Roots Analysis

JANUARY 27, 2025

DYNAMICS OF RADIOPHARMACEUTICAL MANUFACTURING A COMBINATION OF RADIOISOTOPES AND PHARMACEUTICALS Radiopharmaceutical manufacturing is a highly specialized field that involves the production of radioactive drugs used in medical imaging and treatment procedures.

Manufacturing 40

Manufacturing Production Medicine Contract Manufacturing 40

pharmaphorum

OCTOBER 27, 2020

US biotech BioSig Technologies has abandoned a phase 2 trial of its antiviral drug merimepodib with Gilead’s Veklury in severe COVID-19 patients, after concluding the safety of the combination was in doubt. However the Grade 3 group had “markedly different outcomes… making it unlikely that the trial would meet its primary safety endpoints.”.

Drug Trials 98

Drug Trials Trials Drugs Contract Manufacturing 98

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 264

Drugs Manufacturing Hormones Clinical Trials 264

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.

Gene Therapy 98

Gene Therapy Clinical Trials Clinical Trials Gene 98

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 246

Drugs Manufacturing Hormones Clinical Trials 246

Fierce Pharma

OCTOBER 31, 2023

Even as Catalent dusts itself off from a pandemic sales plunge, the company may be teetering on the edge of another contract manufacturing precipice.

Gene Therapy 59

Gene Therapy Gene Contract Manufacturing Trials 59

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 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

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

pharmaphorum

AUGUST 10, 2020

There are ongoing phase 3 trials testing its safety and efficacy in patients infected by the SARS-CoV-2 coronavirus that causes COVID-19, including combination trials with other drugs. Under the terms of the agreement Pfizer will become one of several external partners who manufacture the investigational treatment for the disease.

Drugs 99

Drugs In-Vivo In-Vitro Contract Manufacturing 99

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

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.

Clinical Trials 86

Clinical Trials Clinical Trials Trials Contract Manufacturing 86

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. Testing in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic modal solid tumors began in July.

Manufacturing 52

Manufacturing Contract Manufacturing FDA Approval Development 52

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 Immune Response 97

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

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. Enzalutamide overview Enzalutamide (Xtandi) is a phenylimidazolidine derivative, acts as anti neoplastic agent.

Hormones 113

Hormones Contract Manufacturing Manufacturing Development 113

pharmaphorum

JULY 7, 2021

Three months ago, the FDA said it was unconvinced by a bridging study designed to show equivalence between Provention’s product intended for commercial sale, made by contract manufacturer AGC Biologics, and the drug that teplizumab’s original developer Eli Lilly used in clinical trials.

Drugs 98

Drugs Insulin Contract Manufacturing Antibody 98

Outsourcing Pharma

JULY 22, 2020

A leader from the specialty logistics firm discusses how the clinical researching industry is shifting, thanks in large part to the pandemic, and how to prepare for the future.

Trials 101

Trials Clinical Research Research Contract Manufacturing 101

pharmaphorum

OCTOBER 9, 2020

In the US, Health and Human Services Secretary Alex Azar suggested this week that the country will have enough doses of vaccine available for every America citizen by March or April next year, with production underway for six shots backed by the US government across more than 23 manufacturing facilities.

Vaccination 105

Vaccination Vaccine Drugs Contract Manufacturing 105

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. Enzalutamide overview Enzalutamide (Xtandi) is a phenylimidazolidine derivative, acts as anti neoplastic agent.

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. Enzalutamide overview Enzalutamide (Xtandi) is a phenylimidazolidine derivative, acts as anti neoplastic agent.

Hormones 100

Hormones Contract Manufacturing Manufacturing Development 100

Outsourcing Pharma

SEPTEMBER 22, 2021

A logistics leader from the CRO offers advice on navigating borders, cultures, regulatory issues and other important considerations on worldwide studies.

Trials 98

Trials Contract Manufacturing Manufacturing 98

pharmaphorum

JANUARY 7, 2021

Shortly after launching large-scale trials of its COVID-19 vaccine candidate, CureVac has the partner it will need to roll the shot out at scale if it works as hoped.

Vaccination 105

Vaccination Vaccine Contract Manufacturing Development 105

BioPharma Reporter

JUNE 5, 2024

As the DIA conference in San Diego approaches, Outsourcing Pharma secured an exclusive preview with FranÃois Torche, chief product & technology officer and co-founder of CluePoints

Research 94

Research Trials Production Contract Manufacturing 94

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 Manufacturing Contract Manufacturing 89

Camargo

JANUARY 19, 2021

However – particularly in rare disease programs with only one Phase 3 trial, often of short duration – sponsors many times find themselves ready to file clinical data before completing the minimum 12 months of stability testing on the to-be-marketed finished product and API. Having a quality agreement in place is critical.

Production 135

Production Branding Manufacturing Contract Manufacturing 135

Outsourcing Pharma

JUNE 10, 2024

Clinical trials play a crucial role in driving medical progress, and the accurate capture of patient data is fundamental to their success.

Clinical Trials 60

Clinical Trials Clinical Trials Trials Contract Manufacturing 60

Outsourcing Pharma

JUNE 10, 2024

Clinical trials play a crucial role in driving medical progress, and the accurate capture of patient data is fundamental to their success.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Contract Manufacturing 59

Outsourcing Pharma

SEPTEMBER 22, 2021

A leader from the global clinical research logistics company shares how to weigh the complex aspects of a decentralized trial and craft intelligent strategy.

Trials 60

Trials Clinical Research Research Contract Manufacturing 60

Pharmaceutical Technology

APRIL 12, 2023

Evidence suggests that API manufacturing is gaining in complexity, as well as sophistication, and therefore adding to the risk profile of drug development. The ingredients used in these drugs are high potency, even at small doses, and pose a risk to both human health and cross-contamination with other drugs in a manufacturing environment.

Manufacturing 130

Manufacturing Production Containment Contamination 130

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 92

Clinical Trials Clinical Trials Life Science Trials 92

Roots Analysis

FEBRUARY 28, 2024

Cell Therapy pipeline update, Talaris Therapeutics , a late-clinical stage biotechnology company based in Boston, MA and Louisville, KY , announced the initiation of FREEDOM-1 ( NCT03995901 ), the company’s Phase 3 clinical trial of FCR001 in living donor kidney transplant (LDKT) recipients.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Manufacturing 40

pharmaphorum

FEBRUARY 8, 2022

Nevertheless, the decision by NICE to back routine NHS use of Wegovy is a win for Novo Nordisk, which has been hit by supply constraints linked to a contract manufacturer for the drug that have affect its rollout in the US, where it was approved last June. billion to the NHS and £27 billion to wider society.

Drugs 105

Drugs Contract Manufacturing Clinical Trials Clinical Trials 105

Roots Analysis

AUGUST 27, 2024

In this article, we will be diving into the details of radiopharmaceutical manufacturing. Applications of Radiopharmaceutical Manufacturing Radiopharmaceuticals are primarily used in the field of nuclear medicine for both therapeutic and diagnostic purposes, which are briefly described below: A.

Manufacturing 40

Manufacturing Medicine Production Contract Manufacturing 40

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.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Trials 52

pharmaphorum

JANUARY 3, 2023

It’s first marketing application was turned down in October 2021 with an FDA request for more technical and manufacturing information focusing on the xenon hyperpolariser system. The post FDA clears Polarean’s lung disease diagnostic Xenoview appeared first on.

Contract Manufacturing 64

Contract Manufacturing Manufacturing FDA Approval Pharma Companies 64