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. We are experts in sourcing licensed and unlicensed medicines for use in trials, ranging from eye drops to the most sought-after blockbuster therapies.

Clinical Trials 104

Clinical Trials Clinical Trials Production Trials 104

Outsourcing Pharma

JANUARY 24, 2023

The CDMO will manufacture the API for the biotechâs lead drug candidate, ahead of plans to begin clinical trials.

Manufacturing 59

Manufacturing Clinical Trials Clinical Trials Trials 59

Pharmaceutical Technology

SEPTEMBER 20, 2022

Unlike commercial pharmaceutical packaging, the primary consideration in clinical trial packaging is protecting the product quality and reliability for research. Finding the best clinical trial packaging services providers. Clinical trial packaging and labelling solutions.

Packaging 100

Packaging Packaging Marketing Clinical Trials 100

Outsourcing Pharma

MARCH 14, 2023

The company releases two SaaS-based applications, GrantPay and GrantPact, to provide clinical trial contract negotiation and payment services.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Contract Manufacturing 52

Pharmaceutical Technology

SEPTEMBER 14, 2022

Pharmaceutical drug research and development (R&D) activities are capital-intensive, which makes the outsourcing of clinical dose manufacturing and marketing popular.

Marketing 100

Marketing Contract Manufacturing Sales Clinical Trials 100

Pharmaceutical Technology

FEBRUARY 24, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. Douglas Pharmaceuticals overview Douglas Pharmaceuticals (Douglas) carries out the development and manufacture of nutraceutical and health products.

Contract Manufacturing 100

Contract Manufacturing Dermatology Hormones Production 100

Pharmaceutical Technology

FEBRUARY 24, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. Douglas Pharmaceuticals overview Douglas Pharmaceuticals (Douglas) carries out the development and manufacture of nutraceutical and health products.

Contract Manufacturing 100

Contract Manufacturing Dermatology Hormones Production 100

Drug Discovery World

MARCH 6, 2024

Proceeds from the financing will enable the company to submit an IND for RNDP-001 and complete Phase I clinical trials, which will initiate within the year. The company will continue to work with its contract manufacturing partner, FUJIFILM Cellular Dynamics for manufacturing and development services.

Contract Manufacturing 52

Contract Manufacturing Life Science Manufacturing Clinical Trials 52

The Pharma Data

JANUARY 6, 2021

Viral immunotherapies company Oncorus announced earlier this week that it will begin building a GMP facility this year to manufacture its pipeline as its candidates move into IND-enabling and clinical studies. ” Harvin joined Oncorus in December after stints at Eli Lilly, Moderna, and bioMérieux SA. .”

Manufacturing 52

Manufacturing Contract Manufacturing FDA Approval Clinical Trials 52

Pharmaceutical Technology

JUNE 6, 2023

According to Globaldata, it is involved in 2 clinical trials, of which 1 was completed, and 1 is ongoing. Pfizer Overview Pfizer discovers, develops, manufactures, and commercializes biopharmaceuticals. It has major manufacturing facilities in India, China, Japan, Ireland, Italy, Belgium, Germany, Singapore, and the US.

Contract Manufacturing 100

Contract Manufacturing Manufacturing Production Pharmacy 100

Outsourcing Pharma

OCTOBER 12, 2023

Munther Baara has worked in the life sciences arena for more than 30 years. He has always been completely committed.

Clinical Trials 84

Clinical Trials Clinical Trials Life Science Trials 84

Pharmaceutical Technology

JANUARY 30, 2023

This is mixed news for contract manufacturing organisations (CMOs), as large CMOs such as Thermo Fisher Scientific (Waltham, MA, US) and Catalent Inc (Somerset, NJ, US) are typically involved in the manufacture of the most innovative products. Lilly has disclosed only in-house manufacturing locations for the drug.

Drugs 130

Drugs Manufacturing Contract Manufacturing FDA Approval 130

Pharmaceutical Technology

JULY 29, 2022

CAMP4’s CSO David Bumcrot PhD tells Pharmaceutical Technology that the company plans to see clinical trials go forward for their urea cycle disorder programs late next year. In preparation for this, drug manufacturing will begin later this year and will be outsourced to external contract manufacturing organisations (CMOs).

RNA 245

RNA Gene Expression Gene Gene Therapy 245

Pharmaceutical Technology

FEBRUARY 27, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. Pfizer overview Pfizer discovers, develops, manufactures and commercializes biopharmaceuticals.

Hormones 113

Hormones Contract Manufacturing Manufacturing Development 113

Roots Analysis

FEBRUARY 14, 2023

Presently, outsourcing of liposomes development and manufacturing related services has become a popular practice. Players Offering Liposome Development and Manufacturing Services Presently, over 70 companies are actively engaged in offering services related to liposomes development and manufacturing, worldwide.

Development 52

Development Manufacturing Drug Delivery Systems Contract Manufacturing 52

Drug Discovery World

MARCH 7, 2023

The two sister companies have developed an anti-cancer and anti-inflammatory drug that was contract-manufactured by Aldevron at the time Dr Ballantyne served there as chief scientific officer. The team and the strength of their recent clinical data is what made me want to invest,” said Dr Ballantyne.

Contract Manufacturing 52

Contract Manufacturing DNA Clinical Trials Clinical Trials 52

Pharmaceutical Technology

FEBRUARY 27, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. Pfizer overview Pfizer discovers, develops, manufactures and commercializes biopharmaceuticals.

Hormones 100

Hormones Contract Manufacturing Manufacturing Development 100

Pharmaceutical Technology

FEBRUARY 27, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. Pfizer overview Pfizer discovers, develops, manufactures and commercializes biopharmaceuticals.

