The Pharma Data

JANUARY 21, 2021

Eli Lilly reported yesterday that its monoclonal antibody bamlanivimab (LY-CoV555) significantly lessened the risk of contracting COVID-19 among nursing home residents and staff, according to findings from a phase 3 trial. James Miessler. Source link.

Nurses 52

Nurses Research Laboratories Laboratories Virus 52

Codon

JANUARY 21, 2024

Human challenge trials were an indispensable part of the development of the malaria vaccine, R21/Matrix-M, endorsed by the World Health Organization last October. But for all of their benefits, human challenge trials have their drawbacks. Jake himself has participated in both Zika and Shigella challenge trials.

Vaccine 109

Vaccine Trials Disease Treatment 109

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.

Hospitals 52

Hospitals Treatment Trials Long-Term Care Facilities 52

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.

Hospitals 52

Hospitals Production Clinical Trials Therapies 52

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.

Hospitals 40

Hospitals Treatment Virus Nurses 40

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.

Clinical Trials 52

Clinical Trials Nurses Trials Treatment 52

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.

Virus 52

Virus Trials Nurses Research Laboratories 52

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.

Nurses 78

Nurses Clinical Research Clinical Trials Hospitals 78

The Pharma Data

DECEMBER 4, 2020

That response is facing its toughest challenge so far, as daily case counts, hospitalizations and deaths continue to set records on a daily basis. “If we don’t act now our hospital system will be overwhelmed,” Gov. Gavin Newsom said. “If we don’t act now, we’ll continue to see our death rate climb.”

Vaccine 52

Vaccine Long-Term Care Facilities Nurses Hospitals 52

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.

Treatment 40

Treatment Trials FDA Hospitals 40

The Pharma Data

JANUARY 24, 2021

With a presidential inauguration and a federal holiday, it wasn’t an enormously busy week for clinical trial news, but there was a fair amount, nonetheless. It inked a deal with the National Institute of Allergy and Infectious Diseases (NIAID) to launch a Phase I trial. Read on to see. COVID-19-Related. Non-COVID-19-Related.

Long-Term Care Facilities 52

Long-Term Care Facilities Trials Virus Clinical Trials 52

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.

Licensing 52

Licensing Licensing Pharmacy FDA 52

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.

Vaccine 52

Vaccine FDA Hospitals Doctors 52

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.

Medical Schools 111

Medical Schools Nurses Research Production 111

The Pharma Data

JANUARY 27, 2021

The report entitled “Pre-Exposure Prophylaxis for COVID-19 in Pregnant Women” was written by nurse practitioner Melissa Fesler and internist Raphael Stricker from the Alan E. The study is available at [link]. Beer Medical Center for Reproductive Immunology in Los Gatos, CA, and Union Square Medical Associates in San Francisco, CA.

Vaccine 52

Vaccine Nurses International Treatment 52

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.

Vaccine 52

Vaccine Nurses FDA Virus 52

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.,

Therapies 52

Therapies FDA Clinical Trials Hospitals 52

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.

Research 52

Research Nurses Disease Immune Response 52

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.,

Government 52

Government Hospitals Virus Clinical Trials 52

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.

Vaccine 52

Vaccine Virus Immune Response Hospitals 52

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.

FDA Approval 52

FDA Approval FDA Clinical Trials Trials 52

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.

Vaccine 40

Vaccine Long-Term Care Facilities Hospitals Nurses 40

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.

Research 52

Research Clinical Trials Compliance Regulations 52

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.

Therapies 52

Therapies Trials Disease Treatment 52

Conversations in Drug Development Trends

NOVEMBER 13, 2024

Luckily, Zak’s mom, a nurse, guided us over the phone, suspecting kidney stones. I rushed back to the health center, where I received shocking news: I had a kidney infection, another UTI, a blood glucose level of 388 (normal is 80-120), and was told to go to the hospital immediately. That was the day my life changed.

Hospitals 64

Hospitals Clinical Trials Doctors Nurses 64

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.–(

Treatment 52

Treatment Trials Therapies Clinical Trials 52

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.

FDA 40

FDA Clinical Trials Hospitals Production 40

The Pharma Data

DECEMBER 1, 2020

13 to 17 and attracted participants from around the world, including cardiovascular specialists, surgeons, and nurses as well as other health care professionals. “It is important to remember that this is a single clinical trial,” Maruthur said. AHA: Obese Patients More Likely to Be Hospitalized for COVID-19.

Hospitals 52

Hospitals Disease Treatment Therapies 52

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.

Vaccine 52

Vaccine Virus Assisted Living Nurses 52

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.

Treatment 52

Treatment Pharmaceutical Companies Therapies Virus 52

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?

Trials 52

Trials Hospitals Clinical Trials Nurses 52

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.

Pharmaceuticals 52

Pharmaceuticals Treatment Packaging Doctors 52

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.

Clinical Trials 40

Clinical Trials Trials Therapies Treatment 40

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.

Disease 40

Disease Treatment Nurses Doctors 40

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.

Treatment 40

Treatment Trials Therapies Clinical Trials 40

The Pharma Data

JUNE 18, 2021

The GLOW study is a randomized, open label Phase 3 trial comparing progression-free survival in patients treated with either I+V or C+O as assessed by an Independent Review Committee. IMBRUVICA is the most comprehensively studied BTK inhibitor, with more than 150 ongoing clinical trials. About the GLOW Study.

Treatment 52

Treatment Therapies FDA FDA Approval 52

The Pharma Data

JUNE 18, 2021

Additionally, there are other ongoing company-sponsored and investigator-initiated trials exploring the potential of ibrutinib and venetoclax in combination for CLL treatment, including the Phase 3 GLOW study. IMBRUVICA is the most comprehensively studied BTK inhibitor, with more than 150 ongoing clinical trials.

Treatment 40

Treatment FDA Therapies FDA Approval 40