Clinical Development, Clinical Trials and Manufacturing

Genenta Science signs manufacturing service deal with AGC Biologics

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.

Manufacturing

Manufacturing Gene Therapy Production Clinical Trials

Sanofi and GSK begin clinical trials of coronavirus vaccine

pharmaphorum

SEPTEMBER 4, 2020

Sanofi and GlaxoSmithKline have begun clinical trials of their coronavirus vaccine, as AstraZeneca expanded studies of its rival into Japan. If data from the phase 1/2 trial are positive, the companies aim to move into a phase 3 trial by the end of the year.

Clinical Trials

Clinical Trials Clinical Trials Vaccination Vaccine

How Can You Manage the Complexity of Early Phase Clinical Development?

XTalks

JUNE 4, 2024

In the ever-evolving landscape of pharmaceutical development, the complexity of early phase clinical trials is increasing. This surge in complexity is driven by escalating drug development costs, heightened competition and advanced scientific innovations. This is the storm that we find ourselves in the midst of.”

Clinical Development

Clinical Development Development Clinical Trials Clinical Trials

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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Complexity in Early Phase Clinical Trials with Dr. Oren Cohen?

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 has more than 30 years of healthcare experience which includes his work on clinical development. Cohen to the Clinical Trial Podcast.

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Research

Astellas to support development of Taysha’s gene therapy programmes

Pharmaceutical Technology

OCTOBER 25, 2022

Ast ellas Pharma has announced plans to make a strategic investment to back the development of Taysha Gene Therapies’ adeno-associated virus (AAV) development programmes for Rett syndrome and giant axonal neuropathy (GAN). This would allow the companies to boost the development of new therapy options for Rett syndrome and GAN patients.

Gene Therapy

Gene Therapy Gene Development Genetics

Fixed-dose combination: Considerations for design, formulation, manufacturing and analysis

Pharmaceutical Technology

OCTOBER 25, 2022

Understanding both the significant competitive advantages that FDC products can offer, and the difficulties and potential pitfalls associated with development and manufacturing of FDC drugs in oral solid dosage forms is a critical first step for companies exploring this approach. Developing and manufacturing FDCs factors to consider.

Manufacturing

Manufacturing Production Packaging Packaging

FDA suggests ways to curb constraints with rare disease gene therapy trials

Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases. GlobalData is the parent company of Pharmaceutical Technology.

Gene Therapy

Gene Therapy Gene Trials Clinical Trials

Rising demand for pediatric dosage forms requires reformulation, expertise, and to-scale manufacturing capabilities

Pharmaceutical Technology

NOVEMBER 25, 2022

PDF scale and reformulation challenge manufacturers. But the challenges for drug producers developing PDFs are numerous and varied. First and foremost, CDMOs must have expertise in formulation sciences and proven formulation success in clinical development and commercial approvals.

Manufacturing

Manufacturing Production Pharma Companies Development

Plus Therapeutics and PPS expand partnership for cGMP drug production

Pharmaceutical Technology

MAY 2, 2023

This will help to meet the rising demand for Plus Therapeutics’ lead investigational targeted radiotherapeutic, rhenium (186Re) obisbemeda, for clinical trials that are underway and planned. Our services allow us to deliver solutions that benefit our partners and ultimately patients.”

Production

Production Drugs Clinical Trials Clinical Trials

Cell and gene therapies: why advanced medicines call for specialised logistics

Pharmaceutical Technology

JULY 7, 2022

But there are many challenges it will face along the way, such as how to manufacture these drugs in a reproducible, scalable, cost-effective, and safe way for patients. It is certainly a pivotal moment for the cell and gene industry, with the next decade of R&D and clinical trials expected to transform the future of medicine.

Gene Therapy

Gene Therapy Gene Medicine Genetics

Symvivo’s Oral COVID-19 Vaccine Enters Clinical Trials

XTalks

NOVEMBER 6, 2020

Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinical trials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinical trial. COVID-19 Clinical Trials.

