Despite not achieving its primary endpoint in the pivotal ALSummit trial, Neuronata-R®, an innovative stem cell therapy for amyotrophic lateral sclerosis (ALS), has shown promising clinical improvements in a vital subgroup of patients. Developed by South Korean biotech powerhouse CorestemChemon, the therapy has demonstrated significant efficacy in patients whose disease progression is slower than average. […]
Tag: Biologics
Advancing Hope: Stem Cell Transplant for Severe Monogenic IBD
In the ongoing quest to treat severe monogenic inflammatory bowel disease (IBD) in children, a groundbreaking new study from The Children’s Hospital of Philadelphia (CHOP) offers a beacon of hope. The retrospective study provides compelling evidence that allogeneic hematopoietic stem cell transplant (HSCT) can radically transform treatment strategies, offering the potential for long-term, medication-free remission. […]
Strategic Partnership to Enhance Drug Development
In a significant leap forward for the pharmaceutical industry, Radyus Research and Eurofins CDMO Alphora have announced a strategic alliance geared towards accelerating drug development and streamlining the path from lab to market. As the boundaries of biotechnology continue to expand, this collaboration signifies a burgeoning trend in the industry: the drive for integrated, end-to-end […]
Enhancing European CDMO Fill-Finish Trends
In the dynamic world of advanced biologics development, a new player has emerged, offering transformative solutions that look set to revolutionize the field. Experic, a global leader in Contract Development and Manufacturing Organization (CDMO) services, is now providing comprehensive solutions to the European market, specifically designed to accelerate the delivery of inhalation products. Experic’s services […]
Zydus Acquires Agenus’ US Biologics Facilities for Expansion
In a strategic move that will indubitably send ripples through the biologics sector, Zydus Lifesciences has acquired two sophisticated biologics manufacturing facilities in the heart of California’s biotech hub, from renowned immuno-oncology company Agenus Inc. This acquisition marks a significant step forward for Zydus, positioning the company to not just dip its toes, but dive […]
Samsung Biologics Plans Holding Company for CDMO, Biosimilar Biz
In a strategic move to create a clear demarcation and optimize operational focus, Samsung Biologics is looking to establish a holding company to separate its Contract Development and Manufacturing Organization (CDMO) and biosimilar business units. This planned division represents a paradigm shift in the company’s operational strategy and underscores its commitment to maximizing growth potential […]
Bioburden Testing Market Growth Trends and Opportunities
The bioburden testing market is in the midst of a robust expansion propelled not only by the burgeoning healthcare sector but also by the rigorous regulatory norms imposed by organizations such as the U.S. FDA, EMA, and PMDA. These stringent regulations play a pivotal role in ensuring product safety and efficacy throughout pharmaceutical production processes, […]
Zydus Lifesciences Acquires Agenus Cancer Immunotherapy Rights
Zydus Lifesciences, a reputed name in the Indian biotech industry, has made a strategic move, securing the rights for Agenus’ innovative cancer immunotherapy BOT/BAL in India and Sri Lanka. This partnership, which aligns perfectly with Zydus’ vision for advancing biologics and addressing high-unmet medical needs, is poised to significantly transform the oncology landscape in the […]
Candel Therapeutics Adds Maha Radhakrishnan, M.D. to Board
Candel Therapeutics, a clinical-stage biopharmaceutical company with significant focus on developing multimodal biological immunotherapies for cancer patients, has recently announced the appointment of Maha Radhakrishnan, M.D., to its Board of Directors. This move aligns with the company’s strategic roadmap, which emphasizes innovative research, product development, and effective commercialization of treatment options for patients grappling with […]
Top Biotech Stocks: Daily Updates
Title: “The Evolving Landscape of the Biopharmaceutical Industry: A Closer Look at Pfizer and its Peers” In the dynamic world of biopharmaceuticals, a few industry leaders continue to set the pace, leveraging their innovative capabilities and strategic partnerships to drive significant advancements in healthcare. Pfizer Inc., a titan of the global biopharmaceutical industry, is a […]
Rising Healthcare Costs Amid Employer and Insurer Pressure
