AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 25, 2024

The recent regulatory developments to relax clinical trial norms in India are poised to have a significant impact on the pharmaceutical industry and drug pricing. By easing regulations, Indian pharma could see a reduction in the costs associated with human studies.

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Clinical Trials Clinical Trials Trials Drugs 186

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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Clinical Trials Clinical Trials Regulation Trials 147

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 12, 2023

The Subject Expert Committee (SEC), which advises the drug regulator on the approval of drugs and clinical trials of antimicrobial and antiviral drugs, has recommended waiver of phase III clinical trial on Emcure Pharmaceuticals’ application for manufacturing and marketing of HIV drug doravirine 100 mg and its bulk drug in the country.Merck Sharp and (..)

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Clinical Trials Clinical Trials Trials Drugs 184

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 20, 2025

A Parliamentary Panel has recommended implementation of a comprehensive, nationwide and phased Medicines Regulatory Maturity Enhancement Programme on the lines of World Health Organisation’s (WHO) vaccine benchmarking process to ensure a consistently high standard of drug regulation across the country.

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Regulation Drugs Vaccine Vaccination 113

Pharmaceutical Technology

MAY 24, 2023

By Luisa Sterkel & Joana Loureiro , Tenthpin Consultants The promise and potential of cell and gene therapies (CGT) has emerged in the recent past and currently over 1.500 CGT are registered for clinical trials holding great hope for the treatment of challenging and uncurable diseases.

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Clinical Trials Clinical Trials Gene Therapy Clinical Supply Chain 246

Bio Pharma Dive

MAY 17, 2023

The biotech plans to discuss the study results with regulators to determine next steps toward an approval application for the rare disease treatment.

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Clinical Trials Clinical Trials Regulation Trials 258

Worldwide Clinical Trials

NOVEMBER 12, 2024

Despite their exciting potential, the smooth operation of cell therapy development trials requires extraordinary orchestration, perfectly aligning the product and patient journeys. While clinical supply is essential to any successful trial, autologous cell therapy trials occupy the far end of the spectrum regarding risk tolerance.

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Gene Therapy Clinical Supply Trials Gene 182

Pharmaceutical Technology

MARCH 21, 2025

Clinical trials must use effective electronic data capture platforms that prioritise data integrity and comply with regulations.

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Clinical Trials Clinical Trials Trials Regulation 130

pharmaphorum

MARCH 1, 2024

There is a pressing need for companies to transition their EU clinical trials that are ongoing under the “old” regulatory framework of the Clinical Trials Directive to the Clinical Trials Regulation.

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Clinical Trials Clinical Trials Regulation Trials 119

Bio Pharma Dive

AUGUST 2, 2021

The regulator cleared Saphnelo despite mixed clinical trial data, giving patients another option after the recent OK for a drug aimed at the autoimmune disease's severe side effects.

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FDA Approval Clinical Trials Clinical Trials Drugs 342

Pharmaceutical Technology

FEBRUARY 27, 2025

New EU Clinical Trial Regulations simplify international trials while offering the means to counter drug shortages for trials in Europe.

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Regulation Trials Clinical Trials Clinical Trials 147

Pharmaceutical Technology

SEPTEMBER 20, 2024

The Outsourcing in Clinical Trials New England conference will gather pharma experts to discuss the current clinical trial landscape.

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Clinical Trials Clinical Trials Trials Regulation 130

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 15, 2024

The Pharmacy Council of India (PCI) has framed regulations on the manner of conducting enquiry imposing penalty and appeal procedures in case of violation of certain provisions of the Pharmacy Act, 1948, in tune with the amendments notified in the Jan Vishwas (Amendment of Provisions) Act, 2023.

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Regulation Pharmacy Clinical Trials Clinical Trials 241

Worldwide Clinical Trials

DECEMBER 19, 2024

At the recent World Orphan Drug Congresses (WODC) in Europe and the United States, Worldwide Clinical Trials Derek Ansel , Vice President, Therapeutic Strategy Lead, Rare Disease, facilitated roundtable discussions to explore the operational challenges and ethical barriers surrounding genetic testing.

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Genetics In-Vitro Drugs Clinical Trials 130

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 6, 2023

The expert committee which advises the drug regulator on clinical trials and drug approvals has recommended for grant of permission for import and marketing of Swiss multinational pharma major Roche’s ophthalmic drug faricimab intravitreal injection in India, with waiver of local phase III clinical trial subject to conditions.

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Trials Clinical Trials Clinical Trials Drugs 189

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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Clinical Trials Clinical Trials Regulation Trials 111

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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Clinical Trials Clinical Trials Drugs Regulation 243

Velocity Clinical Research

DECEMBER 30, 2024

Topics include rising costs and uncertain regulations, as well as the continued emergence of site networks, AI-driven efficiency (with technology built by trial sites, for trial sites), and enhanced diversity initiatives.

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Clinical Trials Clinical Trials Trials Clinical Research 52

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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Clinical Trials Clinical Trials Regulation Trials 95

Pharmaceutical Technology

JANUARY 16, 2025

The new pan-European group of 73 regulators, companies and trial sites is backed by 66.8m in funding with a six-year goal.

