FDA greenlights first generics of blood thinner

in-PharmaTechnologist.com | January 06, 2020

Eliquis (apixaban) is an anticoagulant used for the treatment of blood clots and prevention of stroke in people with nonvalvular atrial fibrillation, marketed by Bristol-Myers Squibb and Pfizer. Indications of the drug product also include the prevention and treatment of deep vein thrombosis, which may lead to pulmonary embolism, in patients who have undergone hip or knee replacement surgery. ​A blockbuster drug,​, Eliquis brought BMS sales of over $5.9bn (€5.2bn) in the first three quarters of 2019. The approved generic versions are not projected to enter the market soon, as Eliquis is protected by patent until 2026.During a Q3 earnings conference call, Giovanni Caforio, BMS’ CEO, commented that the company has reached settlements with over 20 other developers of apixaban, however.

Spotlight

As any senior executive within an organisation knows, the reduction of waste and, more importantly, the cost associated with that waste can have a major effect on any business. Whilst some waste is unavoidable, an executive can begin to implement principals to eliminate this additional “cost of poor quality” (COPQ) by considering which costs would be eliminated if every system, process and product in the business were run at maximum optimisation. In the pharmaceutical industry, it is not uncommon for such costs to range between 25 and 40 percent of total sales revenue1 and yet reducing the COPQ is not a well understood or implemented practice.

Spotlight

As any senior executive within an organisation knows, the reduction of waste and, more importantly, the cost associated with that waste can have a major effect on any business. Whilst some waste is unavoidable, an executive can begin to implement principals to eliminate this additional “cost of poor quality” (COPQ) by considering which costs would be eliminated if every system, process and product in the business were run at maximum optimisation. In the pharmaceutical industry, it is not uncommon for such costs to range between 25 and 40 percent of total sales revenue1 and yet reducing the COPQ is not a well understood or implemented practice.

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BUSINESS INSIGHTS

PostEra spearheads AI-driven drug discovery collaboration to develop antiviral therapeutics with initial $68M in NIH funding

PostEra | May 19, 2022

PostEra, a biotechnology company specializing in machine learning for preclinical drug discovery, announced a multi-year collaboration with the National Institutes of Health to develop small molecule antiviral therapeutics to prevent pandemics. The center will receive initial funding of $68M. PostEra co-leads this initiative with the Drugs for Neglected Diseases Initiative, a global charity with expertise in drug development for global equitable access, and the Memorial Sloan Kettering Cancer Center. As part of the National Institutes of Health's National Institute of Allergy and Infectious Diseases Antiviral Program for Pandemics, the AI-driven Structure-Enabled Antiviral Platform (ASAP) consortium aims to discover dozens of lead compounds against key viruses of significant pandemic concern, such as flaviviruses (responsible for endemic diseases such as Dengue and Zika), picornaviruses (including potentially debilitating enteroviruses as well as other cold-causing viruses), and coronaviruses. ASAP will further deliver three IND-ready candidates which can be immediately ready for clinical evaluation in the event of a viral outbreak, so that future pandemics can be halted before severe outbreaks occur. The consortium is committed to making resulting antivirals globally and equitably accessible, so that no patient population is left behind. ASAP will use PostEra's end-to-end AI-first approach to accelerate the discovery process, generating molecules with optimised properties, designing rapid synthesis, and optimally prioritising experiments. In particular, AI approaches are tightly integrated into structural biology to realize next generation structure-based design. ASAP is built on the success of the COVID Moonshot project, a global open-science AI-driven initiative that began in March 2020 and rapidly identified antiviral drug candidates that target the main protease of the SARS-CoV-2 virus. "We are honored to be co-leading this consortium. We believe that our AI platform will accelerate the discovery of therapeutics that will prevent pandemics." Dr Alpha Lee, Chief Scientific Officer of PostEra, who co-founded COVID Moonshot About PostEra PostEra was founded in 2019 and its technology is built on pioneering academic research done by its founding scientists. PostEra's technology addresses some of the key challenges in drug discovery R&D by integrating molecular design with chemical synthesis. PostEra advances small molecule programs through partnerships with biopharma, working on its own internal pipeline, and also offering some of its synthesis technology via its Manifold web platform. PostEra also helped launch the world's largest open-science drug discovery effort; COVID Moonshot, along with an NIH-funded antiviral research center for the prevention of future pandemics.

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PHARMACY MARKET

Jubilant HollisterStier LLC enters into cooperative agreement of $149.6 Mn with US Government to expand critical vaccine manufacturing capacity

