XTalks

NOVEMBER 7, 2022

“Liquid biopsies have demonstrated promising activity in multiple clinical settings, but the great enthusiasm and expectations around them can be harmful if not adequately managed,” said Dr. El Mustapha Bahassi, PhD, Director, Clinical Laboratory Sciences, at the global clinical research organization (CRO) Medpace.

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Drug Discovery World

APRIL 14, 2023

She is also a Professor of Pathology at the Johns Hopkins University School of Medicine, Co-director of the Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and Deputy Director of the Johns Hopkins Institute for Clinical and Translational Research.

Genetics 52

Genetics Research Medicine Clinical Research 52

STAT News

MARCH 6, 2023

Neoantigen vaccines are designed to target certain proteins called neoantigens on tumor cells. “The biology is pretty solid,” Wu said in a Globe interview, although she estimated that the treatment is still one to five years from FDA approval.

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Vaccination Vaccine Drugs Clinical Trials 98

Intouch Solutions

JUNE 30, 2022

But brands are increasingly going to have to address this unfamiliarity, and normalize therapeutics that aren’t just made out of cellulose and proteins. Blockchain in healthcare: top 10 use cases (medium.com) – How can distributed shared ledgers be leveraged by, and revolutionize, healthcare?

Pharmacy 52

Pharmacy Radiology Cosmetics Manufacturing 52

The Pharma Data

JANUARY 22, 2021

22, 2021 /PRNewswire/ — The Lupus Research Alliance (LRA) is excited to share that the U.S. Food and Drug Administration (FDA) approved the use of Aurinia Pharmaceuticals’ Lupkynis TM (voclosporin) as the first oral treatment developed specifically for adults with active lupus nephritis (LN) in combination with standard of care.

Research 52

Research Antibody FDA Approval Trials 52

XTalks

SEPTEMBER 17, 2020

While clinical researchers occasionally need to identify and validate a new surrogate endpoint for a given trial, choosing endpoints that have been previously used as the basis of NDAs and BLAs can clear the path to eventual approval. Nizoral is prescribed off-label, while the others are FDA approved.

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The Pharma Data

JULY 8, 2021

KEYTRUDA has shown meaningful efficacy in patients with locally advanced or recurrent or metastatic cutaneous squamous cell carcinoma that cannot be cured by surgery or radiation,” said Dr. Vicki Goodman, vice president, clinical research, Merck Research Laboratories. 1) as determined by an FDA-approved test.

FDA Approval 52

FDA Approval Containment Trials Genome 52

The Pharma Data

NOVEMBER 16, 2020

I want to thank the NIH, particularly NIAID, for their scientific leadership including through years of foundational research on potential pandemic threats at the Vaccine Research Center that led to the discovery of the best way to make Spike protein antigens that are being used in our vaccine and others’. About mRNA-1273.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

XTalks

DECEMBER 17, 2021

While researchers are still learning more about Omicron, what we know is that it has the ability to spread quickly, has over 30 mutations in its spike protein and can impact the effectiveness of current vaccines. One of the answers to this is personalization, it’s respecting the fact that every brain is different.”.

Life Science 98

Life Science Vaccination Vaccine Trials 98

The Pharma Data

SEPTEMBER 1, 2020

study investigator and Professor of Clinical Neurology, University of California San Francisco (UCSF) Weill Institute for Neurosciences and clinical research director, UCSF MS Center. Inhibition of drug transporter breast cancer resistance protein has no effect on the pharmacokinetics of major active metabolites of ozanimod.

Trials 52

Trials Clinical Trials Clinical Trials Vaccination 52

Drug Discovery World

AUGUST 10, 2022

Finally, in 2017, after years of improving T cell engineering techniques, the first chimeric antigen receptor (CAR) T cell therapy received FDA approval. Since 2017, five CAR T cell therapies have been approved and have shown incredible success in the clinic. Identifying the right CAR T cell target.

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The Pharma Data

JULY 6, 2021

accelerated approval indication for KEYTRUDA for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 [combined positive score (CPS ?1)] Merck has the industry’s largest immuno-oncology clinical research program.

FDA Approval 52

FDA Approval Containment Trials Genome 52

pharmaphorum

SEPTEMBER 12, 2022

Reddy says one of LabCorp’s groundbreaking tests, OmniSeq INSIGHT, is an “all-in-one test that includes comprehensive genomics and immune profiling from a single tissue sample to identify all FDA-approved therapeutics, confirm immunotherapy eligibility for a patient, and identify appropriate nearby clinical trials.”.

Genome 104

Genome Genomics Clinical Trials Clinical Trials 104

The Pharma Data

MARCH 30, 2021

“KEYTRUDA has become an important treatment option for certain patients with locally advanced or metastatic bladder cancer in the European Union and other countries around the world,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “We 1] as determined by an FDA-approved test.

FDA Approval 52

FDA Approval Containment Trials Genome 52

XTalks

DECEMBER 12, 2023

Efficacy: By comparing with baseline data, clinicians can discern changes in key imaging biomarkers, from the size of brain structures like grey matter, white matter and CSF, to the size of an infarct or the presence of specific proteins like tau or amyloid.

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Trials Clinical Trials Clinical Trials Genetics 111

XTalks

AUGUST 30, 2022

Clinical research experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. What About Small Proteins and Antibodies Reaching Extracellular CNS Targets? Targeting the CNS directly has been successful in modern medicine.

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Trials Drug Delivery Drugs Gene 83

pharmaphorum

DECEMBER 7, 2021

The researchers from the Cleveland Clinic discovered the association between Viagra and a lower risk of Alzheimer’s as part of a wide-ranging study that looked at more than 1,600 FDA-approved medicines to try to find drugs that could be re-purposed as dementia therapies.

Drugs 52

Drugs Clinical Trials Clinical Trials Scientist 52

The Pharma Data

MARCH 23, 2021

Merck has the industry’s largest immuno-oncology clinical research program. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

HR 52

HR FDA Approval Containment Genome 52

The Pharma Data

SEPTEMBER 8, 2020

The findings are expected to improve current understanding of MS disease biology and treatment response, among African-American and Hispanic- and Latinx-American patients with MS, with the ultimate goal of increasing high-quality standard of care to traditionally underserved communities and enhancing equality through clinical research.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Medicine 52

The Pharma Data

NOVEMBER 30, 2020

The study also included communities that have historically been under-represented in clinical research and have been disproportionately impacted by COVID-19. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. These medically high-risk groups represent 42% of the total participants in the Phase 3 COVE study.

Vaccination 52

Vaccination Vaccine Medicine Clinical Trials 52

Drug Discovery World

FEBRUARY 22, 2024

The FDA has approved the supplemental Biologics License Application (sBLA) supporting the traditional approval of LEQEMBI (lecanemab-irmb) injection, for reducing the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer’s disease (AD).

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