Clinical Research Informer

IPC’s Pharmacovigilance Programmes complements CDSCO & Pharmexcil initiatives to fortify patient safety

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 2, 2024

In a concerted effort to bolster patient safety measures within the healthcare landscape, the Indian Pharmacopoeia Commission (IPC) is set to roll out its Skill Development Programmes on Pharmacovigilance.

Development

Development Drugs Clinical Trials Clinical Trials

4 Reasons to Attend the Upcoming 18th Annual Canadian Summit on Food Safety

XTalks

APRIL 16, 2024

The 18th Annual Canadian Summit on Food Safety , happening on Wednesday, April 24, and Thursday, April 25, is an unrivaled platform for exploring the latest trends and innovations in food safety. This year’s summit promises to be an essential event for anyone involved in food safety and quality assurance.

Regulation

Regulation Compliance Allergies Manufacturing

Ultragenyx says Angelman therapy is working, but safety questions remain

Bio Pharma Dive

APRIL 15, 2024

Treatment appeared to result in functional and cognitive gains in people with the neurological disorder. Three participants experienced lower extremity weakness, however.

Rankings: Safety

Pharmaceutical Technology

NOVEMBER 1, 2022

FEATURED COMPANIES COMMENDED : • Innovation • Product Launch • Safety VIEW PROFILE COMMENDED : • Business Expansion • Innovation • Investments VIEW PROFILE COMMENDED: • Social VIEW PROFILE. It also includes projects and initiatives by companies to improve health and safety in other public environments other than their own workspaces.

Compliance

Compliance Production Marketing

Commercial Drug Sourcing for Clinical Trials

Sponsors can face a number of challenges when trying to obtain these critical supplies for their studies, including addressing product lead times, availability, expiry limitations, safety and cost, among others.

Clinical Trials

CDSCO issues draft revised guidance on quality & safety documents for post approval changes in biological products

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 7, 2024

The Central Drugs Standard Control Organisation (CDSCO) has come out with a draft of revised guidance document for the industry related to the quality, safety and efficacy documents for Post Approval Changes (PACs) in biological products in order to align the standards with the international guidelines including that of World Health Organisation (WHO) (..)

Production

Production Drugs Clinical Trials Clinical Trials

A new approach for post-marketing safety studies

Bio Pharma Dive

APRIL 4, 2022

presents an enormous opportunity to shift dramatically how post-marketing safety studies can and should be conducted. The large quantity of digitized healthcare data in the U.S.

Marketing

Securing the future: Innovating pharmaceutical supply chain for resilience and safety

pharmaphorum

APRIL 2, 2024

Explore the innovative use of artificial intelligence (AI) and machine learning (ML) in securing the pharmaceutical supply chain for resilience and safety. Learn how cutting-edge technology is shaping the future of pharmaceutical logistics.

What to expect at the FDA's two-day meeting on gene therapy safety

Bio Pharma Dive

SEPTEMBER 1, 2021

A group of advisers convened by the regulator will spend Thursday and Friday weighing a range of safety worries with gene therapy, and how best to prevent them.

Gene Therapy

Gene Therapy Gene Regulation

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Revvity Signals provides a centralized analytics platform built to support today’s clinical study requirements and increase trial efficiency, glean actionable analytic insights, automate data collection and harmonization, support safety and efficacy decision-making, and enable a singular view across a company’s entire candidate portfolio.

Clinical Trials

The Challenges in Medical Device Safety Operations

Cloudbyz

APRIL 9, 2024

Medical devices play a critical role in healthcare, but ensuring their safety and reliability can be a complex and challenging task. The medical device industry is constantly evolving, and with that evolution come new and complex safety issues.

Clinical Trials

Clinical Trials Clinical Trials Compliance Trials

High-impact milling: Are you compromising operator safety?

Pharmaceutical Technology

NOVEMBER 8, 2023

Worker safety and prevention of cross-contamination are vital when working with fine powders and toxic ingredients.

Contamination

Worst Food Safety Scandals of 2023

XTalks

NOVEMBER 23, 2023

Despite technological advancements in food safety in recent years, 2023 has been marked by some alarming food safety scandals globally, impacting public health and trust in the food industry. Here, we uncover some of the worst food safety scandals of 2023, shedding light on the causes and consequences of these outbreaks and recalls.

Contamination

Contamination Regulation Bacterium Allergies

UBC to bolster safety functions with Oracle’s cloud technology

Pharmaceutical Technology

AUGUST 2, 2023

United BioSource (UBC) has selected Oracle Life Sciences’ safety case management solution to bolster its safety functions.

