AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 3, 2024

The Drugs Consultative Committee (DCC), the advisory committee of the Central government to advise the Central and state governments on matters that require uniform implementation of drug laws across the country, has recommended to all the States to set a deadline for the manufacturing companies to upload all the formulation details in the Sugam portal, (..)

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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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Outsourcing Pharma

MAY 7, 2024

Walgreens and Boehringer Ingelheim have joined forces in a move to enhance diversity and accessibility in clinical trials, aiming to make participation more inclusive and equitable.

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Fierce Pharma

MAY 6, 2024

Following Nucleus RadioPharma’s 2022 debut, the GE HealthCare- and Mayo Clinic-backed radiopharmaceuticals CDMO is ready to put its production thesis to the test. Nucleus on Tuesday revealed that it has signed its first manufacturing partnership with clinical-stage radiopharma player ARTBIO.

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AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 2, 2023

India is strengthening its scope in contract manufacturing as the global customers commend the strengths and dependability of its pharma and biotech sectors.

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XTalks

MARCH 27, 2024

The collaboration between IVD manufacturers and lab testing partners is central to precise and efficient diagnostic processes. So, what considerations should IVD manufacturers bear in mind when determining this crucial partnership? But why should IVD manufacturers choose Quest Diagnostics as one of these partners?

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BioPharma Reporter

SEPTEMBER 19, 2023

The contract development and manufacturing organization (CDMO) Fujifilm Diosynth Biotechnologies has completed a UK manufacturing facility for the production of advanced therapies including viral gene therapies, oncolytic viruses and viral vaccines for use in clinical trials.

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Pharmaceutical Technology

DECEMBER 12, 2022

In this last 2022 edition of the series, which started in June , Pharmaceutical Technology is tracking major trial announcements and decisions by regulators and reimbursement agencies that have occurred since mid-October, as well as their potential impact on manufacturing plans. Regulatory decisions and clinical trial news.

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Clinical Trial Podcast

FEBRUARY 3, 2024

To learn more about clinical trials in diabetes, I invited Dr. Stayce Beck, Global Vice President of Clinical Affairs at Dexcom Inc. The post Diabetes Clinical Trials with Dr. Stayce Beck appeared first on Clinical Trial Podcast & Blog. on the podcast.

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Pharmaceutical Technology

FEBRUARY 8, 2023

Genenta Science and AGC Biologics have signed a development and manufacturing service agreement (MSA). Under the deal, AGC Biologics will be responsible for manufacturing the cell therapy lentivirus-based product for the ongoing clinical programmes of Genenta Science.

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XTalks

MAY 17, 2023

The Foundation for the National Institutes of Health (FNIH) announced this week that the Accelerating Medicines Partnership Bespoke Gene Therapy Consortium (AMP BGTC) has selected eight rare diseases for its clinical trial portfolio.

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Pharmaceutical Technology

MAY 2, 2023

Marker Therapeutics has reached a non-dilutive agreement to sell cell manufacturing assets to CellReady for $19m in cash. CellReady is a newly created contract development and manufacturing organisation (CDMO) founded by Marker board member and co-founder John Wilson. Both firms expect to complete the deal on 26 June 2023.

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Pharmaceutical Technology

JUNE 8, 2023

Mendus has entered an alliance with NorthX Biologics to co-establish a cell therapy manufacturing unit for its lead asset, vididencel, in Sweden. Mendus has partnered with NorthX and Swedish investment firm Flerie Invest, which will make an initial investment of Skr90m ($8.25m) in the manufacturing unit.

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Pharmaceutical Technology

MARCH 30, 2023

The US FDA has revealed its detailed budget proposal for FY2024, which would require pharma companies to name their active pharmaceutical ingredient (API) suppliers, restart President Biden’s Cancer Moonshot, inject cash into amyotrophic lateral sclerosis (ALS) research, and enforce stricter rules around manufacturing, recalls, and shortages.

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Contract Manufacturing Manufacturing Pharma Companies Cosmetics 147

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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XTalks

DECEMBER 22, 2022

Neilan has contributed to the rare disease community through his comprehensive work in the rare disease space that has included research, academia, medical practice and clinical trial design and execution. Can you tell us a bit about the work you are doing at NORD and how it impacts clinical trials for rare diseases?

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Cloudbyz

NOVEMBER 14, 2023

Clinical trials play a pivotal role in bringing new medical devices to market, ensuring their safety, efficacy, and compliance with regulatory standards. This can hinder the adoption of innovative approaches, such as electronic data capture (EDC) or remote monitoring, which are becoming increasingly important in clinical trials.

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Pharmaceutical Technology

NOVEMBER 21, 2022

RVAC Medicines has signed a master research partnership agreement with the Agency for Science, Technology and Research (A*STAR) for analysing and developing solutions to build messenger ribonucleic acid (mRNA) manufacturing and analytics expertise in Singapore. Topic sponsors are not involved in the creation of editorial content.

