Tag: due

By [email protected]_84

Cottonelle wipes recalled due to possible bacteria contamination

A consumer product in heavy demand during the pandemic is being recalled due to the possible presence of bacteria. 

Kimberly-Clark is recalling specific lots of Cottonelle wet wipes sold nationwide because they could be contaminated with bacteria that can cause infections in people, according to the household goods maker.

Billed as having the “texture and the cleansing power of water to deliver long-lasting freshness,” the affected products include Cottonelle Flushable Wipes and Cottonell GentlePlus Flushable wipes manufactured between February 7, 2020, and September 14, 2020, and could contain the bacterium Pluralibacter gergoviae, the company announced Friday.

“At this time there is a low rate of non-serious complaints, such as irritation and minor infection, reported for the affected wipes,” Kimberly-Clark said. 

Those with weakened immune systems or who have serious pre-existing conditions are at particular risk of infection, it added. 

product-code.jpg
Recalled product packaging.

Kimberly-Clark


The wipes are sold broadly in the

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By [email protected]_84

Johnson & Johnson Pauses Coronavirus Vaccine Trials due to ‘Unexplained Illness’ in Participant | Health News

Johnson & Johson has paused the clinical trial for its coronavirus vaccine following an “unexpected illness” in a participant.

Health experts have said that pauses in vaccine trials aren’t uncommon and mean that safety precautions are working. It’s the second vaccine trial to be paused in the U.S. A vaccine from AstraZeneca and Oxford University was put on pause last month after a participant fell ill. That trial hasn’t yet resumed in the U.S.

Photos: Daily Life, Disrupted

TOPSHOT - A passenger in an outfit (R) poses for a picture as a security guard wearing a facemask as a preventive measure against the Covid-19 coronavirus stands nearby on a last century-style boat, featuring a theatrical drama set between the 1920s and 1930s in Wuhan, in Chinas central Hubei province on September 27, 2020. (Photo by Hector RETAMAL / AFP) (Photo by HECTOR RETAMAL/AFP via Getty Images)

It is unclear how long Johnson & Johnson’s pause could last. The company said there is a “significant distinction” between a study pause and a regulatory hold of a clinical trial, which could last much longer.

“We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information,” the company said in a press release Monday night.

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By [email protected]_84

J&J Pauses Coronavirus Vaccine Trials Due to Unexplained Illness | Top News

(Reuters) – Johnson & Johnson

has paused clinical trials of its coronavirus vaccine candidate due to an unexplained illness in a study participant, delaying one of the highest profile efforts to contain the global pandemic.

The move comes around a month after AstraZeneca

also suspended trials of its experimental coronavirus vaccine – which uses a similar technology – due to a participant falling ill.

J&J said on Monday the illness was being reviewed by an independent data and safety monitoring board as well as the U.S. group’s clinical and safety physicians.

The company, which reports quarterly financial results on Tuesday morning, said such pauses are normal in big trials, which can include tens of thousands of people.

It added the voluntary “study pause” in giving doses of the vaccine candidate was different from a “regulatory hold” imposed by health authorities.

AstraZeneca last month paused late-stage trials of its experimental coronavirus

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By [email protected]_84

J&J pauses coronavirus vaccine trials due to unexplained illness

(Reuters) – Johnson & Johnson JNJ.N has paused clinical trials of its coronavirus vaccine candidate due to an unexplained illness in a study participant, delaying one of the highest profile efforts to contain the global pandemic.

The move comes around a month after AstraZeneca AZN.L also suspended trials of its experimental coronavirus vaccine – which uses a similar technology – due to a participant falling ill.

J&J said on Monday the illness was being reviewed by an independent data and safety monitoring board as well as the U.S. group’s clinical and safety physicians.

The company, which reports quarterly financial results on Tuesday morning, said such pauses are normal in big trials, which can include tens of thousands of people.

It added the voluntary “study pause” in giving doses of the vaccine candidate was different from a “regulatory hold” imposed by health authorities.

AstraZeneca last month paused late-stage trials of its

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By [email protected]_84

MacKinnon Dance Academy owner says she must close due to COVID-19

CLOSE

Otis Gillespie, a salsa dance instructor for the MacKinnon Dance Academy in Oxnard, uses a scissor lift to remove the studio’s sign on Wednesday, Sept. 30, 2020, as it prepare to close after more than four decades due to loss of revenue from COVID-19 restrictions. (Photo: ANTHONY PLASCENCIA/THE STAR)

Joy MacKinnon opened up a post on her Facebook page and started to type.

The words didn’t come easily. She didn’t want the message to be too wordy or a sob story or “woe is me” at all.

Mostly, she just kept thinking: “Oh my gosh, I really have to say this now.”

