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 […]

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Cosmetics Drugs Licensing Licensing 167

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 […] (..)

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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. […]

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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.

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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 […]

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Drugs Licensing Licensing Manufacturing 150

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 (..)

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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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Velocity Clinical Research

AUGUST 18, 2023

Even as a teen in Egypt, Amira Nada was drawn to the idea of clinical research and how it could help people live healthier, richer lives. They weren’t getting the relief they needed, and I wanted to help change that,” Amira adds. She decided to focus on patient recruitment to promote diversity in clinical trial populations.

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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 […].

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Cosmetics Licensing Licensing Drugs 129

XTalks

MAY 20, 2022

Do you possess laboratory skills, an analytical mindset and a penchant for research? If you enjoy working with biological samples and are enthusiastic about healthcare, a career as a clinical scientist might be just right for you. To start applying to clinical scientist jobs today, head over to the Xtalks Job Search platform.

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Scientist Life Science Clinical Research Doctors 105

Advarra

APRIL 30, 2024

For example, non-medical personnel should not assess adverse event causality or confirm the clinical significance of lab results. A cross-check ensures curriculum vitae (CVs), and medical licenses (if appropriate) are on file and current. associates, residents, research fellows). Sites outside of the U.S.

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Pharmaceutical Technology

OCTOBER 11, 2022

Swiss biotech company Stalicla has signed a licensing deal with Evgen Pharma for the latter’s lead asset, SFX-01, in neurodevelopmental disorders and schizophrenia. It is claimed to be the only grade of sulforaphane which is suitable for clinical research and will eventually be approved as a medicine. Evgen will receive $160.5m

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Imperical Blog

SEPTEMBER 7, 2023

Avoiding “Customs Chaos” in Clinical Trials Means Working Closely with Your Importer of Record Many global clinical trial shipments get muddled regarding the critical role and responsibilities of the importer of record (IOR) for clinical trials.

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Imperical Blog

SEPTEMBER 7, 2023

Avoiding “Customs Chaos” in Clinical Trials Means Working Closely with Your Importer of Record Many global clinical trial shipments get muddled regarding the critical role and responsibilities of the importer of record (IOR) for clinical trials.

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ACRP blog

JANUARY 8, 2024

Few industries have a need to understand the complexities of compliance more than clinical research. The importance of compliance in clinical research cannot be stressed enough. But the scope of risk extends beyond the tangible to more intangible areas such as organizational reputation and trust.

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Compliance Clinical Research Research Licensing 59

BioTech 365

AUGUST 5, 2020

Executes Exclusive License Agreement with G1 Therapeutics for Global Development and Commercialization of Preclinical Cyclin-Dependent Kinase 2 (CDK2) Inhibitor Program Scientific Founders Comprised of Industry Experts with Proven Track Record of Successfully Delivering Innovative Oncology Therapeutics to the Clinic RESEARCH … Continue reading (..)

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Olympian Clinical Research

AUGUST 19, 2022

In addition, clinical research may provide new information and breakthrough treatments. . The Benefits of Clinical Research for Pediatric Dermatology Conditions. Although there is currently no cure for either psoriasis or eczema, clinical research is constantly working to develop new and improved treatments.

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Clinical Research Allergies Doctors Doctor 52

BioTech 365

AUGUST 11, 2020

Completes License and Development Agreement with NONPI Medical LUND, Sweden–(BUSINESS WIRE)–Random Walk Imaging AB (RWI), a company developing novel software solutions for diffusion magnetic resonance imaging (MRI), today announced the launch of its first commercial software product for clinical researchers … Continue reading → (..)

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Licensing Licensing Clinical Research Production 52

BioSpace

DECEMBER 21, 2022

Pourhassan and the CEO of Amarex Clinical Research on multiple counts of fraud. Department of Justice indicted former CytoDyn Inc. CEO Nader Z.

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Clinical Research Licensing Licensing Research 40

pharmaphorum

AUGUST 16, 2022

Immunomedics had licensed the rights to the drug in Asian markets to Everest in 2019 for $65 million upfront and with up to $710 million in potential milestones, including $65 million due on US approval. The new deal means that the licensing deal has been terminated, and the Chinese pharma is no longer on the hook for any remaining payments.