Life Science

How Machine Learning Drives Clinical Trial Efficiency

Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

Clinical Trials

EMA follows FDA in scrutinizing safety of certain immune drugs

Bio Pharma Dive

FEBRUARY 14, 2022

The European regulator began a safety review of so-called Janus kinase inhibitors from Pfizer, AbbVie, Eli Lilly and Galapagos, citing worrisome data from a study of Pfizer's drug Xeljanz.

Drugs

Drugs Regulation

Pfizer aims to restart late-stage trial of Duchenne gene therapy following safety setback

Bio Pharma Dive

FEBRUARY 10, 2022

Safety concerns, including the recent death of a patient in an early study, led the FDA to place a hold on the therapy and Pfizer to redesign its Phase 3 trial.

Gene Therapy

Gene Therapy Trials Gene

Takeda halts studies of touted sleep disorder drug over safety concern

Bio Pharma Dive

OCTOBER 6, 2021

The drugmaker suspended dosing in two mid-stage studies of its experimental narcolepsy treatment after a "safety signal" emerged.

Drugs

Safety finding weighs on Pfizer's inflammation drug, and could spell trouble for others

Bio Pharma Dive

JANUARY 27, 2021

A large safety study found that patients given Pfizer's Xeljanz had health issues like major heart complications and cancer at a higher rate than those who got a different kind of anti-inflammation drug.

Drugs

Lead in Cinnamon: A Rising Concern for Food Safety

XTalks

APRIL 11, 2024

The presence of lead in cinnamon has recently emerged as a significant food safety concern. As a staple spice in many kitchens, the discovery of elevated lead levels in cinnamon products has prompted a closer look at food safety practices and regulations.

Contamination

Contamination Branding Production Containment

Rishi Sunak addresses existential AI threats ahead of UK safety summit

Pharmaceutical Technology

OCTOBER 30, 2023

UK Prime Minister Rishi Sunak has vowed to tackle fears surrounding AI in a speech ahead of the world’s first AI safety summit next week.

With safety worries mounting, FDA limits who can take certain immune-regulating drugs

Bio Pharma Dive

SEPTEMBER 1, 2021

The agency has new rules for who can take Pfizer's Xeljanz, Eli Lilly's Olumiant or AbbVie's Rinvoq after a large study raised concerns about the safety of so-called JAK inhibitors.

Regulation

Regulation Drugs

Clinical effectiveness of co-trimoxazole versus leading antibiotics proves its cost-effectiveness, efficacy & safety

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 11, 2024

Click here Corporate + Font Resize – Clinical effectiveness of co-trimoxazole versus leading antibiotics proves its cost-effectiveness, efficacy & safety Shardul […]

Clinical Trials

Clinical Trials Clinical Trials Clinical Research Trials

Inizio Engage and Applied Driving partner to support clinical workers with safety app

Pharma Times

MARCH 26, 2024

The Companion+ Mobile Safety App will be rolled out to a further 115 users within the UK and US

Pacylex Pharma's phase one trial: Zelenirstat safety in heavily pre-treated patients

Outsourcing Pharma

APRIL 22, 2024

has announced the presentation of phase 1 safety and efficacy findings for small molecule drug zelenirstat for cancer treatment. Pacylex Pharmaceuticals Inc.

Trials

Trials Drugs Clinical Development Development

Cloudbyz Safety & Pharmacovigilance | Digitize Safety & Pharmacovigilance Management

Cloudbyz

DECEMBER 6, 2023

The post Cloudbyz Safety & Pharmacovigilance | Digitize Safety & Pharmacovigilance Management first appeared on CLOUDBYZ.

Computational chemistry helps in prediction of toxic behavior of Nitrosamine for drug safety: Experts

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 8, 2023

Computational chemistry is today very much required for pharmaceutical compliance including prediction of toxic behaviour of nitrosamine for drug safety, according to experts. Identification and determination of toxic behaviour of a molecule is one of the most difficult challenges faced in ensuring drug safety.

Compliance

Compliance Drugs Clinical Trials Clinical Trials

FibroGen admits misleading safety data for anemia drug, dimming prospects

Bio Pharma Dive

APRIL 7, 2021

In a surprising announcement, the company said data used to tout the safety of the anemia pill roxadustat included “post hoc changes” that executives became aware of during regulatory review.

Drugs

Lilly drug regrows hair in autoimmune disease study, but safety questions linger

Bio Pharma Dive

MARCH 3, 2021

Safety concerns have diminished the drug's prospects in arthritis, however. The results could help baricitinib become the first treatment for alopecia areata, a leading cause of hair loss.

