Home > News > featured news > Douglas Pharmaceuticals Forms Lead Program R-107 Clinical Advisory Board

PHARMA TECH

Douglas Pharmaceuticals Forms Lead Program R-107 Clinical Advisory Board

Douglas Pharmaceuticals | January 27, 2023 | Read time : 02:08 min

Douglas Pharmaceuticals Forms Lead Program R-107 Clinical

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.

Spotlight

Upcoming Online Seminar: Where to use XRF in Pharma and Cosmetics?

Working in strictly regulated environments, pharma and cosmetics companies need to ensure the quality and safety of their products.

More featured news

Spotlight

Upcoming Online Seminar: Where to use XRF in Pharma and Cosmetics?

Working in strictly regulated environments, pharma and cosmetics companies need to ensure the quality and safety of their products.

Related News

BUSINESS INSIGHTS, PHARMA TECH

Innate Pharma Announces Preclinical Data Publication in Nature Biotechnology

Innate Pharma | January 17, 2023

On January 16, 2023, Innate Pharma SA announced the publication of preclinical findings demonstrating the control of acute myeloid leukemia (AML) cells by a trifunctional NKp46-CD16a-NK cell engager (NKCE) targeting CD123 in the scientific journal Nature Biotechnology. Innate and Sanofi conducted the experiments, which were published in Nature Biotechnology on January 12, 2023. This study demonstrates that CD64 expression on AML blasts imparts resistance to anti-CD123 antibody-dependent cell cytotoxicity (ADCC) and that redirecting NK cells against cancer targets by binding to CD16a and NKp46 circumvents this resistance. Moreover, through their binding to NKp46, CD123-NKCE primarily target NK cells and have substantial antitumor activity against primary AML blasts; they stimulate NK cell activation and cytokine secretion exclusively in AML cells' presence. In vivo, its antitumor activity observed in a mouse tumor model surpasses that of the anti-CD123 antibody used as the comparator. Furthermore, in vitro in human peripheral blood mononuclear cells and in vivo in nonhuman primates, the efficacy of CD123-NKCE was associated with the induction of low pro-inflammatory cytokine release and the absence of toxicity. These results support CD123-NKCE clinical development. IPH6101/SAR'579 (SAR443579), the first NKp46/CD16-based CD123-targeted ANKETTM NK cell engager, is currently being evaluated in a Phase 1/2 clinical trial by Sanofi in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL), or high-risk myelodysplastic syndrome (HR-MDS). About Innate Pharma Headquartered in Marseille (France), Innate Pharma SA is a global, clinical-stage oncology-focused biotech firm dedicated to enhancing patient treatment and clinical outcomes using therapeutic antibodies that employ the immune system to combat cancer. Its extensive antibody pipeline has numerous potentially first-in-class clinical and preclinical candidates for cancers with a high unmet medical need. In addition, Innate has been a pioneer in the study of natural killer cell (NK cell) biology and developed its expertise in tumor antigens, tumor microenvironment, and antibody engineering. This innovative strategy has resulted in a varied proprietary portfolio and substantial alliances with biopharmaceutical industry leaders, including Sanofi, Bristol-Myers Squibb, Novo Nordisk A/S, and a multi-product collaboration with AstraZeneca.

