XTalks

MAY 2, 2022

Lecanemab, the product of Phase IIb clinical research completed by BioArctic and collaborator Eisai, is one therapy making strides this year for Alzheimer’s disease. Lecanemab , the product of Phase IIb clinical research completed by BioArctic and collaborator Eisai, is one such therapy making strides this year.

Clinical Trials 98

Clinical Trials Clinical Trials Antibody Trials 98

Cloudbyz

MARCH 17, 2021

Monitoring patient safety during a clinical trial is one of the founding principles to be followed throughout the drug development life cycle. It can be defined as a collaborative relationship between sponsors, sites, researchers, and everyone involved in the clinical trial phases.

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Clinical Trials Clinical Trials Trials Clinical Research 67

Clinical Trial Podcast

JULY 18, 2020

Have you been tasked to develop a clinical trial budget? Well, you’re in luck because I’m going to share everything you need to know about clinical trial costs. Clinical trial budgets are often put together in haste. Developing a clinical trial budget can be a confusing exercise for sponsors and CROs.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

pharmaphorum

JUNE 30, 2021

The US-based company was founded in 2019 and is on a mission to bring the practice of pharmacy into clinical research. He explores how COVID-19 has disrupted healthcare delivery and why virtual and decentralised trials could help increase patient access.

Pharmacy 52

Pharmacy Clinical Research Research Clinical Trials 52

ACRP blog

FEBRUARY 21, 2023

Decentralized clinical trial (DCT) elements enabled clinical research to continue during the pandemic, when physical attendance at healthcare facilities was often impossible. Author: Jill Dawson The post Decentralized Clinical Trial Models: Are They Here to Stay? DCT Models: Are They Here to Stay?

Clinical Trials 59

Clinical Trials Clinical Trials Trials Clinical Research 59

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 30, 2023

Even as the Centre has listed the New Drugs, Medical Devices and Cosmetics Bill, 2023 to be tabled in Parliament during the current session, industry members are apprehensive that the new bill may mean centralisation of licensing and other powers to the Central drug regulatory authority and it may also have provisions which may harm […]

Cosmetics 171

Cosmetics Drugs Licensing Licensing 171

Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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Clinical Trials Clinical Trials Vaccination Vaccine 76

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 14, 2023

The Union ministry of health and family welfare has said that most of the e-pharmacies in the country have informed the Central Drugs Standard Control Organisation (CDSCO) that they are only providing an online platform connecting the users and the licensed pharmacies, in response to the show-cause notice from the drug regulator sent early this […] (..)

Pharmacy 162

Pharmacy Licensing Licensing Regulation 162

Rethinking Clinical Trials

JULY 6, 2023

The Food and Drug Administration (FDA) issued a draft guidance in May 2023 that provided guidance about the conduct of decentralized clinical trials. Learn more Read more about Decentralized Clinical Trials. DCTs can make things easier for patients and the research more efficient.

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Trials Clinical Trials Clinical Trials Licensing 130

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 11, 2023

The Delhi High Court has granted ten days’ time to the Government of India and the nation’s drug regulator to file a counter affidavit on the petitions filed by almost 28 pharma companies against the order prohibiting manufacturing, distribution and sale of 14 FDCs licensed prior to the year 1988, in the beginning of June. […]

Pharma Companies 143

Pharma Companies Licensing Licensing Sales 143

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 23, 2023

With the chemists and druggists across the country opposing the sale of drugs through online, the Central government is taking a stand that the sale of medicines should be strictly under the provisions of the existing regulations and the State Licensing Authorities (SLAs) are legally empowered to act against violation of the legal provisions.

Pharmacy 153

Pharmacy Sales Licensing Licensing 153

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 22, 2023

The point of contention, they pinpoint, is that if any retailer and manufacturer fails to display the license in a prominent place and is not conspicuous to the public, it amounts to violation of the […]

Drugs 153

Drugs Licensing Licensing Manufacturing 153

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 12, 2023

The Central Drugs Standard Control Organisation (CDSCO) has re-issued the list of fixed dose combinations (FDCs), declared as rational by the Prof Kokate Committee earlier and was released in February in connection with their new drug status and the procedure to be followed by the applicants when approaching the state licensing authority, with some (..)