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The Pharma Data

NOVEMBER 5, 2020

Drawing upon 50 years of expertise in clinical research, biopharmaceuticals, biotechnology and drug discovery, Dr. Van Kampen excels as the chief executive officer of The Van Kampen Group, which assists other companies in research and liaisons with government and industry regarding licensing products for commercial use.

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Research Vaccination Vaccine Doctors 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. DCT Models: Are They Here to Stay?

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Clinical Trials Clinical Trials Trials Clinical Research 59

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.

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Clinical Research Clinical Trials Clinical Trials Licensing 52

Delveinsight

JANUARY 21, 2021

Researchers at the Sanford Burnham Prebys Medical Discovery Institute and the University of Glasgow have early proof a combination strategy may work in AML. The researchers stated in the journal Nature Communications. TP53 is frequently mutated across various cancers, so targeting the gene is a popular pursuit in oncology research.

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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 68

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.

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Clinical Trials Clinical Trials Antibody Trials 98

pharmaphorum

MARCH 25, 2022

As few as 2% have peer-reviewed research to back up their claims. ”. These analyses focused exclusively on wellness and smoking cessation apps, bypassing a category of digital therapeutics regulated by the FDA that make scientifically validated claims using sound research. Three Guiding Principles for Digital Therapeutics Research.

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Production Regulation Research Clinical Research 114

Rethinking Clinical Trials

JULY 6, 2023

The DCT space is evolving and will require more commentary on guidance, sharing research, and effective implementation. 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

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.

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Trials Clinical Trials Clinical Trials Life Science 105

Drug Discovery World

SEPTEMBER 16, 2022

The therapy is already licensed in the UK for adults and children aged six to 18, and was approved by the FDA in June 2022 for use in younger children.

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Antibody Licensing Licensing Trials 52

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.

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Clinical Trials Clinical Trials Laboratory Information Management System Compliance 69

The Pharma Data

AUGUST 20, 2020

Patient dosing has begun in a Phase III clinical programme investigating GlaxoSmithKline’s 5-in-1 meningitis (MenABCWY) vaccine candidate compared to licensed meningococcal vaccines, Bexsero and Menveo. Invasive Meningococcal Disease (IMD) is uncommon, with country-specific reported cases ranging from 0.1

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Trials Vaccination Vaccine FDA Approval 52

pharmaphorum

MAY 27, 2022

The adoption of digital healthcare tools in clinical research accelerated dramatically during the COVID-19 pandemic and it is expected that such tools will continue to contribute to clinical research in the future. What comes next?

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Clinical Trials Clinical Trials Trials Packaging 79

Worldwide Clinical Trials

NOVEMBER 27, 2023

Food and Drug Administration (FDA) announced its acceptance of the Biologics License Application (BLA) for exa-cel. In June 2023, the U.S. In recognition of the unmet need and medical urgency for innovative therapies in the sickle cell space, the FDA granted exa-cel Priority Review, with a formal decision expected by December 8, 2023.

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XTalks

AUGUST 13, 2020

The trial is being conducted by investigators at the Kaiser Permanente Center for Health Research in Portland, Oregon, the Department of Research & Evaluation in Pasadena, California and the Division of Research in Oakland, California. Kaiser began Phase III trials of the vaccine at the end of July.

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Vaccination Vaccine Trials Clinical Trials 89

Velocity Clinical Research

JUNE 27, 2023

The prolific researchers also had findings simultaneously published in the New England Journal of Medicine and The Lancet. Novo Nordisk announced that a biologics license application for the insulin icodec has been submitted for FDA review. This research could lead to a more convenient and accessible treatment option.

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Insulin Trials Hormones Clinical Trials 52

Drug Discovery World

FEBRUARY 9, 2023

This means durvalumab is eligible for inclusion in the Innovative Licensing and Access Pathway (ILAP). 4 Data from TOPAZ-1 also show enhanced clinical efficacy after an additional 6.5 The MHRA has been a Project Orbis partner since 1 January 2021. 4 Updated median OS was 12.9 months compared to 11.3 months with chemotherapy alone.3

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