pharmaphorum

FEBRUARY 1, 2022

Across the industry, pharma companies are turning to AI and real-world data to address many of the challenges of running clinical trials. Can the combined potential of new AI technologies and real-world patient data hold the key to overcoming the challenges in clinical trial design that have historically led to trial failure?

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Drug Discovery World

AUGUST 23, 2023

Pfizer’s Abrysvo (Respiratory Syncytial Virus Vaccine) was approved for use at 32-36 weeks gestational age of pregnancy to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth to six months of age. In infants and children, the risk of RSV-associated LRTD is highest during the first year of life.

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FDA Approval Vaccination Vaccine Clinical Trials 52

Drug Discovery World

JUNE 6, 2023

Today’s approval is a monumental step forward in delivering on Pfizer’s commitment to help alleviate the significant burden of RSV in higher-risk populations, which includes older adults,” said Annaliesa Anderson, Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer.

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FDA Approval Vaccination Vaccine Clinical Trials 52

World of DTC Marketing

OCTOBER 21, 2021

SUMMARY: Medicare spent nearly $600 million over a three-year period to pay for four cancer drugs with no clinical benefit an analysis published Monday by JAMA Internal Medicine found. Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5

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Clinical Trials Clinical Trials FDA Approval Trials 234

pharmaphorum

MAY 16, 2022

GLP-1 and GIP are hormones involved in blood sugar control and Mounjaro, a first-in-class medicine that activates both GLP-1 and GIP receptors, demonstrated improved blood sugar control. The findings were made via Lilly’s SURPASS phase 3 global clinical development programme, which comprised studies ranging from 40 to 52 weeks.

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FDA Approval Insulin Drugs Hormones 115

Delveinsight

AUGUST 17, 2021

FDA’s Green Flag to Keytruda and Lenvima combination by Merck and Eisai for Advanced renal cell carcinoma (RCC). The FDA approved the combination of Keytruda and Lenvima produced by Merck and Eisai, as a first-line treatment of adult patients with advanced renal cell carcinoma (RCC). Jazz Pharmaceuticals announced the U.S.

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FDA Approval Medicine Vaccination Vaccine 98

XTalks

NOVEMBER 10, 2023

Today, we are proud to further support the rare disease community by delivering Adzynma as the first FDA-approved therapeutic option for people with cTTP.” It’s also been granted orphan designation by the European Medicines Agency (EMA) and Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of TTP.

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FDA Approval Gene Therapy Gene Clinical Trials 59

Drug Discovery World

APRIL 3, 2023

A team of researchers at the Keck School of Medicine of University of Southern California (USC) have found a drug with the potential for curbing painful hyperinflammation from osteoarthritis, according to results of an animal study. In trying to fix the problem, the immune system causes even more damage,” said Evseenko.

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Clinical Trials Clinical Trials Trials Drugs 52

XTalks

AUGUST 4, 2022

Cardiovascular clinical trials need to have a diversity plan because there can be a difference in disease burden when comparing people of different race and ethnicity. The US Food and Drug Administration (FDA) is emphasizing the need for diversity in clinical trials. In the same webinar, Dr. Hansie M.

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Clinical Trials Clinical Trials Trials Clinical Research 52

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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Clinical Trials Clinical Trials Trials FDA Approval 98

Drug Discovery World

JANUARY 23, 2023

Researchers have discovered a clinical drug that sensitises glioblastoma (GBM) cells to radiotherapy and could replace the current standard of care. Armed with this understanding, the researchers further demonstrated that the genetic inhibition of DGAT1 suppresses radioresistance.

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FDA Approval Drugs In-Vivo In-Vitro 52

XTalks

DECEMBER 29, 2023

. “The FDA’s Priority Review designation for this application underscores the urgency to provide new treatment options for patients with advanced SCLC who have progressed following treatment with platinum-based chemotherapy,” said David M.

