digital or printed learning materials or “modules,” which students would read at home with the guidance of their elders before carrying out specified activities. Most lacked computers and reliable internet connections. Teachers could answer questions by telephone.

The rest of the families preferred for their children to get lessons online or through regional radio and TV educational broadcasts.


“The system may not be perfect and there may be issues as we shift to flexible learning … but we are confident that the Department of Education would address these challenges,” presidential spokesman Harry Roque said.

President Rodrigo Duterte has said school classes should resume only when a COVID-19 vaccine has been made available, fearing classrooms could become infection hotspots.

The Philippines has reported more than 322,400 infections, the highest in Southeast Asia, with more than 5,700 deaths.

In other developments in the Asia-Pacific region:

— Sri Lankan authorities closed a university and imposed restrictions on buses and trains on Monday, a day after a COVID-19 patient was reported from the community for the first time in two months. A curfew was imposed Sunday in the Colombo suburbs where the patient lived, and about 15 hospital staff and 40 co-workers have been quarantined. The state-run University of Kelaniya in the area was also closed down for a week starting from Monday. Buses and trains must transport passengers according to the number of seats, and commuters must wear masks. Schools countrywide have been closed down. For more than two months, health officials have been saying that they have prevented the community spread of the virus. The country has reported 3,388 confirmed cases, including 13 deaths. Of the total, 3,254 have recovered.

— India registered 74,442 new coronavirus cases, driving the country’s tally to 6.6 million. The Health Ministry on Monday also reported 903 deaths in the past 24 hours, taking total fatalities to 102,685. India, the second worst-affected nation in the world after the United States, is witnessing a sustained decline in new coronavirus infections and active virus cases have remained below the million mark for 14 consecutive days. It still is registering the highest number of daily cases globally and is soon expected to cross the U.S. which has 7.4 million confirmed coronavirus cases.

— South Korea reported 73 new cases of the coronavirus, although officials worry of a potential rise after the five-day holiday period that ended Sunday. Health

Euro NCAP begins testing driver-assist technologies

The European New Car Assessment Programme (Euro NCAP) is launching a new set of safety tests designed to evaluate driver assistance systems. Aside from seeing how well these systems function, the new tests are also designed give consumers a better understanding of driver assists with different names and functionalities, by fitting them in neat categories.

Euro NCAP’s new assessment protocols focus on three key main areas: Assistance Competence for how well the systems work, Vehicle Assistance for the extent to which it keeps the driver alert and engaged (Driver Engagement) – and Safety Backup, for the system’s effectiveness in critical situations.

Some of the driver assistance systems that will be tested include Highway Assist (HA), a technology designed to make motorway driving safer by reducing fatigue and encouraging safe driving. Adaptive Cruise Control (ACC), and Lane Centering (LC) equipment will also be tested.

https://www.euroncap.com/
https://www.euroncap.com/

The tests will involve a grading scheme with Very good, Good, Moderate, or Entry ratings. These won’t necessarily affect a car’s overall Euro NCAP star rating. However, they will let car buyers know the effectiveness of these systems and the accuracy of how they are marketed.

The first set of vehicles have already been tested, with the latest test series including ten cars that offer Highway Assist: the Audi Q8, BMW 3 Series, Ford Kuga, the Mercedes GLE-Class, Nissan Juke, Peugeot 2008, Renault Clio, Tesla Model 3, Volkswagen Passat, and Volvo V60.

Among those tested, the Mercedes GLE earned the highest ratings (174 out of 200), with Euro NCAP evaluators noting its ability to keep the “driver engaged with plenty of clear communication regarding the assistance offered.” Not too far behind is the BMW 3 Series (172 out of 200), thanks to its intuitive system, with the Audi Q8 getting the third-best score (162 out of 200). All three of those cars received a ‘Very good’ grading.

https://www.euroncap.com/
https://www.euroncap.com/

“Assisted driving technologies offer enormous benefits by reducing fatigue and encouraging safe driving,” said Dr. Michiel van Ratingen, Euro NCAP Secretary General. “However, manufacturers must ensure that assisted driving technology does not increase the amount of harm incurred by drivers or other road users compared to conventional driving.”

“The results of this round of tests demonstrate that driving assistance is fast becoming better and more readily available, but until driver monitoring is significantly improved, the driver needs to remain responsible at all times,” van Ratingen added.

Photo/s from Euro NCAP

Also read:

2nd-Gen Nissan Juke Secures 5-Star Safety Rating from Euro NCAP

Why Don’t Luxury Cars Have NCAP Safety Ratings?

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450 New Coronavirus Cases Reported In Virginia As October Begins

VIRGINIA — To start the month of October, the Virginia Department of Health coronavirus dashboard showed one of the lower new case totals in recent months. On Thursday, 450 new cases were reported, bringing the cumulative case total to 148,721.

The breakdown of new cases by region is 147 in the southwest region, 121 in the northwest region, 71 in the northern region, 60 in the eastern region, and 51 in the central region. The seven-day average of new cases across Virginia is now 747, compared to 997 on Sept. 1.

The positive average of PCR tests remains at 4.5 percent, below the 5 percent rate recommended by the World Health Organization before reopening. Four regions have averages in the 4-percent range — the northwest and eastern regions with 4.4 percent, northern region with 4.3 percent and central region with 4.1 percent. The southwest region has an average above the statewide average — 5.7 percent. The total of PCR tests completed in Virginia stands at 2,074,236, up 24,248 from Wednesday.

