GSK to invest $120m to expand manufacturing facility in US

Pharmaceutical Technology | September 26, 2019

GlaxoSmithKline (GSK) has committed $120m to expand its biopharmaceutical manufacturing facility in Upper Merion, Pennsylvania, US. The investment is intended to fit the manufacturing facility with technologies that will offer the flexibility and speed required to produce complex speciality medicines to cater to the current market. GSK says the expansion will support essential assets in its pipeline, including therapies for cancer and other speciality diseases. All assets are undergoing clinical trials, subject to trial outcomes and regulatory approval. GSK CEO Emma Walmsley said: “These investments will support and accelerate the transformation of our pipeline to deliver the next generation of medicines and vaccines for patients who need them. This also underscores GSK’s longstanding commitment to making innovative medicines and vaccines here in the US.”The project will combine the R&D and manufacturing teams at the Upper Merion facility, noted GSK. The workforce, technological and scientific expertise and the infrastructure will facilitate research on novel genetic targets and their manufacture into new medicines.

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The Danish National Genome Center Partners with Lifebit to Deliver Nationwide Personalised Medicine

Lifebit Biotech | April 29, 2022

Lifebit, whose leading technology enables secure analysis over sensitive datasets for researchers and interconnects such large patient cohorts worldwide, today announces a long-term partnership with the Danish National Genome Center (NGC). Lifebit will deploy Lifebit CloudOS to create a Federated Trusted Research Environment within the Danish NGC's supercomputing cluster to serve as the scalable and secure data management and analysis platform for Denmark's national researchers, clinical scientists and international collaborators. The Danish NGC, a government agency and authority within the Danish Healthcare system, was created to implement the Danish Government's National Personalised Medicine Strategy. The core vision of the NGC is to develop more precise diagnosis, targeted treatment and strengthen research within the Danish healthcare system. During the first phase of the strategy, the Danish National Genome Center and its collaborators will recruit and sequence whole genomes of 60,000 patients diagnosed with cancer, autoimmune disorders and rare diseases by 2024. The platform will deliver a next-generation computational infrastructure within Denmark's on-premise supercomputing center, allowing the NGC to meet its vision of establishing and operating a state-of-the-art national infrastructure for personalised medicine while keeping the data at all times in the secure national infrastructure. Only Lifebit with both its genomic data expertise as well as its internationally proven ability of managing such complex Government environments through its patented operating system Lifebit CloudOS was deemed capable to deliver this project. The platform will thus enable researchers with secure access, querying and analysis of this sensitive clinico-genomic data in a fully scalable and flexible way; also allowing for them to collaborate at a global scale. Federation will play a crucial role in enabling the future possibility to collaborate with international partners such as Genomics England, France Genomique, Genomic Medicine Sweden and other biobanks from around the world. Virtually connecting these sensitive datasets, enabling joint analysis that is however performed in situ without moving data, can lead to exponentially higher research findings. In some cases, it can be observed that increasing the number of patients in a study by 10x led to ~100x the number of scientific findings and genomic associations making clear how important real connectivity of these datasets is. "Lifebit continues to guide and power the world's largest national and private precision medicine programmes. We are extremely proud to be delivering this flagship programme for the nation of Denmark. This Federated Trusted Research Environment will enable researchers to more effectively collaborate over this rich dataset at scale and drive international collaboration between other government initiatives - many of which already leverage Lifebit's federated technology." Thorben Seeger, Chief Business Development Officer at Lifebit Other examples of Lifebit's data platform at work include Genomics England, NIHR Cambridge and the Hong Kong Genome Institute. About Lifebit Biotech, Ltd. Lifebit builds enterprise data platforms for use by organisations with complex and sensitive biomedical datasets. Lifebit's patented federated technology securely unlocks access to biomedical data. From providing Trusted Research Environments for national precision medicine programmes to enabling pharmaceutical companies to discover new drug targets faster, Lifebit empowers customers to transform how they leverage sensitive biomedical data.

