Novavax Aims for Billions Covid Vaccine Doses Could Be Available by End of 2021

fiercepharma | August 12, 2020

Some of the world’s largest biopharma companies are working to deliver safe and effective COVID-19 vaccines, but at the same time, a much smaller biotech has laid out its own big ambitions in the field. Novavax will have billions of doses of COVID-19 vaccine capacity next year and could single-handedly meet U.S. demand, executives say. On a conference call Monday, chief medical officer Filip Dubovsky said the Gaithersburg, MD-based biotech expects to be able to make "well over a couple billion units" each year, starting in 2021. That would easily outpace U.S. demand, which Dubovsky estimated will come in at 500 million to 600 million doses annually.

Spotlight

Merck & Co, known as MSD outside of the United States and Canada, is a global pharmaceutical company whose mission is to discover, develop and provide innovative products and services that save and improve lives around the world.

Spotlight

Merck & Co, known as MSD outside of the United States and Canada, is a global pharmaceutical company whose mission is to discover, develop and provide innovative products and services that save and improve lives around the world.

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BUSINESS INSIGHTS, PHARMACY MARKET

Patsnap Unveils Synapse Visitor, the Latest AI-Powered Pharmaceutical Intelligence Platform

Prnewswire | April 25, 2023

On April 20, Patsnap, the world's leading SaaS provider for intelligence, announced the launch of its latest version of the intelligence platform, Synapse, available to visitors. This version includes advanced search functions for drugs and pharmaceutical organizations, now publicly accessible for the first time. Users can explore these features without prior registration, making searching easier and more accessible than ever before. Synapse is an innovative Life Sciences Platform that uses AI technology to connect Drug Discovery information with Drug Development insights. This allows professionals in the pharmaceutical industry to make better-informed decisions throughout the entire innovation cycle. With a vast database of millions of free data points from over 150 jurisdictions, Synapse provides access to over 72,000 new drugs, 800,000 clinical trials, 6 million pharmaceutical patents, 62 million literature sources, 360,000 pharmaceutical organizations, and more. This wealth of information is available to users to aid them in their research and decision-making processes. One of the key benefits of Synapse is its extensive database of drugs, particularly those in their preclinical or early developmental stages, which helps to mitigate potential risks for professionals in the pharmaceutical industry. "We want to ensure that we are only developing drugs that are efficiently managed, reducing the risks of failure at the later stages of development," said one of our key clients, the head of R&D. By having access to this valuable information, professionals can make more informed decisions and focus their efforts on drugs with a higher potential for success, ultimately saving time and resources. Available on Synapse's website as a free solution, key features include Drug Advanced Search:Quickly and accurately identify drugs based on specific criteria of interest. The search function covers global drug candidates and marketed drugs, and mines preclinical R&D intelligence in patents and literature to identify early competitive risks. Clinical Progress:Screen clinical trials by drugs, institutions, targets (multi-target), indications, clinical trial phase, and other conditions. Synapse collates data from 18 registries, including CT.gov and WHO, giving users a global view of the clinical landscape. Playbook: Access multiple data sets with a single search, including Due Diligence and Find Organizations. This feature provides comprehensive and visualized insights into the organization's R&D preferences, drug pipeline, investments, financing, and more. Literature Search:With over 62 million literature records in the life sciences field, users can easily screen literature by drugs, targets, indications, authors, and other criteria. This feature allows for efficient and targeted research, saving time and increasing productivity. About Patsnap Founded in 2007, Patsnap is the company behind the world's leading AI-powered innovation intelligence platform. Patsnap provides global businesses with a connected, easy-to-use platform that helps them make better decisions in the innovation process. Customers are innovators across multiple industry sectors, including agriculture and chemicals, consumer goods, food and beverage, life sciences, automotive, oil and gas, professional services, aviation and aerospace, and education.

