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. This means that sponsors are having to fork out for these blockbuster products in order to run their trials more often.

Clinical Trials 104

Clinical Trials Clinical Trials Production Trials 104

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

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

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

Outsourcing Pharma

MARCH 7, 2023

A clinical trial travel solution that can remove administrative burdens for research sites and eliminate logistical and financial barriers for participants has significantly expanded.

Trials 52

Trials Clinical Trials Clinical Trials Research 52

Outsourcing Pharma

OCTOBER 9, 2023

A new patient-first service that will support sponsors and sites accelerate the development of their therapies has been launched by Innovative Trials yesterday (October 9).

Trials 52

Trials Development Contract Manufacturing Manufacturing 52

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. However, non-NME and biosimilar approvals increased in 2022.

Drugs 130

Drugs Manufacturing Contract Manufacturing FDA Approval 130

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 62

Trials Clinical Research Research Contract Manufacturing 62

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

FEBRUARY 24, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The company also offers contract manufacturing and laboratory services.

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. The company also offers contract manufacturing and laboratory services.

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

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. Iovance is also conducting TILVANCE-301, a Phase III trial to confirm clinical benefit.

FDA Approval 52

FDA Approval Contract Manufacturing Manufacturing Trials 52

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

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 97

Clinical Trials Clinical Trials Life Science Trials 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. It also provides sterile injectable pharmaceuticals, biosimilars, active pharmaceutical ingredients (APIs) and contract manufacturing services.

Contract Manufacturing 100

Contract Manufacturing Manufacturing Production Pharmacy 100

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. Dr John Ballantyne, co-founder of Aldevron, has invested $3 million in CureLab Oncology and CureLab Veterinary.

Contract Manufacturing 52

Contract Manufacturing DNA Clinical Trials Clinical Trials 52

pharmaphorum

AUGUST 7, 2020

Under the terms of the agreement Pfizer will become one of several external partners who manufacture the investigational treatment for the disease. Pfizer will provide contract manufacturing services at its facility in McPherson, Kansas, to supply the drug to Gilead. This is the third iteration of the ACTT trial.

Manufacturing 119

Manufacturing Contract Manufacturing Protein Allergies 119

Outsourcing Pharma

DECEMBER 7, 2023

OSP had a great conversation with Mike Connell, chief operating officer, at Enthought. The discussion centered around aritificial intelligence (AI) which have been the buzzwords in pharma and a number of other industries for at least the last year.

Trials 69

Trials Contract Manufacturing Manufacturing 69

Pharmaceutical Technology

DECEMBER 12, 2022

In this last 2022 edition of the series, which started in June , Pharmaceutical Technology is tracking major trial announcements and decisions by regulators and reimbursement agencies that have occurred since mid-October, as well as their potential impact on manufacturing plans. Regulatory decisions and clinical trial news.

Manufacturing 147

Manufacturing Drugs Packaging Packaging 147

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

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

NOVEMBER 5, 2020

The two phase 1/2 trials are zeroing in on NSCLC patients with specific molecular biomarkers, to see if adding Genprex’ Reqorsa (quaratusugene ozeplasmid) – which delivers a gene that suppresses tumour growth – can enhance the activity of the AZ and Merck drugs. Both studies are due to start in the first half of next year.

Gene Therapy 98

Gene Therapy Gene Drugs Contract Manufacturing 98

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 105

Clinical Trials Clinical Trials Trials Research 105

pharmaphorum

NOVEMBER 5, 2021

The phase 3 trial found that Paxlovid – which combines new protease inhibitor PF-07321332 with already-approved HIV drug ritonavir – reduced the risk of hospitalisation or death by 89% when given to newly-diagnosed adults who were at risk of developing severe COVID-19 in the EPIC-HR trial.

Contract Manufacturing 116

Contract Manufacturing DNA HR Manufacturing 116

BioPharma Reporter

DECEMBER 14, 2023

UK-based Lindus Health and US-based Thirty Madison today (December 14) announced they have completed the enrolment of a trial to assess their personalized dermatology telemedicine platform, Facet.

Dermatology 98

Dermatology Trials Contract Manufacturing Manufacturing 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 104

Trials Clinical Research Research Contract Manufacturing 104

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 97

Life Science Clinical Trials Clinical Trials Marketing 97

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

XTalks

JANUARY 23, 2024

This venture also led me to identify a gap in the market for contract manufacturing of recombinant proteins. We’ve conducted Phase II studies, which have met all primary and secondary endpoints and are now moving towards a pivotal Phase III trial. Lumos Pharma places a strong emphasis on being patient focused.

Development 72

Development Hormones Drugs Trials 72

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. It also provides sterile injectable pharmaceuticals, biosimilars, active pharmaceutical ingredients (APIs) and contract manufacturing services.

Hormones 113

Hormones Contract Manufacturing Manufacturing Development 113

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 91

Clinical Trials Clinical Trials Trials Contract Manufacturing 91

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

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. It also provides sterile injectable pharmaceuticals, biosimilars, active pharmaceutical ingredients (APIs) and contract manufacturing services.

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. It also provides sterile injectable pharmaceuticals, biosimilars, active pharmaceutical ingredients (APIs) and contract manufacturing services.

Hormones 100

Hormones Contract Manufacturing Manufacturing Development 100

pharmaphorum

DECEMBER 18, 2020

The FDA approval comes on the back of the BLISS-LN trial results, which showed that 43% of patients on Benlysta hit the target of a significant improvement in kidney function, compared with 32% of those in the control arm. GSK’s drug also improved secondary outcome measures including time to death or a kidney-related complication.

FDA Approval 99

FDA Approval Contract Manufacturing Sales Trials 99

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 Contract Manufacturing In-Vitro 99