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Feds rebuff Pfizer's pleas to speed up supplies of COVID-19 vaccine raw materials

Pfizer | December 21, 2020

Since the time Pfizer was fixed to partake in the U.S. government's Warp Speed exertion to get COVID-19 antibodies to showcase, the organization has made it very clear it didn't have to take any bureaucratic cash to build up the immunization.

In any case, did that refusal of R&D subsidizing add to Pfizer's failure to produce more dosages of its mRNA antibody for the U.S. market?

Pfizer could give more than the 100 million portions it guaranteed in its unique agreement with the U.S. government in the main portion of one year from now—however just if Trump organization authorities request that providers of crude materials rapidly satisfy the organization's requests. Furthermore, CEO Albert Bourla, Ph.D., is approaching the public authority to utilize the Defense Production Act to do precisely that.

The Trump organization hasn't done as such yet on the grounds that they've zeroed in on giving those materials to antibody producers that took government R&D subsidizing, as Moderna, as indicated by anonymous sources who addressed The New York Times.

A representative for Pfizer declined to remark, refering to the privacy of conversations with the U.S. government. Yet, Bourla said during a CNBC meet that the organization is in exchanges to sell an extra 100 million dosages of Pfizer's COVID-19 immunization to the U.S. government.

"We can give a ton of that in the second from last quarter. The U.S. government needs it in the subsequent quarter," Bourla said in the Monday meet. "We are working cooperatively to attempt to discover an answer and have the option to apportion those 100 million [doses] in the subsequent quarter if conceivable, or a ton of them."

Pfizer mentioned almost immediately that the public authority grant it "supported status" with providers of crude materials, however authorities were anxious about the possibility that that would harm contending immunization programs that took government R&D cash, as per the Times report. Among those organizations is Moderna, which is required to win crisis use approval from the FDA for its mRNA immunization this week—and last Friday, inked an arrangement to add 100 million additional portions to its underlying U.S. request.

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XtalPi Announces Collaboration with Lilly, Using AI + Robotics to Uncover First-in-class Therapeutics

PRNewswire | May 31, 2023

Today, XtalPi Inc., a pioneering pharmaceutical technology company powered by artificial intelligence (AI) and automation, announced an AI drug discovery collaboration of up to $250 million in upfront and milestone payments with Eli Lilly and Company. The collaboration will leverage XtalPi's integrated AI capabilities and robotics platform to de novo design and deliver drug candidates for an undisclosed target. XtalPi has established itself as an industry leader in combining mutually informative AI "dry lab" algorithms with large-scale "wet lab" robotics to empower pharmaceutical innovation. Building upon existing success, XtalPi will work closely with the Lilly team to harness the power of its proven one-stop AI drug discovery solution to deliver a novel compound, which Lilly will pursue in clinical and commercial development. XtalPi's ID4Inno™ small-molecule drug discovery platform touts a tightly interwoven trifecta of AI, autonomous labs, and expert domain knowledge that can generate and investigate a target-specific mega chemical space and quickly zero in on the most promising lead series. Each group of synthesized molecules is tested using XtalPi's internal biochemical, cellular, pharmacodynamic, and pharmacokinetic assay capabilities, feeding project-specific R&D data into generative AI models in iterative design-make-test-analyze cycles until a candidate with optimal drug properties emerges. XtalPi's fleet of hundreds of autonomous robotic workstations can carry out precise and energy-efficient parallel chemical synthesis and assays 24/7. This high-quality real-world data generated with speed and at scale, combined with over 500 AI models and quantum physics algorithms, continuously enhance XtalPi's capability to predict and authenticate novel drug candidates with greatly accelerated timeframes and reduced experimental costs. XtalPi's AI + robotics platform is supercharging the shift of pharmaceutical R&D from labor-intensive trial-and-error research to a computation and automation-intensive model, empowering scientists to achieve more with less. Serving over 200 pharmaceutical clients and research institutions from around the world, XtalPi is now bringing its proprietary autonomous lab to Cambridge, MA as its drug discovery business continues to grow. Dr. Jian Ma, CEO of XtalPi, says, "With a closed loop of AI and quantum physics algorithms working in sync with the data factory of large-scale robotics experiments, XtalPi is uniquely equipped to tackle challenging novel targets. We are honored that Lilly has chosen XtalPi's AI + robotics drug R&D platform as a partner in achieving more fruitful pharmaceutical innovation and bringing much-needed treatments to patients worldwide." About XtalPi XtalPi is a pharmaceutical technology company powered by AI and robotics to improve the speed, scale, novelty, and success rate of drug discovery and development. With operations in both China and the U.S., XtalPi has pioneered a new model for drug R&D that leverages a tightly interwoven trifecta of AI, autonomous labs, and expert domain knowledge. Its integrated AI "dry lab" and large-scale robotics "wet lab" capabilities form an iterative feedback loop that empowers continuous innovation to address the unmet needs of patients worldwide.

