Pharmaceutical Technology

DECEMBER 23, 2022

The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Sunlenca (lenacapavir) plus other antiretroviral(s) (ARV) to treat human immunodeficiency virus type 1 (HIV-1) infection. Subcutaneous lenacapavir’s antiviral activity administered every six months was analysed in the trial.

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Pharmaceutical Technology

NOVEMBER 3, 2022

The US Food and Drug Administration (FDA) has granted approval for the supplemental new drug application (sNDA) of Gilead Sciences ’ Vemlidy (tenofovir alafenamide) to treat chronic hepatitis B virus (HBV) infection in paediatric patients.

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Pfizer

OCTOBER 27, 2022

Listen Now—Science Will Win Season 2 Takes on Breast Cancer. Listen Now—Science Will Win Season 2 Takes on Breast Cancer. Science Will Win , one of Pfizer’s premiere podcasts, is back! Part one: Breast Cancer: The Science, The Challenges, The Solutions . Part two: Clinical Trials: Bringing Research to Life.

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XTalks

AUGUST 2, 2023

Eichenfield serves on Verrica Pharmaceuticals’ Board of Directors and spoke to Xtalks about the company’s recent approval of YCANTH (cantharidin) topical solution as the first FDA approved treatment for pediatric and adult patients with molluscum contagiosum, a highly contagious viral skin infection that primarily affects children.

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Pharmaceutical Technology

JULY 22, 2022

Muge Cevik, a clinical scientist, shared an article around the mystery of viral hepatitis cases in children. The World Health Organization (WHO) further stated that at least 18 of the children underwent liver transplants, and one had died. Peter Hotez’s tweet on PAI Life Sciences’ phase 1 trial of its snail fever vaccine.

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The Pharma Data

OCTOBER 25, 2020

NASDAQ: PTCT), today announced the initiation of a registration-directed Phase 2/3 clinical trial to evaluate vatiquinone (PTC743) in patients with mitochondrial epilepsy, the highly morbid condition of refractory seizures in children with inherited mitochondrial disease. . SOUTH PLAINFIELD, N.J. , Peltz , Ph.D.,

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Pharmaceutical Technology

DECEMBER 12, 2022

Regulatory decisions and clinical trial news. Regulatory decisions by the US FDA and EMA and clinical trial announcements for select therapies from late October to late November, and the CMOs contracted to manufacture them. The EMA also recommended Moderna’s Spikevax for children ages six months to five years.

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The Pharma Data

JUNE 17, 2022

In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group Three 3-µg doses had favorable safety profile similar to placebo in young children ages 6 months through 4 years in Phase 2/3 clinical trial Pfizer-BioNTech COVID-19 Vaccine now authorized in the U.S.

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Drug Discovery World

OCTOBER 6, 2023

Total-body PET scans are quicker and more sensitive than the current technology, exposing patients to considerably lower doses of radiation, meaning more patients, including children, can participate in clinical trials.

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XTalks

MAY 24, 2022

It is predicted that there are 5000 new cases of HIV infection every day, and 500 of these happen in children. There has been a lengthy search to find an HIV cure and there have been a few promising trials, including the stem cell transplantation reported at the 2022 Conference on Retroviruses and Opportunistic Infections (CROI-2022).

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Pharmaceutical Technology

MARCH 27, 2023

Gilead Sciences’ (Foster City, CA, US) Veklury (remdesivir), among others, has already provided contracts to multiple CMOs, and as a Covid-19 therapy, it has required high production volume in recent years. There are ongoing Phase II/III trials of Veklury in children.

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Cloudbyz

SEPTEMBER 16, 2021

Cloudbyz, a fast-growing integrated Clinical Research and development solution provider in Healthcare & Life Science, has recently executed a CSR drive at the Samarthanam Trust for the Disabled showcasing its commitment to social responsibility by giving back to the community. Participation has shown promising levels of enthusiasm.

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XTalks

DECEMBER 20, 2023

In 2023, there were significant advancements and notable trends in the life sciences. Xtalks compiled a list of its top life science news and trends of 2023, which provided readers with the latest developments, information and expert insights across life science industries, including pharma, biotech and medical device.

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XTalks

APRIL 7, 2021

In this episode of the Xtalks Life Science Podcast, Ayesha discusses a report from the Center for Countering Digital Hate (CCDH) and Anti-Vax Watch that shows there are just 12 people behind 65 percent of all online anti-vaccine disinformation. Ayesha also talks about the latest clinical trial results for Pfizer/BioNTech’s COVID-19 vaccine.

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The Pharma Data

APRIL 15, 2022

About the Phase 1/2/3 Trial in Children. The Phase 1/2/3 trial initially enrolled up to 4,500 children ages 6 months to under 12 years of age in the United States, Finland, Poland, and Spain from more than 90 clinical trial sites. About the Pfizer-BioNTech Laboratory Study.

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Drug Discovery World

JULY 20, 2023

There will probably already be some clinical data for the drug in question and this can save both time and money, as the company can secure regulatory approval without lengthy and costly early-stage clinical trials. This makes drug repurposing or reformulation very appealing.

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Scienmag

JULY 23, 2021

A University of Arizona Health Sciences study of COVID-19 vaccine effectiveness and immunity among frontline workers has received a $15 million award from the U.S. Centers for Disease Control and Prevention (CDC) to continue the current research for another year and expand to include children and focus on underserved populations.

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XTalks

MAY 10, 2023

RSV is a respiratory virus that causes mild to moderate cold and flu-like symptoms, but it can cause complications like lower respiratory tract disease (LRTD) and pneumonia in older adults and young children. Read more about the vaccine, including clinical trial results on its efficacy and safety.