Clinical Trials

Clinical Trials Clinical Trials Vaccination Vaccine

KFA-115 by Novartis for Melanoma: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 28, 2023

KFA-115 is under clinical development by Novartis and currently in Phase I for Melanoma. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Generic Pharmaceutical

Generic Pharmaceutical Dermatology Clinical Trials Clinical Trials

(LAI-287 + semaglutide) by Novo Nordisk for Type 2 Diabetes: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 24, 2023

(LAI-287 + semaglutide) is under clinical development by Novo Nordisk and currently in Phase III for Type 2 Diabetes. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Insulin

Insulin Hormones Drugs Clinical Trials

Interview: The evolution of data management in clinical development

Outsourcing Pharma

JANUARY 9, 2024

Equally, OSP was delighted to speak to him to discuss the evolution of data management in clinical development and how intelligent data use can reduce clinical trial cancellations, minimise protocol amendments, and accelerate patient recruitment. Gen Li is president and founder of Phesi.

Clinical Development

Clinical Development Development Clinical Trials Clinical Trials

Top 10 Largest MedTech Mergers and Acquisitions of the Decade

XTalks

JANUARY 7, 2025

Medtronics Acquisition of Covidien Deal value : $43 billion Announced : June 2014 Closed : January 2015 In January 2015, Medtronic, a leading medtech company, acquired Covidien , an Ireland-based medical device manufacturer, in a deal worth approximately $43 billion, one of the largest to date. billion in 2021. billion.

Life Science

Life Science Manufacturing Production Clinical Development

The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

NOVEMBER 30, 2022

Manufacturing for Wegovy was also hit when a contract manufacturer in charge of syringe filling halted deliveries due to issues with good manufacturing practices. To overcome manufacturing issues, in December 2021, Novo Nordisk announced its plans to build three new manufacturing facilities.

Drugs

Drugs Manufacturing Hormones Clinical Trials

Pfizer and Valneva Issue Update on Phase 3 Clinical Trial Evaluating Lyme Disease Vaccine Candidate VLA15

Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

Clinical Trials

Clinical Trials Clinical Trials Vaccination Vaccine

PDUFA VII: Implications for Developers of Cell and Gene Therapies

Camargo

DECEMBER 20, 2021

Enhanced product quality reviews conducted under PDUFA VII will focus on innovative manufacturing technologies like those used to produce cell and gene therapies, particularly products with accelerated clinical development timelines. This is targeted for FY 2023.

Gene Therapy

Gene Therapy Gene Development Production

The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

NOVEMBER 30, 2022

Manufacturing for Wegovy was also hit when a contract manufacturer in charge of syringe filling halted deliveries due to issues with good manufacturing practices. To overcome manufacturing issues, in December 2021, Novo Nordisk announced its plans to build three new manufacturing facilities.

Drugs

Drugs Manufacturing Hormones Clinical Trials

IXCHIQ Chikungunya Vaccine Trial Shows Sustained Immune Response in Adolescents

XTalks

JANUARY 22, 2025

Importantly, the vaccine was well tolerated, with no safety concerns identified during the trial. Valneva is also advancing its investigational Lyme disease vaccine candidate, VLA15, currently in Phase II clinical development. These sustained responses build on earlier data showing 99.1% efficacy at six months and 98.8%

Immune Response

Immune Response Vaccination Vaccine Trials

Navigating CAPA in Clinical Development: Ensuring Compliance and Quality Assurance

Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. For clinical development organizations, an effective CAPA serves as an essential compass, directing a path towards continuous improvement while maintaining steadfast regulatory compliance.

Compliance

Compliance Clinical Development Development Clinical Trials

?5 Things You Need to Know from Our Recent Gene Therapy Webinar

Worldwide Clinical Trials

JUNE 15, 2022

Consulting with regulatory experts and experts in toxicology, manufacturing, etc., Early engagement and discussions can help you prevent the risk of a clinical hold. To discuss your study and how to reduce the chances of receiving a clinical hold, talk with us. . The cell and gene therapy pipeline is booming.