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Cerner Enviza Collaborates with FDA to Develop Innovative AI Tools for Drug Safety and Real-World Evidence Studies

prnewswire | April 11, 2023

Cerner Enviza, an Oracle company, along with John Snow Labs, are now helping support the U.S. Food and Drug Administration's drug safety Sentinel Initiative. By developing artificial intelligence (AI) tools aimed at extracting critical information from clinical notes within electronic health records (EHR), Oracle and John Snow will aid the FDA in better understanding the effects of medicines on large populations. Looking at the asthma drug, montelukast, and its possibility of mental health side effects, this two-year project will demonstrate how the use of machine learning and natural language processing (NLP) technology with unstructured data may help fill gaps in knowledge. Cerner Enviza leverages decades of life sciences expertise spanning commercial, real world, clinical and regulatory research. This includes working with a broad range of Oracle provider networks to help accelerate the discovery, development, and deployment of health insights and therapies. John Snow Labs is known for its AI and NLP in healthcare and is the developer of the Spark NLP library. Together, Cerner Enviza and John Snow Labs will develop a new methodology to enhance computerized queries, or phenotyping, of digital patient data and clinical notes to support pharmacoepidemiology. Cerner Enviza, who will lead the team, was chosen by the Sentinel Innovation Center, who is headed by Mass General Brigham and Harvard Pilgrim Health Care Institute. "Development and evaluation of tools that can enhance our ability to utilize unstructured EHR data is a key strategic priority for the Sentinel Innovation Center. We look forward to this new relationship and exciting initiative led by Cerner Enviza," said Rishi Desai, Ph.D., Mass General Brigham executive leadership team member, Sentinel Innovation Center. Traditional manual methods for analyzing clinician notes often can be a bottleneck for fully understanding the symptoms and outcomes that patients experience at the population level. However, advances in AI offer a scalable and transportable NLP processes. "This is an incredible opportunity to work with these exceptional leaders to use Oracle's de-identified EHR data to help transform unstructured clinical notes into validated and useable data for physicians and researchers," said Mike Kelly, global head, Cerner Enviza. "Connected technologies and unified data can accelerate innovation and, in turn, help providers realize better recommendations and outcomes for their patients." "We are thrilled to team with Cerner Enviza to apply NLP in such an important real-world evidence project," said David Talby, CTO, John Snow Labs. "We're honored by the Sentinel Innovation Center's vote of confidence in our joint ability to help investigate this use case. Together, Cerner Enviza and John Snow Labs have all the right expertise, data, and technology to make it happen." The project known as the Multi-source Observational Safety Study for Advanced Information Classification Using NLP (MOSAIC-NLP) is also supported by the participation of Children's Hospital of Orange County, National Jewish Health, and Kaiser Permanente Washington Health Research Institute who will provide clinical expertise and consulting. About John Snow Labs John Snow Labs is an AI and NLP company that provides software, models, and data to help healthcare and life science organizations put AI to good use. The company is the developer of Spark NLP and host of the NLP Summit.