Hospitalizations of COVID-19 patients stand at 913 statewide on Thursday. The breakdown of hospital patients by region is 282 in the central region, 199 in the northern region, 178 in the eastern region, 168 in the southwest region, and 86 in the northwest region.

The current hospitalizations include 210 in the intensive care units and 107 on ventilators, according to the Virginia Hospital & Healthcare Association. Ventilator use stands at 20 percent among all Virginia patients, and ICU occupancy remains at 79 percent. There are no hospitals reporting difficulty obtaining personal protective equipment in the next 72 hours.

Here is the latest breakdown of cases, hospitalizations and deaths by age group:

  • Ages 0-9: 5,452 cases, 93 hospitalizations, 0 deaths

  • 10-19: 14,557 cases, 120 hospitalizations, 1 death

  • 20-29: 30,950 cases, 472 hospitalizations, 7 deaths

  • 30-39: 25,471 cases, 961 hospitalizations, 29 deaths

  • 40-49: 22,941 cases, 1,427 hospitalizations, 87 deaths

  • 50-59: 20,816 cases, 2,037 hospitalizations, 223 deaths

  • 60-69: 13,616 cases, 2,218 hospitalizations, 506 deaths

  • 70-79: 7,226 cases, 1,938 hospitalizations, 820 deaths

  • 80 and up: 6,441 cases, 1,807 hospitalizations, 1,551 deaths

  • Not reported: 1,251 cases, 19 hospitalizations, 4 deaths

Here are the latest coronavirus data updates for our coverage area between Tuesday and Wednesday:

  • Alexandria: 3,859 cases, 324 hospitalizations, 69 deaths; increase of seven cases and one hospitalization

  • Arlington County: 3,997 cases, 500 hospitalizations, 150 deaths; increase of two cases

  • Fairfax County: 21,018 cases, 2,166 hospitalizations, 588 deaths; increase of 37 cases and six hospitalizations

  • Fairfax City: 137 cases, 14 hospitalizations, eight deaths; no changes

  • Falls Church: 71 cases, 13 hospitalizations, seven deaths; increase of one case

  • Loudoun County: 6,887 cases, 436 hospitalizations, 126 deaths; two cases removed, increase of one hospitalization and one death

  • Manassas: 1,931 cases, 130 hospitalizations, 26 deaths; no changes

  • Manassas Park: 613 cases, 55 hospitalizations, eight deaths; one case removed

  • Prince William County: 12,594 cases, 919 hospitalizations, 207 deaths; increase of 27 cases, four hospitalizations and two deaths

  • Fredericksburg: 549 cases, 49 hospitalizations, five deaths; increase of

Expanded Medicaid begins in Nebraska after years of dispute

OMAHA, Neb. (AP) — Nebraska will officially offer expanded Medicaid coverage to low-income people starting Thursday after years of wrangling over it in the Legislature, a statewide ballot campaign that led voters to approve it and a nearly two-year rollout that left some people in health care limbo.

The state will provide coverage to 10,288 residents who have signed up so far, a number roughly in line with the state’s projections. State officials expect expanded enrollment to rise to about 90,000 within a few years.

“This expansion is an excellent opportunity” for people who are now eligible, said Dannette Smith, executive director of the Nebraska Department of Health and Human Services.


Nebraska was among several conservative states where state lawmakers and governors declined to expand Medicaid, only to see the issue go to voters. Republican Gov. Pete Ricketts and his GOP predecessor, Dave Heineman, both argued that expansion would be too costly for the state, and lawmakers rejected six attempts in as many years to adopt it as an optional part of President Barack Obama’s 2010 health care law.

The expansion became law in 2018 when voters approved citizen-led measures in Nebraska, Utah and Idaho. Utah and Idaho officials later attached work requirements to their programs.

In Nebraska, the Ricketts administration implemented two tiers of coverage: a “basic” plan available to all newly qualified recipients and a “prime” plan available to people who are working, in school, volunteering or caring for a relative. The prime plan includes coverage for dental and vision care and over-the-counter drugs.

State health officials have defended the expansion’s slower-than-typical launch and their two-tiered approach, calling it a massive undertaking that required numerous layers of federal approval.

Even so, the delays caused a good deal of uncertainty and stress for people who were waiting to enroll, said Molly McCleery, health care access program director for the group Nebraska Appleseed.

“It was extremely difficult for the folks we worked with,” said McCleery, whose group played a major role in bringing the issue to voters. “A lot of people we worked with had long-standing health needs that they needed to get addressed.”

McCleery said that based on the experience of other states that expanded Medicaid, Nebraska is now likely to see a reduction in personal bankruptcies caused by large medical debts. People who aren’t saddled with huge debts are also able to spend more on other goods and services that help the economy, she said.

State officials said they faced several other challenges in expanding Medicaid, including computer system upgrades for processing applicants; hiring more workers; and negotiating new contracts with the private, managed-care companies that will serve Medicaid recipients. The contractors will administer the program, dubbed Heritage Health, with a financial incentive to provide health care services while keeping costs low.

“There was a lot of work that had to go into this,” said Ricketts, who opposed the expansion but promised to follow the will of voters.

Jeremy Brunssen, the state’s interim Medicaid and Long-Term Care director,