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

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 188

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 188

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 188

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 186

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 181

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. The post Pharmacy and clinical research: the pharmaphorum podcast appeared first on.

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Pharmacy Clinical Research Research Clinical Trials 52

Clinical Trial Gurus

MAY 21, 2021

It is very important to list past research experience which can help the PI stand out as qualified for specific indications. In addition to listing PI experience, it may also help to list the NPI number and medical license number for future reference and verification.

Clinical Research 52

Clinical Research Research Licensing Licensing 52

pharmaphorum

DECEMBER 16, 2020

AbbVie is to begin clinical development of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University. AbbVie will conduct clinical development of ABBV-47D11, and if successful, will manufacture and market the product worldwide.

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Antibody Trials Licensing Licensing 98

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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Clinical Development Licensing Licensing Clinical Research 147

Cloudbyz

NOVEMBER 22, 2024

This prestigious acknowledgment places Cloudbyz among the top-performing companies globally, known for delivering scalable and intuitive CTMS solutions that empower clinical research teams. Selected extracts from Everest Group’s PEAK Matrix® reports do not necessarily provide the full context of our research and analysis. 

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Life Science Clinical Trials Clinical Trials Compliance 52

Pharmaceutical Technology

FEBRUARY 26, 2023

According to the company’s website, the biotech is undertaking research to decide on the future of the ulcerative colitis program, which also includes another candidate called SER-301. Previously, Takeda had licensed the two Finch treatments FIN-524 and FIN-525 for their development in IBD.

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Bacteria Trials Research Medicine 278

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 94

Worldwide Clinical Trials

AUGUST 9, 2024

Advantages and Operational Challenges in Adaptive MRCTs Adaptive trial designs are gaining popularity in clinical research due to their ability to improve trial efficiency and uphold ethical standards, resulting in faster and more reliable outcomes.

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Trials Clinical Trials Clinical Trials Regulation 200

Velocity Clinical Research

AUGUST 8, 2024

Before that, he’d spent 36 years in primary care, treating patients skewed toward the age group most at risk of Alzheimer’s, and it was this experience that, in part, encouraged him to cross over into clinical research. “It If you took a pill today, that was backed by research.”

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Clinical Trials Clinical Trials Genetics Clinical Research 105

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

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

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 189

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 94

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 98

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

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

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 → (..)

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Licensing Licensing Clinical Research Production 40

pharmaphorum

JANUARY 27, 2021

“Traditional methods limit who can participate in a clinical trial and how quickly we can complete the clinical trial,” said Ahmad Namvargolian, Care Access’ chief executive. “We The two antibodies were discovered by Vanderbilt University Medical Center and licensed to AZ in June 2020.

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Antibody Clinical Trials Clinical Trials Trials 94

XTalks

AUGUST 9, 2024

Technological advances, changing patient preferences and evolving guidance from regulators and policy makers have all supported new research methods that break down barriers to participation.

Clinical Trials 52

Clinical Trials Clinical Trials Trials 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

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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Licensing Licensing Hormones Drugs 52

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

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 Trials Clinical Trials 97

XTalks

AUGUST 13, 2020

It is also dedicated to fostering innovations in care, clinical research, health education and the support of community health. Kaiser Permanente has been providing not-for-profit healthcare plans for Americans across the US for 75 years now.

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Vaccine Vaccination Trials Clinical Trials 89

XTalks

DECEMBER 1, 2020

As the research and medical community learns more about population variances in disease outcomes, whether as a result of regional genetic profiles, socioeconomic factors, or environmental inputs, it’s become necessary to ensure that clinical research trials include broad swaths of global participants.

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Clinical Trials Clinical Trials Trials Clinical Research 96

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 Vaccine Vaccination FDA Approval 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

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

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

Cloudbyz

AUGUST 17, 2020

If you’ve been around the clinical research industry, the concept of obtaining electronic consent is probably familiar to you. A secure solution also provides various methods of document authentication by requiring participants to upload multiple forms of identification such as a state ID, driver’s license, and/or a health card.

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Clinical Research Containment Licensing Licensing 98