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Asieris Deepens Strategic Partnership with UroViu to Further Develop Integrated Diagnosis and Treatment Platform for Bladder Cancer

PRNewswire | May 19, 2023

Asieris Pharmaceuticals a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, announced a strategic collaboration with UroViu Corporation ("UroViu"). Asieris Pharmaceuticals will obtain exclusive global rights to UroViu's patented technology of portable single-use cystoscope in the field of fluorescent imaging. Under the agreement, Asieris Pharmaceuticals will use this patented technology in combination with specific optical imaging agents to conduct research on the application of non-white light imaging technology in the diagnosis and postoperative monitoring of None-Muscle Invasive Bladder Cancer (NMBC). At the same time, Asieris Pharmaceuticals will be responsible for the global commercialization of the sterile single-use fluorescent Cystoscope. Previously, Asieris Pharmaceuticals entered a cooperation agreement with UroViu in 2021 for the exclusive registration and commercialization rights of its portable single-use flexible white light cystoscopy system in mainland China, Taiwan, Hong Kong and Macau. "There is still a huge unmet need for more accessible and safer fluorescent cystoscopy in the diagnosis and surveillance of bladder cancer."Dr. Susan Wang, Senior Vice President of Global Business Development & Strategic Partnership of Asieris said, "We are thrilled to deepen and expand our collaboration with UroViu which enabling us not only to broaden our technology portfolio, but also to expedite the implementation of Asieris' integrated strategy for bladder cancer diagnosis and treatment, aiming to provide more effective disease management options for bladder cancer patients." "We are excited about the possibilities that our expanded Partnership with Asieris will create. Our unique and expanding portfolio of single use endoscopic products are fulfilling UroViu's promise to greatly improve both the patient and provider experience, elevate the standard of care in a field with rapidly advancing technologies," said Bruce OuYang, Founder and CEO of UroViu. About Asieris Asieris Pharmaceuticals founded in March 2010, is a global biopharma company specializing in the discovery, development and commercialization of innovative drugs that treat genitourinary tumors and other related diseases. We strive to improve human health and help people live a more dignified life. We aim to become a global pharma leader that integrates R&D, manufacturing, and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide. The company has been developing its proprietary R&D platform and core technologies, exploring new mechanisms of action, and efficiently screening and evaluating drug candidates. With a well-established in-house R&D system and expertise in global drug development, Asieris is committed to launching first-in-class drugs and other innovative products to address huge unmet needs in its areas of focus. Asieris is also enhancing its pipeline for genitourinary diseases via proprietary R&D and strategic partnerships, while closely following cutting-edge technologies and therapeutics. The company strives to discover and identify unmet medical needs, and adopts a forward-looking approach in product planning and life-cycle management. We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally.

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PHARMA TECH

XtalPi Announces Collaboration with Lilly, Using AI + Robotics to Uncover First-in-class Therapeutics

