Bio Pharma Dive

SEPTEMBER 3, 2021

A panel convened by the regulator suggested ways to make gene therapy research safer, but struggled to propose broader recommendations for the field.

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Bio Pharma Dive

JUNE 27, 2022

The biotech company revealed three new drug candidates for breast cancer, while laying out a path to regulators for its most advanced treatment.

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Bio Pharma Dive

AUGUST 29, 2022

With regulators and lawmakers seemingly on board, sponsors have more opportunities than ever to pursue clinical research in this high-velocity area.

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Pharmaceutical Technology

MARCH 23, 2023

This week, the Medicines and Healthcare products Regulatory Agency (MHRA) is introducing major changes to clinical trial regulation in the UK with expedited timelines at several stages. The MHRA hopes this new framework “will remove obstacles to innovation” and “streamline the regulation of clinical trials” amongst other things.

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AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 24, 2023

An MoU […]

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Bio Pharma Dive

JULY 26, 2022

But an apparent effect on a protein of interest in ALS research has Biogen convinced the treatment will pass muster with regulators. Known as tofersen, the drug failed in the main study being used to support its approval.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 11, 2023

Clinical Establishment (CE) Regulation should be adopted on priority basis because it stipulates eligibility and qualification of personnel running a lab, standards or guidelines on the infrastructure and testing facilities.

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Bio Pharma Dive

MARCH 11, 2022

On the heels of its Syndesi acquisition, the company has announced an agreement with Gedeon Richter focused on researching and developing new dopamine-regulating drugs for neuropsychiatric diseases.

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Medical Xpress

FEBRUARY 8, 2025

New research details the subcellular structures in neurons that enable signals to be transmitted from where they are received at specific sites on dendrites to the decision-making cell body located hundreds of micrometers away.

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Advarra

MARCH 7, 2025

Clinical research is a vital driver of medical progress. With more than three decades of experience, Advarra is dedicated to advancing clinical research by providing expert oversight. Clinical research tests new treatments and therapies to determine their safety, effectiveness, and potential to improve health outcomes.

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pharmaphorum

OCTOBER 11, 2022

An explosion of digital mental health tools being offered for sale has presented regulators with a problem – how should they be classified and assessed for safety or efficacy? Mental health problems are estimated to cost the UK economy at least £118 billion a year, according to research by the London School of Economics and Political Science.

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AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 16, 2023

In the search for a treatment for Alzheimer’s disease, researchers have zeroed in on a protein with protective effects. A new study reveals how cholesterol and inflammation in different types of human brain cells interact with a protein called ABCA7, which regulates how molecules pass through cell membranes.

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Outsourcing Pharma

APRIL 29, 2024

OSP spoke to Berkeley Research Group healthcare managing director, Wendy Cheng for a discussion around developments in AI regulation for pharmaceuticals, clinical trials, and drug development at a global scale.

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FDA Law Blog

NOVEMBER 10, 2024

Background on the Grants Program Launched as part of the Orphan Drug Act of 1983, this program aims to encourage research and development of drugs, biologics, medical devices, and medical foods for rare diseases, defined as conditions that affect fewer than 200,000 people in the U.S. The seven awardees included six early-stage trials (e.g.,

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ACRP blog

FEBRUARY 11, 2025

If theres one thing clinical researchers can count on when it comes to regulations and guidance from governing bodies, its change. Its a unique opportunity to not only stay up to date with research initiatives, but also to engage with healthcare research professionals from around the country. This is a sponsored message.

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Worldwide Clinical Trials

DECEMBER 19, 2024

As regulatory frameworks like the General Data Protection Regulation (GDPR) have heightened the emphasis on data privacy and individual rights, Europe is leading the way in terms of privacy and data. In-Vitro Diagnostic Regulation and The FDAs Final Rule The WODC U.S. conversation was highly operationally focused.

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AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 18, 2022

With less than ten days to meet the deadline mandating the registration of Assisted Reproductive Technology (ART) clinics, ART banks and Surrogacy Clinics to be eligible to conduct counselling and procedures, five more States are yet to report to the Centre on appointment of appropriate authority. In a relief to the Centre, 12 out of […].

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ACRP blog

JANUARY 28, 2025

Collection of sensitive personal data is a cornerstone of clinical research involving drugs and medical devices. However, if the personal data relates to European Union (EU) or United Kingdom (UK) residents, this raises particular legal and compliance issues due to the General Data Protection Regulation (GDPR). View complete schedule.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 18, 2023

In particular, researchers noticed a reduction in the interleukin-1-beta (IL-1β) protein, which helps to regulate the body’s […] It seems the chemical compound can stop some of the damage done to the brain that’s usually associated with the disease.

