FDA approves AstraZeneca’s Farxiga for type 2 diabetes patients with risk of CVD

AstraZeneca has announced the US Food and Drug Administration (FDA) has approved Farxiga (dapagliflozin) to reduce the risk of hospitalisation for heart failure (hHF) in patients with type 2 diabetes and either established cardiovascular disease (CVD) or at serious risk of CV outcomes. This follows a similar decision by the European Union in August 2019, when the medicines agency updated its marketing authorisation for Farxiga. The FDA’s decision was based upon results from the DECLARE-TIMI 58 trial, which evaluated 58 CV outcomes, making it the largest of its kind for a sodium-glucose cotransporter 2 (SGLT2) inhibitor. Full results of the Phase III, randomised control trial were published in January in the New England Journal of Medicine. AstraZeneca subsidiary BioPharmaceuticals’ Business Unit executive vice-president Ruud Dobber said: “Farxiga is the first SGLT2 inhibitor approved in the US to reduce the risk of hospitalisation for heart failure in type-2 diabetes patients with established cardiovascular disease or multiple cardiovascular risk factors.

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ISOMORPHIC LABS ANNOUNCES STRATEGIC MULTI-TARGET RESEARCH COLLABORATION WITH LILLY

PR Newswire | January 08, 2024

Isomorphic Labs, a digital biology company with a mission to redefine drug discovery using the power of artificial intelligence, today announced that it has entered into a strategic research collaboration with Eli Lilly and Company. This marks Isomorphic Labs' first pharmaceutical partnership. Under the terms of the agreement, Isomorphic Labs will partner with Lilly to discover small molecule therapeutics against multiple targets and will receive an upfront cash payment of $45 million. Isomorphic Labs is eligible to receive up to $1.7 billion in performance-based milestone payments, excluding the upfront payment and any subsequent tiered royalties of up to low double digits on net sales. "We're thrilled to embark on this partnership and apply our proprietary technology platform, the next generation of AlphaFold, and access to massive computing power to Lilly's development programs," said Demis Hassabis, CEO and founder of Isomorphic Labs. "The focus we share on advancing groundbreaking drug design approaches and appreciation of state-of-the-art science makes this partnership particularly compelling." Isomorphic Labs operates autonomously within Alphabet, with its own dedicated resources and exclusive focus on the application of AI to drug discovery. The company is reimagining the entire drug discovery process from first principles with an AI-first approach, working to build powerful new predictive and generative models of biological phenomena to anticipate how drugs will perform and design novel molecules. Building on the success of AlphaFold and working in collaboration with Google DeepMind, Isomorphic Labs has made remarkable progress in developing the Next Generation of AlphaFold. This new iteration of AlphaFold expands beyond proteins to include small molecules and nucleic acids. Through deep integration of this next generation AlphaFold with other breakthrough AI models developed at Isomorphic Labs, the company is able to better understand the underlying biological mechanisms of drug targets, and rationally design novel therapeutics. ABOUT ISOMORPHIC LABS Isomorphic Labs is an autonomous subsidiary of Alphabet that was launched from Alphabet's DeepMind in 2021 to build on the success of AlphaFold, the company's groundbreaking work in protein folding. That work was heralded as the 'Breakthrough of the Year' by Science and 'Method of the Year' by Nature in 2021. Based in London and now with a second location in Lausanne, Switzerland, Isomorphic Labs was founded and is led by AI pioneer Demis Hassabis, who also co-founded and leads Google DeepMind. As pioneers in digital biology, the company's mission is to use AI to accelerate drug discovery and ultimately find cures for some of humanity's most devastating diseases. Using its AI-first approach to drug discovery and biology, the company's ambition is to advance a new era of medical breakthroughs.

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PHARMA TECH

IDBS announces data management partnership with PharmaEssentia Innovation Research Center

