Tag: Trial

By iwano@_84

Beyond Celiac Chosen by 9 Meters Biopharma as Exclusive Patient Organization to Recruit for First-Ever Phase 3 Clinical Trial

Premier Patient Recruiter for Celiac Disease Research, Beyond Celiac Taps Extensive Network to Advance Study

Go Beyond Celiac, an online patient database launched in 2017, allows its thousands of users to participate in research by sharing their celiac disease stories and experiences and learn how to become involved in research studies such as the Phase 3
Go Beyond Celiac, an online patient database launched in 2017, allows its thousands of users to participate in research by sharing their celiac disease stories and experiences and learn how to become involved in research studies such as the Phase 3
Go Beyond Celiac, an online patient database launched in 2017, allows its thousands of users to participate in research by sharing their celiac disease stories and experiences and learn how to become involved in research studies such as the Phase 3

Philadelphia, PA, Oct. 14, 2020 (GLOBE NEWSWIRE) — Beyond Celiac, the leading catalyst for a celiac disease cure in the United States, today announced it has been chosen by 9 Meters Biopharma, Inc. (Nasdaq: NMTR) as the exclusive patient organization to recruit for the first-ever Phase 3-stage clinical trial therapeutic for treatment of

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By iwano@_84

Eli Lilly pauses trial of antibody drug Trump touted as COVID-19 ‘cure’ over safety concern

By Michael Erman and Carl O’Donnell

(Reuters) – Eli Lilly and Co said on Tuesday that the government-sponsored clinical trial of its COVID-19 antibody treatment similar to one taken by U.S. President Donald Trump has been paused because of a safety concern.

Trump touted the Lilly drug, along with the antibody treatment from Regeneron Pharmaceuticals Inc that he received for his COVID-19, as tantamount to a cure in a video he posted last week.

The announcement comes one day after Johnson & Johnson said it was forced to pause a large high-profile trial of its experimental coronavirus vaccine because a volunteer fell ill. J&J said it does not yet know if that person was given the vaccine or a placebo.

AstraZeneca Plc’s U.S. trial for its experimental COVID-19 vaccine has also been on hold for over a month after a volunteer in its UK study fell ill. Trials of that

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By iwano@_84

Eli Lilly antibody trial paused over safety concerns

Checking in: The trial design calls for the data and safety monitoring board to examine results from the first 300 participants — including their need for supplemental oxygen, mechanical ventilation or other supportive care five days after receiving the treatment or a placebo — before proceeding with further enrollment.

The NIAID trial has so far enrolled 326 patients. An agency spokesperson said that the board overseeing the trial this morning “reached a predefined boundary for safety at day five.” The board will now decide whether the trial should add 700 more participants.

The NIAID spokesperson added that the pause in enrollment is “out of an abundance of caution” and the safety board is “continuing data collection and follow-up of current participants for safety and efficacy.”

The late-stage study is examining whether Lilly’s antibody, known as bamlanivimab, could help hospitalized patients. The treatment is a monoclonal antibody that mimics the antibodies

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By iwano@_84

Eli Lilly’s Antibody Trial Is Paused Over Potential Safety Concern

A government-sponsored clinical trial that is testing an antibody treatment for Covid-19 developed by the drugmaker Eli Lilly has been paused because of a “potential safety concern,” according to emails that government officials sent on Tuesday to researchers at testing sites. The company confirmed the pause.

The news comes just a day after Johnson & Johnson announced the pause of its coronavirus vaccine trial because of a sick volunteer, and a month after AstraZeneca’s vaccine trial was halted over concerns about two participants who had fallen ill after getting the company’s vaccine.

The Eli Lilly trial was designed to test the benefits of the antibody therapy on hundreds of people hospitalized with Covid-19, compared with a placebo. All of the study participants also received another experimental drug, remdesivir, which has become commonly used to treat coronavirus patients. It is unclear exactly what safety issues prompted the pause.

In large clinical

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By iwano@_84

As Dr. Javaid Perwaiz faces trial, the women he treated question decades of care

CHESAPEAKE, Va. — The last time Brittni DuPuy-German saw her trusted gynecologist, she once again explained that the stabbing, mystery pain in her abdomen had not gone away.

It first appeared two years earlier, after she said her doctor, Javaid Perwaiz, surgically tied her tubes. To fix it, he had proposed more surgery — three additional procedures in nine months that she said included a hysterectomy when she was 29. But the pain persisted.

So on Nov. 8, 2019, at his private-practice office, Perwaiz and DuPuy-German discussed the possibility of yet another surgery, she said. He scheduled an ultrasound for just days later, a sign of the efficiency that DuPuy-German had come to expect from her family’s longtime gynecologist. He was her mother’s doctor, her sister-in-law’s doctor, her best friend’s doctor. Perwaiz had delivered DuPuy-German and delivered her children.

Which is why, when her phone buzzed the day after her

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By iwano@_84

Are Antibody Infusions Safe? Eli Lilly Pauses COVID Treatment Trial

KEY POINTS

  • Eli Lilly did not say what symptoms the ill patient developed
  • President Trump was given an antibody cocktail as part of his COVID treatment
  • AstraZeneca earlier paused it’s vaccine trial but has since restarted it in the U.K.