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Clinical Trials Clinical Trials FDA Approval Trials 119

XTalks

JANUARY 26, 2023

The US Food and Drug Administration (FDA) recently granted approval for the Bruton tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) based on the results from two Phase III clinical trials. Brukinsa is now approved to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

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FDA Approval Life Science Clinical Trials Clinical Trials 97

XTalks

MAY 25, 2022

Research suggests that irregularities in the way that the central nervous system processes pain and normal sensations could be the reason for fibromyalgia. On Thursday, the FDA granted De Novo authorization for NeuroMetrix to market the Quell® wearable neuromodulation device for treating fibromyalgia.

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FDA Approval Clinical Trials Clinical Trials Drugs 105

Drug Discovery World

DECEMBER 11, 2023

The US Food and Drug Administration (FDA) has approved the first cell-based gene therapies for the treatment of sickle cell disease (SCD), Casgevy and Lyfgenia. Casgevy, from Vertex Pharmaceuticals and CRISPR Therapeutics, is also the first FDA-approved treatment to use CRISPR gene editing technology.

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Gene Therapy FDA Approval Gene Gene Editing 52

XTalks

JUNE 2, 2021

KRAS mutations have previously been considered ‘undruggable’ targets, but they have been a big focus in cancer research as they are one of the most common gene mutations across all cancers. The sotorasib approval is therefore a major breakthrough in the world of cancer and targeted therapies.

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FDA Approval Clinical Trials Clinical Trials Trials 97

Advarra

NOVEMBER 17, 2022

In 2016, the Food and Drug Administration (FDA) approved Spinraza (nusinersen). While the FDA’s approval of nusinersen may not seem extraordinary, it was. Nusinersen’s approval marked the first time nonclinical data supported conducting initial clinical trials involving children.

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Clinical Trials Clinical Trials Trials Research 52

Pharmaceutical Technology

AUGUST 12, 2022

In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. Thus, FDA funding could be what is needed on this front, says Cudkowicz.

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Research Gene Therapy Drugs Trials 246

XTalks

JUNE 8, 2022

This marks a new indication for Riabni, the fifth FDA-approved biosimilar by the biopharma Amgen. Register for this free webinar to learn about the different ways in which cell culture workflows in preclinical research can be made safe and traceable. Three of their biosimilars are approved in the European Union (EU).

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FDA Approval Antibody Clinical Trials Clinical Trials 96

The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). The update clarifies the indication by emphasizing information about the disease stages studied in the ADUHELM clinical trials.

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Clinical Trials Clinical Trials FDA Approval Trials 52

Find Me Cure

APRIL 2, 2020

The last couple of weeks had us write many emails to patients applying for clinical trials informing them that the trial they are interested in has been suspended. However, right now researchers are still trying to make sense of the way social distancing is going to impact clinical trials in order to plan for the future.

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Clinical Trials Clinical Trials Trials Research 79

Scienmag

DECEMBER 17, 2020

This is the 9th FDA drug approval supported by Stand Up To Cancer research. Credit: Stand Up To Cancer New York –December 16, 2020 — The FDA recently approved the immunotherapy drug pembrolizumab as a first-line treatment for patients with certain types of advanced colorectal cancer.

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FDA Approval Research Drugs Clinical Trials 52

pharmaphorum

SEPTEMBER 16, 2022

Alphabet subsidiary and precision health company Verily recently announced a breakthrough in its AI drug discovery GPCR research collaboration with Sosei Heptares. Kim recognised then, he said, that better tools for medicine needed to be developed, and that they still do. It also bodes well for improving clinical trial success rates.

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Development Research Drugs Clinical Trials 135

XTalks

SEPTEMBER 28, 2023

a Texas-based pharmaceutical firm specializing in psychotropic drug development, revealed that its groundbreaking antidepressant, Exxua (gepirone extended release) for treating major depressive disorder (MDD), received US Food and Drug Administration (FDA) approval on September 22, 2023. Fabre Kramer Pharmaceuticals, Inc.,

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FDA Approval Clinical Trials Clinical Trials Trials 105

XTalks

APRIL 23, 2021

The therapy is indicated for endometrial cancer that has progressed during, or following, prior treatment with a platinum-based chemotherapy, and in women with dMMR tumors as determined by an FDA-approved test. The immunotherapy has also become the first targeted therapy for the dMMR positive subset of endometrial cancers.