“Healthcare costs are escalating, propelled by factors like rising prescription drug spending, the increased use of GLP-1 medications, specialty therapies, and biologics. Despite the disruptions caused by the pandemic, drug development and FDA approvals have promptly resumed, resulting in a surge of new treatments. This influx is anticipated to strain the healthcare system’s capacity for […]
Biologics Contract Manufacturing Market Forecasted to Reach $83.47B by 2033
The biologics contract manufacturing market is projected to attain a robust value of $83.47 billion by 2033, demonstrating promising trends, outlook, and the participation of industry-leading companies such as Datam Intelligence. Biologics are complex biological products that are derived from living organisms, providing innovative solutions for a wide array of diseases. Contract manufacturing plays a […]
Challenges in mRNA Vaccine Fill/Finish
The landscape of fill/finish for mRNA vaccines presents unique challenges for CDMOs. These challenges include the need for capabilities to formulate and supply lipid nano particles (LNP) for mRNA encapsulation, as well as the criticality of cryo-handling. CDMOs face the additional complexity of meeting seasonal availability requirements for mRNA vaccines, which contrasts with steady monthly […]
Zydus Lifesciences Enters Global Biologics CDMO Sector
Zydus Lifesciences is poised to make a significant entry into the global biologics CDMO business through the acquisition of US-based Genus Inc. This move aligns with Zydus’ strategic vision in biologics and their commitment to developing innovative solutions for unmet medical needs, particularly in the field of immuno-oncology. The collaboration with Agenus, a key player […]
Samsung Biologics’ Spin-Off Plan Sparks Stock Volatility
Samsung Biologics’ announcement to split into a contract drug manufacturer and a holding company has caused fluctuations in C&T shares. This move signals a significant restructuring within South Korea’s largest conglomerate. The plan aims to streamline operations by separating the manufacturing arm from the oversight and management functions, potentially enhancing overall efficiency and focus in […]
FDA, CDC Actions Impact COVID-19 Vaccine Coverage
In a commentary by FDA Commissioner Marty Makary, MD, MPH, and Vinay Prasad, MD, MPH, the FDA’s approach to Covid-19 vaccines balances regulatory flexibility with gold-standard science. Trials will focus on high and low-risk individuals, shaping future FDA decisions and meeting healthcare provider and public needs. This strategy aims to ensure vaccine safety and efficacy […]
HT-KIT Activity in Rare KIT-Driven Cancers
Hoth Therapeutics is progressing HT-KIT towards clinical evaluation, aiming to submit an investigational new drug application to the FDA in early 2026. An investigational new drug application is a request for FDA authorization to administer an investigational drug to patients. This step is crucial before administering any new drug not yet approved through a new […]
Enhancing Recombinant Protein Production with EffiX System
WuXi Biologics introduces the EffiX E coli expression system to boost the production of recombinant proteins and plasmid DNA. This innovative system is designed to optimize the expression of nanobodies, providing a more efficient and cost-effective solution for biotechnological applications. EffiX offers a streamlined approach to generating high yields of target proteins, benefiting industries reliant […]
India’s Biologics Manufacturing Leadership
India has a significant opportunity to lead in the transition from generics to biologics by focusing on building capacity for next-generation biologic modalities and securing access to essential inputs. Biologics such as cell and gene therapies, monoclonal antibodies, antibody-drug conjugates, and nucleic acid-based treatments rely on a complex array of components like expression vectors, engineered […]
Agenus, Zydus Lifesciences Collaborate to Advance Biologics Manufacturing
Agenus and Zydus Lifesciences have entered a $141M strategic collaboration to advance their BOT/BAL programs and expand Zydus’ biologics manufacturing in the US. Forward-looking statements in this press release highlight the companies’ botensilimab and balstilimab programs, expected regulatory timelines, and filings. It is crucial to note that these statements are subject to risks and uncertainties […]
Zydus Strengthens Biologics Presence Through Agenus Deal
Zydus has solidified its position in the global biologics market through the acquisition of Agenus, which includes biologics manufacturing sites in Emeryville and Berkeley, California. The deal involves an upfront payment of $75 million, with an additional $50 million in milestone-based payments over three years. These facilities will support Zydus’ new biologics CDMO business, catering […]
