Pfizer uses real-world data to score Ibrance breast cancer nod in males

Pfizer | April 05, 2019

Breast cancer is a rare disease in men, making it tough for drugmakers to conduct clinical trials. But Pfizer came up with a solution. The pharma giant scored a new nod Thursday for big-seller Ibrance in males, based largely on real-world evidence. Along the way, regulators studied data from electronic health records and post-marketing reports from the IQVIA Insurance database, the Flatiron Health Breast Cancer database and Pfizer's own global safety database. The result? An FDA green light for Ibrance, in tandem with an aromatase inhibitor or AstraZeneca’s Faslodex, for men with HR-positive, HER2-negative advanced or metastatic breast cancer. Invasive breast cancer will affect 2,670 men in 2019, Pfizer estimates.

Spotlight

Tissue pathology is at the core of various aspects of the pharmaceutic pipeline. Digital pathology is a technology that converts glass microscope slides with tissue samples into whole slide digital images, which can be used to identify, quantify, and document key characteristics of tissue samples. This opens up a new world of applications that can potentially improve and accelerate pharmaceutic development.


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PHARMA TECH

Babson Diagnostics and Pharmacy Podcast Network Announce Partnership That Will Take Listeners Inside Largest Retail Pharmacy Trade Show

Babson Diagnostics | July 27, 2022

Babson Diagnostics, a science-first, health care technology company, announced a media partnership with the Pharmacy Podcast Network in connection with the 2022 National Association of Chain Drug Stores’ Total Store Expo, the largest gathering of retailers and suppliers in the health and wellness industry. As part of the partnership, the Pharmacy Podcast Network, the most popular and downloaded podcast about the pharmacy industry, will be integrated into Babson Diagnostics’ booth at the Total Store Expo. Todd Eury, founder and chief executive officer of the media company, will host podcasts from the booth featuring industry leaders attending the trade show. In addition, Babson will sponsor two podcasts that will be broadcast prior to the expo, which takes place Aug. 27 through Aug. 29 in Boston. The first of those shows, “Diagnostic Testing in Community Pharmacies,” went live today. “Babson is excited to be collaborating with one of the leading media outlets aimed at community pharmacists, who are the face of neighborhood healthcare. Babson is working with pharmacies to offer medically accurate blood testing that is easier, more convenient and less invasive than traditional methods.” David Stein, CEO of Babson Diagnostics Launched in 2009, the Pharmacy Podcast Network reaches more than 80,000 listeners per month with audio content focused on the critical role pharmacists play in the healthcare industry. “I look forward to bringing exciting new content to my audience through this partnership with Babson Diagnostics,” Eury said. “The Total Store Expo is a one-of-a-kind opportunity to bring insights to pharmacists about new and innovative products and services in health and wellness, such as Babson’s blood-testing ecosystem.” About Babson Diagnostics Babson Diagnostics is a science-first healthcare technology company bringing convenient, medically accurate diagnostic blood testing to the local pharmacy. We are the first and only company to do broad blood panels from a capillary microsample, collected from a finger, at a retail setting. Our core technology was incubated at Siemens Healthineers ​in 2015, and we became Babson Diagnostics in 2017. We have exclusive partnerships with Siemens Healthineers and BD (Becton, Dickinson and Company), two global leaders in healthcare innovation and medical technology. Together we are reimagining the entire blood testing process, helping people get the care they need, when they need it. Babson, based in Austin, Texas, is named in honor of Art Babson, whose legacy of scientific innovation and excellence is the foundation on which the company is built. About Pharmacy Podcast Network Pharmacy Podcast Nation is the flagship show hosting all of the Pharmacy Podcast Network 1400+ episodes. With more than 30 different podcast programs and some 40 different co-hosts helping to develop audio content about the pharmacy sector, its reach includes communities, hospitals, senior-care residences, military and public health settings that meet the information needs of 300,000 pharmacists with more than 100,000 monthly listeners. PPN also delivers a unique publication called Rx Influencer to all healthcare professionals with a specific focus on pharmacy.

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BUSINESS INSIGHTS

FDA Accepts Dupixent® (dupilumab) for Priority Review in Adults with Prurigo Nodularis

