FDA Approval, In-Vitro and Life Science - Clinical Research Informer

Veklury Becomes the First FDA-Approved COVID-19 Treatment for Children Under 12

XTalks

APRIL 27, 2022

Gilead’s Veklury (remdesivir) gets FDA approval to treat young children with COVID-19 and becomes the first and only approved COVID-19 treatment for children under 12. The drug is approved for children hospitalized with COVID-19 or non-hospitalized children who fall under the high-risk category for developing severe COVID-19. “As

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Ixchiq Wins FDA Approval as World’s First Chikungunya Vaccine

XTalks

NOVEMBER 15, 2023

The FDA says chikungunya is an emerging global health threat as at least 5 million cases of chikungunya virus infection have been reported in the last 15 years. Today’s approval addresses an unmet medical need and is an important advancement in the prevention of a potentially debilitating disease with limited treatment options.”

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Sunlenca (lenacapavir) Receives FDA Approval as HIV Treatment Option for Multi-Drug Resistant Infection

XTalks

JANUARY 9, 2023

Gilead Sciences, Inc. recently announced in a press release that Sunlenca (lenacapavir) received approval from the US Food and Drug Administration (FDA) for use as a twice-yearly treatment option for people living with multi-drug resistant HIV (human immunodeficiency virus).

FDA Approval

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Repurposing FDA-approved drugs may help combat COVID-19

The Pharma Data

FEBRUARY 25, 2022

Several FDA-approved drugs – including for type 2 diabetes, hepatitis C and HIV – significantly reduce the ability of the Delta variant of SARS-CoV-2 to replicate in human cells, according to new research led by scientists at Penn State. ” The findings published today (Feb. ” The findings published today (Feb.

FDA Approval

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Standigm and SK Chemicals Repurpose FDA-approved Drug into Rheumatoid Arthritis Candidate and Apply for Patent through their Open Innovation Partnership

The Pharma Data

JANUARY 6, 2021

SK Chemicals has shared their expertise in these diseases and validated the predicted targets and compounds through in vitro and in vivo studies. SK Chemicals is a leading company in the fields of chemistry and life science. SK Chemicals is a leading company in the fields of chemistry and life science.

FDA Approval

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Xdemvy Sets a New Standard in Demodex Blepharitis Care with FDA Nod

XTalks

AUGUST 9, 2023

a leader in developing therapeutic solutions for common diseases with limited treatment alternatives, has secured approval from the US Food and Drug Administration (FDA) for its drug, Xdemvy (lotilaner ophthalmic solution) 0.25%. California-based Tarsus Pharmaceuticals Inc., What Is Demodex Blepharitis?

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Top 20 Drugs in 2023 by 2022 Sales Statistics

XTalks

DECEMBER 19, 2023

From life-saving cancer medications to treatments for chronic conditions, these top-selling drugs underscore the industry’s focus areas and innovation trajectories. billion Company: Pfizer Disease it is FDA-approved to treat: Comirnaty is an active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.

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Innovative Nipocalimab Trial for HDFN Treatment Powered by BillionToOne

XTalks

DECEMBER 28, 2023

This results in anemia, characterized by a decreased number of RBCs, and jaundice, indicated by high bilirubin levels, typically appearing within the first days or weeks of life. Although recruitment has not started, AZALEA plans to enroll and assess the therapy in 120 participants.

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Brain Awareness Week 2024: A Spotlight on Brain Health and New Treatments for Neurological Diseases

XTalks

MARCH 6, 2024

It also emphasizes the importance of brain health across the lifespan, advocating for strategies to maintain brain function, improve mental health and enhance quality of life. This relates to neurological conditions like dementia and Alzheimer’s disease, which account for up to 70 percent of dementia cases.

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Can vertical AI advance cell and gene therapies?

Drug Discovery World

DECEMBER 8, 2023

With human clinical trials with AI-designed drugs now ongoing, it’s only a matter of time until the FDA approves its first AI-designed drug. Andrew Busey , Co-Founder, Form Bio discusses why vertical AI is set to reshape the cell and gene therapy sector. Here’s what this means for pharmaceutical leaders and patients.

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The Utility of Liquid Biopsy in Oncology Clinical Trials

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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Top 10 Medical Device Companies in 2023 by Revenue Statistics and Trends

XTalks

JUNE 12, 2023

Medtronic’s proactive stance towards R&D is evident from the over 230 clinical trials it conducted and the more than 200 regulatory approvals it received in the US, Europe, Japan and China in the 2022 fiscal year. Join us as we explore the inspiring journey and significant contributions of these top 10 medical device companies.

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Microscopic innovations in women’s health

Drug Discovery World

SEPTEMBER 28, 2023

This transfer imparts immune advantages: Infants born vaginally have a greater concentration of Bacteroides, Bifidobacteria, and Lactobacillus , as well as more diverse microbial compositions in their first weeks of life compared to children born by C-section (caesarean section). The influence of these microbiomes extends to children as well.

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What the Glycome Can Tell Us About Persistent HIV Infection

XTalks

AUGUST 12, 2020

Despite the effectiveness of anti-retroviral therapy (ART) in significantly improving health, quality of life and reducing mortality among HIV-positive individuals, new research shows that persistent infections may be due to the ability of the virus to take refuge in distinct subsets of immune T cells.

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Lab to jab in 100 days: manufacturing flexibility for future rapid responses

Pharmaceutical Technology

NOVEMBER 22, 2022

The live attenuated vaccine was authorized by the EMA and FDA five years later in 2019 — half the time than normal. The live attenuated vaccine was authorized by the EMA and FDA five years later in 2019 — half the time than normal. Before COVID-19, Merck held the record for the fastest modern vaccine ever developed.

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Clinical Research Informer

Veklury Becomes the First FDA-Approved COVID-19 Treatment for Children Under 12

Ixchiq Wins FDA Approval as World’s First Chikungunya Vaccine

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Sunlenca (lenacapavir) Receives FDA Approval as HIV Treatment Option for Multi-Drug Resistant Infection

Repurposing FDA-approved drugs may help combat COVID-19

Standigm and SK Chemicals Repurpose FDA-approved Drug into Rheumatoid Arthritis Candidate and Apply for Patent through their Open Innovation Partnership

Xdemvy Sets a New Standard in Demodex Blepharitis Care with FDA Nod

Top 20 Drugs in 2023 by 2022 Sales Statistics

Innovative Nipocalimab Trial for HDFN Treatment Powered by BillionToOne

Brain Awareness Week 2024: A Spotlight on Brain Health and New Treatments for Neurological Diseases

Can vertical AI advance cell and gene therapies?

The Utility of Liquid Biopsy in Oncology Clinical Trials

Top 10 Medical Device Companies in 2023 by Revenue Statistics and Trends

Microscopic innovations in women’s health

What the Glycome Can Tell Us About Persistent HIV Infection

Lab to jab in 100 days: manufacturing flexibility for future rapid responses

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