The Pharma Data

DECEMBER 17, 2020

(NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. “The investigational cocktail is now available to indicated high-risk U.S.

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Olympian Clinical Research

JUNE 25, 2020

Environmental changes such as travel, hospitalization, new visitors, etc. Changes in living situation, such as moving to a new residence home or nursing home. The introduction of a new caregiver. Misperceived threats. Fear and fatigue. Alteration to their normal routine. Medications For Agitation Associated With Alzheimer’s Dementia.

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The Pharma Data

OCTOBER 25, 2020

The Company plans to initiate a Phase 2 trial within the next several months. “We Agitation associated with delirium is commonly seen in numerous hospital settings, resulting in serious medical complications and extended hospital stays. Food and Drug Administration (“FDA”) for the treatment of agitation associated with delirium.

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Advarra

APRIL 30, 2024

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct is complicated. Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. Below are examples of key items auditors/inspectors look for during an audit.

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Drug Target Review

AUGUST 16, 2024

In those roles, she oversaw the direction, planning, execution and interpretation of clinical trial data. I graduated with my BS in physiology and later attended the University of Michigan Medical School. Their contributions have paved the way for subsequent generations, leading to ground-breaking discoveries and technological innovation.

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The Pharma Data

JULY 23, 2021

. “Serious infections in children can be difficult to treat and the impact of ABSSSI among children is significant, as these infections often require IV antibiotics, resulting in hospitalization,” said Margaret Burroughs, medical director, infectious diseases, AbbVie. Use in Specific Populations.

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Advarra

SEPTEMBER 7, 2023

This can include independent IRBs or those at other academic medical centers or hospitals. This includes the IRB or EC, sponsored research, and the clinical trials office – when a COI is identified, HRPP staff can collaborate to determine appropriate management. material transfer agreements and data use agreements) and study budgets.

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Altus Drug Development

MAY 31, 2022

Adoption of value-based healthcare practices leads to patients requiring fewer visits to the hospital, testing, invasive procedures, and expensive medication. Developing novel methodologies can help nurses and other people in charge of delivering care to better handle the treatment of patients.

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On Medicine

FEBRUARY 26, 2023

After many trials, and misdirection to the sexual health clinic, at the age of twenty-three, Daniella was finally diagnosed with Behçet’s disease. She also disclosed a childhood medical history of fainting from bowel cramping, classified as irritable bowel syndrome, and being hospitalized on one occasion.

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The Pharma Data

DECEMBER 29, 2020

29, 2020 /PRNewswire/ — Phase 3 program in hospitalized patients to continue based on passing futility analysis on ability to reduce incidence of death or mechanical ventilation. As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes.

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The Pharma Data

JANUARY 12, 2021

Doses are being supplied for use pursuant to the FDA Emergency Use Authorization for high-risk patients with mild to moderate COVID-19 in order to reduce the risk of progression to severe COVID-19 and/or hospitalization. To date, nearly 15,000 people have participated in casirivimab and imdevimab clinical trials. Yancopoulos , M.D.,

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The Pharma Data

NOVEMBER 18, 2020

18, 2020 /PRNewswire/ — Tampa General Hospital provided the first monoclonal antibody treatment to a COVID-19 positive patient today. Eli Lilly and Company’s antibody therapeutic will be distributed as part of the federal government’s Operation Warp Speed. . TAMPA, Fla., For more information, visit health.usf.edu.

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The Pharma Data

DECEMBER 12, 2020

Health care workers and nursing home residents and staff should get the initial shots, according to guidelines issued recently by a U.S. The nursing home industry applauded the approval. The association represents 14,000 nursing homes and assisted living facilities. Third of Americans live where hospitals are short on ICU beds.

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The Pharma Data

AUGUST 27, 2020

The anti-PD-1 therapy combo was approved in Europe in September 2019 based on findings from the pivotal Phase III KEYNOTE-426 trial, which demonstrated that the drug reduced the risk of death by 47% compared with sunitinib in the indication. Source link.

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The Pharma Data

NOVEMBER 20, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. Yancopoulos, M.D.,

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The Pharma Data

DECEMBER 14, 2020

14, 2020 (Healthday News) — The first shipments of nearly 3 million doses of the Pfizer coronavirus vaccine were on their way to hospitals in all 50 U.S. Because the vaccines can cause side effects including fevers and aches, hospitals have said they will stagger vaccinations among their workers. MONDAY, Dec.

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The Pharma Data

DECEMBER 14, 2020

Recently published CDC guidelines recommend that health care workers and nursing home residents and staff should be the first to receive the vaccine. The vaccine is administered in two doses three weeks apart.

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The Pharma Data

DECEMBER 3, 2020

Professor of Neurology at UCSF Benioff Children’s Hospitals and Director of the UCSF Pediatric Epilepsy Center of Excellence. Clinical Trials. STK-001 is an investigational new medicine for the treatment of Dravet syndrome currently being evaluated in a Phase 1/2a clinical trial. Antiepileptic Drugs / 7B. About STK-001.

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The Pharma Data

AUGUST 11, 2020

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -577 trial evaluating Opdivo (nivolumab) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction (GEJ) cancer met its primary endpoint of disease-free survival (DFS) at a pre-specified interim analysis.

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The Pharma Data

NOVEMBER 21, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron.