Read More

BUSINESS INSIGHTS, PHARMACY MARKET

Envision Pharma Group Announces Acquisition of OKRA.ai

Envision Pharma Group | February 10, 2023

Envision Pharma Group (Envision), a leading evidence-based communication services and industry-leading technology solutions provider serving biotech, pharmaceutical, and medical device companies recently announced the acquisition of OKRA.ai, a leading technology company active in the development of artificial intelligence (AI) solutions for commercialization, medical, real-world evidence and data analytics, and pricing for the life sciences and pharmaceutical industries. OKRA.ai's AI products and solutions transform enormous scientific, clinical, and commercial data sets into actionable insights for customers in the health sciences industry, empowering decision-making and driving action. Dr. Loubna Bouarfa, the founder of OKRA.ai, will join the Executive Leadership Team of Envision. Loubna recently received the renowned Deloitte Fast 50 Women in Leadership Award as well as the Forbes 50 Top Women in Tech. OKRA.ai has offices in the United Kingdom and the Netherlands and employs around 30 people. With the purchase of OKRA.ai, Envision Pharma Group will have over 1,400 employees spread across four continents. Envision Pharma Group's CEO Meg Heim commented, "We are delighted to welcome OKRA.ai into the Envision Pharma Group family." She added, "The acquisition of OKRA.ai marks an exciting milestone in Envision's evolution as we continue to accelerate and deliver a compelling combination of technology-enabled capabilities and solutions to clients. The combination of Envision's leading technology, capabilities, and solutions with OKRA.ai's artificial intelligence solutions and expertise enables us to strengthen our offerings to clients across the product life cycle, but more importantly, support patients in their journey to health and wellness." (Source – Globe Newswire) About Envision Pharma Group Founded in 2001, Envision is a leading evidence-based communication service and industry-leading technology solutions provider serving biotech, pharmaceutical, and medical device companies. It works with over 200 pharmaceutical and biotech firms, including 18 of the top 20 pharmaceutical firms. The company began by reinventing how biopharma companies managed their global data communications programs by leveraging smart technology and best-in-class publication planning. It has since grown to become a leading provider of healthcare communications services and medical affairs technology solutions. It assists clients throughout the pharmaceutical product lifecycle, establishing solid partnerships and gaining client trust in purpose-built solutions.

Read More

BUSINESS INSIGHTS, PHARMACY MARKET

VERO Biotech Announces FDA Approval for Its Second-gen GENOSYL DS

VERO Biotech | February 03, 2023

On February 2, 2023, VERO Biotech Inc., a commercial-stage biotechnology company focused on neonatal intensive care and the acute care hospital community, announced that FDA has approved its innovative second-generation GENOSYL® Inhaled Nitric Oxide (iNO) delivery system for use in the operating room with rebreathing anesthesia. The second generation GENOSYL® DS is now the first and only iNO delivery device approved for use in both rebreathing and non-rebreathing anesthesia procedures, enhancing patient care, saving money for the hospital, and minimizing waste anesthetic gas pollution. GENOSYL® DS is the first tankless inhaled nitric oxide delivery system. Nitric oxide, when inhaled, dilates the pulmonary blood vessels and can improve oxygenation in neonates suffering from hypoxic respiratory failure and pulmonary hypertension. GENOSYL® DS, unlike tank-based systems, generates and delivers iNO at the bedside via a small disposable cassette. This helps eliminate the need for hospitals to manage large, cumbersome tanks while also aiding in the simplification of clinical workflow. The following are the expected advantages of the second generation GENOSYL® DS Ability to employ rebreathing anesthesia: Rebreathing allows reduced gas flows, resulting in less usage of expensive anesthetic drugs, thereby reducing hospital costs; enhanced patient comfort (by preserving patient body temperature and moisture). Smoother care process: seamless iNO delivery from the ICU to surgery and post-operative care leads to process and workflow enhancements for the healthcare organization, thus lowering the hospital's overall cost. Set and forget: It allows anesthesiologists to continue using rebreathing anesthesia, thereby preventing potentially dangerous, time-consuming and cumbersome workarounds. Reduced ecological consequences of anesthesia delivery: less anesthetic is released into the environment. It is important to note that FDA has only approved the second generation GENOSYL® DS for use with rebreathing anesthesia in the surgical suite. The third generation GENOSYL® DS, which was recently approved, has not been tested with rebreathing anesthesia. VERO Biotech is currently conducting similar validations and expects to have data available in the first quarter of 2023. About VERO Biotech Headquartered in Atlanta, GA, VERO Biotech is an emerging biotechnology firm that focuses on designing, developing, and commercializing next-generation inhaled nitric oxide (NO) delivery systems to tackle unmet medical needs in patients with cardiopulmonary conditions. The company's mission is to improve patients' lives by pioneering innovative technologies for inhaled NO delivery in acute care hospitals and beyond, wherever nitric oxide treatment is required. By focusing on the science, development, and commercialization of its innovations, it aims to exceed customer expectations regarding safety, efficacy, and growth.

