RESEARCH, PHARMA TECH
Alliance Pharma | December 08, 2022
Alliance Pharma a global leader providing bioanalytical, DMPK, and CMC testing services in the pharmaceutical and biopharmaceutical industry, has opened its new 20,000-square-foot bioanalytical laboratory, Alliance Pharma Pty, Ltd., in Brisbane, Australia.
The new Australia facility, which the company announced plans for earlier this summer, includes an expansive lab to provide much-needed small and large molecule bioanalytical services for a region with limited choices for bioanalytical support.
“Alliance Pharma’s expanded presence in Australia affirms our commitment to combining scientific talent and technology to deliver global drug development solutions. In this new purpose-built laboratory, our talented teams will use their diverse experience and expertise to provide high-quality bioanalytical services.”
Alliance CEO, Patrick Bennett
“Our new state-of-the-art science facility in Brisbane will further strengthen our global bioanalytical capabilities. It will allow biotech companies to work with us in Australia in the early phase and then transfer the knowledge on these assays to other regions to support the later development phases. Our objective is to accelerate the growth of our best-in-class portfolio and deliver industry-leading drug development service for our worldwide clients,” said Alliance Pharma Site President, Australia, Jason Wang, Ph.D.
About Alliance Pharma
Founded in 2008, Alliance is a contract research organization with bioanalytical, DMPK, and CMC testing labs in Malvern, PA, Brisbane, AU, Cambridge, U.K., and Sandwich, U.K. The labs specialize in advanced research services for all drug molecules, cell and gene therapies, and drug metabolism studies to support pharmaceutical and biotechnology companies’ drug discovery and development programs. Alliance’s mission is to build a trusted partnership with our clients to support their successful drug development programs. Our business philosophy is based on a foundation of trust, professional ethics, scientific excellence, and regulatory compliance.
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
Tetra Bio-Pharma Inc. | December 07, 2022
Tetra Bio-Pharma Inc. a leader in cannabinoid-derived drug discovery and development announced significant results from the study of Onternabez combined with Favipiravir against ARDS powered platform which purposely integrates target identification, validation, lead discovery optimization, drug synthesis, and preclinical testing. Leveraging the power of AI enables more answers and greater insights, faster.
Results from the study demonstrate that Tetra's investigational therapeutic, ARDS-003, which contains the active pharmaceutical ingredient Onternabez, acts against various ARDS and Sepsis targets, such as IL-6 and IL-8. Onternabez plays an important role in mitigating the inflammatory response in various targets of inflammatory conditions. Favipiravir acts against different SARS-CoV-2 targets, such as spike glycoprotein and nucleoprotein. The interaction between Favipiravir and Onternabez against SARS-COV-2 yields a positive Molecule Synergy probability which is considered significant and justifies the combination of the two drugs to create a new therapeutic that is expected to be beneficial to increase treatment efficacy and reduce the duration of disease. Favipiravir can control the source of infection. Onternabez would contribute to the antiviral efficacy and can control the result of infection.
"We are very pleased by these artificial intelligence results as well as the recent positive results from the PIONEER trial. This underscores our commitment with Cellvera to developing an innovative combination drug candidate to combat viral diseases. We are more excited than ever about our collaboration with Cellvera and the possibility of delivering the next scientific breakthroughs."
Dr. Guy Chamberland, CEO and Chief Regulatory Officer at Tetra
Favipiravir, discovered and developed by FUJIFILM, was first approved under the brand name Avigan® by regulators in Japan in 2014 as a potent broad-spectrum antiviral treatment for influenza. This antiviral drug is effective against 12 families of viruses, including coronaviruses Filoviruses RABIES, NOROVIRUS, and many others. Favipiravir works by inhibiting a viral enzyme called RNA polymerase, preventing viral replication within human cells. Favipiravir has potent antiviral activity against single-stranded RNA viruses, including coronaviruses. This is the protein responsible for "building" the viral proteins. Favipiravir can target the protein necessary for the coronavirus to replicate, making it impossible for the virus to copy itself.
Cellvera is a biopharmaceutical company focused on discovering, developing, and commercializing oral therapies and monitoring tools to address the unmet medical needs of patients with life-threatening viral diseases.
Leveraging the Company's deep understanding of antiviral drug development, nucleotide chemistry, biology, biochemistry and virology, Cellvera has built a nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases.
Currently, Cellvera is focused on the clinical and commercial development of orally available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 the virus that causes COVID-19, dengue virus, hepatitis C virus and respiratory syncytial virus. Driven to Discover. Cellvera's team includes PhDs in computational biology, biochemistry, and chemistry, as well as senior software engineers.
About Global Response Aid
Agility one of the world's leading logistics companies and CELLVERA, an innovative pharma research, development and commercialization company based in Dubai, established Global Response Aid to address the market challenges created by the COVID-19 pandemic and other threats to public health. GRA delivers innovative, effective healthcare solutions through a range of pharmaceutical products and technology platforms. It works closely with governments, regulatory authorities, hospitals, clinics, healthcare providers, life sciences companies, NGOs and public institutions to develop strategies that allow them to tackle public health challenges.
FUJIFILM Corporation, Tokyo, Japan is one of the major operating companies of FUJIFILM Holdings Corporation. The company brings cutting edge solutions to a broad range of global industries by leveraging its depth of knowledge and fundamental technologies developed in its relentless pursuit of innovation. Its proprietary core technologies contribute to the various fields including healthcare, graphic systems, highly functional materials, optical devices, digital imaging and document products. These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2020, the company had global revenues of $21 billion, at an exchange rate of 109 yen to the dollar. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship.
About Tetra Bio-Pharma
Tetra Bio-Pharma is a leader in cannabinoid-derived drug discovery and development with a FDA and a Health Canada cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. Their evidence-based scientific approach has enabled them to develop a pipeline of cannabinoid-based drug products for a range of medical conditions, including pain, inflammation, and oncology. With patients at the core of what they do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing biopharma industry by regulators, physicians and insurance companies.