AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 20, 2023

Empowering of the Central Drugs Standard Control Organisation (CDSCO) through centralisation of drug licensing may not be the path to improve the quality of drugs manufactured in the country both for domestic and international markets, says SME Pharma Industries Confederation (SPIC), the apex organisation of small and medium pharma industries in the (..)

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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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Worldwide Clinical Trials

OCTOBER 19, 2022

With regulators and lawmakers seemingly on board, sponsors have more opportunities than ever to pursue clinical research in this high-velocity area. Vice President of Scientific Solutions, Neuroscience, at Worldwide Clinical Trials. But patient safety doesn’t stop being the priority when the session — or even the trial — ends.

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Pharmaceutical Technology

JULY 28, 2022

According to the deal, Cidara will continue to oversee the international Phase III ReSPECT prophylaxis clinical trial underway. The post Melinta and Cidara sign licensing deal for rezafungin appeared first on Pharmaceutical Technology. At the time points mentioned in the deal, the NDA will be transferred to Melinta. “We

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Pharmaceutical Technology

OCTOBER 4, 2022

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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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. We are pleased with Biogen’s decision to license ATV: Aβ and we are hopeful this will foster the development of next-generation anti-Aβ therapeutics.”

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XTalks

FEBRUARY 4, 2025

MZE782 also shows potential in treating phenylketonuria (PKU), a metabolic disease, with further studies planned after the Phase I trial. To further expand its research, Maze has entered several strategic partnerships and licensing agreements. Notably, MZE001, a program for Pompe disease, was licensed to Shionogi & Co.

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Pharmaceutical Technology

APRIL 29, 2024

Biodexa’s worldwide rights of eRapa come with a $17m grant from CPRIT to support the asset into Phase III clinical trials.

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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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XTalks

JANUARY 29, 2021

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. Biosimilars are increasingly becoming the standard of care and both have several licensed biosimilar drugs (e.g.

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XTalks

JULY 6, 2022

The adoption of decentralized clinical trial models has gained significant momentum in the past several years, even before the COVID-19 pandemic that triggered the need for more remote options to mitigate trial disruptions. Rachel Colite, VP Decentralized Clinical Trials, Cogstate.

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Clinical Trials Clinical Trials Trials Licensing 98

Cloudbyz

MARCH 31, 2024

The landscape of clinical trial management is undergoing a significant transformation, driven by the complex demands of modern medical research. As we delve into the challenges posed by point systems, it becomes clear that a platform approach is not just beneficial but essential for the future of clinical trials.

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Pharmaceutical Technology

APRIL 25, 2023

German biotechnology firm 3B Pharmaceuticals (3BP) has entered into a licensing agreement with Novartis Innovative Therapies for its fibroblast activation protein (FAP)-targeting peptide technology. The therapy candidate is currently under evaluation in the Phase l LuMIERE clinical trial.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 7, 2024

The national drug regulator has withdrawn the powers delegated to the State and Union Territory (UT) Licensing Authorities to issue No Objection Certificates (NOCs) for manufacture of unapproved, banned or new drugs solely for export purpose, asking the industry to file fresh applications with the central authority online from May 15.

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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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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.

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Bio Pharma Dive

AUGUST 20, 2024

In addition to new stock offerings, this week saw Merck license an antibody drug conjugate and BARDA further work trying to innovate remote clinical trials.

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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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Clinical Trial Podcast

JULY 18, 2020

Have you been tasked to develop a clinical trial budget? Well, you’re in luck because I’m going to share everything you need to know about clinical trial costs. Clinical trial budgets are often put together in haste. Developing a clinical trial budget can be a confusing exercise for sponsors and CROs.

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Pharmaceutical Technology

NOVEMBER 28, 2022

C4X Discovery (C4XD) and AstraZeneca have entered an exclusive global licensing agreement worth up to $402m to develop oral therapy to treat inflammatory and respiratory ailments. According to the deal, C4XD is entitled to get up to $16m in pre-clinical milestone payments before the commencement of the first clinical trial. .

