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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AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 23, 2023

The Central drug regulator has issued alert on suspected falsified versions of Glucagon-like peptide 1 receptor agonist (GLP-1-RA) products, an anti-diabetes management drug, in the market. GLP-1-RA […]

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Worldwide Clinical Trials

APRIL 3, 2024

Are you aware of the challenges you must address for a successful radiopharmaceutical trial? Enhancing Patient Participation in Radiopharmaceutical Trials Patient recruitment is a critical yet challenging part of radiopharmaceutical trials.

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Drug Patent Watch

FEBRUARY 18, 2025

Unlocking the Potential of Biosimilars: Navigating Regulatory Considerations for Clinical Efficacy Trials As the pharmaceutical industry continues to evolve, biosimilars have emerged as a game-changer in the fight against high healthcare costs. Should the trial compare the biosimilar to the reference product, or to a placebo?

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Pharma Mirror

MAY 7, 2021

The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner, Avance Clinical, has expanded its gene technology clinical trial services to meet the increasing global demand predicted to reach $17.4 The post Avance Clinical Expands Gene Technology Clinical Trial Services to Meet $17.4

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FDA Law Blog

JANUARY 30, 2025

However, as we note in that post, the design, timing of initiation, and timely conduct of confirmatory trials are also important considerations in FDAs determination of whether accelerated approval is appropriate. This blog post focuses on interpreting these new authorities with respect to timely conduct of confirmatory trials.

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Worldwide Clinical Trials

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.

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Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.

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Pharmaceutical Technology

JUNE 20, 2023

SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator. In a Phase III clinical trial, SKYCovione showed neutralising antibody responses against the SARS-CoV-2 parental strain.

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Pharmaceutical Technology

AUGUST 30, 2022

International companies investing in the emerging market of Brazilian pharmaceutical manufacturing will see a higher return on investment than from developed market equivalents, if they choose to compete with local manufacturers to supply Brazil’s growing market and the greater South American region.

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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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pharmaphorum

NOVEMBER 22, 2022

GSK confirmed this morning that the disappointing readout from the DREAMM-3 trial of multiple myeloma therapy Blenrep reported earlier this month means that it will take the drug off the US market. The post GSK will pull Blenrep from US market after failed trial appeared first on.

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Pharmaceutical Technology

NOVEMBER 28, 2022

Under the agreement, AstraZeneca will be responsible for the development and marketing of oral therapy for inflammatory and respiratory diseases with a key focus on chronic obstructive pulmonary disease (COPD). A key natural regulator, NRF2 controls antioxidant genes’ expression.

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Pharmaceutical Technology

NOVEMBER 21, 2022

Japan is currently the fourth largest market in the world. Based on GlobalData estimates, the Japanese pharmaceutical market generated JPY9.392 trillion ($67.32 A lower number of clinical trials and regulatory filings were other important influences behind the decision. in 2022 to JPY9.498 trillion ($68.08

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Pharmaceutical Technology

MARCH 2, 2023

There are three more drug candidates with major trial readouts that are expected in 2023. The European Medicines Agency (EMA) is also reviewing Reata’s marketing authorisation application (MAA) for SKYCLARYS in Europe. The FDA granted Orphan Drug, Fast Track, and Rare Pediatric Disease Designations for the medication.

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World of DTC Marketing

FEBRUARY 7, 2022

According to Endpoint News” We’ve seen Biogen’s CSO exit under pressure in recent weeks, and senior marketing execs leave in an exodus as the company recoiled from a fierce backlash against the FDA’s ultra controversial approval of Aduhelm for Alzheimer’s. Finally, they need to withdraw Aduhelm from the market.

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AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 12, 2022

The Subject Expert Committee (SEC) for Reproductive and Urology, which advices the nation’s drug regulator on clinical studies and approvals, has recommended approval for the State-run HLL Lifecare Ltd to manufacture and market graphene condom, the next generation thinner; and stronger condom that is expected to improve the acceptability of the (..)

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Pharmaceutical Technology

JULY 18, 2022

receptor antagonist indicated for the treatment of severe eosinophilic asthma, is currently being investigated in the Phase III MAHALE trial (NCT05006573). The Phase II WILLOW trial (NCT03218917) assessed the efficacy, safety, tolerability and pharmacokinetics of brensocatib and has reported positive results.

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AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 14, 2022

The medical devices industry in the country has sought the Centre to define online and offline mode of sale, provide more clarity on the regulations that are binding the online sales and suggested inclusion of online medical devices players under the Uniform Code for Medical Devices Marketing Practices (UCMDMP).

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Pharmaceutical Technology

MAY 4, 2023

Idorsia has received marketing authorisation from Health Canada for Quviviq (daridorexant) to manage insomnia in adult patients. The regulator recommended one Quviviq 50mg oral tablet each night, taken 30 minutes before going to bed with a minimum of seven hours remaining before planned awakening.

