AZ to accelerate drug discovery with BenevolentAI partnership

pharmatimes | April 30, 2019

AstraZeneca has announced a collaboration with Benevolent AI in order to use machine learning and artificial intelligence (AI) to discover potential new drugs for chronic kidney disease and idiopathic pulmonary fibrosis.The two companies will create a team of scientists that will work side-by-side to combine AstraZeneca’s genomics, chemistry and clinical data with BenevolentAI’s target identification platform and biomedical knowledge graph – a network of contextualised scientific data such as genes, proteins, diseases and compounds, and the relationship between them. Benevolent AI’s machine learning capabilities systematically analyses data to find connections between facts, and AI-based reasoning is used to extrapolate previously unknown connections. The companies will use the technology to interpret the results to understand the underlying mechanisms of these complex diseases and more quickly identify new potential drug targets.

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Identifying safe and effective immunotherapy based combinations is one of the biggest challenges facing cancer researchers today. Testing every possible combination isn’t practical as it would require hundreds of individual studies. Here at Roche, we saw this as an opportunity to rethink the way we approach clinical studies.


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PHARMACY MARKET

medical leverage, a communications company positions itself for 2022 growth

medical leverage | January 15, 2022

medical leverage, a communications company is pleased to announce the promotion of Justin Reed to VP of Finance, Alexandra Rivers to HR and Training Manager, and Janeanne Josephson to Associate Marketing Manager. These changes drive the company's mission to meet the challenges of today's unique market. With the additional hiring of several project managers to the team, ml is positioning itself well for growth in 2022. These promotions are all important shifts in responsibility that will ensure ml's service levels are enhanced during its expansion efforts. "Our 2022 expansion efforts started at the stroke of midnight on the new year, thus spring-boarding our talent acquisition initiatives. We continue to attract top-notch thinkers and doers by focusing on creating a culture where we offer improved operations, continued staff training, and product enhancements to best serve our current and future clients. As always, our expansion approach is guided by our core values and steered by our Executive Leadership Team." medical leverage's president, Dave Oury ABOUT medical leverage is a medical communications company that provides full-service solutions to pharmaceutical, biotech, biopharmaceutical, medical device, and medical diagnostic companies. We elevate healthcare communications through education by partnering strategically with life science companies and providers. For over twenty years, we have had the distinct honor of working with marketing, medical affairs, sales training, and market access teams within US and international companies. We know that behind every program there is a product and behind every healthcare professional there is a patient. We focus on our clients, so they can focus on healthcare professionals and, ultimately, their patients.

