Novavax, advancing COVID-19 shot, recruits AstraZeneca exec as its chief medical officer

Fiercepharma | June 17, 2020

On the heels of some big fundraising moves and in the hunt for a COVID-19 vaccine, Novavax is adding some Big Pharma experience to its executive team.  Joining the company's leadership team as chief medical officer is Filip Dubovsky, an AstraZeneca veteran. Dubovsky joins Novavax directly from the British drugmaker, where he served as head of clinical engagement and policy, plus as chief medical officer for clinical affairs. Before that role, he oversaw a portfolio of more than two dozen malaria vaccines at the PATH Malaria Vaccine Initiative.  Dubrovsky will be tasked with overseeing development of the company's COVID-19 candidate. The company in late May kicked off a phase 1/2 study of the prospect, and it's been working through steps to scale up its manufacturing in parallel. Aside from its COVID-19 work, the company is getting ready to submit an FDA application for its flu vaccine, NanoFlu.

Spotlight

The fully realized vision of precision medicine includes the capability to rapidly diagnose, sequence and develop a personalized treatment plan based on combined analysis of genotype, phenotype, environmental, clinical and behavioral data. Precision medicine can be advanced through the “All of Us” research initiative of the Precision Medicine Initiative, the most ambitious accumulation of human genomic, personal health and clinical information in history; but accelerating precision medicine to achieve this vision will require new capabilities and speed in personal health, clinical and genomic data storage transfer and analysis, as well as in interoperability and security. Further, precision medicine will demand new private sector, legislative and regulatory approaches for review and approval of genomic sequencing technologies and other software and devices needed to advance knowledge of disease factors that demonstrate variability among individuals.


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Teva Reaches Agreement With Texas to Settle the State’s Opioid-Related Claims

Teva Pharmaceuticals | February 08, 2022

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. and its affiliates, has reached an agreement with the Attorney General (AG) of Texas that settles the state’s and its subdivisions opioid-related claims. Under the terms of the settlement, Teva will pay Texas $150 million over a 15-year time period and will provide the recently launched, lifesaving medicine generic Narcan®, valued at $75 million over 10 years. “Expanding access to lifesaving medicines is at the core of Teva’s mission. The Texas Attorney General is taking steps to address the opioid epidemic in the State by negotiating a settlement that includes critical medicines as part of their solution. While the settlement includes no admission of wrongdoing by Teva or its affiliates, it remains in the best interest of Teva to put these cases behind us and continue to focus on the patients we serve every day.” Kåre Schultz, Teva’s President and CEO Naloxone is a life-saving medication that can reverse an overdose from opioids.1 As of December 2021, Teva has made available the first generic version of this critical medicine and has included this product in the Company’s ongoing pursuit of a national or narrower settlement with individual states such as the deal announced today. The Company will continue to defend itself in court in states where we have not reached terms of a settlement agreement. Teva believes that today’s settlement with the state of Texas is a critical step forward in getting life-saving treatments to people suffering from opioid addiction. About Teva Teva Pharmaceutical Industries Ltd. has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products.

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Bruker Acquires Optimal Companies for Pharma PAT Software and Biopharma Manufacturing Automation Expertise and Technologies

