Douglas Pharmaceuticals | January 27, 2023
A clinical advisory board has been established to support Douglas Pharmaceuticals' lead program R-107, an oral extended-release dose of racemic ketamine being developed as an adjunctive or stand-alone therapy for treatment-resistant depression.
Douglas Pharmaceuticals is a New Zealand-based pharmaceutical company specializing in the development of specialty generic and repurposed medications (TRD).
Peter Surman, Chief Scientific Officer expressed, "We are very excited to bring together a group of world-class experts in the field of psychiatry, to help guide our late-stage development of R-107." "We believe their deep knowledge in the field, insights and contributions will be instrumental in charting an efficient course through pivotal clinical studies in TRD," he added.
(Source – Cision PR Newswire)
Some of the members of the clinical advisory board are as follows:
• Prof. Paul Glue [MB, ChB (Otago), MD (Bristol), FRCPsych]
• Prof. Alan F. Schatzberg, [MD] • Prof. Sanjay J. Mathew [MD]
• Prof. Allan Young [MB, ChB, MPhil, Ph.D., FRCP (Edin.), FRCPC, FRCPsych]
• Prof. Wiesław J. Cubała, [MD, PhD]
• Prof. Colleen Loo [MBBS (Hons), FRANZCP, MD]
About Douglas Pharmaceuticals
New Zealand's largest private pharmaceutical and healthcare firm, Douglas Pharmaceuticals, employs over 700 people and exports to over 40 countries. The company provides creative, competitive, and high-quality healthcare solutions to 'improve lives'. It designs, manufactures, and distributes unique and generic products, preferring those with significant intellectual property and technological complexity in high-unmet need sectors. The company's presence in international markets continues to grow, exposing New Zealand to the world. It is dedicated to improving people's health all around the globe. Some of the products that the company works with cutting-edge partners to develop, make, market, and distribute are pharmaceuticals, nutraceuticals, automated compliance systems, and consumer healthcare items.
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.
PHARMACY MARKET, PHARMA TECH
Capsida Biotherapeutics | February 27, 2023
Capsida Biotherapeutics Inc., a fully integrated next-generation gene therapy platform company, and AbbVie, a pharmaceutical company dedicated to discovering and providing innovative medicines to address serious health issues, have recently announced an expanded strategic collaboration.
The collaboration aims to develop genetic medicines for eye diseases with high unmet needs. Capsida's novel adeno-associated virus (AAV) engineering platform and manufacturing capability will be combined with AbbVie's extensive capabilities to identify and advance three programs. This expanded collaboration builds on the neurodegenerative disease partnership established in 2021.
As per the agreement's terms, Capsida will receive $70 million, comprising upfront payments and possible equity investment. Capsida could receive up to $595 million in option fees and research and development milestones for the three programs, with the potential for further commercial milestones. Additionally, Capsida will be eligible to receive mid-to-high single-digit royalty payments on future product sales.
Capsida will be responsible for leading capsid discovery efforts for all programs, utilizing its high throughput AAV engineering platform, and will also be responsible for process development and early clinical manufacturing. AbbVie, on the other hand, will lead innovative therapeutic cargo approaches and be responsible for commercialization and development.
Capsida's CEO Peter Anastasiou commented, "AbbVie has been an excellent partner, and we are excited to expand our collaboration into ophthalmology with the world leader in this therapeutic area." He added, "Combining AbbVie's expertise in eye disease drug development and commercialization with Capsida's fully integrated next-generation AAV engineering platform and manufacturing capabilities offers the potential to provide novel therapies enabling unprecedented benefit to patients with serious eye diseases."
(Source- PR Newswire)
About Capsida Biotherapeutics
Capsida Biotherapeutics Inc. is a leading gene therapy platform company that develops targeted, non-invasive gene therapies for patients suffering from severe and life-threatening genetic disorders. Its innovative approach allows for the treatment of rare and common diseases across all age groups. The company focuses on creating customized therapies that selectively target specific organ systems while minimizing exposure to non-targeted organs. Capsida is a fully integrated biotechnology company with proprietary adeno-associated virus (AAV) engineering, translational biology, advanced manufacturing capabilities, multi-modality cargo development and optimization, process development, as well as extensive clinical development expertise.