BioTechLogic, Inc.’s Post

Eder Therapeutics and xcube.bio have announced a strategic cooperation to facilitate the market entry and commercialization of biotech assets in Canada and Europe. The two companies will coordinate their offerings to biopharma innovators in their respective regions and leverage the numerous synergies that exist between the healthcare systems of Europe and Canada. The collaboration will specifically focus on product profiling, regulatory processes, Health Technology Assessment (HTA), and medical communication, and commercialization - ultimately benefiting patients and biopharma partners.   "Eder Therapeutics is thrilled to combine its unique depth in the Canadian market with the breadth of a European platform like xcube.bio. This partnership will enhance access to innovative treatments for Canadian patients, which is our ultimate goal," said Jared Rhines, CEO of Eder Therapeutics.   Pierre-Henri Belin, CEO of xcube.bio, stated, "xcube.bio, a European market-entry specialist, has found a valued like-minded partner in Eder Therapeutics. We look forward to expanding this cooperation to accelerate patient access and provide added value to our biopharma partners."   An initial phase of expert cooperation will begin with Eder Therapeutics' investigational gene therapy for Lipoprotein Lipase Deficiency. #biopharma #partnering #commercialization

🚨 FDA OTP Virtual Town Hall: Best Practices for Regulatory Interactions 🚨 The upcoming OTP Town Hall on December 12, 2024, provides an excellent opportunity for developers of cell and gene therapies to gain insights into best practices for interacting with the FDA's Office of Therapeutic Products (OTP). If you're involved in the development of advanced therapies like cell and gene therapies, mark your calendars for the upcoming event on December 12, 2024 from 11:00 a.m. to 12:30 p.m. ET! This town hall will provide invaluable insights for developers navigating the IND/BLA pathway. Experts from the Office of Review Management & Regulatory Review (ORMRR) will share best practices and guidance on formal meetings with OTP and discuss how to optimize regulatory interactions throughout the product development lifecycle. 🎯 What to Expect: 1. Key advice on the IND/BLA process for advanced therapies. 2. Guidance on scheduling, preparing, and documenting formal meetings with OTP. 3. Expert insights from ORMRR staff to ensure efficient interactions and regulatory success. 🔍 Important Notes: Questions can be submitted during registration (by November 13). The focus is on general regulatory practices, not specific product inquiries. Let’s collaborate to drive the future of advanced therapies forward! C&R Research, Inc and ABC Bioscience (https://lnkd.in/gufTD7Dq) offer deep expertise and practical insights through our integrative and pragmatic consultation services. Our dedicated team, equipped with professional expertise, is committed to delivering solutions that meet global standards and cater to your specific needs for advanced therapy. 👉 Register Today: Please secure your seat. #FDA #Biotech #GeneTherapy #CellTherapy #RegulatoryAffairs #FDARegulations #AdvancedTherapies #Pharmaceuticals #DrugDevelopment #ClinicalTrials #RegulatoryScience #CNRResearch

The role of CDMOs is evolving, driven by market opportunities and the demand for breakthrough therapies such as cell and gene therapies, mRNA treatments, and innovative vaccines. These advancements require innovative manufacturing capabilities, pushing CDMOs to lead in this landscape.

I am very excited to share my latest article 2024 New Drug Modalities Report, co-authored by me and my BCG colleagues Brian Bush, Mike Brochu, Gian King, PharmD. It's been an exciting year since our 2023 report. New modalities represent $168 billion in projected pipeline value in 2024, up 14% from 2024. ADCs and GLP-1s have had breakout success. Gene therapies for rare diseases, microbiomes, and oncolytic virus saw their first US approvals in the past year. CAR-T and mRNA continue to mature and broaden their applications beyond the initial therapeutics. Large Biopharmas have spent nearly $200B since 2022 in deal making in new modalities. The next few years are likely to be exceptionally competitive for new modalities. Not all new modalities can be winners. The success of each new modality will hinge on its unique value proposition and its capacity to enhance the standard of care. As you review the insights, please reach out with any feedback and perspective. Always excited to bounce ideas with fellow 'new modalities enthusiasts'! https://lnkd.in/g6rYim6s

🚀 Weekly Roundup - PHARMA  – 5 August 2024 🚀 Stay in the lead with last week's top pharmaceutical industry highlights! 📈💊 Click here to read more ➡ https://lnkd.in/eDV8dXVv    🔊 Pfizer Receives Conditional Authorization from EC for DURVEQTIX Gene Therapy in Hemophilia B  🔊 Luye Pharma's Extended-Release Injectable Suspension ERZOFRI for Schizophrenia and Schizoaffective Disorder Receives FDA Approval  🔊 Boehringer Ingelheim to Acquire Nerio Therapeutics for Up to $1.3B in a Strategic Move Towards Immuno-Oncology  🔊 Japan’s Otsuka Pharma to Buy Jnana Therapeutics for Up to $1.1B  🔊 Prelude Forms New Partnership with Merck to Evaluate PRT3789 for Cancers Associated with the SMARCA2 and SMARCA4 Genes    #Pfizer #DURVEQTIX #LuyePharma #ERZOFRI #BoehringerIngelheim #NerioTherapeutics #OtsukaPharma #JnanaTherapeutics #Prelude #Merck #PRT3789 #PharmaNews #Biotech #Pharma #Healthcare #ClinicalTrials 