Bruker Corporation | April 06, 2022

Bruker Corporation announced the acquisition of Optimal Industrial Automation and Technologies, a leader in pharma and biopharma process analytical technology pharma manufacturing automation and Quality Assurance (QA) software and systems integration, based in the United Kingdom. The Optimal biopharma tools acquisition strengthens Bruker as a key software and solutions provider for small molecule, biologics and new drug modalities pharma companies. Financial details of the acquisition were not disclosed. Optimal’s 2022 revenue is expected to be approximately $10 million, and Optimal’s revenue growth rate and operating margins are projected to be accretive to Bruker in 2023 and beyond. The Optimal biopharma tools and automation capabilities complement Bruker’s innovative and differentiated high-value NMR, mass spectrometry, SPR, molecular spectroscopy and X-ray scientific instruments, and life-science solutions for biopharma drug discovery and development, as well as for PAT analytical and QA solutions. Together these biopharma tools enable Bruker’s global biopharma customers to bring efficacious and safe medicines to market more quickly. Optimal has a focus on the automation and optimization of batch and continuous processes in the biopharma industry – from R&D to manufacturing. As an integrated PAT solutions provider, Optimal offers development, testing, deployment and support of quality-centric pharmaceutical production systems. Optimal has more than 30 years of experience in successfully delivering regulatory-compliant biopharma solutions, ranging from the development of automated control systems for process control to the market-leading, vendor-agnostic PAT knowledge management software synTQ®. The synTQ PAT software can interface between multiple analytical instruments (spectral and univariate), multi-variate analysis (MVA) packages, manufacturing control systems and a range of adjacent software solutions to ensure quality in real-time. As a 2021 Pharma Innovation Award winner, synTQ is a proven enabler of quality-by-design (QbD) via PAT. For users of synTQ, this can significantly increase productivity and quality, while reducing waste, time-to-manufacture and time-to-market, with proven Optimal use cases tripling biopharma productivity. While remaining a vendor-agnostic biopharma solutions provider, Optimal can integrate bioanalytical technologies such as nuclear magnetic resonance (NMR), mass spectrometry (MS) and FTIR/NIR/Raman systems into innovative drug discovery, development, PAT and quality control workflows. Combining next-generation, high-performance technologies with Optimal solutions eases the transition from development to biopharma manufacturing, while remaining in regulatory compliance. “The acquisition of Optimal is a very exciting step for Bruker as it supports more comprehensive solutions for the biopharmaceutical industry, now adding the capabilities to integrate cutting-edge systems into biopharma manufacturing processes and workflows. We welcome the Optimal team with their strong PAT and automation expertise and, together, are eager to support biotech and pharmaceutical companies in increasing their manufacturing efficiency and flexibility – a global need highlighted by the response to the pandemic crisis.” Dr. Falko Busse, President of the Bruker BioSpin Group Mr. Martin Gadsby, the CEO and Co-Founder of Optimal Industrial Automation and Technologies, added: “We are delighted to become part of the Bruker family. Optimal and Bruker together are a perfect fit – we share the common ethos of innovation with integrity, together with our industry recognition as a high-quality solutions provider delivering tangible benefits to our customers. The whole Optimal team is excited by this new chapter in our history and looks forward to delivering benefits to even more biopharma customers and ultimately to patients around the world.” About Optimal Industrial Technologies and Automation A well-established system integrator with more than 30 years of experience, at Optimal we specialize in automating a client’s R&D or manufacturing system to ensure that their processes remain at the highest level of efficiency. The demands being placed on manufacturers in relation to production costs, product quality and business sustainability are ever increasing, and our primary aim within Optimal is to assist you in being the most competitive supplier of your product to the highest level of quality in the worldwide marketplace, and to ensure that you continue to maintain your lead in the years ahead. We have a rare and wide-ranging skill set covering a multitude of automation technologies, manufacturing processes and industry types, with very specific knowledge in highly regulated environments. In addition, we manufacture the world leading PAT Data Management software package - synTQ® and the widely used integrated Print and Inspect system - synTI®. The combination of our PAT implementation knowledge and synTQ® product together with our automation experience positions us with unique skills that can be leveraged to great advantage by our customers. About Bruker Corporation Bruker is enabling scientists to make breakthrough discoveries and develop new applications that improve the quality of human life. Bruker’s high-performance scientific instruments and high-value analytical and diagnostic solutions enable scientists to explore life and materials at molecular, cellular and microscopic levels. In close cooperation with our customers, Bruker is enabling innovation, improved productivity and customer success in life science molecular research, in applied and pharma applications, in microscopy and nanoanalysis, and in industrial applications, as well as in cell biology, preclinical imaging, clinical phenomics and proteomics research and clinical microbiology.

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Elligo Health Research® Partners With Peoples Rx