Gene Therapy

Gene Therapy Gene Clinical Trials Clinical Trials

Strategies to Successfully Manage Complex Cell Therapy Clinical Trials

XTalks

FEBRUARY 10, 2023

According to a recent review published in Nature , as of April 2022 almost 1,800 active cell therapy clinical trials were listed in ClinicalTrials.gov, a 33 percent increase from 2021. In a recent webinar, Dr. Vassallo discussed the operational considerations for complex cell therapy clinical trials.

Clinical Trials

Clinical Trials Clinical Trials Trials Gene Therapy

ASP-1570 by Astellas Pharma for Metastatic Melanoma: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 25, 2023

ASP-1570 is under clinical development by Astellas Pharma and currently in Phase II for Metastatic Melanoma. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. It is administered through oral route.

Clinical Trials

Clinical Trials Clinical Trials Drugs Clinical Development

ASP-1570 by Astellas Pharma for Solid Tumor: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 25, 2023

ASP-1570 is under clinical development by Astellas Pharma and currently in Phase II for Solid Tumor. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. It is administered through oral route.

Clinical Trials

Clinical Trials Clinical Trials Drugs Clinical Development

AlgoTherapeutix Receives Regulatory Approval to Initiate Clinical Development of ATX01

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

Clinical Development Development Clinical Supply Packaging

ASP-1570 by Astellas Pharma for Non-Small Cell Lung Carcinoma: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 25, 2023

ASP-1570 is under clinical development by Astellas Pharma and currently in Phase II for Non-Small Cell Lung Carcinoma. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Drugs

Drugs Clinical Trials Clinical Trials Clinical Development

Viral Vector Manufacturing: Current Landscape and Opportunities

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.

Manufacturing

Manufacturing Gene Therapy Gene DNA

Pfizer cut vaccine production targets because of raw material shortage – reports

pharmaphorum

DECEMBER 4, 2020

Results from Pfizer’s clinical trial also took longer than expected to materialise and caused further delays, the spokesperson added. The company said it is still on course to manufacture between 500 million and up to a billion doses of the vaccine globally in 2021.

Vaccination

Vaccination Vaccine Production Regulation

BioInvent and Cantargia sign manufacturing agreement for monoclonal antibody CAN10

The Pharma Data

NOVEMBER 25, 2020

26, 2020 /PRNewswire/ — Cantargia AB (OMXS: CANTA) and BioInvent International AB (OMXS: BINV), today announced that BioInvent has been contracted as manufacturer of Cantargia’s antibody CAN10 in preclinical development for the treatment of systemic sclerosis and myocarditis. LUND, Sweden , Nov. About BioInvent.

Antibody

Antibody Manufacturing Clinical Trials Clinical Trials

Keeping tabs on Covid-19: Cell and gene clinical trials advance despite Covid-19…

The Pharma Data

AUGUST 7, 2020

The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinical trials to combat Covid-19.

Clinical Trials

Clinical Trials Clinical Trials Gene Trials

Novavax Announces COVID-19 Vaccine Clinical Development Progress

The Pharma Data

NOVEMBER 30, 2020

We continue to make meaningful progress as we work to test, manufacture and ultimately deliver NVX-CoV2373 with unprecedented speed, as well as put partnerships in place that would ensure widespread and equitable access worldwide.”. pivotal Phase 3 trial update. Mexico pivotal Phase 3 trial update. United Kingdom (U.K.)

Clinical Development

Clinical Development Vaccination Vaccine Development

EU orders 300 million doses of BioNTech/Pfizer’s COVID-19 vaccine

pharmaphorum

NOVEMBER 12, 2020

The vaccine supply for the EU will be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium and based on current projections, the companies expect to produce globally up to 1.3 There is an option for a further 100 million doses. billion doses in 2021.