Licensing 149

Licensing Licensing Drugs Clinical Trials 149

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 6, 2022

The medical devices industry has urged the Centre to ensure obligation on the part of the buyer or users to purchase or use only those medical devices with required licenses and certifications under the New Drugs, Medical Devices and Cosmetics (NDMDC) Bill, 2022, the draft of which has been circulated by the Union Health Ministry […].

Cosmetics 131

Cosmetics Licensing Licensing Drugs 131

Worldwide Clinical Trials

NOVEMBER 27, 2023

Food and Drug Administration (FDA) announced its acceptance of the Biologics License Application (BLA) for exa-cel. The post The Significance of the MHRA Approval and Upcoming FDA Review of the First Gene Editing Treatment appeared first on Worldwide Clinical Trials. In June 2023, the U.S.

Gene Editing 174

Gene Editing Gene Gene Therapy In-Vivo 174

Advarra

APRIL 30, 2024

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct is complicated. Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. associates, residents, research fellows). based sites.

Licensing 52

Licensing Licensing Pharmacy Clinical Trials 52

pharmaphorum

AUGUST 19, 2021

A common set of standards for randomised clinical trials (RCTs) aims to help researchers develop the drugs and interventions of the future – no matter what they do or where they are based. Many guidelines focus narrowly on clinical trials that are intended to generate data for regulatory submission to support a new drug license.

Trials 105

Trials Clinical Trials Clinical Trials Life Science 105

Cloudbyz

JUNE 2, 2023

Electronic Data Capture (EDC) has revolutionized clinical research and pharmaceutical drug development. Direct costs include purchasing or licensing the EDC software, hardware acquisition (servers, devices), and system installation. However, adopting this system requires a significant financial commitment.

Clinical Trials 68

Clinical Trials Clinical Trials Laboratory Information Management System Compliance 68

XTalks

AUGUST 13, 2020

As the rush for a COVID-19 vaccine continues, healthcare services company Kaiser Permanente has joined in on the clinical testing of Pfizer Inc. and BioNTech’s lead vaccine candidate in a Phase III trial being conducted at sites in California and Oregon. Kaiser began Phase III trials of the vaccine at the end of July.

Vaccination 89

Vaccination Vaccine Trials Clinical Trials 89

Worldwide Clinical Trials

OCTOBER 19, 2022

BioPharma Dive interviewed our Christine Moore on how to conduct psychedelic clinical research. With regulators and lawmakers seemingly on board, sponsors have more opportunities than ever to pursue clinical research in this high-velocity area. These trials are often someone’s last hope,” Moore said.

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Clinical Trials Clinical Trials Trials Production 130

Worldwide Clinical Trials

MAY 31, 2022

I was lost in my head thinking about how he may never get his driver’s license, attend his high school prom, or even graduate from kindergarten. Considering Clinical Trials. When it became clear that Kai’s chemo plan was not helping, we turned to clinical trials.

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Clinical Trials Clinical Trials Trials Doctors 130

XTalks

MAY 20, 2022

Doctors and physicians rely on the results provided by a clinical scientist to make an accurate prognosis, diagnosis and assessment for a patient’s treatment plan. What is it Like to Work as a Clinical Scientist? A clinical scientist is often synonymous with: Clinical Research / Clinical Laboratory Scientist.

Scientist 105

Scientist Life Science Clinical Research Doctors 105

XTalks

APRIL 24, 2023

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases. Reference: Chung DC, et al.

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

Olympian Clinical Research

JANUARY 5, 2022

Speaking with a licensed therapist can help you manage these overwhelming feelings and help you improve your overall quality of life. Contact Olympian Clinical Research. At Olympian Clinical Research, we understand how difficult it can be to cope with a loved one’s Alzheimer’s diagnosis.

Clinical Research 52

Clinical Research Clinical Trials Clinical Trials Licensing 52

XTalks

JULY 25, 2022

Byondis announced that the US Food and Drug Administration (FDA) accepted their Biologics License Application (BLA) for [vic-]trastuzumab duocarmazine (SYD985), an investigational therapy being studied to treat HER2-positive unresectable locally advanced or metastatic breast cancer. Clinical Trial Results for [Vic-]Trastuzumab Duocarmazine

Antibody 59

Antibody Drugs Clinical Trials Clinical Trials 59

Cloudbyz

AUGUST 2, 2022

PMRs/PMCs are studies or clinical trials that are conducted by the applicant after the Food and Drug Administration (FDA) has approved or licensed a product for marketing. These studies or clinical trials can be required either by regulation or statute (PMR), or by a written agreement, between FDA and the applicant (PMC). .