Read More

BUSINESS INSIGHTS, PHARMA TECH

Innate Pharma Announces Preclinical Data Publication in Nature Biotechnology

Innate Pharma | January 17, 2023

On January 16, 2023, Innate Pharma SA announced the publication of preclinical findings demonstrating the control of acute myeloid leukemia (AML) cells by a trifunctional NKp46-CD16a-NK cell engager (NKCE) targeting CD123 in the scientific journal Nature Biotechnology. Innate and Sanofi conducted the experiments, which were published in Nature Biotechnology on January 12, 2023. This study demonstrates that CD64 expression on AML blasts imparts resistance to anti-CD123 antibody-dependent cell cytotoxicity (ADCC) and that redirecting NK cells against cancer targets by binding to CD16a and NKp46 circumvents this resistance. Moreover, through their binding to NKp46, CD123-NKCE primarily target NK cells and have substantial antitumor activity against primary AML blasts; they stimulate NK cell activation and cytokine secretion exclusively in AML cells' presence. In vivo, its antitumor activity observed in a mouse tumor model surpasses that of the anti-CD123 antibody used as the comparator. Furthermore, in vitro in human peripheral blood mononuclear cells and in vivo in nonhuman primates, the efficacy of CD123-NKCE was associated with the induction of low pro-inflammatory cytokine release and the absence of toxicity. These results support CD123-NKCE clinical development. IPH6101/SAR'579 (SAR443579), the first NKp46/CD16-based CD123-targeted ANKETTM NK cell engager, is currently being evaluated in a Phase 1/2 clinical trial by Sanofi in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL), or high-risk myelodysplastic syndrome (HR-MDS). About Innate Pharma Headquartered in Marseille (France), Innate Pharma SA is a global, clinical-stage oncology-focused biotech firm dedicated to enhancing patient treatment and clinical outcomes using therapeutic antibodies that employ the immune system to combat cancer. Its extensive antibody pipeline has numerous potentially first-in-class clinical and preclinical candidates for cancers with a high unmet medical need. In addition, Innate has been a pioneer in the study of natural killer cell (NK cell) biology and developed its expertise in tumor antigens, tumor microenvironment, and antibody engineering. This innovative strategy has resulted in a varied proprietary portfolio and substantial alliances with biopharmaceutical industry leaders, including Sanofi, Bristol-Myers Squibb, Novo Nordisk A/S, and a multi-product collaboration with AstraZeneca.