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Pharmaceutical Technology

JANUARY 13, 2023

Currently, there are no licensed vaccines against these viruses. The organisation has commenced Phase II clinical trial planning in Uganda and Kenya. Sabin’s Ebola Sudan vaccine was found to be immunogenic and safe based on previous clinical trials.

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pharmaphorum

JANUARY 10, 2023

Astellas has licensed rights to a drug developed by Selecta Biosciences that could make more patients eligible for treatment with its gene therapy for inherited neuromuscular disorder Pompe disease. The post Astellas licenses companion drug for Pompe gene therapy appeared first on.

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Pharmaceutical Technology

AUGUST 8, 2022

The approval was based on findings from the international, randomised, open-label Phase III DESTINY-Breast04 clinical trial. Furthermore, Enhertu’s safety profile was in line with prior clinical trials without any new safety concerns detected. Enhertu-treated subjects had a median overall survival (OS) of 23.4

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pharmaphorum

SEPTEMBER 27, 2022

While a rumoured takeover by Merck & Co has yet to materialise, Seagen is getting on with its own business development, including a just-agreed licensing deal for a cancer immunotherapy developed by Dutch biotech Lava Therapeutics. The biotech said earlier it planned to seek FDA approval to start clinical trials towards the end of 2022.

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Pharmaceutical Technology

JANUARY 9, 2023

Leqembi is indicated to treat mild cognitive impairment or mild dementia stage of the disease in patients whose treatment started in clinical trials. The regulatory approval is based on the data obtained from the Phase II trial. Leqembi met the primary endpoint and all the critical secondary endpoints in the Clarity AD trial.

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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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AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 22, 2024

The Central Drugs Standard Control Organisation (CDSCO) has requested stakeholders to take appropriate action for timely reporting of adverse events related to medical devices to the Materiovigilance Programme of India (MvPI), in the backdrop of shifting the segment to licensing regime.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 21, 2024

A unified licensing authority titled as Indian Drug Regulatory Authority (IDRA) will garner the much needed recognition globally like US FDA or EMA, said Dr BR Jagashetty, former National […] India must now move towards looking to merge its Central and state enforcement wings and form a single authority.

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Pharmaceutical Technology

JULY 21, 2022

In June 2020, these antibodies, discovered at Vanderbilt University Medical Center, were licensed to AstraZeneca. According to data from the PROVENT clinical trial, AZD7442 demonstrated a statistically significant decline in symptomatic Covid-19 development risk.

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Worldwide Clinical Trials

FEBRUARY 21, 2024

The on-site cGMP Phase 1 pharmacy must have radiolabel drug preparation experience A clinical pharmacology unit (CPU) must be licensed and experienced in handling radioactive investigational drugs in order to complete your AME study.

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XTalks

DECEMBER 4, 2024

Proceeds from the IPO will propel key initiatives, including the Phase II clinical trial of Jotrol in Parkinson’s disease. These efforts aim to fast-track commercialization and out-licensing agreements in one of the world’s most promising pharmaceutical markets.

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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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Pharmaceutical Technology

JULY 29, 2022

The Food and Drug Administration (FDA) has acc epted to review ImmunityBio’s Biologics License Application (BLA) for N-803 to treat Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients with or without Ta or T1 disease.

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Trials Clinical Trials Clinical Trials Licensing 264

Pharmaceutical Technology

DECEMBER 19, 2022

Initially, the companies signed a research collaboration and licensing agreement in 2016 to develop and assess up to two bispecific NK cell engagers. These two molecules are presently being analysed by the research and development (R&D) team of Sanofi, with one currently being evaluated in clinical trials.

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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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Pharmaceutical Technology

JUNE 23, 2022

It was discovered by Incyte and licensed to Novartis in 2009. The EC approval is based on positive findings from the Phase II GEOMETRY mono-1 clinical trial of Tabrecta in patients with advanced NSCLC harbouring alterations leading to METex14 skipping. A kinase inhibitor, Tabrecta acts on MET.

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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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