Feliza Mirasol

This podcast explores the challenges of and the progress made so far by the biopharma industry toward alternative drug delivering methods for biologic drugs.

Under the long-term supply agreement, Lonza will manufacture CASGEVY (exagamglogene autotemcel) for Vertex at its facility in Geleen, the Netherlands, and plans to expand manufacturing to Portsmouth, NH, in the United States.

By approving EBGLYSS (lebrikizumab-lbkz), FDA has made available a new biologic treatment for moderate-to-severe atopic dermatitis that is not well controlled with topical treatments.

Lilly has increased its manufacturing investment for biologics in Limerick, Ireland, by $1 billion while launching its new $800 million facility in Kinsale.

The new Vivaflow SU tangential flow filtration cassette is designed to be more flexible and user-friendly and offers enhanced ultrafiltration and diafiltration efficiency.

The finalists for the 2024 CPHI Pharma Awards are spread across 14 categories, which include future leaders, women of the year, and an “at the heart of pharma” category.

Alternative delivery methods for biologics continues to be explored that offer less invasive, less painful administration.

Viral vectors and other complex biologic modalities require more specificity and higher sensitivity to detect and distinguish contaminants.

Rentschler Biopharma now offers a new lentiviral vector manufacturing toolbox at its site in Stevenage, UK.

FDA’s latest approval of Imfinzi (durvalumab) in combination with chemotherapy for treating resectable non-small cell lung cancer before and after surgery is based on Phase III trial results showing that the regimen reduced the risk of recurrence, progression, or death by 32%.

With the completion of its acquisition of Morphic, Lilly expands its immunology pipeline to include Morphic's oral integrin therapies to address inflammatory bowel disease.

Under a deal worth potentially up to $1.3 billion, Merck, known as MSD outside of the United States and Canada, will acquire CN201, a next-generation bispecific antibody, from Curon Biopharmaceutical.

Genentech will leverage Sangamo’s proprietary capsid delivery platform and epigenetic regulation capabilities to develop genomic medicines to address certain neurodegenerative diseases.

Under the license agreement, Andelyin Biosciences will expand its AAV Curator Platform by including MyoAAV plasmids developed by Broad Institute of MIT and Harvard.

Optimizing AAV vector manufacturing will be necessary to meet anticipated future market demand.

With a $15 million fund-raising goal, US Specialty Formulations plans to invest in expanding its biopharma facility in Allentown, Pa.

AAV and lentivirus both have pros and cons in their use for specific gene therapy applications.

The biopharma industry is seeking ways to apply cell and gene therapies to mass patient populations.

BioIVT has launched new cleanroom manufacturing space using Germfree’s technology that boosts its cell and gene therapies development capabilities.

Freudenberg Medical now offers custom single-use assemblies to expand its offerings in silicone extrusion and molding for biopharma applications.

With this acquisition, AbbVie gains Cerevel’s clinical-stage assets that complement AbbVie's emerging neuroscience pipeline as well as branded products for treating psychiatric disorders, migraine, and Parkinson's disease.

The new biotech company will use the Series A financing to advance the development of enhanced biologics to treat solid tumors and inflammatory and immunology diseases.

STADA and Alvotech have launched Uzpruvo, the first approved biosimilar to Stelara (ustekinumab), in the European market, marking the second biosimilar brought to market by this partnership.

Scorpius Holdings expects to launch its first CGMP campaign for mammalian-based biomanufacturing in the 2024 third quarter.

BeiGene has invested $800 million into a new biologics manufacturing facility in Hopewell, NJ, which also houses its clinical R&D capabilities.

Under the expanded agreement, Univercells and University of Pennsylvania will evaluate certain bioreactors for scalable gene therapy production.

GSK’s submission is supported by Phase III trials showing significant progression-free survival benefit and positive overall survival trends using Blenrep combinations compared to standard care.

Pluri’s newly launched CDMO business will manufacture two novel cell therapy product candidates for Kadimastem.

The acquisition adds a Phase III therapeutic peptide candidate to AstraZeneca’s late-stage pipeline for rare diseases.

The acquisition of EyeBio adds a late-phase antibody drug candidate for diabetic macular edema and neovascular age-related macular degeneration to Merck’s pipeline.