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Category: Research and Development


Clinical Trials, FDA, Regulations, Research and Development

FDA sets out its thinking on protecting children in clinical trials

September 27, 2022

Via: Pharmaphorum

The move is an attempt by the US regulator to encourage sponsors to run paediatric studies – where it is appropriate – and solve the problem of new drugs, biologics, and medical devices coming to market with very little information […]


Clinical Trials, Research and Development

Targeting Collateral Damage in Cancer Cells May Revolutionize Precision Oncology

September 27, 2022

Via: GEN

While cancer-triggering mutations often inactivate tumor suppressor genes, they also frequently delete genes essential for survival. This causes cancer cells to rely on other genes that function like the essential genes lost as collateral damage in the cancer-causing mutation. Complete […]


Cell and Gene Therapy, Clinical Trials, Industry, Research and Development

Pfizer, Sangamo resume haemophilia gene therapy trial

September 26, 2022

Via: Pharmaphorum

The phase 3 AFFINE trial was paused voluntarily by the two partners almost a year ago, and subsequently placed on hold by the FDA, after patients treated with the therapy produced higher than expected levels of Factor VIII – the […]


Clinical Trials, Research and Development

Cloned Minipigs Support Fourth Gene Mutation as Causal for Alzheimer’s Disease

September 26, 2022

Via: GEN

Collaborating researchers at Aarhus University’s department of biomedicine and department of clinical medicine have harnessed CRISPR-Cas9 gene editing technology to generate a herd of Göttingen minipigs that could help to advance Alzheimer’s disease (AD) research and potentially unlock future treatment […]


Clinical Trials, Research and Development

New Strategy for Tackling Harmful Inflammation

September 26, 2022

Via: GEN

Scripps Research scientists led a team that reports that it has uncovered key details of an immune-cell process that frequently underlies excessive inflammation in the body. The findings could lead to new ways of preventing and/or treating inflammation-related conditions such […]


Cell and Gene Therapy, Clinical Trials, Industry, Research and Development

Pfizer, Sangamo set to resume gene therapy study after safety delay

September 23, 2022

Via: Biopharma Dive

Pfizer and Sangamo Therapeutics will soon resume a Phase 3 trial of their gene therapy for the blood disorder hemophilia A, nearly a year after safety concerns forced its suspension. Specifically, the companies said Thursday evening they plan to resume […]


Clinical Trials, Research and Development

How Prostate Cancer May Begin

September 23, 2022

Via: GEN

Scientists at the University of East Anglia published a paper “The architecture of clonal expansions in morphologically normal tissue from cancerous and non-cancerous prostates” in Molecular Oncology that describes how prostate cancer may start to develop. The team’s research reveals […]


Clinical Trials, Research and Development

Longer-Term Use of Investigational Drug Stabilizes ALS Symptoms

September 22, 2022

Via: GEN

In an open-label extension of a Phase III clinical trial sponsored by the pharmaceutical company Biogen, investigators have shown that the use of the drug tofersen for one year may help stabilize muscle strength and motor control in patients with […]


Clinical Trials, Research and Development

Uncovering How Medulloblastoma Tumors Develop

September 22, 2022

Via: GEN

Medulloblastoma (MB) is an aggressive pediatric brain tumor. A new study by an international research team reveals the tumor exists in a pre-malignant form at birth after initially developing during the first or second trimester of pregnancy. The findings suggest […]


Clinical Trials, Research and Development

Takeda farms out cancer drug alisertib to Puma Biotech

September 21, 2022

Via: Pharmaphorum

Enter Puma Biotech, which is paying a modest $7 million upfront for rights to alisertib (formerly MLN8237) and plans to run clinical trials of the compound in breast and lung cancers. Takeda is also in line for just over $287 […]


Clinical Trials, Research and Development

Study Finds Immune System Antimicrobial Peptide Represents Link between Diabetes and UTIs

September 20, 2022

Via: GEN

Impaired immunity and recurring infections are common in type 1 and type 2 diabetes. Studies by researchers at Karolinska Institute, have now shown that the immune system of individuals with diabetes displays reduced levels of the antimicrobial peptide (AMP) psoriasin, […]


Clinical Trials, Research and Development

How the Circadian Clock Helps Heal the Brain after Injury

September 20, 2022

Via: GEN

“Time heals all wounds” is a popular phrase that means that grief and sorrow lessen over time. A new study takes this phrase in a literal sense and may lead to new avenues of research for traumatic brain injury (TBI). […]


Manufacturing, Research and Development

Advanced Biopharma Manufacturing Key to White House Cancer Moonshot

September 16, 2022

Via: Biopharm International

The White House hopes to expand US modern biotech manufacturing and reduce reliance on foreign sources of bioindustrial materials. An important component of the White House initiative to speed the development of innovative cancer therapies and other critical treatments for […]


Clinical Trials, Research and Development

Mucosal Antibodies in Airways Reduce Risk of Omicron Infection

September 16, 2022

Via: GEN

A research team led by scientists from the Karolinska Institute and Danderyd Hospital in Sweden report that high levels of mucosal antibodies in the airways reduce the risk of being infected by omicron. However, many people do not receive detectable […]


Clinical Trials, Research and Development

The future of AI drug discovery & development in immunology and GPCR research

September 16, 2022

Via: Pharmaphorum

A mere six months ago Verily launched the study with Sosei Heptares – a global leader in GPCR structure-based drug design – with an aim to “prioritise protein targets for therapeutic targeting in immune-mediated disease”. Now, Verily has announced that […]


Clinical Trials, Research and Development

New Treatment Approach Boosts Odds Against 2 Types of Skin Cancer

September 15, 2022

Via: Drugs.com

Skin cancer patients appear to fare better if they receive immunotherapy before their cancers are surgically removed, a pair of clinical trials show. In fact, some do so well that their immune system essentially dissolves their tumors, potentially removing the […]


Clinical Trials, Research and Development

CDISC standards in clinical research

September 15, 2022

Via: Pharmaphorum

The Clinical Data Interchange Standards Consortium (CDISC) is dedicated to the improvement of medical research through data standardization. CDISC has produced a suite of standards that should be used to standardize content from planning and data collection through to data […]


Clinical Trials, Industry, Research and Development, Vaccines

Pfizer reports success in trial of all-in-one meningitis vaccine

September 15, 2022

Via: Biopharma Dive

An experimental meningococcal vaccine that protects against five strains of the bacteria succeeded in a Phase 3 clinical trial, Pfizer said Thursday, potentially offering an alternative to existing shots that cover fewer variants and require more doses. By the end […]


Clinical Trials, Research and Development

Adaptive Optics Reveals Cellular Changes in Genetic Blindness Disorder

September 14, 2022

Via: GEN

Choroideremia is an X-linked genetic disease that leads to retinal degeneration and blindness. The disease is marked by a progressive loss of photoreceptors, retinal pigment epithelial (RPE) cells, and choriocapillaris. By combining traditional eye imaging techniques with adaptive optics—a technology […]


Clinical Trials, Research and Development

Commensal Gut Bacteria May Help Switch off Immune Response to Cancer-Causing Retrovirus

September 14, 2022

Via: GEN

A new study by researchers from the University of Chicago has found that some commensal bacteria may promote the development of leukemia caused by the murine leukemia virus (MuLV) in mice, by suppressing the adaptive anti-tumor immune response. The team’s […]