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Clinical Trials Clinical Trials Trials Regulation 147

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 14, 2024

A Subject Expert Committee (SEC), which advices the national drug regulator on approvals and clinical trials related to Covid-19 vaccines, has recommended grant of permission to Serum Institute of India (SII) for Omicron XBB 1.5

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Vaccine Vaccination Clinical Trials Clinical Trials 189

Bio Pharma Dive

SEPTEMBER 16, 2020

Encouraged by the early study results, Arrowhead plans to ask regulators to streamline its clinical trials, which could pressure rivals Vertex and Dicerna.

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Clinical Trials Clinical Trials Regulation Trials 265

Worldwide Clinical Trials

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

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Trials Clinical Trials Clinical Trials Regulation 200

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 13, 2024

The Subject Expert Committee (SEC), which advises the Central drug regulator regarding clinical trials and approvals of drugs, has recommended approval for additional indication of Zydus Lifesciences’ inactivated trivalent influenza vaccine in children above six months with clinical trial waiver subject to condition.

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Vaccine Vaccination Clinical Trials Clinical Trials 188

Pharmaceutical Technology

SEPTEMBER 26, 2022

Clinical trials were thrown into turmoil on the morning of 24 February 2022, along with every aspect of life in Ukraine. In July, approximately a third of companies had paused a trial in the country. By August, 28 foreign-sponsored, multi-country trials were affected, almost half with sites in Ukraine and Russia. [1].

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Clinical Trials Clinical Trials Trials Regulation 130

pharmaphorum

FEBRUARY 6, 2024

For the latest episode of the pharmaphorum podcast, web editor Nicole Raleigh sat down with Chris Bamford, director of clinical trial regulatory management at IQVIA, and Shirley Rutter, associate director and strategic quality lead of global quality management at IQVIA Biotech.

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Clinical Trials Clinical Trials Regulation Trials 115

AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 2, 2023

The Subject Expert Committee (SEC) that advises the drug regulator of the country has recommended waiver of local phase III and IV clinical trials in India for Sanofi Healthcare India’s orphan drug to treat the Pompe disease. The […]

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Trials Clinical Trials Clinical Trials Drugs 188

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 13, 2022

The National Commission for Homoeopathy has prepared a regulation defining a structure to the Bachelor of Homoeopathic Medicine and Surgery (BHMS) course with changes including incorporation of a methodology to supplement modern advancement, research and technology in Homoeopathy (SMART-Homoeopathy).

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Regulation Medicine Research Clinical Trials 189

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 2, 2024

With a focus on equipping regulators with advanced skills, the CDSCO conducted 23 residential training programmes tailored to address critical aspects such as […]

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Regulation Drugs Clinical Trials Clinical Trials 188

FDA Law Blog

NOVEMBER 10, 2024

Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field. In October, FDA announced seven new clinical trial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2

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Production Clinical Development Development Regulation 69

Cloudbyz

APRIL 17, 2024

Decentralized clinical trial (DCT) platforms represent a paradigm shift in the way clinical research is conducted. By leveraging technology, DCTs aim to make clinical trials more accessible and convenient for patients, reduce costs and increase efficiency.

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Worldwide Clinical Trials

DECEMBER 12, 2022

Genetic testing provides patients with a diagnosis for their illness, helps patients and family members to understand risks of developing new diseases, and can be used to support clinical trial advancement. Can prior genetic testing results be utilized in a trial, or should a new genetic sample be taken before participating?

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Clinical Trials Clinical Trials Genetics Trials 130

Cloudbyz

APRIL 23, 2024

The landscape of clinical trial management is marked by complexity, with organizations facing numerous challenges in effectively managing trial budgets while ensuring adherence to regulatory requirements and maintaining high standards of quality.

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Clinical Trials Clinical Trials Trials Clinical Research 98

Worldwide Clinical Trials

OCTOBER 19, 2022

With regulators and lawmakers seemingly on board, sponsors have more opportunities than ever to pursue clinical research in this high-velocity area. Vice President of Scientific Solutions, Neuroscience, at Worldwide Clinical Trials. Of note, these programs differ significantly from conventional psychiatry trials.

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Clinical Trials Clinical Trials Trials Production 130

CTTI (Clinical Trials Transformation Initiative)

OCTOBER 17, 2024

A new CTTI publication , published in Clinical Pharmacology & Therapeutics , reviews current applications of disease progression modeling (DPM) and opportunities to advance the awareness and value of DPM in clinical trials.

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Clinical Trials Clinical Trials Trials Production 81

Pharmaceutical Technology

APRIL 20, 2023

The face of clinical research is evolving. Rather than bringing patients to sites, study teams are now exploring ways they can bring the trial to patients using a varying combination of direct-to-patient drug shipments, home nursing, video conferencing, and electronic data collection. Everybody got used to doing things remotely.

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XTalks

NOVEMBER 15, 2024

Syros Pharmaceuticals announced that its cancer drug tamibarotene failed to meet its primary endpoint in the SELECT-MDS-1 Phase III trial. The placebo-controlled SELECT-MDS-1 trial involved 190 patients with complete response rate (CRR) being the study’s primary endpoint. percent and 18.8

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Trials HR Immune Response FDA Approval 105