Jubilant Pharmova Limited | May 31, 2022

Jubilant Pharmova Limited has announced today that Jubilant Pharma Limited, a wholly owned subsidiary of the Company, through one of its wholly owned subsidiaries, Jubilant HollisterStier LLC, (JHS) a leading US-based pharmaceutical contract manufacturer has entered into a cooperative agreement for $149.6 million (USD) with the Army Contracting Command, in coordination with the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) on behalf of the Biomedical Advanced Research and Development Authority (BARDA), within the US Department of Health and Human Services. The effort was funded under the American Rescue Plan, this agreement will enable the Company to double its injectable filling production capacity at a total cost of $193 million, at its Spokane, Washington manufacturing facility. This will be completed by 2025. This agreement is in addition to the $92 million filling line expansion announced in November 2021, which will be commercially available by the end of 2024. "Jubilant HollisterStier LLC is committed to making the US pharmaceutical supply chain more resilient with domestic manufacturing facilities and less reliant on foreign suppliers. Jubilant HollisterStier has a long history of supporting the US Department of Health and Human Services (HHS) and Department of Defense (DOD) biodefense and medical countermeasure programs, including production for national preparedness efforts. We are proud to support the US government in their efforts of making the US more prepared and ready for future pandemics." Speaking on the announcement, Pramod Yadav, CEO, Jubilant Pharma Limited "Jubilant HollisterStier LLC's expansion will target large Pharmaceuticals and Biotech companies for parenteral products as well as feature a flexible manufacturing platform able to produce several types of vaccines (live, mRNA and inactivated/subunit). We are committed to investing in capability and capacity. This investment will ensure our ability and flexibility to speedily produce quality vaccines and treatments for our customers and be better prepared for any future threats to the country," shared Amit Arora, President, Contract Manufacturing Organization (CMO), Jubilant HollisterStier LLC. About Jubilant HollisterStier LLC Jubilant HollisterStier LLC, a subsidiary of Jubilant Pharma Limited, is a leading integrated contract manufacturer of sterile injectables, ophthalmics, optics, sterile and non-sterile topicals and liquids. With facilities in North America, Jubilant HollisterStier LLC provides specialized manufacturing for the pharmaceutical and biopharmaceutical industries. Services include a full range of support to streamline manufacturing, from process qualifications through commercial release. About Jubilant Pharma Limited Jubilant Pharma Limited, a Company incorporated under the laws of Singapore and a wholly-owned subsidiary of Jubilant Pharmova Limited, is an integrated global pharmaceutical company engaged in manufacturing and supply of Radiopharmaceuticals with a network of radio-pharmacies in the US, Allergy Immunotherapy, Contract Manufacturing of Sterile Injectables and Non-sterile products, APIs and Solid Dosage Formulations through six manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies. The Company has a team of over 4,600 multicultural people across the globe and is committed to delivering value to its customers spread across over 75 countries. It is well recognized as a 'Partner of Choice' by leading pharmaceutical companies globally. About Jubilant Pharmova Limited Jubilant Pharmova Limited is a company engaged in Pharmaceuticals, Contract Research and Development Services and Proprietary Novel Drugs businesses. Pharmaceuticals business through Jubilant Pharma Limited Singapore (JPL) is engaged in manufacturing and supply of Radiopharmaceuticals with a network of 48 radio-pharmacies in the US, Allergy Immunotherapy, Contract Manufacturing of Sterile Injectables and Non-sterile products, APIs and Solid Dosage Formulations through six manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies. Jubilant Biosys Limited provides contract research and development services through two world class research centers in Bangalore and Noida in India. Jubilant Therapeutics is involved in Proprietary Novel Drugs business and is an innovative biopharmaceutical company developing breakthrough therapies in the area of oncology and auto-immune disorders. Jubilant Pharmova Limited has a team of over 6,000 multicultural people across the globe. The Company is well recognized as a 'Partner of Choice' by leading pharmaceuticals companies globally.

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PHARMA TECH

PathAI Announces Strategic Partnership with Roche to Enable Development and Distribution of Digital Pathology Diagnostics

Roche | October 15, 2021

PathAI, a global leader in artificial intelligence (AI)-powered technology for pathology, and Roche, a global pioneer in pharmaceuticals and diagnostics, announced a strategic partnership to develop and distribute PathAI's AI-powered technology through Roche's uPath enterprise software, enabling broad access to digital pathology diagnostics to support clinical research and companion diagnostic (CDx) programs globally. AI-powered pathology has the potential to inform biomarker development, better identify and treat patients, and enable personalized medicine. However, the digital pathology industry is largely fragmented across various software, hardware and algorithm providers, which has prevented effective implementation of AI platforms in labs. The collaboration between PathAI and Roche now provides a comprehensive menu of AI-powered digital pathology solutions in diagnostics. "This collaboration brings together all of the components required to deliver and commercialize a differentiated AI-based digital pathology medical device including assay, scanner, image management system, and image analysis algorithms. We believe this collaboration will unlock the potential for digital pathology in the CDx setting, offering a differentiated service to biopharma sponsors and ultimately new opportunities to improve patient outcomes," - Dr. Andy Beck, CEO of PathAI. The collaboration will initially involve distribution of PathAI-developed research-use-only (RUO) algorithms through NAVIFY Digital Pathology, the cloud version of Roche's uPath enterprise software, focusing on immuno-oncology in multiple cancer types. The collaboration will also support biopharmaceutical partners with an end-to-end solution for CDx development, leveraging Roche's diagnostic assays and pathology lab solutions with new and expanded innovative imaging tools from PathAI, in addition to the AI tools already provided by Roche. About PathAI PathAI is a leading provider of AI-powered research tools and services for pathology. PathAI's platform promises substantial improvements to the accuracy of diagnosis and the efficacy of treatment of diseases like cancer, leveraging modern approaches in machine and deep learning. Based in Boston, PathAI works with leading life sciences companies and researchers to advance precision medicine. To learn more, visit pathai.com. About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics, as well as growing capabilities in the area of data-driven medical insights help Roche deliver truly personalised healthcare. Roche is working with partners across the healthcare sector to provide the best care for each person. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. In recent years, Roche has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognized as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

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