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BUSINESS INSIGHTS

Vivera Enters $23 Billion Telehealth Industry with Patent Allowance for MDZone

Vivera Pharmaceuticals, Inc. | April 25, 2022

Vivera Pharmaceuticals, Inc. is pleased to announce that it has received a Notice of Allowance for U.S. Patent Application No. 17/066,985 entitled, "Self-Contained, Portable, Sanitization Device and Telemedicine Station," for the Company's MDZone platform from the United States Patent and Trademark Office. This Notice of Allowance indicates that the patent application has passed its examination for issuance. MDZone will be a HIPAA compliant, portable telemedicine station that will allow patients to access health care and connect with a medical provider remotely. Broadly patented for multiple points of utilization, MDZone will make health care more affordable and accessible than ever for communities across the country. Telehealth services and technology are often more convenient in terms of both scheduling and transportation than in-office visits and have been instrumental in improving access to medical care for many patients. Patients who can benefit from telehealth include those with mobility limitations or other challenges that can make it difficult to attend in-person doctor visits. Virtual care has also been considered a tool to increase accessibility to health care in rural communities where physician shortages are more prevalent. The COVID-19 pandemic accelerated the use of telehealth for various appointment types, including general wellness and preventative care, medication management, and pre-visit lab orders. Lockdowns, social distancing, hospitals at capacity, and delayed surgeries and routine preventative care visits have contributed to a current surge in serious illnesses and even an increased incidence of death from medical complications that could have been prevented. While telehealth won't completely replace in-office appointments, it is helping a health care system, stretched thin on everything from beds to staffing to heightened costs, with a more streamlined and effective touchpoint to provide patients with enhanced access to medical care. "The pandemic prompted a shift in the rapid adoption of telehealth services worldwide. A number of serious illnesses and even deaths could have been prevented if we had technology like MDZone available from the beginning of the pandemic to provide quality care to patients from the comfort of their homes, schools, or offices. Many people developed new medical conditions or experienced worsening of existing ones, and their suffering could have been prevented if we had the right systems in place." Paul Edalat, CEO of Vivera MDZone is designed to be a complete turn-key solution for health screenings. It can measure a patient's biometric data, including heart rate, blood pressure, and blood glucose, and allow the medical provider to provide interactive medical evaluation and feedback. If the measured values were outside of recommended ranges, the patient would be provided with a treatment plan, which could include dietary change suggestions, a prescription for medication, a lab order, or a recommendation for an in-person. "MDZone will give people access to health care as often as they need it without having to visit a doctor's office," said Vivera's Chief Medical Officer, Stephen J. McColgan, M.D., M.B.A. "In turn, they will be able to make real-time decisions about their treatment plan, translating to better patient outcomes." Even with patients returning to in-person doctor's office visits, the need for telehealth services is expected to continue increasing. In 2021, the U.S. telehealth market size was valued at $23.5 billion and is expected to expand at a compound annual growth rate (CAGR) of 44.4% from 2022 to 2028. In addition to making health care more accessible, MDZone will also make it more affordable. Vivera's technology can be life-changing for low-income communities and schools with limited resources. Many schools don't have a full-time on-site nurse. By utilizing the telemedicine station to conduct student health screenings, MDZone may eliminate the need to see a nurse in some instances while still providing quality care. Vivera maintains a solid intellectual property strategy with six patents granted and 26 patents pending. Receiving its patent for MDZone as a self-contained, portable telemedicine station will strengthen and expand the Company's patient-centric patent portfolio. About Vivera Pharmaceuticals Vivera Pharmaceuticals is an innovative, science-driven pharmaceutical company located in Southern California. The Company has global exclusivity to license the patented and patent-pending TABMELT® sublingual drug delivery system for pharmaceutical use and holds its own issued patents on ZICOH®, a smart dose-controlled medical device. It also has patents pending on its telemedicine station, MDZone. With multiple divisions, including its pharmaceutical, neurosciences, medical technology, biosciences, and advanced diagnostics divisions, Vivera Pharmaceuticals is vertically integrated with patented technology, manufacturing capabilities, and distribution for its products.

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BUSINESS INSIGHTS

Jazz Pharmaceuticals Announces Agreement to Divest Sunosi® (solriamfetol) to Axsome Therapeutics

