Veeva Systems | May 21, 2021
A growing number of life sciences companies are adopting Veeva Development Cloud applications from Veeva Systems in an industrywide shift to streamline drug development. quite 650 companies use Veeva Development Cloud applications today, and quite 250 are leveraging multiple Veeva Vault applications across functional areas to enable and connect drug development and manufacturing teams.
Veeva Development Cloud brings together suites of unified applications for clinical, regulatory, quality, and safety on one cloud platform, eliminating organizational siloes. quite 350 companies are accelerating trial execution with Vault Clinical applications, quite 250 are streamlining regulatory processes with Vault RIM, quite 350 are unifying quality management with Vault Quality, and quite 35 are improving pharmacovigilance with Vault Safety.
Vault Connections in Veeva Development Cloud drive cross-functional business processes across the merchandise lifecycle. For instance, Connections enable companies to compile clinical operations and regulatory for faster submissions; quality and regulatory for simplified change control and variation management; and clinical data and operations for real-time visibility into patient enrollment.
"We're dedicated to bringing innovations to plug that help the industry accelerate drug development," said Jim Reilly, vice chairman of Veeva Vault R&D. "Veeva Development Cloud is enabling customers to enhance collaboration across teams and speed the delivery of treatments to patients."
About Veeva Systems
Veeva is that the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves quite 975 customers, starting from the world's largest pharmaceutical companies to emerging biotechs. As a Public Benefit Corporation, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders, and therefore the industries it serves.
Arrowhead Pharmaceuticals Inc. | February 19, 2022
Arrowhead Pharmaceuticals Inc. announced that it has dosed the first subjects in AROC3-1001, a Phase 1/2 clinical study of ARO-C3, the company’s investigational RNA interference (RNAi) therapeutic designed to reduce production of complement component 3 (C3) as a potential therapy for various complement mediated diseases.
“We believe a C3 targeted drug has the potential to address multiple complement mediated and complement associated diseases, where significant unmet medical need exists. These include IgA nephropathy, C3 glomerulopathy, paroxysmal nocturnal hemoglobinuria, and additional renal and hematologic diseases that we intend to evaluate in the future. ARO-C3 has progressed rapidly, and our preclinical data have been very encouraging. We are eager to continue this progress as we evaluate ARO-C3 in clinical studies.”
James Hamilton, M.D., MBA, senior vice president of discovery and translational medicine at Arrowhead
AROC3-1001 is a Phase 1/2, placebo controlled, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-C3 in up to 24 adult healthy volunteers, up to 24 adult patients with paroxysmal nocturnal hemoglobinuria (PNH), and up to 14 adult patients with complement-mediated renal disease. In Part 1 in healthy volunteers, four cohorts with four escalating dose levels of ARO-C3 will be evaluated. Each cohort will enroll 6 eligible subjects who will be randomized to receive a single subcutaneous injection of ARO-C3 (n=4) or placebo (n=2). In Part 2, eligible subjects with PNH or complement-mediated renal disease will be enrolled to receive open-label ARO-C3 on day 1 and day 85 at one of two dose levels to be determined in Part 1. The primary objective of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of ARO-C3 in normal healthy volunteers and to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of ARO-C3 in subjects with PNH and in subjects with complement-mediated renal disease.
About Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
Pfizer | December 03, 2020
The two organizations' BNT162b2 has become the primary COVID-19 immunization permitted in the Western world as medication controllers in the U.K. given out a crisis use approval on Wednesday, in front of choices by the U.S. also, Europe, which are normal soon.
For the more extensive immunization world, the Medicines and Healthcare items Regulatory Agency's choice methods the world currently has the principal mRNA shot approved for far reaching use, opening up a fresh out of the box new part for antibody advancement.
The principal portions will be conveyed to the U.K. quickly, the organizations said. A representative at the U.K's. Department of Health and Social Care said the antibody will be made accessible the nation over from one week from now. The U.K. has requested 40 million portions of the antibody—enough to immunize 20 million individuals—through an arrangement endorsed in July and extended in October.
"As we envision further approvals and endorsements, we are centered around moving with a similar degree of criticalness to securely flexibly an excellent immunization around the globe. With a great many individuals turning out to be tainted, each day matters in the aggregate competition to end this staggering pandemic," Pfizer CEO Albert Bourla, Ph.D., said in an explanation, calling the U.K. gesture a "noteworthy second."
Pfizer has appointed COVID-19 antibody assembling to three destinations in the U.S. also, one in Belgium. BioNTech has offices in Mainz and Idar-Oberstein in Germany, which have been delivering dosages for clinical preliminaries. The German biotech as of late purchased a Novartis plant in Marburg, Germany, to quicken business assembling of the COVID-19 immunization. In general, the two organizations have said they can create up to 50 million dosages in 2020 and up to 1.3 billion portions in 2021.