RESEARCH

Pfizer/Biontech Weren't Alone: Moderna Covid-19 Vaccine Data Aimed in Ema Cyberattack

Moderna | December 16, 2020

It would appear that Pfizer and BioNTech's COVID-19 immunization was not the sole objective of a new cyberattack at the European Medicines Agency.

Moderna said Monday that reports from its pre-accommodation conversations with EMA about its shot, mRNA-1273, were "unlawfully gotten to" by programmers, refering to a warning from the organization.

The assailants didn't get individual data about preliminary members, Moderna said. The organization's EMA accommodation did exclude any information recognizing people in the examination.

Now, no extra insights concerning the cyberattack, for example, the size of the penetrate or the character of any suspects—are accessible, and Moderna said it anticipates results from EMA's progressing examination.

The disclosure came days after the EMA initially uncovered the cyberattack, and Pfizer and BioNTech's COVID-19 immunization applicant, BNT162b2, was the principal distinguished as an objective.

EMA choices on the two immunizations are moving close. Medication commentators at the EMA's Committee for Medicinal Products for Human Use are booked to evaluate BNT162b2 on Dec. 29 and mRNA-1273 on Jan. 12.

Moderna was recently focused by programmers looking for its COVID-19 examination, in a cyberattack supposedly upheld by the Chinese government.

The U.S. Branch of Justice in July arraigned two Chinese nationals for running a 10-year hacking effort that most as of late rotated to focusing on organizations doing COVID research. Reuters later affirmed Moderna as the antibody producer referenced in the arraignment. China has denied any function in such practices.

Other than Moderna and Pfizer/BioNTech, rival COVID immunization designers AstraZeneca, Johnson and Johnson and Novavax apparently have arrived in the line of sight of North Korean programmers. In those hacking endeavors, the assailants regularly conveyed noxious reports or connections by means of email under the appearance of occupation enrollment specialists, partners or different associates of the person in question, as indicated by individuals acquainted with the issue refered to by The Wall Street Journal.

Country state programmers from Iran and Russia have likewise been blamed for attempting to take COVID-related data.

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Questex’s Digital Pharma East 2022 brought hundreds of pharma marketers together to network, discover the latest marketing trends and digitization transformation efforts, share ideas and help shape the future of pharma marketing.

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RESEARCH, PHARMA TECH

OM1 Releases Analytic Reports, Uncovering Medication Discontinuation in Patients

OM1 | February 06, 2023

OM1, a leading real-world data, results, and technology firm focused on chronic diseases, recently announced the release of its Reasons for Discontinuation (RfD) Analytic Reports. Utilizing the OM1 Real-World Data CloudTM, Immunology Real-World Data Network, and proprietary artificial intelligence (AI) technology, the RfD reports provide difficult-to-obtain, extremely valuable discontinuation trends for cDMARDs, bDMARDs, and tsDMARDs in primary dermatologic and rheumatologic conditions. Each year, millions of Americans cease their prescriptions prematurely, costing the pharmaceutical industry in the United States an estimated $250 billion in lost income and can affect the health of these patients. Therefore, it is crucial for pharmaceutical businesses to comprehend patient discontinuation patterns so they may act on information regarding tolerability, costs, and emerging contraindications to enhance the patient experience. Prior to this point, it was extremely difficult to extract these insights due to the fact that crucial information was not reflected in claims or any other sort of structured data but was only available in clinical notes. OM1 is elevating the clinical narrative into actionable insights that pharmaceutical companies can rely on to comprehend patient adherence and clinician prescribing behavior, thanks to its data cloud built on billions of data points from over 300 million patients and unique AI and modeling capabilities. The analyses, which are conducted across multiple strata, such as demographic groups, patient characteristics, medical histories, comorbidities and care pathways, extract insights from the extensive clinical data sets available to OM1 and notes from prescribing clinicians dating back to 2013. Currently, accessible RfD reports include psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, and atopic dermatitis, with more to come, including schizophrenia, depression, and bipolar illness. About OM1 Founded in 2015, OM1 is a renowned health outcomes, and registries firm focused on treatment outcome measurement, comparison, and prediction. OM1 created the first intelligent data cloud for healthcare, leveraging big data, standardized outcomes measurement, and artificial intelligence technologies to provide more precise information and improve decision-making for stakeholders across the healthcare ecosystem. The company is reimagining real-world data and evidence in immunology, cardiometabolic, mental health and neurosciences, respiratory and ENT specialty areas by establishing vast electronically connected networks of clinicians and health data.

