Clinical Supply, Development and Medicine - Clinical Research Informer

Catalent Adds New Cryogenic Capabilities at Shiga, Japan, Facility to Support Clinical Supply Demand for Cell and Gene Therapy Development

The Pharma Data

MAY 26, 2023

The expansion forms part of Catalent’s ongoing global strategy to increase its ability to handle, store and manage advanced therapies for clinical supply, and follows investments at its facilities in Philadelphia, Singapore, and Shanghai, China, in specialized, ultra-low temperature storage capabilities. With sites in the U.S.,

Clinical Supply

Clinical Supply Gene Therapy Gene Development

Abiogen acquires EffRx to fortify bone disease portfolio

Pharmaceutical Technology

MAY 30, 2023

The company has developed three bisphosphonates, clodronate, alendronate and Nerixia (neridronate), for the treatment of bone pathologies such as osteoarthritis. The company developed and launched Binosto (alendronate sodium) as the first and only buffered solution for osteoporosis. Alkindi is one of EffRx’s three marketed drugs.

Contract Manufacturing

Contract Manufacturing Clinical Supply Licensing Licensing

Leading clinical packaging companies in contract marketing

Pharmaceutical Technology

SEPTEMBER 20, 2022

Clinical packaging and labelling follow stringently controlled procedures and high-standard quality control measures to assure the safety and functionality of investigational medicinal products, during their storage, distribution, and use.

Packaging

Packaging Packaging Marketing Clinical Trials

How to plan for uncertainty while maximizing the efficiency of your clinical sup…

The Pharma Data

SEPTEMBER 14, 2020

Supply chain uncertainty is a challenge every clinical supply chain manager wrestles with – stemming from increasing product demand and quality, the growing complexity of clinical trial designs and a lack of visibility in the supply chain. Achieving clinical supply chain flexibility now and in the future.

Clinical Supply Chain

Clinical Supply Chain Clinical Supply Clinical Trials Clinical Trials

How Concordance Healthcare Solutions Aims to Optimize the Supply Chain

XTalks

JULY 24, 2023

This innovative platform aims to revolutionize the industry by seamlessly connecting providers, distributors and suppliers, providing unprecedented visibility into supply and demand information. Developed in collaboration with Palantir Technologies Inc.,

Clinical Supply Chain

Clinical Supply Chain Clinical Supply Production Marketing

Why demand is rising for secure and climate-controlled gene therapy services

Pharmaceutical Technology

JUNE 19, 2023

Pharmaceutical companies are putting their trust in the immense potential this new generation of medicine has for treating individuals with rare genetic diseases, which currently affect an estimated 280 million patients worldwide. Cell and gene therapies are not your typical clinical supply chain.

Gene Therapy

Gene Therapy Gene Packaging Packaging

J&J’s Carvykti and BMS’ Abecma Win FDA Approvals for Earlier Use in Multiple Myeloma

XTalks

APRIL 11, 2024

The results were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine. This could be seen as a positive for companies developing CAR T-cell therapies for autoimmune diseases and solid tumors.

FDA Approval

FDA Approval Manufacturing Trials Clinical Trials

Why and How Will Ecommerce Transform the Interactive Response Technology (IRT) User Experience?

XTalks

APRIL 6, 2023

Modern software development concepts from ecommerce applications are helping eClinical applications meet the precise needs of each clinical trial. IRT solutions help clinical trial sponsors meet the complexities of patient randomization and clinical supply management. How is Modern Software Impacting IRT Platforms?

Clinical Trials

Clinical Trials Clinical Trials Clinical Supply Trials

Untangling the Complexities of Cell and Gene Therapy Clinical Trials: A Supply Chain Perspective

Pharmaceutical Technology

MAY 24, 2023

The ability to modify or introduce genetic material in human cells in such a precise and patient-centered manner clearly constitutes a breakthrough in personalized medicine. Allogeneic therapies begin with healthy donor samples to develop the eventual therapeutic product which can be administered to multiple patients.

Clinical Trials

Clinical Trials Clinical Trials Gene Therapy Clinical Supply Chain

PharmaDrug Enters Definitive Agreement for Acquisition of Sairiyo Therapeutics Inc. Who Recently Received Orphan Drug Designation from FDA for Esophageal Cancer

The Pharma Data

JANUARY 24, 2021

Management of the Company believe that the proposed acquisition will strengthen PharmaDrug’s product pipeline, intellectual property portfolio and pharmaceutical development expertise. Research and development efforts will be led by Dr. Paul Van Slyke. Food and Drug Administration (“FDA”) approval. PharmaDrug Inc.

Drugs

Drugs Containment Development Sales

Molecular Partners Announces Collaboration With Novartis to Develop Two DARPin(R) Therapies Designed for Potential Use Against COVID-19

The Pharma Data

OCTOBER 27, 2020

MP0420 and MP0423 are potential medicines with a unique approach for both the prevention and treatment of COVID-19, with the possibility to manufacture at scale, easy administration and with the potential to bypass cold storage. Novartis is making multiple contributions to the global efforts to combat the COVID-19 pandemic.

