Batavia Biosciences’ Post

Congratulations to Tiba Biotech for being selected by Biomedical Advanced Research and Development Authority (BARDA) to develop a new RNAi-based therapeutics! Tiba will be starting with a treatment for swine flu. 🐖 Tiba’s technology is a synthetic, biodegradable #nanoparticle platform for delivering RNA-based therapies. It’s meant to be an upgrade from lipid nanoparticles (LNPs) like the ones used in Pfizer and Moderna’s mRNA vaccines for COVID-19. For Tiba, the rationale is that while LNPs are safe at low levels, dosing is limited by the possibility of toxicity and inflammation. https://lnkd.in/e-6e9e8M #RNA #RNAi #Massachusetts #cambridge #startup #startups #biotech #biopharma #influenza #swineflu #LNP #PNP #biology #synthetics #syntheticbiology #PNP #DDS #lipidnanoparticles #drugsafety #pharmaceuticals

𝗨𝗻𝘃𝗲𝗹𝗹𝗶𝗻𝗴 𝗥𝗲𝗰𝗲𝗻𝘁 𝗙𝘂𝗻𝗱𝗶𝗻𝗴,𝗠&𝗔 𝗮𝗻𝗱 𝗙𝗶𝗻𝗮𝗻𝗰𝗶𝗮𝗹 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁𝘀-𝗝𝘂𝗻𝗲𝟮𝟬𝟮𝟰 Foresite Capital raises a $900 million fund focused on precision medicine and healthcare infrastructure. Vaxart, Inc. shares surged 128% after receiving up to $453 million from a BARDA-funded consortium to develop rapid response medical solutions. Telix Pharmaceuticals Limited withdraws its planned $200 million Nasdaq IPO deciding it was not beneficial under current market conditions. Roche partners with Ascidian Therapeutics on RNA exon editing drugs, investing $42 million upfront with up to $1.8 billion in milestone payments. Grifols sells a 20% stake in Shanghai RAAS Blood Products Co.,Ltd. to Haier Group for $1.72 billion, maintaining a 6.58% stake and a board seat. European Renal Association (ERA) secures 665,000 avian flu vaccines, with options for 40 million more. US,EU pledge $2B to help boost vaccine manufacturing in Africa Life sciences investor Decheng Capital targets $700M for fifth fund. UK BiotechNet raises $80M to advance early-stage rare eye cancer treatment. Samsung Biologics and Baxter International Inc. dial uo manufacturing deal to $223M. Can mRNA be harnessed for gene insertion?Moderna’s former chief medical officer has $82M to find out. Exsilio Therapeutics Novo Nordisk budgets $4.1B for new Us manufacturing site as it abandons plans for Irish build. Alexis Borisy and Zach Weinberg Curie.Bio secures $380M to support portfolio's Series A rounds. Zealand Pharma rides obesity wave with $1B raise to advance amyling drug and look for a partner. Adam Steensberg, MD, MBA. With a $372M megaround ,Formation Bio looks to in-license 10 drugs. Benjamine Liu

CHF 12.3 million to boost novel drugs against tuberculosis: TOP 100 Swiss scale-up BioVersys AG secures its Series C and expands collaboration with GSK. Congrats and best of success to the world-class team led by biotech pioneers Marc Gitzinger, Sergio Lociuro, PhD and Glenn E Dale! https://lnkd.in/eyT92AJm About: BioVersys AG is a multi-asset, clinical stage biopharmaceutical company focused on identifying, developing and commercializing novel antibacterial products for serious life-threatening infections caused by multi-drug resistant (“MDR”) bacteria. Derived from the company’s two internal technology platforms (TRIC and Ansamycin Chemistry), candidates are designed and developed to overcome resistance mechanisms, block virulence production and directly affect the pathogenesis of harmful bacteria towards the identification of new treatment options in the antimicrobial and microbiome fields. This enables BioVersys to address the high unmet medical need for new treatments against life-threatening resistant bacterial infections and bacteria-exacerbated chronic inflammatory microbiome disorders. The company’s most advanced research and development programs address nosocomial infections of Acinetobacter baumannii (BV100, Phase 2), and tuberculosis (alpibectir, Phase 2a, in collaboration with GlaxoSmithKline (GSK) and a consortium of the University of Lille 1 Sciences and Technology. BioVersys is a spin-off of ETH Zürich, a 2008 alumnus of Venture Kick, was ranked among the TOP 100 Swiss Startups from 2011 to 2013, and participated in the SIX IPO Academy. #TOP100SSU #SwissStartups #VentureKick