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PHARMACY MARKET

Simulations Plus Launches New Integrated Pulmonary Software and Services Package to Streamline Drug Development and Improve Patient Outcomes

Businesswire | May 11, 2023

Simulations Plus, Inc. a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, announced the release of a new integrated pulmonary software and services package. This targeted package will support pharmaceutical companies by streamlining their pulmonary drug development processes, enabling them to make better-informed decisions and bring therapies to market faster. The pulmonary package offered by Simulations Plus is founded on the industry leading GastroPlus® modeling and simulation platform, which can be used to predict localized exposure in the lungs. That localized exposure data is then utilized to inform the ILDsym™ or IPFsym™ platforms for efficacy predictions. As client ventures launch and progress, Simulations Plus scientists will leverage their 40+ years of combined experience in pulmonary exposure and efficacy modeling to train in-house client experts on how to use the software and create models to accurately predict the exposure and efficacy of their pulmonary assets. “Developing molecules intended to treat interstitial lung disease (ILD) and idiopathic pulmonary fibrosis (IPF) is a daunting challenge; they are serious conditions with no known cures,” explained Dr. Brett A. Howell, President of the DILIsym Services division at Simulations Plus. “We anticipate that the use of our targeted pulmonary package could lead to an acceleration in the development of treatments to slow or even halt progression of these diseases. By integrating the industry-leading platforms for PBPK/PCAT™, quantitative systems pharmacology (QSP), and the expertise of our scientists, along with the training of in-house scientists, we believe we can help our clients develop therapies that will improve and even extend the lives of patients worldwide.” “Hiring and retaining skilled modelers is difficult, which is why many companies develop talent from within,” noted Vice President of Business Development Josh Fohey. “While we are always pleased to assist with our clients’ drug development programs as an extension of their team, we also want to empower them to engage with their models and data beyond what is typical with consulting relationships. As part of our Pulmonary Package, client teams benefit from a customized learning package using the tools in their program, implemented with support and guidance from our experts. Together, we can better understand lung absorption and efficacy, and find new treatments for respiratory disease.” About Simulations Plus Serving clients worldwide for more than 25 years, Simulations Plus is a leading provider in the biosimulation market providing software and consulting services supporting drug discovery, development, research, and regulatory submissions. We offer solutions that bridge artificial intelligence (AI)/machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, and regulatory agencies worldwide.

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PHARMA TECH

USFDA Accepts BioMarin's sNDA to Expand Use of VOXZOGO

BioMarin Pharmaceutical Inc. | March 08, 2023

On March 7, 2023, BioMarin Pharmaceutical Inc., a global biotech company focused on improving lives via genetic discovery, announced that the US FDA has accepted its supplemental New Drug Application (sNDA) for VOXZOGO® (vosoritide) for injection to expand the treatment of achondroplasia in children under the age of 5. Achondroplasia is a common form of disproportionate short stature. The FDA has set an action date of October 21, 2023, for the sNDA. The sNDA is supported by data from a Phase 2 double-blind, randomized, placebo-controlled clinical trial, which showed similar safety and efficacy profiles in children under five years of age compared to those aged five years and older. The European Medicines Agency (EMA) also validated BioMarin's application for VOXZOGO in January to treat children under the age of 2. If approved, VOXZOGO could be prescribed for over 1,000 additional children from birth for achondroplasia. VOXZOGO is the first EMA and FDA-approved treatment for achondroplasia with open bone growth plates. The treatment uses a new class of therapy, C-type natriuretic peptide (CNP) analog, which promotes bone growth by acting as a positive regulator of the signaling pathway downstream of the fibroblast growth factor receptor 3 gene (FGFR3). The drug is approved in the EU, Brazil, and Australia for children aged two years and above with epiphyses (bone growth plates) and in Japan for children from birth who have achondroplasia with open growth plates. BioMarin has enrolled 250 children with achondroplasia in seven clinical studies in eight countries to evaluate the safety and efficacy of VOXZOGO. About BioMarin Pharmaceutical Inc. BioMarin is a leading biotechnology firm established in 1997 with a mission to transform people's lives by using genetic discovery. The company creates targeted therapies that address the underlying cause of genetic disorders to improve the quality of life for individuals with rare genetic diseases. It has developed eight first or best-in-class treatments and has a range of product candidates to address various genetic disorders using the same science-based approach. As BioMarin continues to create new and innovative solutions, it has the potential to impact the lives of even more people. The company is committed to prioritizing patients and their needs in its approach to drug development.

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