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.
Actinium Pharmaceuticals, Inc. | April 13, 2022
Actinium Pharmaceuticals, Inc., a leader developing targeted radiotherapies for patients and Immedica Pharma AB announced that they signed a license and supply agreement for Iomab-B. It is being developed for targeted conditioning to facilitate bone marrow with topline data expected in the third quarter of 2022. For individuals with active, relapsed, or refractory acute myeloid leukemia, BMT is the only possibly curative therapy option.
"Immedica has established a strong team and impressive capabilities to commercialize specialty products in Europe, the Middle East and North Africa. Europe and the MENA countries are key commercial markets for Iomab-B, with a large addressable AML patient population and access to a strong BMT community that is highly concentrated with select leading centers performing a majority of the BMT procedures. Despite multiple drug approvals for patients with AML in recent years, curative outcomes and access to potentially curative BMT are severely lacking, particularly for patients with active, relapsed or refractory disease. We are excited to partner with Immedica to work to bring Iomab-B to patients with AML in Europe, the Middle East and North Africa who may benefit from a potentially curative transplant."
Sandesh Seth, Actinium's Chairman and CEO
"We are excited about the opportunity to make Iomab-B accessible for patients in Europe, the Middle East and North Africa. It is clear there is a large medical need for these AML patients, which we believe will be addressed by this new innovative treatment. We also look forward to deepening our collaboration with Actinium to bring the best possible support to AML treatment centers and health care professionals in Europe, the Middle East and North Africa", says Anders Edvell, CEO at Immedica.
Actinium will receive a $35 million upfront payment and will be eligible for an additional $417 million in regulatory and marketable milestone payments and royalties in the mid-twenty percent range on net sales, per the terms of the agreement. Immedica has been granted commercialization rights in Europe and, the Middle East and North Africa (MENA). Actinium will maintain all rights to Iomab-B in the United States and around the world and will be accountable for clinical and regulatory operations, as well as Iomab-B manufacturing.
Wavegate Corporation | January 14, 2022
Wavegate Corporation announced that the U.S. Food and Drug Administration has granted Breakthrough Device designation for its StimuLux™ optical reflectometry system for closed-loop adaptive modulation of spinal cord stimulation. The FDA's Breakthrough Device designation is designed to expedite the development and regulatory review of medical devices that are intended to treat serious or life-threatening diseases. To qualify for this designation, preliminary evidence must demonstrate a reasonable expectation that the device will provide improved effectiveness compared to the standard of care.
"We are pleased the FDA has granted Breakthrough Device designation for our novel StimuLux™ technology. This underscores the urgent need within our society for more effective treatments of chronic, debilitating pain. We are eager to closely collaborate with the FDA as Wavegate works toward advancing the state of the art."
Erich Wolf, MD, PhD, Chief Executive Officer
"This designation underscores the urgent need within our society for more effective treatments of chronic, debilitating pain."
StimuLux™ is a component of Wavegate Corporation's Ellipse neuromodulation platform which integrates multiple patented technologies which aim to systematically address unmet clinical needs within the neuromodulation industry.
About Wavegate Corporation
Wavegate Corporation is a privately-held start-up neuromodulation company focused on developing and commercializing a suite of technological innovations including: waveform-independent closed-loop adaptive stimulation, a stimulation paradigm for modulation of both ascending and descending spinal cord pain pathways, new implant geometry for reduced surface contact pressures, rapid lead anchoring, and others.