AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 30, 2024

The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on stability studies of In-vitro Diagnostic Medical Device (IVDMD) to aid manufacturers in the preparation of premarket review documents for the import or manufacturing license applications.

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Pharmaceutical Technology

OCTOBER 4, 2022

An investigational Covid-19 drug, ensitrelvir is an inhibitor of 3CL protease. In the Phase III portion of a Phase II/III clinical trial in Asia, ensitrelvir met the primary endpoint. The post Shionogi and MPP enter Covid-19 antiviral licensing deal appeared first on Pharmaceutical Technology.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 22, 2023

The Central Drugs Standard Control Organisation (CDSCO) has said that a joint investigation team of its East Zone office and the State Licensing Authority (SLA) of Sikkim have declared the samples of Glenmark Pharmaceuticals’ blood pressure-lowering drug Telma 40 failed in the quality tests in February, 2023, as spurious.

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Cloudbyz

MAY 11, 2023

Clinical trials play a vital role in bringing new therapies and treatments to patients, but they can be expensive and resource-intensive endeavors. Understanding the factors driving clinical trial costs is essential for researchers, sponsors, and other stakeholders involved in the drug development process.

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Drug Discovery World

JANUARY 16, 2024

The Jenner Institute at the University of Oxford is conducting the study using Bacille Calmette-Guérin (BCG), the current licensed vaccine against TB. The post Clinical trial will test novel inhaled TB vaccine appeared first on Drug Discovery World (DDW).

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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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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 22, 2023

Drug regulatory experts have advocated for decriminalizing the existing drugs act without compromising on the drug quality and patient safety.

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Worldwide Clinical Trials

OCTOBER 26, 2022

Bringing a psychedelic into a clinical trial setting is complex and requires a thorough operational approach to ensure the study’s success. That’s because psychedelic trials are logistically heavy, requiring special licensing for drug handling, training for staff in Schedule I drug requirements, and standardized facilities.

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BioTech 365

JANUARY 27, 2022

Systemic Hypertension Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, Licensing and Acquisitions, and Drug-specific Revenue Forecasts – ResearchAndMarkets.com Systemic Hypertension Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, Licensing (..)

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Clinical Trials Clinical Trials Licensing Licensing 40

BioTech 365

JANUARY 27, 2022

Glioblastoma (GBM) Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, Licensing and Acquisitions, and Drug-specific Revenue Forecasts – ResearchAndMarkets.com Glioblastoma (GBM) Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, Licensing and (..)

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Clinical Trials Clinical Trials Licensing Licensing 40

BioTech 365

JANUARY 27, 2022

Atrial Fibrillation (AF) Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, Licensing and Acquisitions, and Drug-Specific Revenue Forecasts – ResearchAndMarkets.com Atrial Fibrillation (AF) Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, (..)

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Clinical Trials Clinical Trials Licensing Licensing 40

XTalks

JANUARY 29, 2021

Oncology products monopolise the list of best-selling drugs. This is relevant for clinical trials as more regulators require evidence of efficacy in comparison to the standard of care, which is likely to be one of the blockbuster products. Herceptin (Trastuzumab) and Mabthera (Rituximab).

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BioTech 365

JANUARY 27, 2022

Systemic Lupus Erythematosus (SLE)Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, Licensing and Acquisitions, and Drug-specific Revenue Forecasts – ResearchAndMarkets.com Systemic Lupus Erythematosus (SLE)Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, (..)

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Clinical Trials Clinical Trials Licensing Licensing 40

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 21, 2023

The Union Ministry of Ayush has submitted in the Delhi High Court that it has instructed the licensing authority for the Ayush systems of medicines in all the States and Union Territories that they should ensure that the labelling and naming of the products for the Ayurvedic and Unani drugs should be as per the […]

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Regulation Drugs Licensing Licensing 151

pharmaphorum

MAY 27, 2022

This is the second in a two-part series examining how pharma can embrace the DEI agenda to create more effective medicines through more representative clinical trials. The same principles are increasingly being applied to clinical trials to improve diversity, mitigate bias, and reinforce inclusion in clinical trials.

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BioTech 365

JUNE 9, 2021

World Pancreatic Cancer Market Spotlight 2021-2031: Key Marketed and Pipeline Drugs, Events, Clinical Trials, Regulations, Disease Prevalence, Licensing and Acquisition, Revenue – ResearchAndMarkets.com World Pancreatic Cancer Market Spotlight 2021-2031: Key Marketed and Pipeline Drugs, Events, Clinical Trials, Regulations, Disease Prevalence, (..)

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BioTech 365

OCTOBER 14, 2021

Exelixis In-Licenses Second Anti-Cancer Compound from Aurigene Following FDA Acceptance of Investigational New Drug Application for Phase 1 Clinical Trial in Non-Hodgkin’s Lymphoma Exelixis In-Licenses Second Anti-Cancer Compound from Aurigene Following FDA Acceptance of Investigational New Drug Application for Phase … Continue reading → (..)

