Coronavirus Vaccine: Johnson & Johnson Pledges 100M Doses to U.S. For $10 Each

Johnson & Johnson | August 06, 2020

With leading COVID-19 vaccines in late-stage testing, companies have been inking supply deals with the U.S. government for a quick rollout if their programs succeed. Now, Johnson & Johnson is getting into the act. The pharma giant struck a deal to supply 100 million doses of its candidate, Ad26.COV2.S, if the shot is cleared for use by the FDA. The U.S. government is committing just over $1 billion under the agreement for a price per dose of about $10.  That compares with a lower price-per-dose of $4 for AstraZeneca and a higher figure of $19.50 for Pfizer and BioNTech under agreements between those drugmakers and the U.S. government. J&J and AZ have pledged to provide their vaccines under a not-for-profit basis during the pandemic. Under the new J&J deal, which stipulates manufacturing in the U.S., the feds could later buy another 200 million doses under a separate agreement. The company previously won $456 million in funding to support its R&D and manufacturing scale-up, according to a government database.

Spotlight

At EY, we have conducted a survey among healthcare professionals (HCPs) and pharmaceutical companies to understand their perspective of the Medical Council of India’s (MCI) guidelines and the Department of Pharmaceuticals’ (DoP) marketing code. We are pleased to share the findings of our study with you in this report.

Spotlight

At EY, we have conducted a survey among healthcare professionals (HCPs) and pharmaceutical companies to understand their perspective of the Medical Council of India’s (MCI) guidelines and the Department of Pharmaceuticals’ (DoP) marketing code. We are pleased to share the findings of our study with you in this report.

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PHARMACY MARKET

AbCellera and Everest Medicines Announce Multi-Target Collaboration to Advance New Antibody Therapies

Everest Medicines | September 23, 2021

AbCellera and Everest Medicines Limited announced that they have entered into a multi-year collaboration and license agreement to discover therapeutic antibodies for up to 10 targets selected by Everest. The partnership will help to expand Everest’s portfolio of novel medicines across multiple indications, with the initial programs focusing on targets in oncology. We are proud to partner with Everest as they build a robust pipeline of innovative medicines for patients in Asia and beyond, We believe our full-stack discovery engine, combined with Everest’s clinical development capabilities, creates synergy and the opportunity to speed the delivery of therapies to patients around the world. - Carl Hansen, Ph.D., CEO and President of AbCellera. By partnering with AbCellera, Everest will benefit from an operating system that supports many antibody modalities to unlock new target classes and open new disease areas to therapeutic access. The collaboration will leverage the full breadth of AbCellera’s technology stack, including sourcing fully humanized antibodies from the Trianni Mouse®, sourcing single domain antibodies from camelids, and combining any two antibodies to create native bispecifics using the OrthoMabTM protein engineering platform. This collaboration will allow us to gain access to AbCellera’s cutting edge, AI-powered antibody discovery platform, which will greatly accelerate and increase the efficiency of our internal discovery efforts. - Jennifer Yang, Ph.D., Chief Scientific Officer of Everest Medicines. Under the terms of the agreement, Everest will have the rights to develop and commercialize antibodies resulting from the collaboration. AbCellera will receive research payments and is eligible to receive from Everest downstream clinical and commercial milestone payments and royalties on net sales of products. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Asia markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations in Asia and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of ten potentially global first-in-class or best-in-class molecules, many of which are in late stage clinical development. The Company’s therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. 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. AbCellera Forward-looking Statements This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements are based on management’s beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations.

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PHARMA TECH

Saama Launches Active Safety Analytics for Pharma (ASAP), Co-built With Gilead to Transform Safety Surveillance

Saama Technologies, Inc. | October 27, 2020

Saama Technologies, Inc. (“Saama”), the AI clinical analytics platform company, announced today the launch of the new Active Safety Analytics for Pharma (ASAP) product. ASAP is the first validated pharmacovigilance solution to leverage the U.S. Food and Drug Administration’s (FDA) Sentinel Common Data Model and the TreeScan methodology for detecting safety signals. ASAP was co-built with Gilead Sciences, a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. Saama and Gilead partnered to develop ASAP, with scientific advice from the Reagan-Udall Foundation for the FDA, and accelerate the life sciences industry’s paradigm shift to adopt active safety analytics.

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BUSINESS INSIGHTS

MHRA Expands Relationship with Commonwealth Informatics to Transform Drug Safety

Commonwealth Informatics, a Genpact company | January 25, 2022

Commonwealth Informatics, an independently-operated subsidiary of Genpact, and leading technology and services company with industry expertise in medical product safety and public health surveillance, today announced that it has expanded its relationship with the Medicines and Healthcare products Regulatory Agency, a medical regulatory body for the United Kingdom. MHRA has selected Commonwealth Informatics' state-of-the-art signal detection and signal management solution, Commonwealth Vigilance Workbench (CVW), to support the MHRA transformation of safety monitoring through a single integrated platform across all medicines, vaccines, blood components and devices. "The MHRA is looking to transform our vigilance services through new ways of working, underpinned by the technology we use and how we operate our services. We see our partnership with CVW enabling us to deliver a more responsive safety surveillance system through innovative technology." Mick Foy, Head of Pharmacovigilance Strategy at MHRA "We are delighted to have the opportunity to build on our longstanding research collaboration with the MHRA and deliver future value through greater efficiencies within signal detection," said Bill Blackwell, Commonwealth VP Safety Science Solutions. "The collaborative partnership will enable us, together with the MHRA, to bring new innovative methodologies to safety surveillance on behalf of patients." Commonwealth's solution will be implemented to perform signal detection and signal management across multiple data sources leveraging advanced automation, such as artificial intelligence, to ensure more accurate multivigilance analysis and processing. CVW is an integrated cloud-based signal management system supporting the detection, tracking and refinement of safety signals using evidence across multiple data sources. The MHRA is deploying Insife's HALOPV solution for case processing management, advanced automation, and real-time reporting and analytics. Commonwealth Informatics has partnered with Insife, to integrate CVW with HALOPV and to collaboratively deploy the end-to-end multi-vigilance platform in Q2 2022. Insife, headquartered in Denmark, offers specialist consulting services in multivigilance (Medicines and Devices), Regulatory Affairs (RA), and Information Technology (IT) implementation. Insife's services are based on expertise across the life sciences value chain with an understanding of digital transformation and drug safety assurance through process optimisation and automation. About Commonwealth Informatics Commonwealth Informatics is a technology and services company with industry expertise in medical product safety and public health surveillance. Pharmaceutical and biotechnology companies, government agencies, and healthcare providers use Commonwealth's products and services to assemble relevant data and answer complex clinical and safety analysis questions quickly and accurately. Commonwealth is an independently-operated subsidiary of Genpact, a global professional services firm focused on delivering digital transformation. About Medicines and Healthcare products Regulatory Agency MHRA, based in London, is an executive agency sponsored by the Department of Health and Social Care, that regulates medicines, medical devices and blood components for transfusion in the United Kingdom. Recognised globally as an authority in its field, the agency plays a leading role in protecting and improving public health and supports innovation through scientific research and development.

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