PR Newswire | January 24, 2024

IDBS announced today that it has entered into a partnership with Massachusetts-based PharmaEssentia Innovation Research Center (PIRC) on its Polar platform to help digitize data management and facilitate collaboration between the company's global research and development (R&D) teams. The Polar platform will provide PIRC, the newly established U.S. hub of PharmaEssentia's R&D efforts, the ability to electronically collaborate with its team headquartered in Taipei, Taiwan, who have traditionally recorded experimental data on paper. "The IDBS Polar platform provides superior functionality beyond traditional Electronic Laboratory Notebook (ELN) offerings, backed up by our broad customer base and customer support, as well as the ability to support languages like Mandarin," said Pietro Forgione, General Manager at IDBS. "We are proud to help PIRC better capture, structure and interrogate their key data from a single source of truth, thereby making their collaboration more efficient." "We are looking forward to partnering with IDBS, not only to implement the Polar platform to help us manage our data more efficiently and to more seamlessly collaborate with our R&D team in Taipei, but also to work together to further explore ways to bring our innovative therapeutics to market faster," said Lih-Ling Lin, Ph.D., PIRC Founder and Chief Scientific Officer, PharmaEssentia. About IDBS IDBS helps BioPharmaceutical organizations accelerate the discovery, development and manufacturing of the next generation of life-changing therapies that advance human health worldwide. From lab through manufacturing, IDBS leverages its 30+ years of experience working with a diverse list of customers – including 18 of the top 20 global BioPharma companies – and deep expertise in scientific informatics and process data management to tackle today's most complex challenges. Known for its signature IDBS E-WorkBook product, IDBS has extended solutions across the entire value chain for BioPharma Lifecycle Management (BPLM). Built on analytics-centric and cloud-native technology, IDBS Polar and IDBS PIMS platforms are powered by a digital data backbone to drive faster and smarter decisions in drug development and across the supply chain.

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PHARMA TECH

SHL Medical partners with SteriPack Group to set up final assembly service

PR Newswire | January 25, 2024

SHL Medical, a world-leading solutions provider of advanced drug delivery systems and SteriPack Group, renowned global supplier of secondary packing and final assembly services to the pharmaceutical industry, enter a non-exclusive strategic partnership. Together, they aim to establish a pre-validated final assembly service at the SteriPack facility in Poland, enhancing the overall flexibility of supply chain strategies for their customers. In addition to SHL Medical's existing final assembly, labeling, and packaging¬ services in the United States, this collaboration extends high-quality CMO options to Europe. Markus Puusepp, SHL Medical's Chief Growth Officer, expressed enthusiasm about the partnership, stating "This partnership is a significant addition to the Molly platform value proposition. We share common values with SteriPack, from focus on the customer to a commitment to quality, making the decision to collaborate straightforward." Recognizing the importance of flexibility and time-to-market, especially in clinical production, the partnership with SteriPack will offer SHL Medical's customers highly flexible and personalized final assembly and packaging solutions. This is particularly beneficial for small batch handling in clinical supply and niche markets like rare diseases. Emphasizing the comprehensive capabilities of the Molly platform, SHL Medical aims to deliver right-sized solutions that ensure improved service, faster timelines, and a more streamlined supply chain for its diverse customer base. John Ward, SteriPack Group's VP Pharmaceutical Solutions commented "SteriPack Group looks forward to supporting SHL Medical and their customers in providing quality and flexible solutions to a fast- moving market. With an emphasis on creating service solutions designed around specific customer requirements, this partnership will make the process of working with the Molly platform an easy decision." About SHL Medical As a world-leading solutions provider of advanced drug delivery systems, SHL Medical is the partner of choice for many leading pharma and biotech companies. Driven by its company purpose – Enabling Patients' Independence – SHL Medical offers patient-centric solutions for the design, development, and manufacturing of autoinjectors, pen injectors, as well as innovative specialty delivery systems for large-volume and high-viscosity formulations. It also offers final assembly, labeling, and packaging solutions for its drug delivery systems. In response to the rising trend in home therapy, SHL Medical has increased its developmental work in the digital healthcare sector to help improve the drug delivery ecosystem. Located across Switzerland, Taiwan, Sweden, and the US, SHL Medical's global team of experts collaborate seamlessly as one team in utilizing its comprehensive in-house manufacturing capabilities. Its solutions offer customization and optimization for each project while proactively weaving sustainability-driven measures into its designs and processes to contribute to a cleaner earth. About SteriPack Group SteriPack Group is a globally renowned contract packing and manufacturing organisation serving the pharmaceutical and medical device sectors respectively. With a strong emphasis on innovation, quality and compliance, SteriPack's services to the pharmaceutical industry include device design and development, final assembly, labelling, secondary packing, serialisation and aggregation of injectable formats including vials, pre-filled syringes, and autoinjectors. SteriPack's tailored customer-focused solutions make it an ideally suited supplier for small to medium-sized batch volumes required for a growing market of targeted therapies as well as clinical trials. Its proven capabilities in cleanroom assembly and labelling as well as secondary packing services for drug delivery systems and medical devices, combined with significant investment into growing cold chain storage capacity, have helped to make it a trusted partner to top global pharmaceutical companies.

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