PRNewswire | May 31, 2023

Today, XtalPi Inc., a pioneering pharmaceutical technology company powered by artificial intelligence (AI) and automation, announced an AI drug discovery collaboration of up to $250 million in upfront and milestone payments with Eli Lilly and Company. The collaboration will leverage XtalPi's integrated AI capabilities and robotics platform to de novo design and deliver drug candidates for an undisclosed target. XtalPi has established itself as an industry leader in combining mutually informative AI "dry lab" algorithms with large-scale "wet lab" robotics to empower pharmaceutical innovation. Building upon existing success, XtalPi will work closely with the Lilly team to harness the power of its proven one-stop AI drug discovery solution to deliver a novel compound, which Lilly will pursue in clinical and commercial development. XtalPi's ID4Inno™ small-molecule drug discovery platform touts a tightly interwoven trifecta of AI, autonomous labs, and expert domain knowledge that can generate and investigate a target-specific mega chemical space and quickly zero in on the most promising lead series. Each group of synthesized molecules is tested using XtalPi's internal biochemical, cellular, pharmacodynamic, and pharmacokinetic assay capabilities, feeding project-specific R&D data into generative AI models in iterative design-make-test-analyze cycles until a candidate with optimal drug properties emerges. XtalPi's fleet of hundreds of autonomous robotic workstations can carry out precise and energy-efficient parallel chemical synthesis and assays 24/7. This high-quality real-world data generated with speed and at scale, combined with over 500 AI models and quantum physics algorithms, continuously enhance XtalPi's capability to predict and authenticate novel drug candidates with greatly accelerated timeframes and reduced experimental costs. XtalPi's AI + robotics platform is supercharging the shift of pharmaceutical R&D from labor-intensive trial-and-error research to a computation and automation-intensive model, empowering scientists to achieve more with less. Serving over 200 pharmaceutical clients and research institutions from around the world, XtalPi is now bringing its proprietary autonomous lab to Cambridge, MA as its drug discovery business continues to grow. Dr. Jian Ma, CEO of XtalPi, says, "With a closed loop of AI and quantum physics algorithms working in sync with the data factory of large-scale robotics experiments, XtalPi is uniquely equipped to tackle challenging novel targets. We are honored that Lilly has chosen XtalPi's AI + robotics drug R&D platform as a partner in achieving more fruitful pharmaceutical innovation and bringing much-needed treatments to patients worldwide." About XtalPi XtalPi is a pharmaceutical technology company powered by AI and robotics to improve the speed, scale, novelty, and success rate of drug discovery and development. With operations in both China and the U.S., XtalPi has pioneered a new model for drug R&D that leverages a tightly interwoven trifecta of AI, autonomous labs, and expert domain knowledge. Its integrated AI "dry lab" and large-scale robotics "wet lab" capabilities form an iterative feedback loop that empowers continuous innovation to address the unmet needs of patients worldwide.

Read More

BUSINESS INSIGHTS, PHARMA TECH

Cerner Enviza Collaborates with FDA to Develop Innovative AI Tools for Drug Safety and Real-World Evidence Studies

prnewswire | April 11, 2023

Cerner Enviza, an Oracle company, along with John Snow Labs, are now helping support the U.S. Food and Drug Administration's drug safety Sentinel Initiative. By developing artificial intelligence (AI) tools aimed at extracting critical information from clinical notes within electronic health records (EHR), Oracle and John Snow will aid the FDA in better understanding the effects of medicines on large populations. Looking at the asthma drug, montelukast, and its possibility of mental health side effects, this two-year project will demonstrate how the use of machine learning and natural language processing (NLP) technology with unstructured data may help fill gaps in knowledge. Cerner Enviza leverages decades of life sciences expertise spanning commercial, real world, clinical and regulatory research. This includes working with a broad range of Oracle provider networks to help accelerate the discovery, development, and deployment of health insights and therapies. John Snow Labs is known for its AI and NLP in healthcare and is the developer of the Spark NLP library. Together, Cerner Enviza and John Snow Labs will develop a new methodology to enhance computerized queries, or phenotyping, of digital patient data and clinical notes to support pharmacoepidemiology. Cerner Enviza, who will lead the team, was chosen by the Sentinel Innovation Center, who is headed by Mass General Brigham and Harvard Pilgrim Health Care Institute. "Development and evaluation of tools that can enhance our ability to utilize unstructured EHR data is a key strategic priority for the Sentinel Innovation Center. We look forward to this new relationship and exciting initiative led by Cerner Enviza," said Rishi Desai, Ph.D., Mass General Brigham executive leadership team member, Sentinel Innovation Center. Traditional manual methods for analyzing clinician notes often can be a bottleneck for fully understanding the symptoms and outcomes that patients experience at the population level. However, advances in AI offer a scalable and transportable NLP processes. "This is an incredible opportunity to work with these exceptional leaders to use Oracle's de-identified EHR data to help transform unstructured clinical notes into validated and useable data for physicians and researchers," said Mike Kelly, global head, Cerner Enviza. "Connected technologies and unified data can accelerate innovation and, in turn, help providers realize better recommendations and outcomes for their patients." "We are thrilled to team with Cerner Enviza to apply NLP in such an important real-world evidence project," said David Talby, CTO, John Snow Labs. "We're honored by the Sentinel Innovation Center's vote of confidence in our joint ability to help investigate this use case. Together, Cerner Enviza and John Snow Labs have all the right expertise, data, and technology to make it happen." The project known as the Multi-source Observational Safety Study for Advanced Information Classification Using NLP (MOSAIC-NLP) is also supported by the participation of Children's Hospital of Orange County, National Jewish Health, and Kaiser Permanente Washington Health Research Institute who will provide clinical expertise and consulting. About John Snow Labs John Snow Labs is an AI and NLP company that provides software, models, and data to help healthcare and life science organizations put AI to good use. The company is the developer of Spark NLP and host of the NLP Summit.

