Combatting Superbugs With Nanocapsules

Technology Networks | October 18, 2019

Scientists have uncovered a novel antibiotic-free approach that could help prevent and treat one of the most widespread bacterial pathogens, using nanocapsules made of natural ingredients.
Helicobacter pylori (H. pylori) is a bacterial pathogen carried by 4.4 billion people worldwide, with the highest prevalence in Africa, Latin America and the Caribbean. Although the majority of infections show no symptoms, if left untreated the pathogen can cause chronic inflammation of the stomach lining, ulcers and is associated with an increased risk of gastric cancer. In 2017, the World Health Organisation included H. pylori on its list of antibiotic-resistant "priority pathogens" – a catalogue of bacteria that pose the greatest threat to human health and that urgently need new treatments. Current treatments involve multi-target therapy with a combination of antibiotics, but this has promoted the emergence of resistant strains.

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PHARMACY MARKET, PHARMA TECH

Jazz Pharmaceuticals Maintains Exclusive Rights to Develop and Sell Zymeworks' Zanidatamab

Jazz Pharmaceuticals plc and Zymeworks Inc. | December 28, 2022

Jazz Pharmaceuticals plc and Zymeworks Inc. recently informed that the former has chosen to keep its exclusive rights to develop and sell Zymeworks' Zanidatamab in key markets, such as the U.S., Europe, and Japan, as part of the license and collaboration agreement made in October 2022. A pivotal trial in previously treated HER2-amplified biliary tract tumors (BTC) found that 41.3% (95% CI: 30.4, 52.8) of recruited patients with HER2-amplified and expressing (IHC2+ and 3+) illness achieved an objective response as judged by independent central review. The median response length was 12.9 months (95% CI: 5.95 to not attained). In this trial, Zanidatamab's safety profile was similar to what had been found in previous studies of monotherapy, while no new safety signals were found. Jazz Pharmaceuticals stated that the compelling top-line clinical data from the pivotal study in patients with BTC demonstrated the transformative potential of Zanidatamab. This big win gives the company more confidence that it can make this medicine better for cancer patients who have big unmet needs. Even though its main focus will be on the ongoing clinical trials for BTC and GEA, these data will add to the growing amount of evidence that Zanidatamab is effective against a wide range of HER2-expressing cancers. Zymeworks expressed that the collaboration with Jazz is going well, which will speed up the global development of Zanidatamab in many types of cancer and may give patients with hard-to-treat cancers and few treatment options access to a basic HER2-targeted drug. Jazz will pay Zymeworks $325 million to exercise its option to develop and sell Zanidatamab in all countries except Asia-Pacific in the fourth quarter of 2022. About Jazz Pharmaceuticals Jazz Pharmaceuticals, founded in 2003 and located in Dublin (Ireland), innovates to improve the lives of patients and their families. The company transforms biopharmaceutical discoveries into innovative medications to reimagine what's possible. About Zymeworks Zymeworks develops next-generation multifunctional biotherapeutics. Zanidatamab is a new Azymetric™ HER2-targeted bispecific antibody being examined in numerous Phase 1, Phase 2, and pivotal clinical trials globally as a targeted therapeutic option for patients with HER2-positive solid tumors. Zanidatamab Zovodotin (ZW49) is a bispecific antibody-drug combination in Phase 1 clinical development. It combines Zanidatamab's unique design and antibody framework with Zymeworks' ZymeLink™ linker-cytotoxin.

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RESEARCH, PHARMA TECH

Alliance Pharma Opens State-of-the-Art Bioanalytical Laboratory in Brisbane

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.

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BUSINESS INSIGHTS, VIEWS AND ANALYSIS

Hovione and GEA announce a strategic collaboration to advance Continuous Tableting