Read More

BUSINESS INSIGHTS, PHARMACY MARKET

Envision Pharma Group Announces Acquisition of OKRA.ai

Envision Pharma Group | February 10, 2023

Envision Pharma Group (Envision), a leading evidence-based communication services and industry-leading technology solutions provider serving biotech, pharmaceutical, and medical device companies recently announced the acquisition of OKRA.ai, a leading technology company active in the development of artificial intelligence (AI) solutions for commercialization, medical, real-world evidence and data analytics, and pricing for the life sciences and pharmaceutical industries. OKRA.ai's AI products and solutions transform enormous scientific, clinical, and commercial data sets into actionable insights for customers in the health sciences industry, empowering decision-making and driving action. Dr. Loubna Bouarfa, the founder of OKRA.ai, will join the Executive Leadership Team of Envision. Loubna recently received the renowned Deloitte Fast 50 Women in Leadership Award as well as the Forbes 50 Top Women in Tech. OKRA.ai has offices in the United Kingdom and the Netherlands and employs around 30 people. With the purchase of OKRA.ai, Envision Pharma Group will have over 1,400 employees spread across four continents. Envision Pharma Group's CEO Meg Heim commented, "We are delighted to welcome OKRA.ai into the Envision Pharma Group family." She added, "The acquisition of OKRA.ai marks an exciting milestone in Envision's evolution as we continue to accelerate and deliver a compelling combination of technology-enabled capabilities and solutions to clients. The combination of Envision's leading technology, capabilities, and solutions with OKRA.ai's artificial intelligence solutions and expertise enables us to strengthen our offerings to clients across the product life cycle, but more importantly, support patients in their journey to health and wellness." (Source – Globe Newswire) About Envision Pharma Group Founded in 2001, Envision is a leading evidence-based communication service and industry-leading technology solutions provider serving biotech, pharmaceutical, and medical device companies. It works with over 200 pharmaceutical and biotech firms, including 18 of the top 20 pharmaceutical firms. The company began by reinventing how biopharma companies managed their global data communications programs by leveraging smart technology and best-in-class publication planning. It has since grown to become a leading provider of healthcare communications services and medical affairs technology solutions. It assists clients throughout the pharmaceutical product lifecycle, establishing solid partnerships and gaining client trust in purpose-built solutions.

Read More

BUSINESS INSIGHTS, PHARMACY MARKET

VERO Biotech Announces FDA Approval for Its Second-gen GENOSYL DS

VERO Biotech | February 03, 2023

On February 2, 2023, VERO Biotech Inc., a commercial-stage biotechnology company focused on neonatal intensive care and the acute care hospital community, announced that FDA has approved its innovative second-generation GENOSYL® Inhaled Nitric Oxide (iNO) delivery system for use in the operating room with rebreathing anesthesia. The second generation GENOSYL® DS is now the first and only iNO delivery device approved for use in both rebreathing and non-rebreathing anesthesia procedures, enhancing patient care, saving money for the hospital, and minimizing waste anesthetic gas pollution. GENOSYL® DS is the first tankless inhaled nitric oxide delivery system. Nitric oxide, when inhaled, dilates the pulmonary blood vessels and can improve oxygenation in neonates suffering from hypoxic respiratory failure and pulmonary hypertension. GENOSYL® DS, unlike tank-based systems, generates and delivers iNO at the bedside via a small disposable cassette. This helps eliminate the need for hospitals to manage large, cumbersome tanks while also aiding in the simplification of clinical workflow. The following are the expected advantages of the second generation GENOSYL® DS Ability to employ rebreathing anesthesia: Rebreathing allows reduced gas flows, resulting in less usage of expensive anesthetic drugs, thereby reducing hospital costs; enhanced patient comfort (by preserving patient body temperature and moisture). Smoother care process: seamless iNO delivery from the ICU to surgery and post-operative care leads to process and workflow enhancements for the healthcare organization, thus lowering the hospital's overall cost. Set and forget: It allows anesthesiologists to continue using rebreathing anesthesia, thereby preventing potentially dangerous, time-consuming and cumbersome workarounds. Reduced ecological consequences of anesthesia delivery: less anesthetic is released into the environment. It is important to note that FDA has only approved the second generation GENOSYL® DS for use with rebreathing anesthesia in the surgical suite. The third generation GENOSYL® DS, which was recently approved, has not been tested with rebreathing anesthesia. VERO Biotech is currently conducting similar validations and expects to have data available in the first quarter of 2023. About VERO Biotech Headquartered in Atlanta, GA, VERO Biotech is an emerging biotechnology firm that focuses on designing, developing, and commercializing next-generation inhaled nitric oxide (NO) delivery systems to tackle unmet medical needs in patients with cardiopulmonary conditions. The company's mission is to improve patients' lives by pioneering innovative technologies for inhaled NO delivery in acute care hospitals and beyond, wherever nitric oxide treatment is required. By focusing on the science, development, and commercialization of its innovations, it aims to exceed customer expectations regarding safety, efficacy, and growth.

Read More

More featured news