Marketing 75

Marketing Research Clinical Trials Clinical Trials 75

Drug Discovery World

OCTOBER 12, 2022

10-15 years ago, there were few validated medical devices for clinical research, and now we have a lot of technology to choose from. Why are digital biomarkers important in clinical trials? . What are the challenges using sensors in clinical trials? How does Sensor Cloud address this? . About the author .

Clinical Trials 52

Clinical Trials Clinical Trials Trials Sales 52

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.

Clinical Trials 79

Clinical Trials Clinical Trials Trials Compliance 79

XTalks

SEPTEMBER 29, 2022

To honor this year’s World Heart Day, Xtalks spoke with American Heart Association/American Stroke Association’s (AHA/ASA) Chief Clinical Science Officer, Dr. Mitchell S. Read on to learn more from the AHA about topics related to CVD clinical trials and more. How does the AHA/ASA support clinical trials in CVD and stroke? .

Clinical Trials 52

Clinical Trials Clinical Trials Trials Research 52

pharmaphorum

MAY 26, 2022

Racial disparities are still commonplace in many clinical trials with white-ethnic groups often overrepresented amongst trial participants. Inadequate clinical trial representations of all populations can therefore leave underrepresented groups vulnerable due to the lack of subgroup-specific data.

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Clinical Trials Clinical Trials Trials Medicine 143

Pharmaceutical Technology

JUNE 30, 2022

In the wake of Russia’s invasion of Ukraine, sponsors are increasingly evaluating other European countries to conduct their clinical trials. Among them, the Eastern European nation of Georgia has emerged as a key rescue country for multinational clinical trials that were put on hold due to the war. Room to grow.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Licensing 130

Delveinsight

JANUARY 21, 2021

Vera Therapeutics bags USD 80 Million for trials. Vera Therapeutics has raised USD 80 million to take a drug licensed from Merck KGaA into a phase 2b kidney disease clinical trial. The drug, atacicept, has flunked multiple autoimmune clinical trials, but Vera contemplates that it is a prospect in IgA nephropathy.

Research 52

Research Protein Clinical Trials Clinical Trials 52

pharmaphorum

MARCH 25, 2022

While these NPDT products do not require FDA clearance, they must substantiate their claims with rigorous, clinical research. These products require clinical trials to demonstrate their safety and efficacy before they can be prescribed by a licensed healthcare professional.

Production 115

Production Regulation Research Clinical Research 115

Cloudbyz

AUGUST 2, 2022

PMRs/PMCs are studies or clinical trials that are conducted by the applicant after the Food and Drug Administration (FDA) has approved or licensed a product for marketing. Essentials of Clinical Research. Research, C. Retrieved from [link] The post Post Marketing Research first appeared on CLOUDBYZ.

Marketing 52

Marketing Research Clinical Trials Clinical Trials 52

pharmaphorum

AUGUST 27, 2020

The common challenge is undertaking lengthy and capital-intensive phase II/III clinical trials. For example, if a company is carrying out clinical trials, then a clinical research organisation is needed to run them. Companies have struggled to access intermediate capital.

Vaccination 122

Vaccination Vaccine Life Science Clinical Trials 122

XTalks

AUGUST 25, 2020

Business as usual is anything but in the COVID-19 era, but as the pharmaceutical and clinical trials industries adjust, the US Food and Drug Administration (FDA) has received an influx of questions regarding site inspections and manufacturing-related queries.

Manufacturing 89

Manufacturing Clinical Trials Clinical Trials Production 89

pharmaphorum

JUNE 14, 2021

Eventually it was bought by Amryt who, keen to get the drug licensed, resubmitted it to NICE in 2020. Sanders has been on metreleptin treatment herself for over 10 years, and from the start has been involved in fighting for access to the drug, engaging with the pharma companies, clinical researchers, and NICE.

Drugs 105

Drugs Pharma Companies Licensing Licensing 105