"Three pillars of viral risk mitigation have been defined in ICH Q5A (R1) Quality of biotechnological products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin as sourcing, testing, and clearance. These have ensured the safety of biologic products over the past 30 years." #DahliaConsulting #BiopharmaceuticalIndustry #CommercialLifeSciences #ManagementConsultant #LifeSciencesBusinessStrategy #GlobalPharma #GlobalBioTech #SupplychainOperations #CommercialOperations #CGTcommercialization #Manufacturing #QualityAssurance #OperationalExcellence #FinancialAnalysis #OpModelDesign #LifeScience #BioTechnology #Bioprocessing #Biosimilars #BioPharmaIndustry #MedicalResearch #CDMO #GMP #GMPbatch #GMPmanufacturing #GenomeEditing #GeneTherapy #CellTherapy #Car_T #mRNA #cGMP #ClinicalGradeManufacturing #ClinicalGradeProduction #BiologicsLicenseApplication #BLA #Pharmaceuticals #RegenerativeMedicine #CellAndGene #ViralClearance

Stories making headlines today in the biopharma industry: The Human Medicine Committee (CHMP) of the European Medicines Agency gave their approval to two new medication applications while turning down two others. One of the notable rejections was for Apellis's Syfovre, a treatment for geographic atrophy, although it has been approved in the United States for close to a year. A recent report from the European Commission claims that over the last few years, competition and merger enforcement have led to fairness in medication pricing and a competitive market. The report evaluated the enforcement actions carried out both by the National Competition Authorities and EC between 2018 to 2022, concluding that improved access to medications was the result of these actions. In a recent development, Johnson & Johnson unveiled "Dad Genes," a new communication campaign focusing on BRCA (breast cancer gene). Its objective is to raise awareness about the gene's role in prostate cancer and encourage early screening and gene testing. According to a report by The Biotechnology Innovation Organization, the global focus on Covid-19 might be leading to a pipeline of vaccines that lacks breadth. Of the 249 vaccine programs currently in development globally, around 28% are primarily for Covid-19 prevention. The report suggests that this overemphasis on Covid-19 results in less work being done on other infectious diseases. AbbVie recently announced a $223 Million investment to expand its biologics manufacturing capability in Singapore, which is at present their only production site in Asia. The expansion, due to commence operation in 2026, is set to create a minimum of 100 jobs. The U.S Food and Drug Administration just released a revised Q&A guidance that focuses on using mandatory remote regulatory assessments, a move aimed at assisting with approval decisions and further comprehension of biopharma manufacturers. #pharma #biotech #topstories #biodatastudio

How Entos’ delivery platform is realizing the untapped promise of genetic medicines Unique proteolipid vehicle (PLV) technology developed by Entos Pharmaceuticals is broadening the scope for biopharma to deliver nucleic-acid payoffs to target cells throughout the body, paving the way for a new generation of curative drugs. #bioeurope2023 #biotechnology #biotechinnovation

Bioprocessing in a Post COVID-19 World 💉 COVID-19 has compressed bioprocessing timelines, leaving no room for uncertainty in the characterization of raw materials and contaminants Bioprocessing has taken quite a remark­able journey over the last 30 years. In recent years, the demand for powerful and specific biopharmaceuticals has continued to increase, driven by monoclonal antibodies (mAbs), where the market can be expected to approach $140 billion by 2024. Rising de­mand for biopharmaceuticals also reflects how biologics are expanding into new therapeutic areas, such as neurodegenerative and cardio­vascular diseases. Finally, rising demand is be­ing sustained by better geographic reach, label extensions, and the emergence of biosimilars. 🔬 Developments in molecular biology and clinical insight have also supported emerging modalities, such as cell and gene therapies, nucleic acid–based medicines, and new workflows in engineered vaccines. As part of this next frontier of medicine, cell and gene thera­pies will continue to provide novel ways to address chronic conditions and diseases. The emergence of COVID-19, a pandemic unleashed by the SARS-CoV-2 virus, caused a rapid and unexpected evolution in the industry over the last year. As the industry has moved swiftly from research to production of new vaccines, the importance of system and raw material characterization has been magnified. 🕓 Accelerated timelines leave no room for uncertainty or unnecessary challenges related to documentation, stability, critical impurities, and other factors related to raw materials, quality, and consistency. No matter how much emphasis is placed on speed, it remains under­stood that no compromises to patient safety can be tolerated.