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Pharma Times

APRIL 29, 2021

ViroCell Biologics will meet the growing demand for viral vectors in clinical trials

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Clinical Trials Clinical Trials Trials Manufacturing 109

pharmaphorum

JANUARY 6, 2023

The cancer immunotherapies will mainly be provided in the context of clinical trials over the alliance, which extends out to 2030, but also covers supply of commercial therapies if approved in the interim. If successful, the partnership may also lead to manufacturing investments in the UK.

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Clinical Trials Clinical Trials Trials Vaccination 111

BioTech 365

JANUARY 31, 2022

ImmixBio Initiates IMX-110 GMP Manufacturing Scale-Up, Potentially Accelerating Clinical Trial Data ImmixBio Initiates IMX-110 GMP Manufacturing Scale-Up, Potentially Accelerating Clinical Trial Data Manufactured IMX-110 to be utilized in both clinical trials: 2022 planned monotherapy IMX-110 Clinical Trial in soft tissue … Continue reading → (..)

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Drug Discovery World

SEPTEMBER 22, 2022

A new bioreactor platform that aims to support the cell and gene therapy (CGT) sector from process development to commercial manufacturing has been launched. Using the system, developers can complete early process development on the same platform as manufacturing.

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ACRP blog

JULY 20, 2022

Along with MSM, the Yale School of Medicine and Vanderbilt University Medical Center have launched “ Equitable Breakthroughs in Medicine Development ,” an “historic” collaboration designed to increase diversity in clinical trials and address systemic barriers to participation in them by communities of color, Rice said.

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Pharmaceutical Technology

JANUARY 20, 2023

Increasing manufacturing capacity for pandemic prevention “The other piece we are working on is … how do we build manufacturing capacity around the world?”, The biotech has also made plans to expand manufacturing capacity elsewhere. The manufacturing expansion plans go beyond Covid-19 vaccines and therapeutics. “We

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Pharmaceutical Technology

AUGUST 17, 2022

Biopharmaceutical contract development and manufacturing organisation (CDMO) AGC Biologics has entered a strategic collaboration with RoosterBio to expedite the manufacturing of cell and exosome therapies. It will also have the potential to scale to Phase III clinical development and commercial manufacturing.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 10, 2024

Biopharmaceutical involves substantial investments in research, clinical trials, regulatory compliance, and manufacturing. Hence the affordability of these medicines are a complex issue, said Dr Amaresh Tumbagi, Karnataka additional drugs controller.

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Production Clinical Trials Clinical Trials Compliance 144

pharmaphorum

JULY 26, 2021

A lack of racial diversity in clinical trials is a long-standing, well-documented problem that contributes to the stark health inequalities that have been brought into sharp focus by COVID-19. Tackling it, however, has not been easy, thanks in no small part to the reasons being as complex as they are multi-faceted. Pillars of change.

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Clinical Trials Clinical Trials Trials Production 116

Clinical Trial Podcast

SEPTEMBER 26, 2022

To answer these two questions, regulatory authorities around the world require medical product manufacturers to conduct Phase I, also known as early phase clinical trials. Cohen to the Clinical Trial Podcast. appeared first on Clinical Trial Podcast & Blog. And will this interaction be safe?

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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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pharmaphorum

FEBRUARY 7, 2022

The last three years in pharma have seen a growing awareness of and dissatisfaction with a trend that has plagued the industry for its whole life: Nondiverse and unrepresentative clinical trials, which lead to incomplete data and compounded health disparity for minority populations.

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AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 6, 2024

Patients of cystic fibrosis (CF) and their relatives have requested the Department for Promotion of Industry and Internal Trade (DPIIT) to take steps to provide CF drugs at an affordable cost using the provisions of the Patents Act, 1970, considering that the drugs at present cost anywhere from Rs. 21 lakh to Rs. crore. […]

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Pharma Mirror

APRIL 28, 2021

Catalent will provide process development and CGMP manufacturing of AavantiBio’s adeno-associated viral (AAV) vector-based therapeutic candidate for use in clinical trials in the U.S. and Europe. and Europe. Catalent will further support process optimization and look to reduce material.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 13, 2023

The Indian Council of Medical Research (ICMR) has issued list of technologies supported under ICMR-Medical Device and Diagnostics Mission (MDMS) Secretariat to foster indigenous manufacturing of medical devices and diagnostics.

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FDA Law Blog

NOVEMBER 6, 2023

A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections.

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Roots Analysis

FEBRUARY 27, 2024

Over the last few decades, various viral vector manufacturing have been developed, optimized and standardized for introduction of therapeutic DNA / gene of interest into a patient’s body / cells. For more details, you can also download the SAMPLE REPORT on viral vector manufacturing by Roots Analysis.

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Manufacturing Gene Therapy Gene DNA 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

JUNE 12, 2023

Bristol Myers Squibb (BMS), a multinational pharmaceutical company based in New York City, has announced that its new state-of-the-art cell therapy manufacturing facility in Devens, Massachusetts, has received approval for commercial production from the US Food and Drug Administration (FDA).

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