In March, the coronavirus pandemic hit California and soon public health officials ordered closures and people to stay safe at home. The 45-year-old MacKinnon Dance Academy canceled its classes and had to close its doors, like thousands of other local businesses.

MacKinnon expected to weather the closure,

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By [email protected]_84

Johnson & Johnson COVID-19 vaccine trial paused due to ‘unexplained illness’

Johnson & Johnson on Monday night announced that it has paused its COVID-19 vaccine trial due to one of the volunteers coming down with an “unexplained illness.”

In a statement, Johnson & Johnson said that under its guidelines, the “participant’s illness is being reviewed and evaluated” by the study’s independent Data Safety Monitoring Board (DSMB), as well as internal clinical and safety physicians. The company also said that “adverse events — illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies.”

Johnson & Johnson’s vaccine arm, Janssen, began the Phase 3 clinical trial in September. There are 60,000 participants, and each are receiving one dose of the vaccine. Advanced clinical trials are conducted so researchers can determine whether participants are experiencing side effects, and Johnson & Johnson said it is not revealing what illness the volunteer has due to privacy

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By [email protected]_84

Johnson & Johnson pauses COVID-19 vaccine trial due to unexplained illness

The drug and pharmaceutical company failed to provide additional information about the trial participant’s illness.

Johnson & Johnson has halted its advanced clinical trials for a coronavirus vaccine due to an “unexplained illness” of a volunteer participating in medical tests, CNN reports.

“Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians,” the drug and pharmaceutical company said in a statement of the study, which is named ENSEMBLE.

“Adverse events — illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies.”

It’s not clear what the unexplained illness is, however, as CNN points out, such clinical trials could cause side effects for participants. Trials are commonly stopped when side effects occur. Doctors are then able to evaluate the illness and

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By [email protected]_84

Charter School In Hoboken Goes Remote For Now Due To Coronavirus

HOBOKEN, NJ — Elysian Charter School, one of the city’s three charter schools, confirmed over the weekend that it’s going all-remote for now. Sources said that the decision was made after a student at the K-8 school tested positive for coronavirus.

Vijay Chaudhury, a spokesman for Mayor Ravi Bhalla, said over the weekend, “Elysian Charter School has made the decision to go remote given recent developments and in consultation with the Hoboken Health Department. We are confident their precautions will help keep our children safe.”

A representative for the school, located at the north end of town, declined to discuss the matter further or say how long they’ll be closed, but said that they had informed the school community. This story will be updated if more information is received, such as a reopening date.

Charter schools in New Jersey are considered public and do not charge tuition, but receive state

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By [email protected]_84

Newborn Tests Negative After First-Time Mother Gets COVID-19 Ahead of Due Date

A baby in California tested negative for COVID-19 after her mother contracted the disease ahead of the birth earlier this year.



The child’s mother, Rachel Collette, opened up about the “emotional rollercoaster” she endured after contracting the infectious respiratory illness roughly six months ago -- as coronavirus outbreak was spreading globally.


© Anastasiia Chepinska/Unsplash
The child’s mother, Rachel Collette, opened up about the “emotional rollercoaster” she endured after contracting the infectious respiratory illness roughly six months ago — as coronavirus outbreak was spreading globally.

The child’s first-time mom, Rachel Collette, has now opened up about the “emotional rollercoaster” she endured after contracting the infectious respiratory illness roughly six months ago—as the ongoing coronavirus outbreak was spreading rapidly.

Collette revealed her personal experience after taking part in a University of California San Francisco (UCSF) study that found COVID-19 symptoms for pregnant people can be prolonged, lasting two months or longer for some participants.

In the days before giving birth to her daughter, Collette said her symptoms consisted of a dry cough, a sore throat and a headache. Luckily, she said

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By [email protected]_84

Diabetes Drug Recalled Due to High Levels of Substance that ‘Could Cause Cancer,’ FDA Says

Getty

A drug commonly used to treat Type 2 diabetes has been recalled due to cancer concerns.

This week, the Food and Drug Administration announced that Marksans Pharma Limited had expanded its voluntary recall of Metformin Hydrochloride Extended-Release Tablets. An additional 76 unexpired lots were determined to possibly contain levels of NDMA — which is classified by the FDA as a “probable human carcinogen (a substance that could cause cancer)” — that exceed acceptable daily amounts.

The recall applies to Metformin tablets in 500 mg and 750 mg packages, which are both off-white and embossed with either ‘101’ or ‘102’ on one side, and are plain on the other side. More detailed information can be found on the FDA’s website.

FDA Metformin Hydrochloride Extended-Release Tablets

Although the FDA does not know how long patients have potentially been exposed to higher levels of NDMA, they do not believe that any “shorter

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