The Pharma Data

JUNE 7, 2023

Originally launched in 2019 for early-phase protein therapy development, OneBio Suite offers customers an integrated service to accelerate programs from development to manufacturing, including fill/finish and packaging, and support for clinical supply and commercial launch. at the BioProcess International Theater.

Manufacturing 40

Manufacturing Development Protein Gene Therapy 40

The Pharma Data

DECEMBER 14, 2020

The trial, which will explore the pharmacokinetics and safety of ATX01 in healthy volunteers, is due to start in January 2021. AlgoTherapeutix recently raised a 12M€ Series A that will fund the Phase 1 and 2 clinical development of ATX01. More information at www.algotx.com. View source version on businesswire.com: [link].

Clinical Development 52

Clinical Development Development Clinical Supply Packaging 52

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. Accelerating your clinical trial supply through digitalization.

Clinical Supply Chain 52

Clinical Supply Chain Clinical Supply Clinical Trials Clinical Trials 52

Pharmaceutical Technology

JUNE 19, 2023

According to GlobalData’s clinical trials database, there are currently 1,231 planned and ongoing trials for gene therapies and gene-modified cell therapies alone. Cell and gene therapies are not your typical clinical supply chain. The requirements When handling personalised medicines, time is of the essence.

Gene Therapy 130

Gene Therapy Gene Packaging Packaging 130

Pharmaceutical Technology

MAY 24, 2023

By Luisa Sterkel & Joana Loureiro , Tenthpin Consultants The promise and potential of cell and gene therapies (CGT) has emerged in the recent past and currently over 1.500 CGT are registered for clinical trials holding great hope for the treatment of challenging and uncurable diseases.

Clinical Trials 246

Clinical Trials Clinical Trials Gene Therapy Clinical Supply Chain 246

Client Pharma

SEPTEMBER 18, 2020

Client-Pharma is proud to be a Bronze sponsor at this year’s first-ever Global Clinical Supplies Group – GCSG 2020 Virtual Conference.

Clinical Supply 40

Clinical Supply Clinical Trials Clinical Trials Trials 40

Client Pharma

SEPTEMBER 18, 2020

Client-Pharma is proud to be a Bronze sponsor at this year’s first-ever Global Clinical Supplies Group – GCSG 2020 Virtual Conference.

Clinical Supply 40

Clinical Supply Clinical Trials Clinical Trials Trials 40

VirTrial

APRIL 18, 2024

Data is the single most important thing in a clinical trial. The data serves as the cornerstone for critical decisions determining the fate of therapies and the performance of trials. The data highlights fast or slow recruitment and how the drug supply is managed.

Regulation 59

Regulation Clinical Trials Clinical Trials Trials 59

The Pharma Data

AUGUST 4, 2020

. UK-based Oxford Biomedica has signed a new development, manufacture and license agreement with Beam Therapeutics for next-generation CAR-T therapeutics. The agreement also puts in place a three year clinical supply agreement for the two companies.

Gene Editing 52

Gene Editing Licensing Licensing Clinical Supply 52

XTalks

APRIL 11, 2024

Concerns of Early Deaths The expanded approvals come after the FDA had flagged reports of early deaths in clinical trials evaluating the therapies in earlier treatment line settings. This could be seen as a positive for companies developing CAR T-cell therapies for autoimmune diseases and solid tumors.

FDA Approval 52

FDA Approval Manufacturing Trials Clinical Trials 52

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.

Clinical Trials 98

Clinical Trials Clinical Trials Clinical Supply Trials 98

The Pharma Data

JANUARY 10, 2021

About MorphoSys MorphoSys is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for patients suffering from cancer and autoimmune diseases. In 2017, Tremfya (R) , developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc.,

Containment 52

Containment Clinical Development Antibody Development 52

Clinical Trial Podcast

JANUARY 17, 2023

In this episode, you’ll learn about the world of Clinical Trial Site Networks. There are advantages and disadvantages when it comes to being a standalone clinical trial site. Standalone clinical trial sites enjoy the freedom of running their own operations. This is where site networks come in.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Supply 52

Clinical Trial Podcast

DECEMBER 29, 2022

In this episode, I’m excited for you to learn about Heart Failure Clinical Trials for medical devices. Sonna is currently the President at NuPulse Inc, an early stage medical device company responsible for developing the first minimally invasive, long-term, ambulatory counterpulsation device that works in sync with the heart.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Supply 52

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. . – January 25, 2021) – PharmaDrug Inc. About PharmaDrug Inc.

Drugs 52

Drugs Containment Development Sales 52

Pharmaceutical Technology

SEPTEMBER 14, 2022

The Phase I clinical trial that is underway is assessing SY-5609 plus chemotherapy in subjects with pancreatic cancer whose disease has advanced after Folfirinox treatment. . Tolerability and safety, as well as efficacy parameters, such as disease control rate and progression-free survival, will be analysed in the trial. .

Drugs 130

Drugs Clinical Supply Trials Clinical Trials 130

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 52

Gene Therapy Gene Manufacturing Development 52

Client Pharma

DECEMBER 13, 2021

Collaboration provides clinical trial sponsors with access to the world’s most efficient clinical supply processes using a single contract. As a result, global clinical supply and operations teams can now single source their commercial drug requirements by utilizing two best-in-class solution providers.

Clinical Supply 52

Clinical Supply Clinical Trials Clinical Trials Life Science 52

The Pharma Data

OCTOBER 27, 2020

Molecular Partners, a global leader in the development of DARPin® therapeutics, will be responsible for the conduct of phase 1 & 2 trials that may lead to emergency use approval; Novartis will be responsible for further development, manufacturing, distribution and commercialization.

Development 52

Development Protein Manufacturing Medicine 52

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 52

Manufacturing Development Drugs Clinical Supply Chain 52

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 52

Gene Therapy Production Development Business Development 52

The Pharma Data

AUGUST 15, 2021

The FDA’s Fast Track program is designed to facilitate the development, and expedite the review of, novel potential therapies that are designed to treat serious conditions and fill unmet medical need. Pfizer is collaborating with Vivet on the clinical supply of VTX-801 for the Phase 1/2 clinical trial.

Gene Therapy 52

Gene Therapy Gene Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 22, 2020

MP0420 is subject to an option and license agreement with Novartis AG to develop, manufacture and commercialize Molecular Partners’ anti-COVID-19 DARPin® program. Upon option exercise, Novartis would be responsible for all further development and commercialization activities. Chief Medical Officer of Molecular Partners.

Trials 40

Trials Protein Clinical Trials Clinical Trials 40

The Pharma Data

NOVEMBER 18, 2020

. Final two patients enrolled into Archer-1 Phase 1 safety trial of Betalutin® plus rituximab in 2L R/R FL Preliminary data readout expected in H1’2021. Trial to be paused pending analysis of data and evaluation of plans for further development. Financial Highlights.

Trials 40

Trials Production Development Marketing 40

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. Clinical trials data for Africa Globally, research has found that 62.2% being African American, 3.4%

Clinical Trials 130

Clinical Trials Clinical Trials Trials Clinical Supply Chain 130

Pharmaceutical Technology

MAY 23, 2023

The war in Ukraine has had a significant impact on clinical trials in Europe, exacerbating supply chain delays that were already causing multiple problems even before the Covid-19 pandemic intensified the situation. The company operates globally but was founded in Ukraine. We couldn’t put people’s lives at risk.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Clinical Supply Chain 130