Vaccination

Vaccination Vaccine Manufacturing Regulation

Patient Safety and Radiopharmaceuticals Administration: Minimizing Radiation Exposure and Risks

Worldwide Clinical Trials

JULY 8, 2024

With radiopharmaceuticals emerging as a diagnostic and therapeutic (theranostics) procedure, many are in the clinical development pipeline and are expected to play a crucial role in the future of healthcare. Whether you’re considering a new study or need support with an ongoing trial, we’re here to partner with you.

Hormones

Hormones Regulation Clinical Trials Clinical Trials

STRO-002 by Sutro Biopharma for Refractory Acute Myeloid Leukemia: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 19, 2023

STRO-002 is under clinical development by Sutro Biopharma and currently in Phase I for Refractory Acute Myeloid Leukemia. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Antibody

Antibody Protein Clinical Development Manufacturing

AbbVie begins trials of COVID-19 antibody therapy

pharmaphorum

DECEMBER 16, 2020

AbbVie is to begin clinical development of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University. AbbVie has begun a phase 1 clinical trial of the antibody, with clinical development beginning in the US and expanding into Europe.

Antibody

Antibody Trials Licensing Licensing

(Lopinavir + ritonavir) by Douglas Pharmaceuticals for Genital Warts (Condylomata Acuminata): Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 24, 2023

(Lopinavir + ritonavir) is under clinical development by Douglas Pharmaceuticals and currently in Phase I for Genital Warts (Condylomata Acuminata). GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Contract Manufacturing

Contract Manufacturing Dermatology Hormones Production

(Lopinavir + ritonavir) by Douglas Pharmaceuticals for Cervical Intraepithelial Neoplasia (CIN): Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 24, 2023

(Lopinavir + ritonavir) is under clinical development by Douglas Pharmaceuticals and currently in Phase I for Cervical Intraepithelial Neoplasia (CIN). GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Contract Manufacturing

Contract Manufacturing Dermatology Hormones Production

Getting Cancer Cell Therapies to Patients: Insights from a Biopharma Industry Veteran

XTalks

JUNE 23, 2022

Jason Bock is a biopharma industry veteran who helped build the Biologics Development team that was formerly part of the Therapeutics Discovery division at the University of Texas MD Anderson Cancer Center. Dr. Bock is currently the CEO of the Cell Therapy Manufacturing Center at the Texas Medical Center.

Manufacturing

Manufacturing Development Engineer Clinical Development

Rezvilutamide by Jiangsu Hengrui Medicine for Liver Failure (Hepatic Insufficiency): Likelihood of Approval

Pharmaceutical Technology

JUNE 5, 2023

Rezvilutamide is under clinical development by Jiangsu Hengrui Medicine and currently in Phase I for Liver Failure (Hepatic Insufficiency). GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Medicine

Medicine Hormones Production Clinical Trials

Rezvilutamide by Jiangsu Hengrui Medicine for Prostate Cancer: Likelihood of Approval

Pharmaceutical Technology

JUNE 5, 2023

Rezvilutamide is under clinical development by Jiangsu Hengrui Medicine and currently in Phase III for Prostate Cancer. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Medicine

Medicine Hormones Production Clinical Trials

?The Current State of Advanced Therapeutics

Worldwide Clinical Trials

MAY 20, 2022

Though some of the disparity can be attributed to the difficulty of advanced therapeutic development, it is more a testament to the influx of research in the past few years that is only beginning to flow through development. The Current State of Advanced Therapeutics appeared first on Worldwide Clinical Trials.

Gene Therapy

Gene Therapy Gene Development Research

Givinostat by Italfarmaco for Myelofibrosis: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 27, 2023

Givinostat is under clinical development by Italfarmaco and currently in Phase II for Myelofibrosis. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. It is a hydroxamate.

