AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 23, 2024

The Central Drugs Standard Control Organisation (CDSCO) has requested all stakeholders in the medical devices sector to deposit the requisite fee for retention of license or registration certificate under the Medical Devices Rules (MDR), 2017, well before the stipulated timeline in order to avoid cancellation of the approvals.The drug regulator, in (..)

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Licensing Licensing Regulation Drugs 189

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 8, 2025

The Central Drugs Standard Control Organisation (CDSCO) and Indian Council of Medical Research (ICMR) have together released the draft standard evaluation protocols for the purpose of issuing license for in-vitro diagnostics (IVDs) under the Medical Devices Rules (MDR), 2017.

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Licensing Licensing In-Vitro Regulation 180

AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 13, 2024

The Union Ministry of Ayush will soon amend the Drugs and Cosmetic Rules, 1945 to mandate good manufacturing practices for Homoeopathy drug manufacturing, stipulating procedures for loan licensing in the system of Homoeopathy and specifying timelines for issuance of license, among others.

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Licensing Licensing Manufacturing Cosmetics 189

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 25, 2024

The Central government’s actions to mandate licensing of all medical devices is posing a challenge to the industry, especially the micro and small enterprises in the sector, says the Surgical Manufacturers and Traders Association (SMTA), the pan India organisation of manufacturers and traders of surgical equipment for healthcare services providers (..)

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Licensing Licensing Manufacturing Clinical Trials 189

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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Clinical Trials Clinical Trials Trials Compliance 103

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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Licensing Licensing Drugs Manufacturing 189

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. This means that sponsors are having to fork out for these blockbuster products in order to run their trials more often.

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Clinical Trials Clinical Trials Production Trials 104

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

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 Trials Clinical Trials Trials Compliance 98

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 94

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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Clinical Trials Clinical Trials Trials Clinical Research 98

XTalks

JANUARY 16, 2025

Sling Therapeutics has positive topline results from its Phase IIb/III LIDS clinical trial evaluating its oral small-molecule therapy linsitinib for the treatment of thyroid eye disease (TED). Ninety patients in the trial were randomized to receive one of two doses of linsitinib or placebo.

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Trials Clinical Trials Clinical Trials Insulin 59

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

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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Licensing Licensing Clinical Trials Clinical Trials 130

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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FDA Approval Antibody Clinical Trials Clinical Trials 246

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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Licensing Licensing Clinical Trials Clinical Trials 147

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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FDA Approval HR Clinical Trials Clinical Trials 264

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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Licensing Licensing Manufacturing Medicine 147

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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Clinical Trials Clinical Trials Licensing Licensing 144

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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Licensing Licensing Antibody Clinical Trials 130

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

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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Vaccination Vaccine Clinical Trials Clinical Trials 246

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

Camargo

OCTOBER 15, 2020

As a sponsor designs clinical studies, the respective comparison control groups become a critical factor to consider. If a single-arm trial was conducted as the pivotal trial for regulatory approval of those existing products, the sponsor will certainly want to do the same.

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Production Trials Development Clinical Trials 190

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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Drugs Licensing Licensing Regulation 241

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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Development Gene Expression Licensing Licensing 264

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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Licensing Licensing Clinical Trials Clinical Trials 130

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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Licensing Licensing Clinical Development Clinical Trials 130

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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Medicine Clinical Trials Clinical Trials Licensing 263

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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Clinical Trials Clinical Trials Pharmacy Trials 200

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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Bioavailability Genetic Disease Marketing RNA 111

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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Gene Therapy Gene Licensing Licensing 119

Pharmaceutical Technology

AUGUST 25, 2022

The approval is based on comprehensive data from the clinical development programme of Roctavian, including two-year findings from the international Phase III GENEr8-1 clinical trial. The company plans to resubmit a Biologics License Application (BLA) for Roctavian by the end of next month.

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Gene Therapy Gene Clinical Trials Clinical Trials 264

Pharmaceutical Technology

AUGUST 8, 2022

The latest approval is based on positive data from the multicentre, double-blind, randomised, placebo-controlled Phase III ARASENS clinical trial that analysed the safety and efficacy of oral darolutamide plus androgen deprivation therapy (ADT) and the chemotherapy docetaxel in mHSPC patients.

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Hormones Clinical Trials Clinical Trials Licensing 246

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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Antibody Compliance Clinical Trials Clinical Trials 264

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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Licensing Licensing FDA Approval Clinical Trials 111

Pharmaceutical Technology

DECEMBER 2, 2022

Under the Mission COVID Suraksha Program, DBT, the Indian Government and BIRAC provided funding for the development and clinical trials of the vaccine. Phase III trials of BBV154 were conducted to evaluate its safety and immunogenicity in approximately 3100 participants in 14 trial sites across the country.

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Vaccination Vaccine Clinical Trials Clinical Trials 217