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BUSINESS INSIGHTS, PHARMA TECH

Neochromosome Announces Successful Collaboration with Sumitovant Biopharma

Sumitovant Biopharma, Inc. | January 20, 2023

On January 19, 2023, Neochromosome, Inc., announced a partnership with Sumitovant Biopharma, Inc., a technology-driven biopharmaceutical firm expediting the discovery and commercialization of novel therapeutics. This collaboration blends Neochromosome's neoYeast™ platform with Sumitovant's DrugOME™ computational ecosystem to identify new proteins that would benefit from non-canonical amino acid chemistries that are unavailable in nature. As part of the collaboration, Sumitovant used a combination of natural language processing (NLP), artificial intelligence (AI), machine learning (ML), and computational algorithms to identify opportunities for Neochromosome to enhance the discovery and production of proteins limited by evolution and traditional fabrication processes. For example, non-canonical amino acid inclusion allows new-to-nature proteins with improved structures and functions but often requires chemical synthesis, which is expensive, size- and complexity-restricted, and environmentally damaging. neoYeast™, based on Neochromosome's world-leading genome-scale cell engineering technology stack, enables the highly efficient and environmentally friendly integration of non-canonical amino acids into proteins, with both discovery and manufacturing possible in a single genome-engineered yeast strain. Sumitovant used DrugOME to explore libraries of traditional and non-traditional sources of data to recommend targeted protein development candidates for neoYeast. Co-Founder and CEO of Neochromosome, Leslie Mitchell, commented, "The combination of Sumitovant's technology platform and life-sciences expertise with Neochromosome's ability to both discover and biomanufacture novel proteins in a single system enables Neochromosome to accelerate and streamline the delivery of better therapies for patients." She added, "We are excited to partner with the world-class team at Sumitovant to identify opportunities to create better versions of existing drugs, along with new-to-nature compounds, and to manufacture them efficiently at scale." (Source – Business Wire) Sumitovant Biopharma, Inc. The firm has supported the development of multiple FDA-approved products and a strong pipeline of early-through late-stage investigational assets addressing unmet needs in pediatrics, oncology, urology, women's health, specialty respiratory, and infectious diseases through its proprietary computing and data platforms, scientific expertise, and diverse company portfolio. It is a wholly-owned subsidiary of Sumitomo Pharma.

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BUSINESS INSIGHTS, PHARMACY MARKET

Innovation Pharmaceuticals Announces BT BeaMedical Technologies Receives FDA Clearance for New Surgical Laser Family

Innovation Pharmaceuticals Inc | November 29, 2022

BT BeaMedical Technologies a private company developing a next-generation laser-based platform for epilepsy and cancer surgery, has notified Innovation Pharmaceuticals that it has received U.S. Food and Drug Administration clearance for its MANTA surgical laser family. The clearance is an important milestone for BeaMed in its development of an advanced laser technology with respect to shaping energy and matching it to patient specific anatomy, a novel concept that BeaMed is proving a reality. Innovation Pharmaceuticals made a strategic investment to acquire a minority stake in BeaMed in June 2022. BeaMed is the inventor and developer of the StingRay Laser System a novel laser-based thermal ablation technology designed for treatment of previously inoperable cases of epilepsy and for improvement of outcomes and enablement of new treatment options for oncology procedures, including those treating brain, prostate, liver, breast, and lung cancers. The StingRay Laser System will utilize the MANTA laser family as its core energy generation devices coupled to new fiber optic technology, allowing a perfect match between the exact structure of tumors and epileptic focal points and the energy delivery, while protecting vital functional areas against thermal damage. The MANTA surgical laser family was cleared by the FDA including five different wavelengths and soft tissue use in a very wide set of clinical specialties, including Neurosurgery, Spinal Surgery, Urology, Thoracic Surgery, Pulmonary Surgery, Gynecology, General Surgery, ENT/Head and Neck, Plastic Surgery, Orthopedics, Arthroscopy, Ophthalmology, Radiology, and Oral Surgery. BeaMed expects to soon make requisite submissions to the FDA for clearance of its fiber optics for use in multiple medical indications. “We are excited with the speed of progress BeaMed is making towards introduction of its new platform product with the potential to help millions of patients globally suffering from epilepsy and cancer in multiple specialties. The execution of this submission and the speed of clearance speaks volumes to the commercialization strategy and the exceptional capabilities of the regulatory team at BeaMed,” Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals “This is an exciting and important milestone for our company. This clearance gives us two key achievements. First, U.S. market access to a wide range of potential laser energy sources, each allowing us different and unique tissue interaction, an achievement which will have wide clinical implications. The second is a very wide set of intended uses covering many key potential markets for our technology. This underscores the clear regulatory strategy of BeaMed, which goes hand in hand with our broad impact business vision of revolutionizing key treatments, including brain tumors, epilepsy, lung cancer, prostate cancer, breast cancer and more,” said Gil Shapira, co-founder of BeaMed. BeaMed was founded by Moshe Eshkol and Gil Shapira, both highly experienced specialists in surgical lasers and medical devices. BeaMed and the development of the StingRay system are also supported by a special prestigious grant from the BIRD Foundation a bi-national organization supporting Israel-US collaboration. Gil Shapira brings forward 26+ years of engineering and product development and management experience, with over 17 years in the surgical laser industry. Gil owns and manages neoLaser, a company he founded in 2012, and led to revenue growth and profitability, with a 43% CAGR on its way to more than 1200 global installations and performing 50,000+ surgeries annually in over 30 countries. Previously, Gil led product development and marketing at OmniGuide, a successful high-growth laser-based medical device spin-off out of the Massachusetts Institute of Technology. About Innovation Pharmaceuticals Innovation Pharmaceuticals Inc. is a clinical stage biopharmaceutical company developing a portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, and infectious diseases. The Company is also active in evaluating other potential investment opportunities that can add value and diversify its portfolio.

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