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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BUSINESS INSIGHTS, PHARMA TECH
US Pharmacopeia | January 04, 2023
The United States Pharmacopeia (USP) has announced the launch of the USP Advanced Manufacturing Technology Lab in Richmond, Virginia, as a part of its launch of a suite of R&D analytical solutions. These analytical lab services will aid drug manufacturers in adopting advanced manufacturing technologies, such as pharmaceutical continuous manufacturing (PCM), to increase geographic diversity in pharmaceutical manufacturing and support medicine supply chain resilience.
The new R&D analytical solutions will include analytical lab services that take advantage of USP's in-house scientific expertise and cutting-edge facilities at the USP Advanced Manufacturing Technology Lab in Richmond, as well as its headquarters in Rockville, Maryland. These capabilities will be utilized to characterize materials and qualify and develop ways to help ensure the quality of PCM-based medicines.
PCM involves a continuous flow of materials through a process pipeline in which two or more unit operations are directly connected and the sequential transformation of those materials. As the input materials are fed in, the process output, such as an active pharmaceutical ingredient or drug product, is collected, and the complete procedure is carried out in a single facility.
USP's emphasis on R&D analytical solutions and PCM-specific quality assessments is part of a broader set of activities aimed at addressing the problems of PCM adoption and bolstering pharmaceuticals' supply chain resilience.
Consulting services provided by a USP company, Pharmatech Associates, Inc., can assist manufacturers with decision-making and problems associated with PCM adoption. Pharmatech Associates consulting services, which operate independently of USP's standards-setting processes, provide manufacturers interested in PCM and other advanced manufacturing technologies with technical, business, and regulatory strategies, workforce training, and equipment and process design.
About The U.S. Pharmacopeia (USP)
USP is a non-profit, independent scientific organization that provides safe, high-quality pharmaceuticals. The organization has strived to establish confidence in the world's drugs, dietary supplements, and foods for more than two centuries. It protects patient safety and enhances global health via rigorous science and the establishment of public quality standards.
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BUSINESS INSIGHTS, PHARMACY MARKET
DirectRx Pharmacy | February 15, 2023
On February 14, 2023, DirectRx, a leading national specialty pharmacy committed to serving individual patients with chronic and complex health needs, announced the launch of a new website and a suite of team member training programs.
The new website emphasizes the company's dedication to working with patients and prescribers to provide the best possible care. The training programs are designed to assist team members in developing professionally.
The DirectRx website emphasizes the company's concern for patients and dedication to collaborating with doctors to offer the highest quality care. The new additions to the website consist of a Prescribers tab highlighting the key ways in which DirectRx collaborates with its prescriber partners; a manufacturers tab highlighting the company's "industry best" time-to-fill, adherence and conversion rates; and an interactive Careers tab to help grow the DirectRx team.
Additionally, DirectRx has launched new training and development programs for team members to help them improve their skill set and stay with the firm longer. The new programs include pharmacy technicians in training, account managers in training and regional patient care coordinators in training. The specialty pharmacy is also expanding its managerial positions, including a customer service manager role and others.
DirectRx's Director, Alban Ivezaj, commented, "We're very excited to launch our new website as we feel it better captures our commitment to compassionate patient care and the best-in-class services we offer to our provider partners." He added, "As a result of that commitment, DirectRx has experienced significant growth across all regions of the U.S. - including servicing all 50 states and a 26 percent increase in the number of patients we serviced in 2022."
(Source – Globe Newswire)
About DirectRx Pharmacy
Founded in 1985, DirectRx is an independent pharmacy committed to providing patients with exceptional, individualized pharmaceutical care. With the belief that communication and teamwork are crucial to achieving good treatment outcomes, the physician, patient, and pharmacist form a circle of integrated services and coordinated care, so there are no gaps in patient care between physician and pharmacist. It stands apart from the competition due to its concern and commitment to providing unmatched customer service. The company is accredited by ACHC, NABP, WBENC and URAC. Since its establishment over three decades ago, the company has expanded to 49 states.
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