Valeritas Receives Court Approval of Sale of Business to Zealand Pharma

PR Newswire | March 20, 2020

Valeritas Holdings, Inc.("Valeritas" or the "Company"), a medical technology company and maker of the V-Go® Wearable Insulin Delivery device, today announced that the U.S. Bankruptcy Court for the District of Delaware (the "Court") approved the sale of substantially all of the business to Zealand Pharma A/S (NASDAQ: ZEAL) ("Zealand"), a Denmark-based biotechnology company. The transaction is expected to be completed during the first week of April, subject to the satisfaction of applicable closing conditions.

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Meddevicetracker recorded 62 medical device approvals from outside the United States in the first quarter for 2018, including 46 CE Marks from Europe.


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PHARMACY MARKET

Harbour BioMed Announces IND Approval for Next-Gen Anti-TSLP Fully Human Monoclonal Antibody

Harbour BioMed | February 22, 2022

Harbour BioMed announced that China National Medical Products Administration had approved its investigational new drug (IND) application for HBM9378 a next-gen fully human antibody targeting thymic stromal lymphopoietin for the treatment of moderate-to-severe asthma. HBM9378/SKB378 is a co-development project conducted by HBM and Kelun-Biotech, who together equally share the global rights in respect of HBM9378. The IND approval of HBM9378 is an achievement of the strategic collaboration between the parties. According to the strategic collaboration and license agreement between HBM and Kelun-Biotech, the parties will jointly explore innovative therapies of monoclonal antibodies and antibody-drug conjugate. Building on HBM's innovative business model leveraging its productive R&D platform to lead the next generation of valuable and innovative therapies and its mission to address the unmet medical needs, HBM will continue to expand its collaboration with industry leading partners and further leverage on the combined capabilities of HBM and its collaborators. "HBM9378/SKB378, a next-gen fully human monoclonal antibody, is developed from HBM's H2L2 platform. Its long half-life optimization and outstanding biophysical properties support the favorable dosing advantage. The approval of this IND application once again proves HBM's powerful innovation capability. Unleashing the power of our unique R&D engine, we are highly confident and determined to defeat intractable diseases across the world." Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed About HBM9378/SKB378 HBM9378/SKB378 is a fully human monoclonal antibody against TSLP generated from two heavy chains and two light chains (H2L2) platform. It inhibits the TSLP mediated signaling pathway by blocking the interaction between TSLP and TSLP receptor. TSLP plays important roles in DC cell maturation, T helper 2 (Th2) cell polarization and inflammation, particularly in both eosinophilic and non-eosinophilic inflammation asthma. About Asthma Asthma is a heterogeneous disease defined by the history of respiratory symptoms that vary over time and in intensity, together with variable expiratory airflow limitation. The disease is estimated to affect more than 300 million people worldwide and affect more than 45.7 million adult people (≥20 years) in China. Approximately 5-10% of those afflicted with asthma have severe disease that is poorly controlled. Despite the use of medium to high dose inhaled corticosteroids (ICS) in combination with a long-acting β2-agonist (LABA), currently available biologic therapies and oral corticosteroids (OCS), many severe asthma remain uncontrolled. Current biologics are mainly targeting Type 2 severe asthma which manifests clinically with a combination of peripheral eosinophilia, sputum eosinophilia and/or elevated fractional exhaled nitric oxide (FENO). Severe asthma patients experience frequent exacerbations, significant limitations on lung function and a reduced quality of life. The healthcare burden associated with care for these patients is also high. Therefore, there are still significant unmet needs to develop safer and broader therapies for severe asthma. About Harbour BioMed Harbour BioMed is a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics focusing on immunology and oncology. The Company is building its robust portfolio and differentiated pipeline through internal R&D capability, collaborations with co-discovery and co-development partners and select acquisitions.

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BUSINESS INSIGHTS

Protect Pharmaceutical Corporation has acquired top notch software development company.

PROTECT PHARMACEUTICAL Corp | June 28, 2022

Protect Pharmaceutical Corporation has acquired the 100% of the shares of CJSC “Inaiapp”, a Belarusian developer of corporate software for business digitalization. With 8 years of blockchain development experience and list of long term clients, Inaiapp will bring its qualification and management processes to a new level. “Robotic process automation, AI systems and machine learning systems, blockchain-based solutions, Data Science tools for business growth - we closely follow global trends in IT technology and are now ready to create the most profitable solution for your business.” Nick Greb, President of PRTT PRTT offers range of services and software products, to solve painful problems. The company is using time-tested practices in the field of robotics, artificial intelligence, machine learning and blockchain, creating first-class solutions that meet current business needs. “Now we will combine the US market presence with extensive technical expertise that enable us to develop products that accelerate and streamline business processes through autonomy, transparency and security.” - Nick adds. About PRTT Protect Pharmaceutical Corporation is a full-cycle software development and delivery company that produces, releases, and supports digital products for the business-to-business and business-to-consumer markets. The company’s expertise lies in custom software development and consulting services in Business automation, Artificial Intelligence, Machine Learning, Data Science, Big Data, Image recognition, Blockchain development, and cloud services. Its domain focus includes Supply chain, Logistics, Healthcare, Finance, Real estate, Legal, Insurance, Advertising, and more.