🔬🌐 Elevating Viral Vector Manufacturing with GMP Excellence 🌐🔬 In the realm of biopharmaceuticals, where innovation meets precision, the manufacturing of viral vectors presents unparalleled opportunities and challenges. As we forge ahead, the embrace of rigorous GMP (Good Manufacturing Practice) strategies in commissioning, validation, and qualification becomes our beacon, guiding us towards manufacturing prowess and therapeutic breakthroughs. 🛠️ Commissioning with Foresight: Our journey begins with the strategic commissioning of facilities and equipment designed to not only comply with GMP standards but to surpass them. This foresighted approach ensures that our foundation is robust, ready to support the sophisticated demands of viral vector production. 🔬 Validation with Rigor: The heart of our operation lies in the validation processes. Here, we employ stringent protocols to confirm that every manufacturing step is reproducible, consistent, and in strict adherence to regulatory standards. This commitment to validation excellence is our assurance of product integrity and efficacy. 📋 Qualification with Precision: Qualification of our equipment and processes is the final cornerstone, ensuring operational excellence. Through detailed IQ, OQ, and PQ, we validate performance within precise parameters, embodying the GMP ethos in every aspect of our production cycle. 🤝 Collaboration for Innovation: The path to excellence is a collaborative endeavor. Engaging with regulatory bodies, industry peers, and the scientific community enriches our strategies and fuels innovation, setting new standards in viral vector manufacturing. In the quest for groundbreaking gene therapies, our commitment to GMP commissioning, validation, and qualification strategies is unwavering. These practices are not just regulatory checkboxes but the backbone of our mission to deliver safe, effective, and revolutionary treatments. Let’s champion these standards together, shaping a future where gene therapy’s potential is fully realized. Your thoughts and insights on these strategies are invaluable – let’s connect and advance our collective mission. Come back tomorrow for an in depth coverage on the same topic. #Biopharmaceuticals #GMP #ViralVectors #GeneTherapy #Innovation #Collaboration

Pepper wins $6.5m to develop ‘transomic’ drug discovery platform Here are some key insights 1. #Pepper's #strategy involves a combination of #technological #innovation, #data #integration, and a targeted focus on addressing challenges in drug development, particularly in the #oncology space. The infusion of significant funding underscores the company's commitment to advancing its unique approach to drug discovery 2. #Pepper's #Approach Leveraged the transomic capabilities of the Compass platform, which provides real-time insights into the functions of proteins. This approach allows for a more dynamic understanding of biological processes. 3.#Target #Funds #raised : $6.5m 4.#Focus #Pipeline: #oncology , specifically targeting the #MYC gene. This gene is known for its association with malignancy, aligning Pepper's efforts with addressing critical needs in the cancer therapeutics market. 5. #Market #Potential: Growth potential in the #cancer drug market, with global projections reaching $242.2 billion by 2027. Pepper's strategy aligns with the need for innovative solutions in this lucrative and impactful sector. #PPInsights #PepperBio #DrugDiscovery #CompassPlatform #BiotechInnovation #OncologyResearch #InvestmentSuccess #HealthcareRevolution #DataIntegration #TransomicTechnology #Genomics #Transcriptomics #Proteomics #Phosphoproteomics #FundingNews #EYParthenon #AIinHealthcare #PrecisionMedicine #BiologicalMapping #InnovationInScience #CancerTherapeutics #GlobalHealth #StartupSuccess #StrategicInvestment #HealthTech #ConsultingInnovation #EYP #HealthcareStrategy #BioTechStartups #TechInnovation #AIConsulting #FutureOfMedicine #PrecisionOncology #WomenInAI #AIInnovation #WomenInLeadership #LeadershipExcellence #WomenInPharma #PharmaLeaders #WomenInSTEM #DiversityInTech #WomenEmpowerment #AIForAll #TechLeadership #InclusiveInnovation #WomenInScience #WomenInTech #PharmaInnovation #WomenLeaders #AIEquality #PharmaWomen #EmpowerHer #WomenInMedicine #STEMLeadership #BreakingBarriers #WomenInHealthcare #AIInclusion #PharmaLeadership #TechEquality #WomenInBioTech #FutureLeadership #EmpowerWomen #AIAndDiversity #WomenInBusiness #HealthcareEquality #DiverseLeadership #TechForAll #PharmaTrailblazers #LeadershipJourney #InnovativeWomen #AIInPharma #LeadershipDiversity #WomenInHealthTech #TechLeadershipWomen #InclusiveAI #PharmaPioneers #WomenInTechLeadership #BreakingGlassCeilings #LeadershipImpact #PharmaInclusivity #AIAndWomenLeadership #LeadershipDevelopment #WomenInPharmaTech #HealthcareLeadershipWomen #DrugDevelopment #MarketInsights #DataCuration #AIInDrugDiscovery #CancerMarketStats #BiologicalInsights #HealthcareLeadership #EmergingTechnologies #InvestmentGrowth #EYAdvisory #EYInsights