Production

Production Manufacturing Drugs Development

Givinostat by Italfarmaco for Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF): Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 27, 2023

Givinostat is under clinical development by Italfarmaco and currently in Phase II for Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF). GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Production

Production Manufacturing Drugs Development

Genenta Science signs manufacturing service deal with AGC Biologics

Sanofi and GSK begin clinical trials of coronavirus vaccine

Webinars

Trending Sources

How Can You Manage the Complexity of Early Phase Clinical Development?

Webinars

Complexity in Early Phase Clinical Trials with Dr. Oren Cohen?

Astellas to support development of Taysha’s gene therapy programmes

Fixed-dose combination: Considerations for design, formulation, manufacturing and analysis

FDA suggests ways to curb constraints with rare disease gene therapy trials

Rising demand for pediatric dosage forms requires reformulation, expertise, and to-scale manufacturing capabilities

Plus Therapeutics and PPS expand partnership for cGMP drug production

Cell and gene therapies: why advanced medicines call for specialised logistics

Symvivo’s Oral COVID-19 Vaccine Enters Clinical Trials

KFA-115 by Novartis for Melanoma: Likelihood of Approval

(LAI-287 + semaglutide) by Novo Nordisk for Type 2 Diabetes: Likelihood of Approval

Interview: The evolution of data management in clinical development

Top 10 Largest MedTech Mergers and Acquisitions of the Decade

The “Medical Bypass”: new drugs to strike obesity

Pfizer and Valneva Issue Update on Phase 3 Clinical Trial Evaluating Lyme Disease Vaccine Candidate VLA15

PDUFA VII: Implications for Developers of Cell and Gene Therapies

The “Medical Bypass”: new drugs to strike obesity

IXCHIQ Chikungunya Vaccine Trial Shows Sustained Immune Response in Adolescents

Navigating CAPA in Clinical Development: Ensuring Compliance and Quality Assurance

?5 Things You Need to Know from Our Recent Gene Therapy Webinar

Strategies to Successfully Manage Complex Cell Therapy Clinical Trials

ASP-1570 by Astellas Pharma for Metastatic Melanoma: Likelihood of Approval

ASP-1570 by Astellas Pharma for Solid Tumor: Likelihood of Approval

AlgoTherapeutix Receives Regulatory Approval to Initiate Clinical Development of ATX01

ASP-1570 by Astellas Pharma for Non-Small Cell Lung Carcinoma: Likelihood of Approval

Viral Vector Manufacturing: Current Landscape and Opportunities

Pfizer cut vaccine production targets because of raw material shortage – reports

BioInvent and Cantargia sign manufacturing agreement for monoclonal antibody CAN10

Keeping tabs on Covid-19: Cell and gene clinical trials advance despite Covid-19…

Novavax Announces COVID-19 Vaccine Clinical Development Progress

EU orders 300 million doses of BioNTech/Pfizer’s COVID-19 vaccine

Patient Safety and Radiopharmaceuticals Administration: Minimizing Radiation Exposure and Risks

STRO-002 by Sutro Biopharma for Refractory Acute Myeloid Leukemia: Likelihood of Approval

AbbVie begins trials of COVID-19 antibody therapy

(Lopinavir + ritonavir) by Douglas Pharmaceuticals for Genital Warts (Condylomata Acuminata): Likelihood of Approval

(Lopinavir + ritonavir) by Douglas Pharmaceuticals for Cervical Intraepithelial Neoplasia (CIN): Likelihood of Approval

Getting Cancer Cell Therapies to Patients: Insights from a Biopharma Industry Veteran

Rezvilutamide by Jiangsu Hengrui Medicine for Liver Failure (Hepatic Insufficiency): Likelihood of Approval

Rezvilutamide by Jiangsu Hengrui Medicine for Prostate Cancer: Likelihood of Approval

?The Current State of Advanced Therapeutics

Givinostat by Italfarmaco for Myelofibrosis: Likelihood of Approval

Givinostat by Italfarmaco for Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF): Likelihood of Approval

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