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BUSINESS INSIGHTS

AbCellera and Empirico Expand Strategic Multi-Target Antibody Discovery Collaboration

AbCellera | May 04, 2022

AbCellera and Empirico Inc. announced today that they have expanded their strategic multi-target discovery collaboration, which leverages Empirico’s Precision Insights PlatformTM to discover genetically validated drug targets and AbCellera’s technology to identify lead candidate antibodies against those targets. Following the rapid progress of their first collaborative program, which identified a lead candidate against an undisclosed G protein-coupled receptor target in less than 12 months, the companies have expanded their partnership to include seven targets. In addition, under the expanded agreement, AbCellera has a co-development option on a program-by-program basis. Empirico’s platform is designed to uncover causal relationships between genes, proteins, and clinical outcomes by integrating genetic data and health information from millions of individuals together with experimental validation. AbCellera integrates leading technologies to solve all steps in the antibody discovery process and delivers to partners diverse and developable lead candidates against drug targets. “We have been impressed by Empirico’s ability to discover and validate new drug targets and believe the combination of our respective technologies has great potential to bring new first-in-class treatments to patients. We are pleased to build on our productive collaboration with Empirico by expanding the number of targets and maximizing the opportunity for mutual success by having an option to co-invest on a program-by-program basis.” Carl Hansen, Ph.D., CEO and President of AbCellera “AbCellera’s technology enables us to extend our competitive advantage in target discovery and validation with best-in-class antibodies to rapidly advance our programs towards the clinic,” said Omri Gottesman, M.D., CEO and President of Empirico. “We are excited to expand our relationship with AbCellera and to translate many more genetically validated targets into potential new antibody-based therapies together.” Under the terms of the expanded agreement, Empirico will have the right to develop and commercialize therapeutic antibodies resulting from the collaboration, and AbCellera has the option to co-develop each therapeutic program to maintain up to a 50 percent ownership stake. Financial terms were not disclosed. About Empirico Inc. Empirico is a next-generation therapeutics company founded on utilizing human genetics, data science, and programmable biology to power novel target discovery and development. Empirico’s Precision Insights PlatformTM, a proprietary human genetics-focused discovery platform, leverages a world-leading dataset, hyperscale infrastructure and algorithmic approaches that encode and enhance human intuition to identify and prioritize therapeutic targets. All potential therapeutic targets are subjected to rigorous in vitro and in vivo experimental validation to elucidate the mechanism by which genetic variation impacts disease risk and provide insights about which therapeutic modality could be ‘programmed’ to mimic or interfere with that mechanism. Empirico is advancing multiple programs across a broad range of indications and therapeutic modalities, both independently and in collaboration with industry partners. Empirico is headquartered in San Diego, California with laboratories in Madison, Wisconsin. About AbCellera Biologics Inc. AbCellera is a technology company that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. AbCellera partners with drug developers of all sizes, from large pharmaceutical to small biotechnology companies, empowering them to move quickly, reduce cost, and tackle the toughest problems in drug development.

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PHARMACY MARKET

Standigm Signs MOU with Merck Korea for AI drug Discovery Research

Standigm | June 02, 2022

Standigm Inc. the leading workflow artificial intelligence (AI) drug discovery company, announced the signing of a Memorandum of Understanding (MOU) with Merck Korea, for AI-based drug discovery research. The MOU signing took place on May 30 at the headquarters of Standigm, attended by Sojeong Yun, CEO of Standigm, and Stephen Namkoo Lee, the Head of Science and Lab Solutions, Life Science business sector of Merck Korea. Under the MOU, Standigm will accelerate its drug discovery research by adopting Merck's AI software SYNTHIA™. which can help Standigm's novel compound synthesis. SYNTHIA™ is a computer-aided retrosynthetic design tool and unites network theory, modern high-power computing, and expert chemical knowledge to rapidly design synthetic pathways. "Applying AI to the drug discovery process can dramatically reduce time in discovering novel drug candidates and finding optimized synthesis paths. By pooling know-how in AI synthesis of Merck and Standigm's AI technology together, we expect better results in drug discovery faster, compared to the traditional AI drug discovery method," Sojeong Yun, co-founder and CEO of Standigm "Candidate chemical discovery using AI technology for new drug development is playing a crucial role in the growth of local bioindustry," said Stephen Nam-Koo Lee, Head of Science and Lab Solutions for South Korea, Life Science business sector, Merck Korea. As a leading workflow AI drug discovery company, Standigm has actively conducted research on AI technology in organic synthesis at its own Synthetic Research Center, established last year. About Standigm Standigm is a workflow AI-driven drug discovery company headquartered in Seoul, South Korea and Standigm has expanded its operations across the world, recently opening offices in the U.S. and UK. Standigm has proprietary AI platforms encompassing novel target identification to compound design, to generate commercially valuable drug pipelines. Founded in 2015, Standigm has established an early-stage drug discovery workflow AI to generate multiple First-in-Class compounds within seven months. Pursuing full-stack, AI-driven industrializing drug discovery, Standigm has achieved the automation of molecular design workflow, and the automation effort has been expanding to the whole drug discovery process based on Standigm AI platforms, including Standigm ASK™ for novel target discovery, Standigm BEST™ for novel compound generation. About Merck Merck a leading science and technology company, operates across life science, healthcare and electronics. Around 60,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2021, Merck generated sales of € 19.7 billion in 66 countries.

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Spotlight

Meddevicetracker recorded 62 medical device approvals from outside the United States in the first quarter for 2018, including 46 CE Marks from Europe.

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