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Pharmaceutical Technology

JUNE 21, 2023

It is claimed to be the first anti-inflammatory atheroprotective cardiovascular treatment to receive approval from the regulator. The regulatory approval was based on the findings obtained from a double-blind, multinational, placebo-controlled, randomised clinical trial conducted in 5,522 chronic coronary disease patients.

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Cloudbyz

AUGUST 2, 2022

Premarketing drug studies vs Post- Marketing research. Premarketing drug studies consist of phase I-III trials, and are represented by pharmacokinetic and pharmacodynamic studies, dose ranging studies, and Randomized Controlled Trials (RCTs). Approximately only 20 % of the drugs that enter phase I are approved for marketing.

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Advarra

DECEMBER 17, 2024

For example, AI tools can pull data from protocols and automatically update clinical trial management systems (CTMS), reducing manual entry errors and increasing workflow speed. This same data could be used to auto-generate study calendars based on the schedule of assessments, streamlining trial planning.

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Worldwide Clinical Trials

OCTOBER 19, 2022

As evidence emerges about their potential for PTSD, depression, cancer-related distress and more, the market for psychedelics could swell from $2 billion in 2020 to $10.75 With regulators and lawmakers seemingly on board, sponsors have more opportunities than ever to pursue clinical research in this high-velocity area. billion in 2027.

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pharmaphorum

DECEMBER 23, 2021

The FDA has published draft guidance on how digital health technologies (DHTs) like smart and wearable devices can be used to capture data remotely from patients in clinical trials – an approach that has come to the fore since the start of the pandemic. The draft is open for comment until 22 March.

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pharmaphorum

JULY 8, 2022

The COVID-19 pandemic has catalysed significant changes in the way pharma develops drugs, particularly in the clinical trial space. Hybrid or decentralised clinical trials (DCTs) have gained traction as technology, infrastructure and knowledge have evolved to support their use. New sensor technology revolutionising data collection.

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Pharmaceutical Technology

FEBRUARY 24, 2023

The overhaul will address drug marketing exclusivity length, pricing, patient access, innovation incentives, antimicrobial resistance, clinical trials, supply chain security and shortages, and environmental impact. She also cautioned against believing that all of the problems with Europe’s medicines can be solved with regulation.

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Pharmaceutical Technology

APRIL 20, 2023

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. Within such a tightly regulated industry, there is natural apprehension to being a first mover.

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Cloudbyz

JUNE 13, 2023

Introduction: Clinical trials are essential for evaluating the safety and efficacy of new medical treatments, therapies, and interventions. Developing an accurate and comprehensive budget is crucial for successful trial planning and execution. Site Selection: Careful site selection is critical for optimizing trial costs.

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pharmaphorum

MARCH 23, 2021

The big Swiss pharma added this drug to its pipeline after it swooped for Endocyte and so far it looks like a good piece of business, with potential blockbuster sales predicted for the drug if it makes it to market. Novartis added that there were no surprises in terms of safety, with side effects similar to those seen in previous trials.

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Pharmaceutical Technology

NOVEMBER 21, 2022

Japan is currently the fourth largest market in the world. Based on GlobalData estimates, the Japanese pharmaceutical market generated JPY9.392 trillion ($67.32 A lower number of clinical trials and regulatory filings were other important influences behind the decision. in 2022 to JPY9.498 trillion ($68.08

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pharmaphorum

AUGUST 8, 2022

As we reported this morning, the deal gives Pfizer already-approved SCD therapy Oxbryta (voxelator) – which industry watchers reckon could see a dramatic uptick in sales with Pfizer’s marketing muscle – plus a phase 3 antibody candidate, a phase 1 follow-up to Oxbryta that could offer improved dosing.

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pharmaphorum

AUGUST 24, 2020

Could collecting, understanding, and disseminating patient-reported outcomes during trials be the key to advancing oncology treatments and improving cancer outcomes? . Project Patient Voice is a dedicated online platform that makes patient-reported symptoms and adverse events (AEs) from the trial data of marketed drugs publicly available.

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Cloudbyz

MARCH 31, 2024

The landscape of clinical trial management is undergoing a significant transformation, driven by the complex demands of modern medical research. As we delve into the challenges posed by point systems, it becomes clear that a platform approach is not just beneficial but essential for the future of clinical trials.

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Cloudbyz

AUGUST 30, 2024

Clinical trials are the backbone of medical advancements, but their complexity and the regulatory environment pose significant challenges to researchers, sponsors, and clinical trial managers. Managing these trials efficiently while ensuring compliance with stringent regulatory standards is paramount to their success.

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Pharmaceutical Technology

OCTOBER 25, 2022

There are options in the future to possibly apply the worldwide research and development (R&D), manufacturing and marketing expertise of Astellas in gene therapy to AAV gene therapy development programmes of Taysha for genetic ailments of the central nervous system (CNS).

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Drug Patent Watch

DECEMBER 30, 2024

This article aims to provide a comprehensive overview of the key aspects of the regulatory framework, highlighting the requirements and challenges faced by pharmaceutical companies seeking to introduce generic drugs into the Japanese market. New Drug Application (NDA) : Needed for marketing approval of new drugs.

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