Drugs

A worrisome safety signal slows Merck's HIV ambitions

Bio Pharma Dive

NOVEMBER 19, 2021

After a study raised safety concerns, Merck has paused development of one of its experimental drugs and will keep a close eye on another that's critical to its plans in HIV.

Development

Development Drugs

There Are New FDA Safety Warnings About Breast Implants. Here’s What We Know

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 27, 2022

The safety notice was published this month and is based on an extensive review of the emerging literature on breast implants. […]. The US Food and Drug Administration (FDA) is now warning that breast implants filled with either silicone or saline may, on rare occasions, give rise to cancer in the scar tissue around breast implants.

Drugs

Drugs Clinical Trials Clinical Trials Clinical Research

Cerner Enviza and FDA partner to develop AI drug safety tools

Pharmaceutical Technology

APRIL 11, 2023

Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and Drug Administration (FDA) for the development of artificial intelligence (AI) tools for drug safety and real-world evidence studies.

Development

Development Drugs Medicine Research

Confidence and Caution as AI Predicts Drug Safety

BioSpace

NOVEMBER 2, 2023

More and more companies are turning to artificial intelligence for drug safety prediction, but as with any new application of AI, experts urge caution.

Drugs

AstraZeneca, Daiichi Address Safety Concerns for DXd ADC at ESMO

BioSpace

OCTOBER 23, 2023

The companies presented data from two pivotal studies of Dato-DXd, focusing on safety concerns and survival data for the investigational antibody-drug conjugate candidate in lung and breast cancer.

Antibody

Antibody Drugs

Safety concerns lead Regeneron to halt testing of COVID-19 drug in some patients

Bio Pharma Dive

OCTOBER 30, 2020

A study monitoring board flagged a "potential safety signal" in some hospitalized COVID-19 patients who require breathing support, telling the biotech to modify its study protocol.

Drugs

Araclon’s Alzheimer’s Vaccine Shows Clean Safety Profile in Phase II Analysis

BioSpace

OCTOBER 24, 2023

While the trial was designed to test safety and not efficacy, patients treated with Araclon Biotech’s experimental ABvac40 vaccine saw a 38% drop in disease progression compared to placebo.

Vaccination

Vaccination Vaccine Trials

CSL Vifor proposes campaign to undo messaging about safety profile of rival product

Fierce Pharma

APRIL 19, 2024

CSL Vifor has proposed to launch a campaign that would undo the potentially misleading messages it sent about the safe | CSL Vifor has proposed to launch a campaign that would undo the potentially misleading messages it sent about the safety of a rival product, the European Commission (EC) said.

Production

Navigating Challenges in Causality Assessment: Best Practices for Clinical Safety and Pharmacovigilance

Cloudbyz

NOVEMBER 9, 2023

The challenges in causality assessment are numerous, reflecting the intricate landscape of clinical safety pharmacovigilance. Data Mining, Signal Detection, and Collaboration: Employing data mining techniques and signal detection methodologies helps identify patterns and potential safety signals that may indicate a causal association.

Compliance

Compliance Clinical Trials Clinical Trials Drugs

FDA Food Budget 2025: Enhancing Food Safety and Nutrition

XTalks

MARCH 21, 2024

This significant financial request is aimed at bolstering food safety and nutrition, alongside advancing medical product safety and strengthening public health initiatives. An additional $8 million is allocated for the Modernization of Cosmetics Regulation Act (MoCRA), which aims to enhance cosmetic product safety.

Cosmetics

Cosmetics Production Regulation Manufacturing

Xtalks People in Life Sciences Series: Day-in-the-Life of a Pharmacovigilance Professional – Interview with Ashish Jain, Senior Director of Clinical Safety and PV, Curis – Xtalks Life Science Podcast Ep. 151

XTalks

MARCH 20, 2024

In this featured episode of Xtalks People in Life Sciences, Ayesha spoke with Ashish Jain, Senior Director of Clinical Safety and Pharmacovigilance (PV) at Curis , a pioneering biotech company specializing in cutting-edge cancer therapies. Jain shared his journey into clinical safety and PV, highlighting key milestones along the way.

Life Science

Life Science Development Drugs

Anthos blood thinner bests Xarelto on safety in mid-stage study

Bio Pharma Dive

NOVEMBER 13, 2023

Trial results add to evidence that so-called Factor XIa inhibitors could have less bleeding risk than currently available oral anticoagulants like Xarelto.