Hormones 100

Hormones Contract Manufacturing Manufacturing Development 100

Drug Discovery World

FEBRUARY 19, 2024

Amtagvi was approved through the Accelerated Approval pathway, which gives patients the opportunity for earlier access to a promising therapy while the company conducts further trials to verify the predicted clinical benefit.

FDA Approval 52

FDA Approval Contract Manufacturing Manufacturing Trials 52

Outsourcing Pharma

DECEMBER 7, 2023

Virtual research organization, ObvioHealth, has just announced the launch of its application programming interface (API) which it says is tailored specifically for digital therapeutics (DTx) clinical trials.

Clinical Trials 91

Clinical Trials Clinical Trials Trials Research 91

FDA Law Blog

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022.

Manufacturing 59

Manufacturing Production Drugs FDA Compliance 59

Outsourcing Pharma

DECEMBER 7, 2023

Today, world-leading generative artificial intelligence (AI) company for life sciences, Yseop, is celebrating its involvement in more than 150 clinical trials with pharma giants around the world.

Life Science 83

Life Science Clinical Trials Clinical Trials Marketing 83

Roots Analysis

FEBRUARY 27, 2024

Currently, product licensing agreements, technology licensing agreements, research and development agreements and clinical trial agreements are the common types of partnerships inked by developers that are currently focused on the development of ADCs pipeline.

Antibody 52

Antibody Licensing Licensing Contract Manufacturing 52

Outsourcing Pharma

OCTOBER 20, 2023

Matteo Lai was part of a panel at DPharm in Boston this year, it was called working together to accelerate the adoption of digital biomarkers in clinical trials.

Clinical Trials 78

Clinical Trials Clinical Trials Trials Contract Manufacturing 78

The Pharma Data

JULY 21, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. This press release features multimedia.

Manufacturing 52

Manufacturing Vaccination Vaccine Clinical Trials 52

Pfizer

DECEMBER 13, 2021

Shot of a Lifetime: How Two Pfizer Manufacturing Plants Upscaled to Produce the COVID-19 Vaccine in Record Time. Shot of a Lifetime: How Two Pfizer Manufacturing Plants Upscaled to Produce the COVID-19 Vaccine in Record Time. A massive manufacturing undertaking. Anonymous (not verified). Mon, 12/13/2021 - 11:40.

Manufacturing 52

Manufacturing Vaccination Vaccine Production 52

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 59

Clinical Development Development Clinical Trials Clinical Trials 59

Roots Analysis

FEBRUARY 27, 2024

NovoCodex will fund global development activities to the end of Phase 1 clinical trials. This fast-growing market offers immense opportunities for contract manufacturers, service providers, and technology developers.

Antibody 40

Antibody Marketing Drugs Contract Manufacturing 40

pharmaphorum

MARCH 21, 2022

Provention has modified its 14-day treatment course with teplizumab to match the exposure to the drug that was seen with the clinical trial material, and has also submitted responses to FDA questions about manufacturing and product quality.

Drugs 52

Drugs Insulin Contract Manufacturing Clinical Trials 52

pharmaphorum

NOVEMBER 5, 2020

Austin-based Genprex has been preparing for the Reqorsa clinical trials programme, over the last few months, ramping up its manufacturing capacity for the gene therapy via an agreement with contract manufacturing organisation (CMO) Aldevron.

Gene Therapy 98

Gene Therapy Gene Drugs Contract Manufacturing 98

XTalks

FEBRUARY 27, 2024

Approximately 95 clinical trials evaluating TIL therapies have been registered globally. According to Iovance, Amtagvi is manufactured using a proprietary process to collect and expand a patient’s unique T cells from a portion of their tumor, and then returning billions of the patient’s T cells back to the body to fight their cancer.

FDA Approval 52

FDA Approval Manufacturing In-Vivo Trials 52

Roots Analysis

JUNE 30, 2023

Download Full Whitepaper COVID-19 Fallout: An Inflection Point for Digital Bioprocessing Since the outbreak of COVID-19, there has been an immense pressure on biopharmaceutical industry to reduce the production timelines and increase the speed and capacity of manufacturing, without compromising on the final product quality. technologies.

Manufacturing 52

Manufacturing Production Big Data Marketing 52

pharmaphorum

NOVEMBER 18, 2022

In a clinical trial, Tzield given once daily as an intravenous infusion for 14 days to patients with stage 2 T1D showed that after a median follow-up of 51 months, 45% had progressed to stage 3, compared to 72% of patients who received a matched placebo.

Drugs 52

Drugs FDA Approval Insulin Clinical Trials 52

Outsourcing Pharma

JULY 26, 2021

A clinical trial logistics expert discusses specialized concerns involved in transporting cell and gene products and other personalized medicine items.

Medicine 93

Medicine Clinical Trials Clinical Trials Gene 93

pharmaphorum

JANUARY 19, 2021

As vaccine manufacturers face unprecedented demand for their newly approved products, the race is on to provide enough shots for billions of people across the world. Pfizer and BioNTech have responded to this by upgrading their manufacturing facility in Puurs, Belgium.

Vaccination 89

Vaccination Vaccine Contract Manufacturing Manufacturing 89

Outsourcing Pharma

JULY 26, 2021

A clinical trial logistics expert discusses specialized concerns involved in transporting cell and gene products and other personalized medicine items.

Medicine 91

Medicine Clinical Trials Clinical Trials Gene 91

pharmaphorum

SEPTEMBER 15, 2020

Humanigen is hoping for emergency use authorisation in the US for an antibody to treat severe COVID-19 before the end of 2020, and has teamed up with Swiss contract manufacturer Lonza to make sure it can meet demand. Roche meanwhile is continuing to trial its drug in combination with remdesivir.

Drugs 97

Drugs Antibody Contract Manufacturing Manufacturing 97