 

Eli Lilly (LLY) on Tuesday paused its coronavirus antibody trial because of a potential safety concern just one day after Johnson & Johnson (JNJ) paused its COVID-19 vaccine trial because of an unexplained illness.

The New York Times reported emails between Lilly and federal government officials concerned the trial testing the benefits of the antibody therapy on hundreds of hospitalized COVID-19 patients. All study patients also were receiving Gilead’s (GILD) trial remedy Remdesivir.

The Times said no details were provided on the number of volunteers who fell ill or any details about their illnesses.

Last week, Lilly reported just two test subjects had serious infusion reactions.

President Donald Trump received

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By iwano@_84

Johnson & Johnson pauses coronavirus vaccine trial following ‘unexplained illness’ in participant

Pharmaceutical giant Johnson & Johnson on Monday night announced that it had paused its late-stage COVID-19 vaccine trial after an “unexplained illness” was reported in a participant. 

“Adverse events – illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies,” the company said in a statement when announcing the temporary halt. 

The pause, which was first reported by the health news site STAT, come after the company began the Phase 3 trial of its vaccine in September. 

The pause, which was first reported by the health news site STAT, come after the company began the Phase 3 trial of its vaccine in September. 
(iStock)

No details on the illness were revealed, and it’s not currently clear if the illness is related to the shot or was a coincidence. It’s also not clear if the volunteer had received the vaccine or the placebo. 

“Based on our strong commitment to safety, all clinical studies conducted by the Janssen Pharmaceutical Companies of Johnson & Johnson have prespecified guidelines. These

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By iwano@_84

U.S. pauses Eli Lilly’s trial of a coronavirus antibody treatment over safety concerns

  • Eli Lilly’s phase-three trial of its ACTIV-3 monoclonal antibody treatment for coronavirus has been paused due to potential safety concerns.
  • The ACTIV-3 trial is designed to test a monoclonal antibody developed by Eli Lilly in combination with remdesivir, an anti-viral with emergency use authorization for the virus.
  • It’s one of several ongoing trials, as part of the National Institute of Health’s “Activ” program, designed to accelerate the development of vaccine treatments in partnership with the pharmaceutical industry.



a group of people standing around a plane: In this May 2020 photo provided by Eli Lilly, researchers prepare mammalian cells to produce possible COVID-19 antibodies for testing in a laboratory in Indianapolis.


© Provided by CNBC
In this May 2020 photo provided by Eli Lilly, researchers prepare mammalian cells to produce possible COVID-19 antibodies for testing in a laboratory in Indianapolis.

Eli Lilly’s late-stage trial of its leading monoclonal antibody treatment for the coronavirus has been paused by U.S. health regulators over potential safety concerns, the company confirmed to CNBC on Tuesday.

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“Safety is of the utmost importance to Lilly. We are aware

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By iwano@_84

Johnson & Johnson vaccine trial; WHO herd immunity

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Since the coronavirus pandemic started, the United States has recorded more than 7.6 million cases of COVID-19 and 213,000 deaths.

USA TODAY

A third of U.S. states are reporting higher coronavirus case counts than they’ve ever had before.

A USA TODAY analysis of Johns Hopkins data shows 16 states set records for new cases in a week. But nearly all the states are surging: 41 states had worse weeks than they did a week earlier. And an analysis of COVID Tracking Project data shows that in 36 states, a higher rate of people were testing positive than in the week before.

While the data continue to show the virus’ reach is not letting up, the head of the World Health Organization said achieving herd immunity by allowing the virus to spread is “scientifically and ethically problematic.”

“Herd immunity is achieved by protecting people from a virus, not by exposing

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By iwano@_84

COVID Vaccine Update as Johnson & Johnson Trial Suffers Setback, Sanofi Aims for Mid-2021 Rollout

There are currently nearly 200 potential COVID-19 vaccine candidates in development, including 42 under clinical evaluation and 151 under pre-clinical evaluation, according to a report by the World Health Organization published on October 2.



a person wearing a costume: A lab technician wearing observing a bottle containing a reagent before performing vaccine tests at French pharmaceutical company Sanofi's laboratory in Val de Reuil in northwest France on July 10. Sanofi is hoping to get its COVID-19 vaccine candidate approved within the first half of 2021.


© Joel Saget/AFP via Getty Images
A lab technician wearing observing a bottle containing a reagent before performing vaccine tests at French pharmaceutical company Sanofi’s laboratory in Val de Reuil in northwest France on July 10. Sanofi is hoping to get its COVID-19 vaccine candidate approved within the first half of 2021.

On Monday, U.S.-based Johnson & Johnson announced a pause on all of its COVID-19 vaccine candidate clinical trials due to an “unexplained illness” in one of its study participants.

French pharmaceutical company Sanofi is hoping to have its vaccine candidate rolled out by mid-next year, according to Olivier Bogillot, its chief executive officer.

“We are in a very concrete environment at the regulatory

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