Trials

Bosch Develops Sensor System to Improve Construction Site Safety

Pharmaceutical Technology

OCTOBER 30, 2022

The system combines robustness and a high level of functional safety even under the most difficult off-highway operating conditions. Electronic assistance systems are the first stage of the automated construction site which can improve safety on the site and make driving easy. This article was originally published in Verdict.co.uk.

Development

Development Manufacturing Research

Gilead's Tecartus gets revised safety demand amid FDA's push for CAR-T boxed warnings

Fierce Pharma

JANUARY 24, 2024

Turns out, the FDA didn’t drop the CD19 CAR-T from a classwide safety alert list. . | The FDA’s letter demanding a labeling change for Gilead Sciences’ Tecartus temporarily went missing on the agency’s website Tuesday. Instead, it's adjusted the wording of a proposed boxed warning.

New Netflix Food Documentary Exposes America’s Faulty Food Safety System

XTalks

AUGUST 7, 2023

This time, the streaming service plunged into the world of food safety with its newest Netflix food documentary, “Poisoned: The Dirty Truth About Your Food,” which promises to question viewers’ perception about everyday foods and their origins. This heart-wrenching event prompted an increased focus on fast-food safety regulations.

Contamination

Contamination Regulation Manufacturing Scientist

IPC’s Pharmacovigilance Programmes complements CDSCO & Pharmexcil initiatives to fortify patient safety

4 Reasons to Attend the Upcoming 18th Annual Canadian Summit on Food Safety

Trending Sources

Ultragenyx says Angelman therapy is working, but safety questions remain

Rankings: Safety

Commercial Drug Sourcing for Clinical Trials

CDSCO issues draft revised guidance on quality & safety documents for post approval changes in biological products

A new approach for post-marketing safety studies

Securing the future: Innovating pharmaceutical supply chain for resilience and safety

What to expect at the FDA's two-day meeting on gene therapy safety

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

The Challenges in Medical Device Safety Operations

High-impact milling: Are you compromising operator safety?

Worst Food Safety Scandals of 2023

UBC to bolster safety functions with Oracle’s cloud technology

How Machine Learning Drives Clinical Trial Efficiency

EMA follows FDA in scrutinizing safety of certain immune drugs

Pfizer aims to restart late-stage trial of Duchenne gene therapy following safety setback

Takeda halts studies of touted sleep disorder drug over safety concern

Safety finding weighs on Pfizer's inflammation drug, and could spell trouble for others

Lead in Cinnamon: A Rising Concern for Food Safety

Rishi Sunak addresses existential AI threats ahead of UK safety summit

With safety worries mounting, FDA limits who can take certain immune-regulating drugs

Clinical effectiveness of co-trimoxazole versus leading antibiotics proves its cost-effectiveness, efficacy & safety

Inizio Engage and Applied Driving partner to support clinical workers with safety app

Pacylex Pharma's phase one trial: Zelenirstat safety in heavily pre-treated patients

Cloudbyz Safety & Pharmacovigilance | Digitize Safety & Pharmacovigilance Management

Computational chemistry helps in prediction of toxic behavior of Nitrosamine for drug safety: Experts

FibroGen admits misleading safety data for anemia drug, dimming prospects

Lilly drug regrows hair in autoimmune disease study, but safety questions linger

A worrisome safety signal slows Merck's HIV ambitions

There Are New FDA Safety Warnings About Breast Implants. Here’s What We Know

Cerner Enviza and FDA partner to develop AI drug safety tools

Confidence and Caution as AI Predicts Drug Safety

AstraZeneca, Daiichi Address Safety Concerns for DXd ADC at ESMO

Safety concerns lead Regeneron to halt testing of COVID-19 drug in some patients

Araclon’s Alzheimer’s Vaccine Shows Clean Safety Profile in Phase II Analysis

CSL Vifor proposes campaign to undo messaging about safety profile of rival product

Navigating Challenges in Causality Assessment: Best Practices for Clinical Safety and Pharmacovigilance

FDA Food Budget 2025: Enhancing Food Safety and Nutrition

Xtalks People in Life Sciences Series: Day-in-the-Life of a Pharmacovigilance Professional – Interview with Ashish Jain, Senior Director of Clinical Safety and PV, Curis – Xtalks Life Science Podcast Ep. 151

Anthos blood thinner bests Xarelto on safety in mid-stage study

Bosch Develops Sensor System to Improve Construction Site Safety

Gilead's Tecartus gets revised safety demand amid FDA's push for CAR-T boxed warnings

New Netflix Food Documentary Exposes America’s Faulty Food Safety System

Stay Connected