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. Keytruda (Pembrolizumab) and Opdivo (Nivolumab).

Clinical Trials 104

Clinical Trials Clinical Trials Production Trials 104

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.

Clinical Trials 80

Clinical Trials Clinical Trials Trials Packaging 80

Pharmaceutical Technology

APRIL 13, 2023

Biogen has exercised an option to license Denali Therapeutics ’ (Denali) programme to develop immunotherapies for the treatment of Alzheimer’s disease. Denali is also expected to receive potential development and commercial milestone payments upon achieving certain milestones, along with royalties based on the future net sales of the drug.

Licensing 130

Licensing Licensing Antibody Clinical Trials 130

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.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Packaging 52

Pharmaceutical Technology

JUNE 19, 2023

Bio-Thera Solutions and Biomm have entered a licensing and supply agreement for Bio-Thera’s BAT2206, a ustekinumab biosimilar. The therapy, which completed a Phase I trial, is now being assessed in an international Phase III clinical trial that includes participants from China and Eastern European countries.

Licensing 130

Licensing Licensing Clinical Trials Clinical Trials 130

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.

Clinical Trials 98

Clinical Trials Clinical Trials Antibody Trials 98

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.

In-Vitro 178

In-Vitro Manufacturing Licensing Licensing 178

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.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Licensing 52

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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Trials Drugs Clinical Trials Clinical Trials 119

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.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Trials 52

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.

Clinical Trials 64

Clinical Trials Clinical Trials Trials Vaccination 64

Pharmaceutical Technology

JULY 28, 2022

The collaboration comes after Cidara filed a New Drug Application (NDA) for rezafungin to treat candidemia and invasive candidiasis. Rezafungin for injection received Qualified Infectious Disease Product (QIDP) designation from the US Food and Drug Administration (FDA) earlier, which gives the NDA priority review.

Licensing 147

Licensing Licensing Clinical Trials Clinical Trials 147

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 (..)

Clinical Trials 40

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 (..)

Clinical Trials 40

Clinical Trials Clinical Trials Licensing 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.

Clinical Trials 180

Clinical Trials Clinical Trials Pharmacy Trials 180

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, (..)

Clinical Trials 40

Clinical Trials Clinical Trials Licensing Licensing 40

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

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, (..)

Clinical Trials 40

Clinical Trials Clinical Trials Licensing Licensing 40

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.

Licensing 147

Licensing Licensing Manufacturing Medicine 147

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.

Drugs 171

Drugs Licensing Licensing Clinical Trials 171

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, (..)

Clinical Trials 40

Clinical Trials Clinical Trials Regulation Licensing 40

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. Nothing is definitive yet, and these are complicated trials, but the world wants to move to safer alternatives that don’t impede daily life or cause further issues.

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Clinical Trials Clinical Trials Medicine Trials 52

Rethinking Clinical Trials

JULY 6, 2023

Over the past several years, a variety of factors have accelerated the need for decentralized trials, including the push to make trials more accessible, the increased speed of science, the possibility of environmentally conscious trials, and the need to be flexible in a rapidly changing world.

Trials 130

Trials Clinical Trials Clinical Trials Licensing 130

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, (..)

Clinical Trials 40

Clinical Trials Clinical Trials Regulation Licensing 40

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 167

Cosmetics Drugs Licensing Licensing 167

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 → (..)

Licensing 52

Licensing Licensing Clinical Trials Clinical Trials 52

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.

Drugs 149

Drugs Licensing Licensing Manufacturing 149

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.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Clinical Research 59

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 […]

Regulation 150

Regulation Drugs Licensing Licensing 150

pharmaphorum

APRIL 22, 2021

Biosensor firm physIQ has licensed its technology to Johnson & Johnson’s Janssen pharma unit in a multi-year deal, to investigate use of wearable sensors in virtual clinical trials. physIQ has a portfolio of FDA-cleared digital biomarkers and a medical-grade platform that can transform raw sensor data into clinical insight.

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Licensing Licensing Trials Clinical Trials 72

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.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76

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.

Licensing 59

Licensing Licensing Trials Clinical Trials 59

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.”

Antibody 130

Antibody Drugs Clinical Development Licensing 130

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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Clinical Trials Clinical Trials Licensing Licensing 162

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.

Licensing 64

Licensing Licensing Development Drugs 64

Delveinsight

SEPTEMBER 28, 2021

Innovent Biologics and UNION therapeutics have announced a strategic and licensing collaboration to develop and commercialize Orismilast , a next-generation PDE4 inhibitor for inflammatory dermatology conditions in China. The drug was initially developed by LEO Pharma and acquired by UNION in 2020.

Clinical Trials 80

Clinical Trials Clinical Trials Trials Dermatology 80

Pharmaceutical Technology

JANUARY 9, 2023

Eisai and Biogen have received approval for their antibody Leqembi (lecanemab-irmb) , 100mg/mL injection for intravenous use, from the US Food and Drug Administration (FDA) under the Accelerated Approval Pathway to treat Alzheimer’s disease (AD). The regulatory approval is based on the data obtained from the Phase II trial.

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