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BioTech 365

JUNE 9, 2021

Global Osteoarthritis and Osteoarthritis Pain Market 2021-2031: Key Marketed and Pipeline Drugs, Events, Clinical Trials, Regulations, Disease Prevalence, Licensing and Acquisition, Revenue – ResearchAndMarkets.com Global Osteoarthritis and Osteoarthritis Pain Market 2021-2031: Key Marketed and Pipeline Drugs, Events, Clinical Trials, Regulations, (..)

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Clinical Trials Clinical Trials Regulation Licensing 40

Worldwide Clinical Trials

FEBRUARY 21, 2024

Also known as a human radiolabeled mass balanced study, the AME study aims to determine the overall metabolism and excretion pathways of the NCE, as well as to identify and quantify circulating metabolites relative to parent or total drug-related exposure.

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Drug Discovery World

AUGUST 9, 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Aleta Biotherapeutics a clinical trial authorisation (CTA) to evaluate biologic ALETA-001 in a Phase I/II clinical trial in patients with B-cell malignancies who are relapsed/refractory to CD19 CAR T cell therapy.

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Clinical Trials Clinical Trials Trials Licensing 52

Cloudbyz

MAY 1, 2023

Clinical trial budget management is a complex yet crucial aspect of conducting a successful clinical trial. One of the most challenging tasks for project managers and sponsors is to identify and account for all possible costs, including hidden ones, to ensure that the trial runs smoothly and within budget.

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Clinical Trials Clinical Trials Trials Packaging 52

XTalks

MAY 2, 2022

The Phase IIb clinical trial focused on the long-term clinical outcomes and safety for patients with MCI and amyloid pathology (early AD). A disease simulation model was created based on the results of the clinical trial and published literature to understand the long-term benefits of lecanemab use.

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Clinical Trials Clinical Trials Antibody Trials 98

pharmaphorum

JANUARY 9, 2023

Swiss biotech Stalicla has continued to diversify its pipeline from a focus on autism therapies with a deal to license Novartis’ mavoglurant, in clinical trials for cocaine use disorder (CUD) as well as neurodevelopmental disorders (NDD). STP-2 was licensed from Evgen Pharma in October last year.

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Drug Discovery World

OCTOBER 11, 2023

Boehringer Ingelheim and CDR-Life entered a licensing agreement in May 2020 and announced the selection of an antibody fragment-based therapeutic candidate in September 2021.

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Clinical Trials Clinical Trials Antibody Trials 52

pharmaphorum

FEBRUARY 24, 2022

Clinical stage pharmaceutical company Cantex Pharmaceuticals has obtained a global licence from Harvard University’s Office of Technology Development to develop the small-molecule drug azeliragon into a treatment for inflammatory lung diseases, including COVID-19. said Cantex CEO Stephen Marcus.

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Licensing Licensing Development Drugs 64

pharmaphorum

JANUARY 18, 2022

Cancer Research UK’s Centre for Drug Development, working with the Ludwig Institute for Cancer Research and Vaccitech, has begun a phase I/IIa clinical trial of a new lung cancer vaccine. Vaccitech and the Ludwig Institute are providing the drug while the Centre manages the trial and provides funding.

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Pharmaceutical Technology

FEBRUARY 14, 2023

Precision oncology firm Corbus Pharmaceuticals and CSPC Megalith Biopharmaceutical have entered an exclusive licensing agreement for the latter’s new clinical stage antibody drug conjugate (ADC), CRB-701 (SYS6002). We look forward to working with CSPC to advance clinical development of this asset and realise its full potential.”

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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

Drug Discovery World

FEBRUARY 1, 2023

Big pharma is helping to shape the focus The good news is that clinical trials are on the increase and market education is upping pace. This data is proving useful in testing hypotheses before starting any clinical trials. Germany only has three licenses, and the current facilities are a small fraction of total sales.

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Clinical Trials Clinical Trials Medicine Trials 52

Pharmaceutical Technology

MAY 12, 2023

On 8 May 2023, China-based Bliss Biopharmaceutical (BlissBio) announced a clinical trial collaboration with Eisai to develop BB-1701, an antibody-drug conjugate (ADC) for multiple cancer types. The drug became a blockbuster last year, with sales reaching $1.9bn, up from $599m in 2021.

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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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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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pharmaphorum

NOVEMBER 15, 2022

Lantheus’ pipeline-building drive in radiopharma has continued with a $260 million upfront deal to license rights to two oncology candidates from POINT Biopharma. Under the terms of the agreement, POINT will complete the study and, if positive, Lantheus will take responsibility for submitting the drug for approval.

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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? appeared first on ACRP.

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Clinical Trials Clinical Trials Trials Clinical Research 59

Drug Discovery World

DECEMBER 7, 2023

A potential schizophrenia treatment, discovered at Vanderbilt University in Tennessee in the US, has been cleared by the US Food and Drug Administration for use in Phase I clinical trials. The post Potentially game-changing schizophrenia drug enters Phase I trials appeared first on Drug Discovery World (DDW).

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Pharmaceutical Technology

APRIL 28, 2023

The US Food and Drug Administration (FDA) has granted an Orphan Drug Designation to Editas Medicine’s gene therapy EDIT-301 in sickle cell disease, based on an April 27 announcement. The US agency previously granted the Orphan Drug Designation to EDIT-301 for its study in beta thalassemia, in May 2022.

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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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