HOVIONE | December 15, 2022

Hovione and GEA announced a strategic collaboration to advance Continuous Tableting. This partnership stemmed from a successful customer-supplier relationship spanning several years. It combines GEA´s engineering expertise with Hovione´s development and manufacturing experience and both parties commit to partner to accelerate the adoption of Continuous Tableting technology. The advantages of continuous over batch manufacturing are well known. Continuous production systems allow for leaner and risk-reduced development paths, leaner supply chains, increased built-in quality, and in general, manufacturing processes of greater flexibility and reduced complexity. In the context of this strategic collaboration, Hovione and GEA will combine their strengths to further advance the technology and contribute to the establishment of new standards and new levels of market acceptance. "Hovione has a track record in industrializing and democratizing emerging pharmaceutical technologies, such as amorphous solid dispersions by spray drying, and turn them into dependable and scalable offerings that are available to all. We have been committed to Continuous Tableting for the last 7 years and we are now ready to contribute decisively to the advancement of one of the most promising technologies in pharma manufacturing. This collaboration with GEA, gives us the opportunity to link up with a leading designer and supplier of Continuous Tableting equipment solutions and bring Continuous Tableting to the next levels of reliability, flexibility and adoption." Jean-Luc Herbeaux, CEO of Hovione. He adds Navin Lakhanpaul, Global Head Pharma-Solid Dosage, GEA, adds: "As a leading supplier of process technology, GEA has established itself as a trusted solution provider in the pharmaceutical industry, and as a pioneer in the development of Continuous Tableting technology." He adds "Our relationship with Hovione over many years has clearly demonstrated the value in further collaborating and developing synergies in our respective areas of expertise. We share a common objective of enabling the wider use of Continuous Tableting in the Pharmaceutical Industry, and firmly believe that our partnership with Hovione will accelerate the growth of this exciting technology." About Hovione Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization with a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the USA, Portugal, Ireland and China as well as development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione is the only independent company offering a complete range of services, from API to formulation development and devices. Hovione is a company with a culture based on innovation, quality and delivery. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards. About GEA GEA is one of the world's largest suppliers of systems and components to the food, beverage and pharmaceutical industries. The international technology­ group, founded in 1881, focuses on machinery and plants, as well as advanced process technology, components, and comprehensive services. With more than 18,000 employees working across five divisions and 62 countries, the group generated revenues of more than EUR 4.7 billion in fiscal year 2021. GEA plants, processes, components and services enhance the efficiency and sustainability of production processes across the globe. They contribute significantly to the reduction of CO2 emissions, plastic usage and food waste. In doing so, GEA makes a key contribution toward a sustainable future, in line with the company's purpose: "Engineering for a better world".This partnership stemmed from a successful customer-supplier relationship spanning several years. It combines GEA´s engineering expertise with Hovione´s development and manufacturing experience and both parties commit to partner to accelerate the adoption of Continuous Tableting technology. The advantages of continuous over batch manufacturing are well known. Continuous production systems allow for leaner and risk-reduced development paths, leaner supply chains, increased built-in quality, and in general, manufacturing processes of greater flexibility and reduced complexity. In the context of this strategic collaboration, Hovione and GEA will combine their strengths to further advance the technology and contribute to the establishment of new standards and new levels of market acceptance. "Hovione has a track record in industrializing and democratizing emerging pharmaceutical technologies, such as amorphous solid dispersions by spray drying, and turn them into dependable and scalable offerings that are available to all." Says Jean-Luc Herbeaux, CEO of Hovione. He adds "We have been committed to Continuous Tableting for the last 7 years and we are now ready to contribute decisively to the advancement of one of the most promising technologies in pharma manufacturing. This collaboration with GEA, gives us the opportunity to link up with a leading designer and supplier of Continuous Tableting equipment solutions and bring Continuous Tableting to the next levels of reliability, flexibility and adoption." Navin Lakhanpaul, Global Head Pharma-Solid Dosage, GEA, adds: "As a leading supplier of process technology, GEA has established itself as a trusted solution provider in the pharmaceutical industry, and as a pioneer in the development of Continuous Tableting technology." He adds "Our relationship with Hovione over many years has clearly demonstrated the value in further collaborating and developing synergies in our respective areas of expertise. We share a common objective of enabling the wider use of Continuous Tableting in the Pharmaceutical Industry, and firmly believe that our partnership with Hovione will accelerate the growth of this exciting technology." About Hovione Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) with a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the USA, Portugal, Ireland and China as well as development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione is the only independent company offering a complete range of services, from API to formulation development and devices. Hovione is a company with a culture based on innovation, quality and delivery. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards. About GEA GEA is one of the world's largest suppliers of systems and components to the food, beverage and pharmaceutical industries. The international technology­ group, founded in 1881, focuses on machinery and plants, as well as advanced process technology, components, and comprehensive services. With more than 18,000 employees working across five divisions and 62 countries, the group generated revenues of more than EUR 4.7 billion in fiscal year 2021. GEA plants, processes, components and services enhance the efficiency and sustainability of production processes across the globe. They contribute significantly to the reduction of CO2 emissions, plastic usage and food waste. In doing so, GEA makes a key contribution toward a sustainable future, in line with the company's purpose: "Engineering for a better world".

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