Regeneron Pharmaceuticals, Inc. | May 31, 2022

Regeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® Medical (dupilumab) to treat adults with prurigo nodularis, a chronic skin disease that causes extreme itch and inflammatory skin lesions. The target action date for the FDA decision is September 30, 2022. The sBLA is supported by data from two pivotal Phase 3 trials evaluating the efficacy and safety of Dupixent in patients 18 years and older with prurigo nodularis Both trials met the primary and key secondary endpoints, showing Dupixent significantly improved disease signs and symptoms compared to placebo, including reduction in itch and skin lesions. The safety results from these trials were generally consistent with the known safety profile of Dupixent in its approved dermatology indications. The adverse event more commonly observed with Dupixent was conjunctivitis. The FDA grants Priority Review to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. Additional regulatory filings around the world are also planned in 2022.The potential use of Dupixent in prurigo nodularis is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority. About Prurigo Nodularis People with prurigo nodularis experience intense, persistent itch, with thick skin lesions (called nodules) that can cover most of the body. Prurigo nodularis is often described as painful with burning, stinging and tingling of the skin. The impact of uncontrolled prurigo nodularis on quality of life is one of the highest among inflammatory skin diseases due to the extreme itch and is comparable to other debilitating chronic diseases that can negatively affect mental health, activities of daily living and social interactions. High-potency topical steroids are commonly prescribed but are associated with safety risks if used long-term. There are approximately 75,000 people in the U.S. who are unable to control their disease with systemic therapy and are most in need of a treatment option. About Dupixent Dupixent, which was invented using Regeneron's proprietary VelocImmune® technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent such as asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyposis (CRSwNP) and eosinophilic esophagitis, as well as investigational diseases such as prurigo nodularis. Dupixent is approved for use in certain patients with atopic dermatitis, asthma, CRSwNP or eosinophilic esophagitis in different age populations in a number of countries around the world. Dupixent is currently approved across these indications in the U.S. and for one or more of these indications in the European Union and Japan and more than 60 countries. More than 400,000 patients have been treated with Dupixent globally. About Regeneron's VelocImmune Technology Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately one in five of all original, FDA-approved or authorized fully human monoclonal antibodies currently available. This includes Dupixent, REGEN-COV® (casirivimab and imdevimab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb) and Inmazeb™. Dupilumab Development Program Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. To date, dupilumab has been studied across 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.

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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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BUSINESS INSIGHTS

Verizon Business Selected to Transform Astellas Pharma’s Global Network Infrastructure

Verizon Sourcing LLC | August 10, 2022

Verizon Business has been selected to manage Astellas Pharma Inc’s global network infrastructure. The network transformation will enable Astellas to harness advanced technologies to help reduce drug development timelines, healthcare costs and drive new revenue opportunities for the Japanese pharmaceutical multinational. Headquartered in Tokyo, Japan, Astellas is a global pharmaceutical company involved in the research, development, manufacture, and marketing of innovative new drugs under the vision of “Stand on the forefront of healthcare change to turn innovative science into VALUE for patients”. The company employs 14,000 employees worldwide. The company has identified digital transformation as a key driver of its business growth and began the search for a global partner to transform all aspects of its global technology infrastructure including building, designing and executing a next-generation secure network. In particular, Astellas was looking for a scalable and predictable platform that could seamlessly manage tens of thousands of devices and endpoints across Astellas’ 70+ global locations across a virtualized multi-sourced environment. Verizon’s relationship with Astellas stretches back more than a decade. In 2016, Astellas successfully deployed Verizon’s Secure Cloud Interconnect solution to provide a high-bandwidth secure connection to its Amazon Web Services and Microsoft Azure cloud services. Verizon’s current remit includes the build and deployment of Astellas’ global integrated network with a full suite of managed services, including Managed Wide Area Network, Local Area Network, Managed Security Services Secure Gateway, Zero Trust Network Access and Unified Communications and Collaboration as a Service. “From R&D to sales, we are seeing enormous amounts of data and intelligence flow through our business, across our 70 locations around the world. We want to ensure that we have a future-proof network in order to utilize cutting-edge technologies such as Artificial Intelligence, machine learning and robotics to make data-driven decisions to deliver better value for our patients. Our network transformation will underpin the next phase of our growth.” Shinya Suda, Senior Vice President, Information Systems, Astellas “The network is transformative in its ability to enable innovation and growth and Astellas is changing the way they are using the tools at their disposal to completely revolutionize their business. This is truly a watershed moment for the pharmaceutical industry as companies grapple with the pressures of reducing time and costs for the development of drugs while improving patient care and value. We’re proud to have been a part of Astellas’ growth journey for more than a decade,” said Robert Le Busque, Regional Vice-President, Verizon Business Group, Asia Pacific. Today’s announcement builds on the company’s network-as-a-service foundation and supports its private networks, mobile edge compute and business solutions vectors of growth. Verizon Communications Inc. was formed on June 30, 2000 and is one of the world’s leading providers of technology and communications services. Headquartered in New York City and with a presence around the world, Verizon generated revenues of $133.6 billion in 2021. The company offers data, video and voice services and solutions on its award-winning networks and platforms, delivering on customers’ demand for mobility, reliable network connectivity, security and control. VERIZON’S ONLINE MEDIA CENTER News releases, stories, media contacts and other resources are available at verizon.com/news. News releases are also available through an RSS feed.

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Spotlight

Tissue pathology is at the core of various aspects of the pharmaceutic pipeline. Digital pathology is a technology that converts glass microscope slides with tissue samples into whole slide digital images, which can be used to identify, quantify, and document key characteristics of tissue samples. This opens up a new world of applications that can potentially improve and accelerate pharmaceutic development.

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