𝐁𝐢𝐨𝐭𝐞𝐜𝐡 𝐚𝐧𝐝 𝐏𝐡𝐚𝐫𝐦𝐚 𝐔𝐩𝐝𝐚𝐭𝐞𝐬: September 24 - 25, 2024 • Emergent BioSolutions raking in $400M in mpox, smallpox vaccine orders • Vertex Pharmaceuticals’s Casgevy approved in Canada • Amgen notches mixed wins in atopic dermatitis and myasthenia graves • Genespire’s $52M Series B, Eurofins to build new $64M biologics site • Asklepios BioPharmaceutical, Inc. (AskBio)’s gene therapy collab with Belief BioMed • Semaglutide continues wonder-drug tirade with studies pointing to treating a chronic skin condition and opioid use disorder • 2seventy bio & Bristol Myers Squibb shutter Abecma myeloma trial • Johnson & Johnson allegedly slashing cardiovascular and metabolic disease divisions • Pfizer’s global recall of Oxbryta sickle cell med due to patient deaths More in today's TLDR Biotech newsletter: https://lnkd.in/guh7SMhn #biotech #pharma #pharmanews #biotechnews #tldrbiotech

🚨 uniQure releases updates about AMT-130’s approval pathway. The pharmaceutical company has made key progress in its pursuit of Accelerated Approval for AMT-130, a gene therapy for Huntington’s Disease, by reaching alignment with the FDA on key elements. 🎯 Highlights: - Agreement on Relevant Data: FDA has agreed that data from the Phase I/II studies, compared to a natural history external control, may serve for an upcoming regulatory submission known as Biologics License Application (BLA). - Clinical Measures Validated: The FDA recognizes the composite Unified Huntington’s Disease Rating Scale (cUHDRS) as a valid intermediate clinical endpoint for the Accelerated Approval Process. - Supporting Evidence: Reductions in neurofilament light chain (NfL) levels in cerebrospinal fluid (CSF) may serve as supportive evidence for therapeutic claims. - Regenerative Medicine Advanced Therapy (RMAT) Status: Confirmed in May 2024, highlighting AMT-130’s potential to meet critical unmet needs in HD treatment. 🔗 Learn more and read the full release here ➡️ https://lnkd.in/eMiznUxe

🌶 𝐃𝐚𝐢𝐥𝐲 𝐏𝐡𝐚𝐫𝐦𝐚 𝐃𝐢𝐠𝐞𝐬𝐭 (May 28, 2024) 👇 💊Novartis: Planning regulatory submissions for rare kidney diseases this year. 🧪Johnson & Johnson: Acquired Numab Therapeutics AG Therapeutics’ bispecific antibody NM26 for Phase II studies. 🧬Innovent Biologics: Achieved primary endpoints in Phase 3 trial for moderate to severe plaque psoriasis. 💡RevolKa Ltd.: Signed a master service agreement with Daiichi Sankyo US for protein engineering technology. 🦠Moderna: Reported smaller-than-expected loss for Q1 due to strong Covid vaccine sales. 🔬Merck Group: Acquired gene therapy tools maker for $600 million. 🧫Biogen: Acquired immune drugmaker HI-Bio for $1.15 billion. 🏭Eli Lilly and Company: Invested an additional $5.3 billion in its Indiana plant. 🎯AstraZeneca: Set a sales target of $80 billion by 2030. 🤝Novavax: Experienced a significant turnaround following its partnership with Sanofi. 📉 LOSERS: 🤷♀️AstraZeneca: Failed to show overall survival benefit in non-small cell lung cancer patients. 🚫 Novo Nordisk: FDA Ad-com voted against Icodec once-weekly insulin in Type1 diabetes, 7-4 💰Pfizer: Plans to save $1.5 billion by 2027 through cost-cutting measures. What are your thoughts on these developments? Share your insights below! Don't forget to follow ATACANA GROUP Inc. for daily updates on Pharma winners and losers! #pharmaceuticals #biotech #news #artificialintelligence #competitiveintelligence

April 2024 Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products Allogeneic cells of human origin may be expanded in culture to manufacture medical products consisting of live cells, inactivated cells, cell lysates, or other cell-based materials such as cell-derived particles. We, FDA, are providing you, sponsors of allogeneic cell-based medical products, recommendations for determining the appropriate cell safety testing to support an Investigational New Drug Application (IND) or a Biologics License Application (BLA). Cell safety testing should be based on a risk analysis that considers the expansion potential of the cells, the reagents that are used to expand the cells in culture, and the number of individuals the cell-based medical product is capable of treating. This guidance supplements the following two final guidances:  -“Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs); Guidance for Industry,” dated January 2020 , and  -“Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs),” dated April 2008. Link: https://lnkd.in/d2MgNDT5 #medicinalproducts #fda #cellbased #produktylecznicze