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PHARMACY MARKET

Alpha Cognition Announces Positive Neuroprotection Data from Pre-Clinical Study of ALPHA-1062 for Traumatic Brain Injury

Alpha Cognition Inc. | February 23, 2022

Alpha Cognition Inc. a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating neurodegenerative disorders, is pleased to announce histology data from their intranasal ALPHA-1062 Traumatic Brain Injury (TBI) program. ALPHA-1062 treatment was neuroprotective, preserving hippocampal structure, reducing cell loss and promoting neurogenesis compared to no treatment. Functional recovery data released in December demonstrated statistically significant improvement in motor, sensory and cognitive functioning in all measures. Today’s histological results, combined with positive functional data released previously, strongly support the further development of ALPHA-1062 for the treatment of TBI. “These data, together with the data released previously, demonstrate that ALPHA-1062 exhibits both neuroprotection and enhances restoration of sensory, motor, and cognitive performance in this model of moderate traumatic brain injury. We are very encouraged by the preclinical data which gives us confidence in the potential of ALPHA-1062 to become an effective treatment for TBI. We plan to meet with the FDA to discuss our clinical development plan in the coming months.” Denis Kay, the Company’s Chief Scientific Officer In a rodent model of TBI, ALPHA-1062 or vehicle was administered intranasally, with treatment initiated 2 hours after injury and continued twice daily for 35 days. A sham cohort of animals was also used for comparison. Compared to vehicle treatment, ALPHA-1062 Demonstrated statistically significant reduction in lesion size measured at 35 days after injury. Preserved greater hippocampal structure. The hippocampus plays a critical role in learning, memory formation, and spatial coding and damage to hippocampus can lead to memory disorders like AD, amnesia, and depression. Demonstrated statistically, significant reduction in neuronal cell loss. The number of neurons in the ALPHA-1062 treated animals were equivalent to those in the uninjured cohort of animals at the end of treatment. Statistically significantly enhanced neurogenesis as evidence by an increase in the number of neuron precursor cells and new neurons in the dentate gyrus, which plays a critical role in learning, information processing, and mood regulation. Lauren D’Angelo, the Company’s Chief Commercial Officer, commented: “Traumatic brain injury is a highly prevalent and increasingly common condition, with nearly 3 million diagnosed events in the United States in 2019, with no FDA approved treatment. There is a significant unmet need for effective therapies to help patients who suffer a traumatic brain injury, and we are encouraged by the commercial opportunity for ALPHA-1062 in this indication.” About Alpha Cognition Inc. Alpha Cognition Inc. is a clinical stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer's disease and Amyotrophic Lateral Sclerosis (ALS), for which there are limited treatment options. ALPHA-1062 is a patented new chemical entity being developed as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer's disease, with expected minimal gastrointestinal side effects. ALPHA-1062's active metabolites are differentiated from donepezil and rivastigmine in that they bind neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer's dementia and as an intranasal formulation for traumatic brain injury.

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Can Fite Announces First Patient Enrolled in Phase IIb NASH Clinical Trial with Namodenoson

CordenPharma | February 01, 2022

Can-Fite BioPharma Ltd. a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced it has enrolled the first patient in a Phase IIb study of its drug candidate Namodenoson in the treatment of NASH. The Phase IIb trial is a multicenter, randomized, double-blind, placebo-controlled study in subjects with biopsy-confirmed NASH. The primary efficacy objective of the trial is to evaluate the efficacy of Namodenoson as compared to placebo in 140 subjects with NASH, as determined by a histological endpoint. Eligible subjects are randomly assigned in a 2:1 ratio to oral doses of Namodenoson 25 mg every 12 hours or a matching placebo for 36 weeks. There is currently no U.S. FDA approved treatment for NASH, an addressable pharmaceutical market estimated to reach $35-$40 billion by 2025 driven by increasing incidence. The U.S. National Institutes of Health estimate the prevalence of NASH in the U.S. at 2-5% of the population. NASH is the leading cause for liver transplants among women and second leading cause overall in the U.S. Given the rate of increase, it is expected to become the leading indication for liver transplants in males as well. “Our Phase IIa study demonstrated very encouraging results based on key liver fibrosis and NASH biomarkers. We hope to see a similar therapeutic effect in a larger patient population as measured by liver biopsy,” Can-Fite CEO Dr. Pnina Fishman Can-Fite has out-licensing agreements for Namodenoson in the treatment of NASH in Eastern Europe, China, and South Korea which include milestone payments and double-digit royalties upon approval and commercialization. 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, is currently in a Phase III trial for psoriasis. Can-Fite's liver drug, Namodenoson, is headed into a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH). 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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LexisNexis® Reed Tech™ and Schlafender Hase® Alliance Provides Mutual Customer Benefits for Pharmaceutical and Medical Device Companies