Jazz Pharmaceuticals plc | March 28, 2022

Jazz Pharmaceuticals plc announced that it has entered into a definitive agreement to divest Sunosi® a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea to Axsome Therapeutics. Under the terms of the agreement, Axsome will receive the rights to Sunosi in all of the existing territories available to Jazz. Jazz will receive attractive financial terms including an upfront payment of $53 million, a high single-digit royalty on Axsome's U.S. net sales of Sunosi in current indications and a mid-single-digit royalty on Axsome's U.S. net sales of Sunosi in future indications. The divestiture of Sunosi to Axsome will enable Jazz to sharpen its focus on its highest strategic priorities designed to deliver sustainable growth and enhanced shareholder value. In assessing the positioning of Sunosi in the overall treatment landscape, Jazz determined Axsome would be well positioned to deliver access to this important medication and to maximize the value of Sunosi to Jazz through future growth. Sunosi's consistent positive feedback from patients, HCPs and providers is underscored by its well-established and clinically meaningful efficacy. Importantly, Jazz and Axsome are committed to ensuring that patients receive uninterrupted access to Sunosi throughout the transition. Wake-promoting agents are most often prescribed by psychiatrists, neurologists and general practitioners. Therefore, Jazz believes Axsome is well placed to leverage its commercial business, which will have highly complementary call points, to drive Sunosi as one of the lead products in their portfolio and ensure Sunosi can continue to reach those patients who may benefit from this important medicine. "This transaction advances our efforts to deliver sustainable growth, enhanced shareholder value and drive the transformation of Jazz to an innovative, global biopharmaceutical leader. Jazz will continue to be laser-focused on investing in our highest strategic priorities including our ongoing launches, advancing our pipeline, pursuing opportunistic corporate development and achieving margin expansion. Through our development and launch of Sunosi, the Jazz team has laid the foundation for Axsome to continue supporting people who may benefit from this much-needed treatment. As a leader in sleep medicine and rare epilepsies, with a growing oncology franchise, Jazz remains committed to developing new, innovative therapies in neuroscience and oncology for patients and delivering on our recently announced Vision 2025." Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals "We are impressed by the clinically meaningful efficacy, unique mechanism of action, positive patient and physician feedback and growth potential of Sunosi, and are excited by the excellent strategic fit with the Axsome portfolio. The addition of Sunosi will augment and accelerate our commercial preparedness ahead of the potential near-term launches of our two existing lead assets and allows us to fully leverage our first-in-class Digital Centric Commercialization™ platform with three complimentary assets," said Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics. Sunosi is a dopamine and norepinephrine reuptake inhibitor indicated for the treatment of excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) in adult patients. Sunosi is the first DNRI approved to treat EDS in adults living with narcolepsy or OSA. About Sunosi® Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea (OSA). Sunosi received U.S. Food and Drug Administration approval on March 20, 2019, to improve wakefulness in adult patients with EDS associated with narcolepsy or OSA and was designated a Schedule IV medicine by the U.S. Drug Enforcement Agency on June 17, 2019. In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize solriamfetol from Aerial Biopharma LLC. Jazz Pharmaceuticals has worldwide development, manufacturing, and commercialization rights to solriamfetol, excluding certain jurisdictions in Asia. SK Biopharmaceuticals Co., Ltd., the discoverer of the compound, maintains rights in 12 Asian markets, including Korea, China and Japan. Sunosi has orphan drug designation for narcolepsy in the United States. About Jazz Pharmaceuticals Jazz Pharmaceuticals plc is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases – often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. Within these therapeutic areas, we are identifying new options for patients by actively exploring small molecules and biologics, and through innovative delivery technologies and cannabinoid science. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries.

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PHARMA TECH

Calyx Named Medical Imaging Provider by Clinscience

Calyx | June 10, 2022

Calyx, the eClinical and Regulatory solutions and services provider relied on for solving complex data challenges in clinical research, announced it has been named an approved provider of centralized medical imaging services by Clinscience, a full service CRO offering smart, end-to-end clinical trial services to the global pharmaceutical industry. "Calyx's commitment to reliably solving the complex aligns with our focus on designing integrated, smart solutions that are tailored to our customers' needs. Clinscience and Calyx are both motivated to help global clinical trial sponsors achieve their clinical development objectives in an agile, expeditious, and smart way." Megan O'Keefe, Chief Commercial Officer at Clinscience "The Clinscience team understands what's important to pharmaceutical and biotech organizations," said Elizabeth Dalton, Vice President, Channel Partnerships Solutions, Calyx. "We're honored to work with Clinscience and to deliver the reliable imaging services their customers need to accelerate and optimize their clinical trials." Clinscience joins a long list of global pharmaceutical companies and CROs who repeatedly leverage Calyx's scientific expertise and experience to assess the safety, efficacy, and effectiveness of their compounds. To date, Calyx Medical Imaging has been used in over 2,600 clinical trials worldwide and has supported the approvals of over 270 medical treatments across a broad range of therapeutic areas. About Calyx Through innovative eClinical and Regulatory solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably. With deep expertise in clinical development and 30 years supporting trial sponsors and clinical research organizations, Calyx harnesses its intelligence and experience to solve complex problems, deliver fast insights, and get new drugs to market every day. About Clinscience Clinscience is a global CRO company offering smart CRO Services, from protocol creation to final study report development. The Company has offices in Poland, Spain, Italy, Germany, and the US and provides its services in 6 European countries. More than 150 Biotechnology companies across Europe and the US trust the Clinscience brand. The Company's procedures and Data-driven approach, harnessed with the Genius Suite™ technology, work together to give the Clients power and flexibility to address even the most unique needs. Clinscience is part of a publicly-traded parent company, Neuca Plc, an organization in the pharmaceutical wholesaling and healthcare industry that provides the structure to meet the needs of commercial and non-commercial studies.

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Spotlight

Identifying safe and effective immunotherapy based combinations is one of the biggest challenges facing cancer researchers today. Testing every possible combination isn’t practical as it would require hundreds of individual studies. Here at Roche, we saw this as an opportunity to rethink the way we approach clinical studies.

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