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XTalks

SEPTEMBER 7, 2022

The approval addresses an unmeet need in this indication, as treatment options for cGVHD in younger children are limited. Learn more about the approval in this episode of the Xtalks Life Science Podcast. Imbruvica Wins Milestone Approval for Children as Young as 1 With Chronic GVHD.

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Drug Discovery World

FEBRUARY 5, 2024

Science and technology innovator Danaher launched a strategic collaboration with Cincinnati Children’s Hospital Medical Center, with the goal of improving patient safety by addressing a leading cause of failure in clinical trials.

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pharmaphorum

JANUARY 13, 2021

Dr Kirsty Wydenbach is an expert medical assessor and the deputy unit manager in the Clinical Trials Unit at MHRA , having joined in 2009. She has been involved in the UK regulation of clinical trials across all therapy areas and all phases of development, including ATMPs and numerous first-in-human studies.

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pharmaphorum

JANUARY 13, 2021

Dr Kirsty Wydenbach is an expert medical assessor and the deputy unit manager in the Clinical Trials Unit at MHRA , having joined in 2009. She has been involved in the UK regulation of clinical trials across all therapy areas and all phases of development, including ATMPs and numerous first-in-human studies.

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The Pharma Data

OCTOBER 6, 2021

GlaxoSmithKline (GSK) plc welcomes and applauds the WHO recommendation for the broader deployment of GSK’s RTS,S malaria vaccine to reduce childhood illness and deaths from malaria in children living in sub-Saharan Africa and other regions with moderate to high transmission as defined by WHO. More than 2.3 Daniel Chandramohan et al.

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Drug Discovery World

SEPTEMBER 28, 2023

The influence of these microbiomes extends to children as well. 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).

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pharmaphorum

NOVEMBER 15, 2021

Under the EU clinical trial regulations, explained EFPIA’s Science Policy and Regulatory Senior Manager Silvia Garcia, sponsors will be required to publish a lay summary of all trial results from February 2022. Clinical trial sponsors work in a very regulated environment. Increasing transparency.

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The Pharma Data

FEBRUARY 13, 2022

Food and Drug Administration has been notified by Pfizer that new data have recently emerged regarding its emergency use authorization request for the use of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age.

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The Pharma Data

JUNE 6, 2022

4] The report also noted 400,000 fewer children entered kindergarten in the 2020-2021 school year than expected nationally, meaning those children may not be up to date on childhood immunisations like their MMR vaccination. [4]. GSK is a science-led global healthcare company. For further information please visit.

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pharmaphorum

NOVEMBER 22, 2021

In late 2006, BRAVEMIND was tested in San Diego, California, at the Naval Medical Center and Camp Pendleton, and good clinical data was obtained in the initial open clinical trials. Other groups started to adopt the platform, which led to more research as to its clinical efficacy. VR clinical trials.

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pharmaphorum

MAY 21, 2021

Once all of that is addressed and a treatment is discovered, it goes through years and sometimes decades of clinical trials and final regulatory review. The challenge is for the patient to be able to access the treatment. A reliable and predictable pathway is vitally important for patients.

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The Pharma Data

OCTOBER 9, 2021

With the limited availability of pediatric patients for clinical trial inclusion, researchers can extrapolate data from trials with adults to determine the potential efficacy and tolerability of a treatment for a pediatric population. Juvenile arthritis occurs in an estimated 20 to 45 children per 100,000 children in the U.S.,

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ACRP blog

FEBRUARY 8, 2023

Nationwide Children’s Hospital in Columbus, Ohio, has invested more than $4 million in an intramural funding program over the last 10 years. Funded by the Abigail Wexner Research Institute, the program is designed to promote, support, and encourage fellows and early-level faculty in conducting clinical and translational research.

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The Pharma Data

MARCH 21, 2021

José championed our transformative collaborations with Daiichi-Sankyo in relation to the clinical development of Enhertu (trastuzumab deruxtecan) and datopotamab deruxtecan, two medicines which have demonstrated great potential to benefit cancer patients. My heart goes out to his wife Silvia and his four children.”. AstraZeneca.

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The Pharma Data

SEPTEMBER 28, 2020

The large-scale project, undertaken in collaboration with researchers and clinicians from Fred Hutchinson Cancer Research Center (Fred Hutch) and the Target Padiatric AML (TpAML) computational working group aims to enable paediatric oncology physicians and researchers to better analyse patient clinical trial and genetic data.

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pharmaphorum

AUGUST 13, 2021

Israeli femtech start-up GinaLife is developing a platform of biomarker strategies supported by artificial intelligence and data science for the early detection of problems in women’s health. Women come to us saying ‘I know I have a chance of diagnosis, but I’m scared, I want to have children one day.’

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pharmaphorum

DECEMBER 15, 2020

million (around $56 million) in a Series B funding round to take its novel group B streptococcus (GBS) vaccine into mid-stage clinical trials. Proceeds will advance the clinical development of MinervaX’s novel GBS vaccine through phase 2 clinical trials, as well as manufacturing and regulatory preparation for phase 3.

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Intouch Solutions

OCTOBER 13, 2023

Children born to parents who have not completed high school are more likely to live in unsafe housing and are less likely to have access to sidewalks, parks or libraries. Pharmaceutical companies can increase diversity in their clinical trials. Elsevier Reference Collection in Biomedical Sciences. Accessed July 5, 2023.

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The Pharma Data

OCTOBER 1, 2021

We want to thank the Japanese Ministry of Health, Labour and Welfare, as well as all those who participated in our extensive clinical trial program and their families, for making this important treatment option a reality. iii,iv In Japan, AD affects approximately 3% of adults and 13% of children.

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