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The Pharma Data

AUGUST 11, 2020

The safety profiles of Opdivo and chemotherapy in this trial are reflective of the known safety profiles of Opdivo and chemotherapy in first-line gastric and esophageal cancers. The company remains blinded to data from this arm and the trial continues in follow-up to allow the data to mature. PRINCETON, N.J.–(

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The Pharma Data

DECEMBER 11, 2020

Health care workers and nursing home residents and staff should get the first shots, according to guidelines issued recently by the U.S. Instead, a modified version of the vaccine will be tested in a smaller trial set to begin in February, the newspaper said. Third of Americans live where hospitals are short on ICU beds.

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The Pharma Data

NOVEMBER 19, 2020

A study out of Rutgers University found that healthcare staffers, especially nurses, have a higher prevalence of COVID-19 than non-healthcare workers. The study data came from a prospective study of participants at Rutgers and affiliated hospitals during the early phase of the pandemic. Healthcare Workers Most at Risk for COVID-19.

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The Pharma Data

DECEMBER 18, 2020

The panel vote came the same day the country set three grim pandemic records: More than 250,000 new coronavirus cases; more than 114,000 hospitalized COVID-19 patients; and more than 3,400 deaths. Moderna’s vaccine was shown to be 94 percent effective in its large clinical trial, while Pfizer’s vaccine was 95 percent effective.

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The Pharma Data

DECEMBER 15, 2020

Food and Drug Administration released a data review that almost guarantees a second vaccine will soon join the Pfizer vaccine that was sent out on Monday: Moderna’s two-shot regimen, which is based on the same technology as the Pfizer vaccine, was found to be 94 percent effective in a clinical trial and carried no serious safety concerns.

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The Pharma Data

DECEMBER 19, 2020

. “With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” FDA Commissioner Dr. Stephen Hahn said in a statement.

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On Medicine

MAY 10, 2023

In 2017, Better Start Bradford (funded by The National Lottery Community Fund) commissioned Bradford Teaching Hospitals NHS Foundation Trust to trial a midwife-led continuity of carer model of maternity care, delivered alongside traditional maternity care. How has the model been implemented in Bradford?

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The Pharma Data

NOVEMBER 24, 2020

And when you do, it’s normal that you have some arm soreness or some fatigue or some body aches or even some fever,” Patricia Stinchfield of Children’s Hospitals and Clinics of Minnesota, told the meeting of the CDC’s Advisory Committee on Immunization Practices. effective, The New York Times reported.

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The Pharma Data

DECEMBER 2, 2020

Still, the temperature requirement could dictate who will be vaccinated first in Britain: While nursing home residents were supposed to be the top priority under an advisory committee’s plans, efforts to limit transportation of the vaccine may mean that National Health Service staff will receive the shots first, the Times reported.

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The Pharma Data

DECEMBER 21, 2020

. “With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said FDA Commissioner Dr. Stephen Hahn. billion, the Post reported.

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The Pharma Data

JANUARY 26, 2021

Eli Lilly expanded its ongoing BLAZE-4 study to include Vir’s monoclonal antibody in the trial. Data published last week showed that bamlanivimab significantly reduced COVID-19 risk for nursing home residents in a Phase III trial. . Food and Drug Administration to treat mild-to-moderate COVID-19 patients.

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The Pharma Data

JANUARY 11, 2021

million, will boost its vaccine rollout to now include health care workers, nursing home residents and staff, as well as those living in congregate settings such as assisted living or shelters. Food and Drug Administration last week said it would stick with the two-shot dose backed by randomized clinical trials. But the U.S.

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The Pharma Data

JANUARY 26, 2021

“The death toll from COVID-19 continues to rise around the world and hospitalizations, particularly in the U.S., These data further support our belief that bamlanivimab and etesevimab together have the potential to be an important treatment that significantly reduces hospitalizations and death in high-risk COVID-19 patients.

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The Pharma Data

DECEMBER 3, 2020

The TAK-620-303 (SOLSTICE) trial (NCT02931539) is a multicenter, randomized, open-label, active-controlled trial comparing eight weeks of treatment with either maribavir or investigator assigned treatment (IAT) in transplant recipients with CMV infection refractory or resistant to existing antiviral treatments (i.e., About Maribavir.

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The Pharma Data

APRIL 28, 2021

The opinion is based on results from the double-blind, placebo-controlled VIALE-A (M15-656) and the Phase 1b open-label, nonrandomized, multicenter M14-358 trial. Professor of Medicine and Director, Department of Hematology, Oncology, Palliative Care, Rheumatology and Infectious Diseases at University Hospital in Ulm, Germany.

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The Pharma Data

MAY 13, 2021

And I was rushed to hospital in the back of an ambulance… As paramedics desperately tried to keep me alive. I could hear doctors and nurses speaking in hushed tones…. And Mary-Anne, a nurse from Arkansas, who says…. In a major double-blind clinical trial published in the American College of Endocrinology….

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The Pharma Data

JUNE 18, 2021

“The CLL14 trial results observed after four years of follow-up with treatment of venetoclax plus obinutuzumab show that these patients can experience long-lasting responses without disease progression, years after stopping treatment,” said Mohamed Zaki , M.D., NORTH CHICAGO, Ill. NORTH CHICAGO, Ill.

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