Mylan, Biocon launch biosimilar of cancer drug Herceptin in US

Biotechnology major Biocon and drug firm Mylan NV on Monday announced the launch of biosimilar Ogivri, used for treatment of certain breast and gastric cancers, in the US market.   Ogivri is available in a 420 mg multi-dose vial and a 150 mg single-dose vial in order to provide the patients dosing and treatment flexibility, the companies said in a joint statement.  "The US launch of Ogivri, the biosimilar trastuzumab co-developed by Biocon Biologics and Mylan, marks a significant milestone in our biosimilars journey," Biocon Biologics CEO Christiane Hamacher said.  The introduction of both 420 mg multi-use vials and 150 mg single-use vials of a high quality biosimilar trastuzumab with robust long-term efficacy and safety data will offer greater choice and value to patients, prescribers and payors in the US, she added.  "We aspire to serve 5 million patients through our biosimilars portfolio and cross a revenue milestone of USD 1 billion by FY22," Hamacher said. Like2:03 am

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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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PHARMA TECH, PRACTICE MANAGEMENT

Lilly Launches End-to-End Digital Healthcare Experience through LillyDirect

PR Newswire | January 05, 2024

Eli Lilly and Company today announced LillyDirect, a new digital healthcare experience for patients in the U.S. living with obesity, migraine and diabetes. LillyDirect offers disease management resources, including access to independent healthcare providers*, tailored support, and direct home delivery of select Lilly medicines through third-party pharmacy dispensing services. "A complex U.S. healthcare system adds to the burdens patients face when managing a chronic disease. With LillyDirect, our goal is to relieve some of those burdens by simplifying the patient experience to help improve outcomes," said David A. Ricks, Lilly's chair and CEO. "LillyDirect offers more choices in how and where people access healthcare, including a convenient home delivery option to fill Lilly medicines they have been prescribed." For patients living with obesity, migraine and diabetes, LillyDirect offers: LillyDirect Pharmacy Solutions, a digital pharmacy for select Lilly medicines powered by third party online pharmacy fulfillment services. LillyDirect Pharmacy Solutions gives patients a simple option to get consistent access to Lilly medicines they have been prescribed with the added convenience of home delivery. By obtaining medicines directly from Lilly, patients can easily access Lilly's affordability solutions and savings card opportunities are automatically applied for patients who qualify. Medicines fulfilled by pharmacy service providers through LillyDirect Pharmacy Solutions ship free of charge. Disease state and healthcare educational information to help empower and support patients on their care journeys. Access to independent telehealth providers that could complement a patient's current primary care team or be an alternative to in-person care for certain conditions. An independent search tool that allows a patient to find healthcare professionals near them if they prefer in-person care. "We know that people have come to depend on the efficiency and convenience of digital solutions to meet a variety of their everyday needs – healthcare being one of them," said Frank Cunningham, group vice president, global value and access at Lilly. "We launched LillyDirect with the hope that it will offer patients an innovative end-to-end experience to manage their health and access their medicines, so they can get back to living their lives." LillyDirect will continue to be updated and expanded to improve the customer experience. Future updates may include new products, partners and services, such as programs designed to help patients with adherence to their medicines. About Lilly Lilly unites caring with discovery to create medicines that make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 51 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges, redefining diabetes care, treating obesity and curtailing its most devastating long-term effects, advancing the fight against Alzheimer's disease, providing solutions to some of the most debilitating immune system disorders, and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable.

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RESEARCH

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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