Elligo Health Research | April 21, 2022

Elligo Health Research, the largest healthcare-enabling research organization, announced they are expanding partnerships to include Peoples Rx, an Austin, Texas-based pharmacy chain. “We’re in a unique position at Peoples Rx to help inform more people about how they can participate in clinical research opportunities. Working with Elligo to offer research as healthcare to our customers helps support our mission to empower people to make educated health decisions.” Stephen Erickson, Peoples Rx president One of the first studies Peoples Rx will be working to share with Elligo is a study for people to advance screening diagnostics for cancer. “Our patients may not hear about clinical research opportunities otherwise, and this empowers patients with knowledge to become more proactive in their own healthcare journey while simultaneously supporting the advancement of health sciences,” Erickson said. Elligo began its mission to provide easy access to clinical research as care to more patients nearly six years ago. Specifically, Elligo is focused on accelerating clinical trials through healthcare by maintaining the integrity of the trusted patient and physician relationship, building local healthcare communities, and leveraging electronic health records. “Accomplishing this mission is made possible by the partnerships we have with real-world healthcare,” said Elligo CEO John Potthoff, Ph.D. “Peoples Rx has a positive impact on our local community and is a trusted partner for healthcare. This is also Elligo’s first partnership with a pharmacy, and it is our hope that this will lead to further opportunities to collaborate with more providers in the healthcare spectrum on similar initiatives and continue contributing to the changing clinical research landscape.” About Elligo Health Research® Elligo Health Research accelerates clinical trials through healthcare with access to known patients and their HIPAA-compliant healthcare data, our IntElligo® Research Stack technology, and our hybrid enrollment model, PatientSelect. Coupled with the largest Known Patient Access Network, Elligo’s Site Solutions enable healthcare practices and research sites to participate in clinical trials. By adaptive engagement of known patients and physicians, we accelerate the development of new pharmaceutical, biotechnology, and medical device and diagnostic products. About Peoples Rx Peoples Rx has been the local favorite pharmacy and wellness headquarters in Austin for over 40 years. Our integrative approach to health and wellness starts with our knowledgeable and experienced pharmacists and wellness specialists, and our cutting-edge, holistic, and professional products. We also compound custom medications in our state-of-the-art lab to meet customers’ specific needs. And because food is medicine too, our own in-house delis serve up scratch-made meals and snacks with the highest quality ingredients. With a mission to empower people to make educated health choices, several of our 170+ employees, including clinical nutritionists, herbalists, naturopaths, and homeopaths also offer their expertise through private consultations and educational events.

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Can-Fite Granted Key NASH Patent in Israel

Can-Fite BioPharma Ltd. | May 17, 2022

Can-Fite BioPharma Ltd. a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, announced that its patent titled "An A3 Adenosine Receptor Ligand For Use In Treating Ectopic Fat Accumulation" has been granted by the Israel Patent Office. This patent has been issued in approximately 40 countries and territories including Japan, South Korea, Hong Kong, Mexico, and in the European Union. It addresses the use of the A3 Adenosine Receptor ligand, the target receptor for Can-Fite's drug platform technology, for the treatment of ectopic fat accumulation particularly in fatty liver as manifested in non-alcoholic fatty liver disease and non-alcoholic steatohepatitis. The treatment of NASH is a market estimated to reach $35 billion by 2025. Can-Fite is currently enrolling and treating patients in a Phase IIb NASH study of its liver drug candidate Namodenoson. The multi-center, randomized, double blind, and placebo controlled study of biopsy-confirmed NASH patients will measure efficacy periodically through biomarkers, with a primary efficacy endpoint determined by liver biopsy at the end of the treatment period. In a prior Phase IIa study, Namodenoson met endpoints including reduced liver fat content, anti-inflammatory effects, and decreased body weight with excellent safety. “The treatment of NASH is an enormous unmet need that Can-Fite seeks to meet through our advanced stage clinical trial and our expanding patent estate for the use of our target A3AR in the treatment of fatty liver disease,” Can-Fite CEO Dr. Pnina Fishman About Namodenoson Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor. Namodenoson is being evaluated in a pivotal Phase III trial as a second line treatment for hepatocellular carcinoma, and in a Phase IIb trial as a treatment for non-alcoholic steatohepatitis. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. About Can-Fite BioPharma Ltd. Can-Fite BioPharma Ltd. is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson has completed enrollment in a Phase III trial for psoriasis. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical studies to date.

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Spotlight

The fully realized vision of precision medicine includes the capability to rapidly diagnose, sequence and develop a personalized treatment plan based on combined analysis of genotype, phenotype, environmental, clinical and behavioral data. Precision medicine can be advanced through the “All of Us” research initiative of the Precision Medicine Initiative, the most ambitious accumulation of human genomic, personal health and clinical information in history; but accelerating precision medicine to achieve this vision will require new capabilities and speed in personal health, clinical and genomic data storage transfer and analysis, as well as in interoperability and security. Further, precision medicine will demand new private sector, legislative and regulatory approaches for review and approval of genomic sequencing technologies and other software and devices needed to advance knowledge of disease factors that demonstrate variability among individuals.

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