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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Pharmacy Licensing Licensing Regulation 156

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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Pharma Companies Licensing Licensing Sales 138

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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Pharmacy Sales Licensing Licensing 148

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 148

Drugs Licensing Licensing Manufacturing 148

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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Licensing Licensing Drugs Clinical Trials 144

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 128

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.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

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. Both the medical licenses and nurse licenses need to be up to date.

Licensing 52

Licensing Licensing Pharmacy Clinical Trials 52

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

Clinical Development 147

Clinical Development Licensing Licensing Clinical Research 147

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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Development Licensing Licensing Clinical Research 40

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 → (..)

Licensing 52

Licensing Licensing Clinical Research Production 52

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.

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Scientist Life Science Clinical Research Doctors 105

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.

Licensing 52

Licensing Licensing Hormones Drugs 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.

Clinical Research 40

Clinical Research Licensing Licensing Medicine 40

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.

Compliance 59

Compliance Clinical Research Research Licensing 59

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.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

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.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

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

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.

Antibody 52

Antibody Licensing Licensing Trials 52

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

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

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

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?

Clinical Trials 59

Clinical Trials Clinical Trials Trials Clinical Research 59

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

Cloudbyz

MARCH 17, 2021

Lack of proper training of medical professionals restricts and hinders a safe and well-organized clinical trial. All these together can impose safety issues on the patient populations and risk the clinical research company’s brand value. Open communication to ensure patient retention during clinical testing.

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Clinical Trials Clinical Trials Trials Clinical Research 67

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. Psychedelic products are having a renaissance moment. billion in 2027.

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Clinical Trials Clinical Trials Trials Production 130

Pharma Business Blog

MARCH 15, 2023

Dears Please find hereinafter the latest news related to Clinical Trials in the EU with a respective indirect tax and pharma regulatory licensing impact: 1. The CTIS database is publicly available and leads to increased transparency for indirect tax & pharma regulatory licensing. • Indirect tax point of view b.)

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Clinical Trials Clinical Trials Trials Regulation 52

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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Gene Editing Gene Gene Therapy In-Vivo 168

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 80

pharmaphorum

AUGUST 19, 2021

Many guidelines focus narrowly on clinical trials that are intended to generate data for regulatory submission to support a new drug license. Many guidelines focus narrowly on clinical trials (including non-randomized studies) 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

Cloudbyz

JULY 20, 2022

In response to this authorization, FDA implemented binding guidance requiring submission of new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain drug master files (DMFs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs) to the Agency in eCTD format.

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Licensing Licensing Drugs Clinical Research 80

Rethinking Clinical Trials

JULY 6, 2023

Interstate licensing and our own institution’s policies are issues that still need to be addressed in terms of oversight and responsibilities. The idea that health care providers in our communities may have data about an adverse event is not necessarily new, and health care providers are often aware of an adverse event very early on.

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Trials Clinical Trials Clinical Trials Licensing 130

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.

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Production Regulation Research Clinical Research 115

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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HR Clinical Research Trials Medicine 52

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). .

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Marketing Research Clinical Trials Clinical Trials 75

Client Pharma

APRIL 3, 2020

Currently, Client-Pharma’s licensed warehouse facilities remain open, with our teams maintaining ongoing communications with approved specialist couriers in order to ensure that vital medicines can continue to be shipped and distributed for clinical research and patients alike.

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Licensing Licensing Containment Clinical Research 52

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.

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Drugs Pharma Companies Licensing Licensing 105