LexisNexis Reed Tech | April 27, 2022

Reed Technology and Information Services Inc. a leading provider of data management and analytics solutions for the life sciences industry, announced an alliance with Schlafender Hase®, the market leader for intelligent, automated proofreading software and services for regulated industries. Current and prospective customers of both companies can leverage exclusive benefits as part of this new alliance ecosystem. Pharmaceutical labelers who have regulatory deadlines for US FDA can benefit from the expert conversion and submission services offered by Reed Tech while ensuring reduced risk and greater accuracy in the proofreading process for drug labels and related documentation with Schlafender Hase's TVT®, the Text Verification Tool®. "Schlafender Hase is already a trusted ally as part of our pharmaceutical SPL conversion process. By offering our UDI and pharma customers the benefits of TVT, we continue advancing our mission of providing innovation for the unique workflows of these specialty manufacturers. Ensuring the accuracy of labels, barcodes, graphics and IFU language is essential. With TVT®, regulatory team members around the world benefit from superior, automated proofreading in order to reduce risk and meet the compliance requirements of local health authorities," Arshad Rahman, General Manager of the Reed Tech Life Sciences division "Schlafender Hase is pleased to recognize Reed Tech as an industry-leading, core SPL conversion service provider. It will be productive for our customers to have access to their deep understanding of regulatory submission requirements for drug manufacturers and distributors," said Peter Muller, Sales Director, North America at Schlafender Hase. Those manufacturers bringing new products to market or maintaining existing portfolios will benefit from the subject-matter expertise offered by Reed Tech." Both the pharmaceutical and medical device industries are continually upgrading processes and preparing for multiple global health authority requirements. The complementary solutions and services between Reed Tech and Schlafender Hase offer critical efficiency gains in managing the product life cycle. About LexisNexis Legal & Professional LexisNexis® Legal & Professional provides legal, regulatory, and business information and analytics that help customers increase their productivity, improve decision-making, achieve better outcomes, and advance the rule of law around the world. As a digital pioneer, the company was the first to bring legal and business information online with its Lexis® and Nexis® services. LexisNexis Legal & Professional, which serves customers in more than 150 countries with 10,500 employees worldwide, is part of RELX, a global provider of information-based analytics and decision tools for professional and business customers. Reed Tech serves manufacturers and distributors of medical device and drug products, and for those who support them in consulting and IT roles by delivering better outcomes for the collection, transformation, submission and analysis of regulatory data. Our solutions support the innovation ecosystem and enable you to achieve regulatory compliance and improved product data management contributing to impactful innovations to our world. The corporate mission is to advance humanity by delivering better outcomes to the innovation community. Reed Tech is a LexisNexis® company. About Schlafender Hase Schlafender Hase leads the way in intelligent, automated text and graphic proofreading solutions. With its flagship product, TVT®, the Text Verification Tool®, users can quickly compare source content with output formats, detecting changes and deviations prior to publication. Schlafender Hase serves regulated industries across the globe. Clients include the world's leading pharmaceutical and medical device companies, as well as healthcare regulatory bodies. The continued success of Schlafender Hase is based on delivering quality products and a strong understanding of customer pain points. Easy to use, our products reduce proofreading workloads, assure the quality of printed and online materials, and mitigate the risk of costly errors.

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