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FDA Approval Trials Antibody DNA 105

The Pharma Data

JANUARY 21, 2021

Today’s FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care,” said Lynn Baxter, Head of North America, ViiV Healthcare. The approval was built on the Phase III ATLAS and FLAIR trials. clinical practices.

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FDA Approval Clinical Trials Clinical Trials Trials 52

XTalks

JANUARY 26, 2024

Technological advancements are revolutionizing cancer research and therapies. By editing these genes, researchers can effectively neutralize their cancer-promoting effects. Personalized medicine: One of the most exciting prospects of CRISPR/Cas9 in oncology is its contribution to personalized medicine.

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Research Gene Editing Gene Genetics 118

Drug Discovery World

AUGUST 3, 2023

In the first part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates the use of medical cannabis in drug discovery. Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance.

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Medicine Scientist Production Regulation 52

pharmaphorum

DECEMBER 22, 2022

For instance, at a recent presentation to the Society of Quality Assurance 2022 Annual Meeting , the FDA Office of Regulatory Affairs Bioresearch Monitoring Division Director Anne Johnson emphasised that DCTs are largely reliant on electronic data integrity and therefore subject to firmly established 21 CFR Part 11 compliance. NPJ Digit Med.

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Clinical Research Research Clinical Trials Clinical Trials 97

Pharmaceutical Technology

JUNE 29, 2022

Almost 40 years since it was instituted, some have described the FDA’s orphan drug program, which is meant to foster innovation, as “ one of the most successful US legislative actions in recent history ”. An orphan drug designation does not automatically translate into approval.

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Drugs FDA Approval Marketing Development 246

Pharmaceutical Technology

AUGUST 5, 2022

In June, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMA) recommended approving the treatment in this setting. This EC approval was based on findings from the parallel-group, double-blind, placebo-controlled, global Phase III OlympiA clinical trial of Lynparza versus placebo.

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FDA Approval DNA Clinical Trials Clinical Trials 147

Bioengineer

JULY 20, 2021

FDA approval based on positive results of international, multi-center ProDERM study. The prospective, double-blind, placebo-controlled Phase III clinical trial enrolled 95 patients at 36 sites globally, including 17 sites in the U.S., Credit: Octapharma. PARAMUS, N.J. – The U.S. residents. . 1, 2, 3, 4.

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FDA Approval Clinical Trials Clinical Trials Trials 40

The Pharma Data

SEPTEMBER 7, 2021

The first patients have been enrolled in a phase 1 randomized placebo-controlled clinical trial to study a therapeutic vaccine for opioid use disorder developed by researchers at the University of Minnesota Medical School. The vaccine currently being tested stimulates the body’s immune system to produce antibodies to oxycodone.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

BioTech 365

SEPTEMBER 16, 2020

Data published in the New England Journal of Medicine positions the medication belimumab to become the first FDA approved drug to treat lupus nephritis MANHASSET, N.Y.–(BUSINESS

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Clinical Trials Clinical Trials FDA Approval Drugs 52

Clinical Trial Podcast

FEBRUARY 23, 2021

Almost everyone I’ve met in clinical research has accidentally discovered this hidden profession. Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. Clinical Research is sometimes also referred to as Medical Affairs or Clinical Affairs.

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Clinical Research Research Clinical Trials Clinical Trials 105

Velocity Clinical Research

JUNE 22, 2023

The Velocity Clinical Research team in Los Angeles, CA, is tackling two of the biggest health threats to Americans today: obesity and diabetes. We’re at the breakthrough,” he says, citing several potentially huge new therapies for which he and his team have been active in the clinical trials. “I

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Clinical Trials Clinical Trials Clinical Research FDA Approval 52

Drug Discovery World

OCTOBER 18, 2023

Sara Donnelly, Director of Research Planning and Business Development at PhoenixBio USA explores why the right pre-clinical model is essential for teams wanting to advance adeno-associated virus vector-based gene therapies. However, NHP models cannot fully predict AAV transduction in the human liver.

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Gene Therapy Gene Clinical Trials Clinical Trials 64