BUSINESS INSIGHTS, PHARMA TECH
Elligo Health Research | January 25, 2023
On January 24, 2023, Elligo Health Research®, the leading healthcare-enabling research organization, presented the DataAI Connect, a new data and technology platform that will facilitate data-driven, rapid clinical research. DataAI Connect, a scalable, end-to-end data platform, optimizes the clinical research workflow by decreasing human error and rapidly digesting patient data to speed up clinical studies.
Elligo has created an industry-first AI-driven platform that sources, processes, analyses, and distributes patient real-world data (RWD) by bringing together data, processes, and clinical expertise. That means an end-to-end solution that solves clinical trial issues directly rather than being an add-on technology. The platform is adaptable and reusable, and it includes the following
An RWD repository of electronic health records (EHRs) and clinical data storage that incorporates EHR, clinical trial, and patient data for analytics, artificial intelligence (AI), and research
A comprehensive medical records retrieval and analytics solution that transforms data into searchable, actionable insights and personalized patient journey information within minutes using NLP, ML, and clinical experience.
A data-driven protocol development service that puts designs to the test in the real world.
Elligo's Chief Data Officer, Michael Ibara, commented, "The application of AI approaches to healthcare and clinical study data is moving from the moon-shot approach to more practical applications." He added, "An example of this approach is the process of getting patients' medical records, which involves manual, non-scalable activities such as getting accurate information on patients' providers, asking sites to track down records, and having humans triage hundreds of pages of medical records. The judicious and intelligent application of natural language processing (NLP), machine learning (ML), and other AI approaches increases speed, accuracy and quality, while removing the burden from the sites and patients."
(Source – Business Wire)
About Elligo Health Research
Founded in 2016, Elligo Health Research® is a leading healthcare-enabling clinical research organization. With access to known patients and their HIPAA-compliant healthcare data, its IntElligo® Research Stack technology and eSolutions Research Accelerator PatientSelect approach expedite clinical trials through healthcare. Elligo's Site Solutions, combined with the largest Known Patient Access Network, enable healthcare practices and research sites to engage in clinical studies. Its services expedite the development of novel pharmaceutical, biotechnology, medical device, and diagnostic products through the adaptive involvement of known patients and clinicians.
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BUSINESS INSIGHTS, PHARMA TECH
Cambrex | January 24, 2023
Cambrex, a renowned global contract development and manufacturing organization (CDMO) offering drug substance, product, and analytical services throughout the drug lifecycle, recently announced the completion of its acquisition of Snapdragon Chemistry, a US-based provider of chemical process development services to a diverse range of emerging and established biopharma customers.
Snapdragon Chemistry specializes in the development of active pharmaceutical ingredient (API) batch and continuous flow processes, employing cutting-edge automated technology and proprietary equipment to address complicated process and analytical development challenges. With its headquarters for R&D and manufacturing in Waltham, Massachusetts, Snapdragon's 70+ employees, including 31 Ph.D. scientists, have strong ties to the local scientific community.
Cambrex's CEO Tom Loewald commented, "Today, we welcome our new colleagues from Snapdragon to Cambrex." He added, "With Snapdragon's depth of scientific expertise in API process development, I'm certain our customers will see the benefits of this combination and be delighted to work with Snapdragon's team."
(Source – PR Newswire)
Cambrex's portfolio of specialized pharmaceutical development and manufacturing solutions continues to grow, with Snapdragon reinforcing its experience in continuous flow production in addition to augmenting the recent investments in continuous flow process development capabilities at its North Carolina facility in High Point.
Snapdragon's CEO Matt Bio said, "I am extremely proud of what our team at Snapdragon has built over the years." He further added, "With Cambrex, we have found an ideal home for our customers and employees, and I look forward to continued success as part of Cambrex."
(Source – PR Newswire)
About Cambrex
Founded in 1981, Cambrex is a contract development and manufacturing organization (CDMO) that offers drug substances, products, and analytical services throughout the drug lifecycle. It provides a variety of specialized medicinal substance technologies and capabilities, such as controlled substances, biocatalysis, continuous flow, material characterization, solid-state science, stability storage and testing, and potent APIs. Cambrex is a trusted partner in the branded and generic markets for the development and manufacturing of API and finished dosage forms. With over 40 years of experience, it has a growing workforce of over 2,300 specialists serving global clients from North America and Europe.
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BUSINESS INSIGHTS, PHARMA TECH
ADC Therapeutics | January 03, 2023
Sobi® and ADC Therapeutics SA informed that Zynlonta® (loncastuximab tesirine) has recently received conditional marketing authorization from the European Commission (EC) for the treatment of diffuse large B-cell lymphoma ((DLBCL) that has relapsed or become resistant. The approval comes after the European Medicines Agency's Committee for Medicinal Products for Human Use issued a favorable opinion in September.
Sobi has said that it wants to give Zynlonta, a new treatment for diffuse large B-cell lymphoma, to people in the European Union who have this debilitating blood cancer.
The approval was granted based on the findings from LOTIS-2, which was a large (n=145), phase 2 multinational, single-arm clinical study of Zynlonta for treating adult patients who had relapsed or refractory DLBCL following two or more prior lines of systemic therapy. Zynlonta was granted accelerated approval by the United States Food and Drug Administration in April 2021. This approval made it the first CD19-targeted antibody-drug conjugate to be used as a single-agent treatment for adult patients who had relapsed or been resistant to two or more lines of systemic therapy for their DLBCL.
Sobi announced an exclusive license agreement with ADC Therapeutics to develop and commercialize Zynlonta in Europe and other international markets. The license aims to boost Sobi's presence in hematology, one of its two main disease areas. Besides, Zynlonta will be sold with other Sobi hematology drugs.
ADC Therapeutics added that this approval expands Zynlonta's global reach. Zynlonta will fill a critical unmet need for DLBCL patients in Europe. The EU decision applies to Iceland, Norway, and Liechtenstein.
According to the terms of the license agreement and as previously communicated, Sobi will pay ADC Therapeutics USD 50 million as a result of the EU's approval of DLBCL. Sobi's clinical development and product supply are handled by ADC Therapeutics.
About ADC Therapeutics
ADC Therapeutics next-generation, targeted antibody-drug conjugates help cancer patients. With a deep understanding of oncology and an ADC platform that the FDA's approval of Zynlonta has proven, the company is working to meet unmet medical needs and improve outcomes for people with hard-to-treat hematological cancers and solid tumors. ADC Therapeutics' highly skilled global team is committed to fighting cancer with science, bringing targeted therapies and hope to patients and their families.
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