Read More

PHARMACY MARKET

Asieris Deepens Strategic Partnership with UroViu to Further Develop Integrated Diagnosis and Treatment Platform for Bladder Cancer

PRNewswire | May 19, 2023

Asieris Pharmaceuticals a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, announced a strategic collaboration with UroViu Corporation ("UroViu"). Asieris Pharmaceuticals will obtain exclusive global rights to UroViu's patented technology of portable single-use cystoscope in the field of fluorescent imaging. Under the agreement, Asieris Pharmaceuticals will use this patented technology in combination with specific optical imaging agents to conduct research on the application of non-white light imaging technology in the diagnosis and postoperative monitoring of None-Muscle Invasive Bladder Cancer (NMBC). At the same time, Asieris Pharmaceuticals will be responsible for the global commercialization of the sterile single-use fluorescent Cystoscope. Previously, Asieris Pharmaceuticals entered a cooperation agreement with UroViu in 2021 for the exclusive registration and commercialization rights of its portable single-use flexible white light cystoscopy system in mainland China, Taiwan, Hong Kong and Macau. "There is still a huge unmet need for more accessible and safer fluorescent cystoscopy in the diagnosis and surveillance of bladder cancer."Dr. Susan Wang, Senior Vice President of Global Business Development & Strategic Partnership of Asieris said, "We are thrilled to deepen and expand our collaboration with UroViu which enabling us not only to broaden our technology portfolio, but also to expedite the implementation of Asieris' integrated strategy for bladder cancer diagnosis and treatment, aiming to provide more effective disease management options for bladder cancer patients." "We are excited about the possibilities that our expanded Partnership with Asieris will create. Our unique and expanding portfolio of single use endoscopic products are fulfilling UroViu's promise to greatly improve both the patient and provider experience, elevate the standard of care in a field with rapidly advancing technologies," said Bruce OuYang, Founder and CEO of UroViu. About Asieris Asieris Pharmaceuticals founded in March 2010, is a global biopharma company specializing in the discovery, development and commercialization of innovative drugs that treat genitourinary tumors and other related diseases. We strive to improve human health and help people live a more dignified life. We aim to become a global pharma leader that integrates R&D, manufacturing, and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide. The company has been developing its proprietary R&D platform and core technologies, exploring new mechanisms of action, and efficiently screening and evaluating drug candidates. With a well-established in-house R&D system and expertise in global drug development, Asieris is committed to launching first-in-class drugs and other innovative products to address huge unmet needs in its areas of focus. Asieris is also enhancing its pipeline for genitourinary diseases via proprietary R&D and strategic partnerships, while closely following cutting-edge technologies and therapeutics. The company strives to discover and identify unmet medical needs, and adopts a forward-looking approach in product planning and life-cycle management. We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally.

Read More

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