Development

Development Protein Manufacturing Medicine

AWS helps Pfizer accelerate drug development and clinical manufacturing

The Pharma Data

DECEMBER 4, 2021

company (NASDAQ: AMZN), announced that it is working with Pfizer to create innovative, cloud-based solutions with the potential to improve how new medicines are developed, manufactured, and distributed for testing in clinical trials. (AWS), an Amazon.com, Inc.

Manufacturing

Manufacturing Development Drugs Clinical Supply Chain

Overcoming inefficiencies to improve access to cell and gene therapy

Drug Discovery World

MARCH 13, 2023

Between the 24 therapies already approved by the FDA 1 and a marked increase in clinical trials, widespread accessibility to precision medicine feels within reach. Before 2019, CGT drug developers still had a young, academic mindset, ordering reagents, materials, and equipment haphazardly and assuming they would show up when needed.

Gene Therapy

Gene Therapy Gene Manufacturing Development

Clinical Trial Data: Navigating Audit Trail Data Regulations and Accessibility Challenges

VirTrial

APRIL 18, 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, the European Medicines Agency (EMA) in the EU, and the Food and Drug Administration (FDA) in the US all have regulations that require a documented audit trail review.

Regulation

Regulation Clinical Trials Clinical Trials Trials

A supply chain to match the changing face of science

Drug Discovery World

NOVEMBER 3, 2022

Paul Viggers , Chief Commercial Officer at TrakCel, explains how it fits into the drug discovery and development sector. . 1 Emily was a seven-year-old girl who relapsed a second time following two years battling leukaemia, out of standard treatment options, and her life was saved by a CAR-T treatment in early clinical trial.

Gene Therapy

Gene Therapy Production Development Business Development

VTX-801 RECEIVES U.S. FDA FAST TRACK DESIGNATION FOR THE TREATMENT OF WILSON DISEASE

The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has granted Fast Track designation to VTX-801, Vivet’s clinical-stage gene therapy for the treatment of Wilson Disease – a rare, genetic disorder that reduces the ability of the liver and other tissues to regulate copper levels, causing severe hepatic damage, neurological symptoms, and potentially death.

Gene Therapy

Gene Therapy Gene Clinical Trials Clinical Trials

Nordic Nanovector ASA: Results for the Third Quarter 2020

The Pharma Data

NOVEMBER 18, 2020

. Trial to be paused pending analysis of data and evaluation of plans for further development. Results of preclinical studies demonstrating Betalutin® reverses tumour resistance to rituximab in NHL disease models published in Journal of Nuclear Medicine. Financial Highlights. million ( NOK 0.0

Trials

Trials Production Development Marketing

Africa: Unleashing the potential of the new superpower in clinical trials

Pharmaceutical Technology

MARCH 20, 2023

Africa has considerable advantages and opportunities for trialling investigational medicinal products that, if pharma companies can correctly harness, will turn the continent into a superpower for clinical trials. Therefore, they are open to clinical trials, because of the lack of costs that they have to put towards it.

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Supply Chain

Clinical trials in Ukraine: Ensuring supply chain continuity during war

Pharmaceutical Technology

MAY 23, 2023

Alongside providing continuity of clinical trial services, Oximio has been involved in delivering life-saving humanitarian aid around the country. Olga has also recently been elected to provide logistics insight to the Clinical Trials Subcommittee (CTS) Executive Board at the European Business Association (EBA) due to the war.

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Supply Chain

Clinical Research Informer

Catalent Adds New Cryogenic Capabilities at Shiga, Japan, Facility to Support Clinical Supply Demand for Cell and Gene Therapy Development

Abiogen acquires EffRx to fortify bone disease portfolio

Trending Sources

Leading clinical packaging companies in contract marketing

How to plan for uncertainty while maximizing the efficiency of your clinical sup…

How Concordance Healthcare Solutions Aims to Optimize the Supply Chain

Why demand is rising for secure and climate-controlled gene therapy services

J&J’s Carvykti and BMS’ Abecma Win FDA Approvals for Earlier Use in Multiple Myeloma

Why and How Will Ecommerce Transform the Interactive Response Technology (IRT) User Experience?

Untangling the Complexities of Cell and Gene Therapy Clinical Trials: A Supply Chain Perspective

PharmaDrug Enters Definitive Agreement for Acquisition of Sairiyo Therapeutics Inc. Who Recently Received Orphan Drug Designation from FDA for Esophageal Cancer

Molecular Partners Announces Collaboration With Novartis to Develop Two DARPin(R) Therapies Designed for Potential Use Against COVID-19

AWS helps Pfizer accelerate drug development and clinical manufacturing

Overcoming inefficiencies to improve access to cell and gene therapy

Clinical Trial Data: Navigating Audit Trail Data Regulations and Accessibility Challenges

A supply chain to match the changing face of science

VTX-801 RECEIVES U.S. FDA FAST TRACK DESIGNATION FOR THE TREATMENT OF WILSON DISEASE

Nordic Nanovector ASA: Results for the Third Quarter 2020

Africa: Unleashing the potential of the new superpower in clinical trials

Clinical trials in Ukraine: Ensuring supply chain continuity during war

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