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Medical Xpress

DECEMBER 6, 2024

Researchers have discovered that astrocytes play an important role in regulating stress responses in the lateral septum in the brain. It is expected to provide new clues for mental health treatments.

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Camargo

JULY 30, 2021

Barry Mangum talks the importance of pediatric research, its evolution over the years, and the obstacles and opportunities that the industry faces as it moves forward. How long have you been in pediatric clinical research, and how did you enter the field? So I’ve been working in that space about 43 years.

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Pharma Marketing Network

NOVEMBER 23, 2024

Just as a chef relies on quality ingredients for the perfect dish, marketers depend on cutting-edge research to craft campaigns that resonate with their audience. The Connection Between Pharma Research and Marketing Effective marketing starts with understanding your audience.

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Medical Xpress

APRIL 27, 2023

Research led by Maynooth University and published today in the journal Science Signaling has found that the protein MYC is essential for MAIT cell growth, proliferation, metabolism and function. The latest findings are of critical importance to the study of MAIT cells and the development of metabolic disease such as obesity.

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Advarra

DECEMBER 17, 2024

2024 has been a year of growth and evolution in clinical research. These topics include perspectives on how artificial intelligence (AI) will be leveraged in clinical research, key regulatory trends shaping the industry, the movements of site consolidation, the continued challenges (and potential solutions) of study startup, and more.

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pharmaphorum

JULY 15, 2024

Framework governing early-stage clinical trials in the UK is stifling research and needs to be simplified, says BJCP paper

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Advarra

MARCH 6, 2025

Institutional review boards (IRBs) play a crucial role in the ever-evolving field of clinical research. Without clinical research, these medical breakthroughs would remain out of reach for patients. Advarra draws members from leading academic institutions, government agencies, and clinical research organizations.

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Pharmaceutical Technology

OCTOBER 30, 2022

Concept: Massachusetts Institute of Technology (MIT)’s Computer Science and Artificial Intelligence Laboratory (CSAIL) researchers have developed a system called ‘series elastic end effectors’ (SEED) that enable robots to use grabbed tools correctly and successfully.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 8, 2025

The Central Drugs Standard Control Organisation (CDSCO) and Indian Council of Medical Research (ICMR) have together released the draft standard evaluation protocols for the purpose of issuing license for in-vitro diagnostics (IVDs) under the Medical Devices Rules (MDR), 2017.

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XTalks

JANUARY 6, 2025

The US Food and Drug Administration (FDA) has approved Alyftrek (vanzacaftor/tezacaftor/deutivacaftor), a next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator, to treat cystic fibrosis (CF) in patients aged six years and older with at least one F508del mutation or another responsive CFTR mutation.

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XTalks

MARCH 26, 2025

In the fast-evolving field of clinical research, thought leaders do more than just keep up; they lead the charge and shape the direction of the industry. Heres how thought leaders are currently making an impact in clinical research: 1.

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AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 26, 2022

The National Medical Commission (NMC), the apex medical education regulatory body, has come out with draft Establishment of Medical College Regulations, (Amendment), 2022 ushering changes in rules for setting up medical institutes. According to […].

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STAT News

FEBRUARY 17, 2023

Federal regulations require certain research conducted on humans to first win approval from such a board. The committees therefore have the authority to approve a study, require modifications, or reject proposed research if the risk to participants is too great. Continue to STAT+ to read the full story…

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 7, 2024

A study suggests eating later in the day can directly impact our biological weight regulation in three key ways: through the number of calories that we burn; our hunger levels; and the way our bodies store fat. link] With obesity now affecting hundreds of millions of people worldwide, this is a valuable insight into how […]

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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 5, 2024

The Subject Expert Committee (SEC) which advises the national drug regulator on drug approvals and clinical trials has recommended grant of permission to drug major Astrazeneca for import and marketing of two strengths of anti-hyperkalaemia therapy drug Lokelma (sodium zirconium cyclosilicate for oral suspension).

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Pharmaceutical Technology

FEBRUARY 2, 2023

Having made significant advances in a relatively short period of time, CRISPR research is now edging closer to reaching the clinic , and this month’s cover story takes a look at the major players in this field and the big events that could break through this year.

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Bio Pharma Dive

JANUARY 26, 2022

regulators halted several studies of a drug Gilead paid almost $5 billion to acquire in 2020 after researchers observed an "apparent imbalance" of serious adverse reactions.

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Rethinking Clinical Trials

APRIL 24, 2024

Matthew Semler In this Friday's PCT Grand Rounds, Lauren Milner of the US Food and Drug Administration (FDA) and Jonathan Casey and Matthew Semler of Vanderbilt University will present "Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations – FDA Regulation Development and Research Landscape."

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