Navigating key news stories in pharma
Featured Stories
Non-invasive drug delivery via pulmonary and nasal routes is increasingly in demand; however, while there has already been significant innovation within the sector, even more is required to meet future needs.
The companies will leverage GSK’s scientific expertise with LTZ’s immune engager platform to develop new first-in-class MCE therapies for the treatment of hematologic cancers and solid tumors.
Regeneron’s investigational gene therapy, DB-OTO, has been found to provide meaningful improvements in hearing for nearly all of the participants in the CHORD clinical trial.
Led by researchers at the University of Liverpool, a team of international scientists have discovered a new, potent class of antibiotics that will help in the fight against antimicrobial resistance.
At the 15th Drug Delivery & Formulation Summit in Boston, Nanoform unveiled proof‑of‑concept data demonstrating new approaches to biologic drug delivery.
Non-invasive drug delivery via pulmonary and nasal routes is increasingly in demand; however, while there has already been significant innovation within the sector, even more is required to meet future needs.
The regulator’s decision will provide a new clinical option for patients with early gastric and gastroesophageal cancers that can deliver a significant survival benefit versus chemotherapy alone.
The company’s circVec 4.0 demonstrates unprecedented gene expression levels in heart and brain tissues to open new therapeutic opportunities across multiple organs.
R&D
Expansion
The company is creating a new flagship manufacturing hub in North Carolina that will enable end-to-end manufacturing of its key medicines in one geographic location.
Backed by the expert team and cutting-edge resources of Re:Build Manufacturing, Ensorcell will offer innovative, high-quality scientific tools designed to accelerate discoveries and improve patient outcomes.
A significant investment from Curewell Capital has been secured by Wilmington PharmaTech, providing growth capital to expand manufacturing and technology capabilities to accelerate drug development with U.S. manufacturing.
The USD 3 billion facility will expand the company’s capacity to produce oral medicines, enabling it to meet rising customer demand, and will also strengthen its global supply chain.
Dealmaking
A strategic research collaboration has been announced by Biogen and Dayra Therapeutics aimed at the discovery and development of oral macrocyclic peptides that could disrupt traditional antibody-based treatments.
In collaboration with A.forall and IMGA, Nanoform has formed a new subsidiary aimed at outlicensing Nanoencorafenib as an attractive patient-centric lifecycle management opportunity or value-added generic medicine opportunity.
The companies have entered into a definitive agreement for the acquisition, which includes an investigational immunotherapy preclinical candidate and a proprietary RNA modular platform.
Through the purchase the contract packaging organization will add 160,000 sq. ft. of manufacturing and warehouse facilities in Florida and will expand its capabilities and market segments.
Strategy
A fundamental, digitally driven overhaul of bio/pharmaceutical manufacturing models are needed to meet the demands of current global supply chain pressures and rising complexity of novel therapeutics.
As a settlement is finally agreed upon for Purdue Pharma and the Sackler family, the pharma industry needs to increase transparency and accountability to ensure profits are not prioritized over public health again.
Yaohui Ji brings nearly two decades of leadership experience as BioDuro strengthens its integrated contract research, development, and manufacturing organization (CRDMO) platform for small and large molecule development.
The Big Pharma companies have voluntarily agreed to a range of measures to reduce the cost of medicines for American patients while also preserving the biopharmaceutical innovation ecosystem of the U.S.
Future Biopharma
Non-invasive drug delivery via pulmonary and nasal routes is increasingly in demand; however, while there has already been significant innovation within the sector, even more is required to meet future needs.
Primary packaging requirements are evolving in line with development trends; however, flexible and easily integrated ready-to-use solutions are beneficial options, highlight Dr. Robert Lindner and Christoph Zauner from SCHOTT Pharma.
For Jacob Werlinger from Bend Bioscience, turning innovative concepts into reality requires CDMOs to not just be service providers but more of a strategic scientific partner that can help advance the concept to commercialization using the right science tools.
Implementation of three-dimensional (3D) cell culture nanofiber systems in industrial vaccine production offers much higher viral vaccine titers, greater scalability and improved process economy, but it will require tight collaboration with the industry to help speed up their wide adoption, stresses Laura Chirica from Cellevate.
Regulatory
The regulator’s decision will provide a new clinical option for patients with early gastric and gastroesophageal cancers that can deliver a significant survival benefit versus chemotherapy alone.
The company’s circVec 4.0 demonstrates unprecedented gene expression levels in heart and brain tissues to open new therapeutic opportunities across multiple organs.
Having secured a European Commercial CGMP Manufacturing License from FIMEA, Nanoform is now able to produce and control the quality of nanoformed APIs for Europe and other key markets.
In light of the evolving therapeutic landscape, increasing use of advanced technologies, and political shifts, regulatory updates are inevitable, meaning that bio/pharma companies will need to adjust quickly to new requirements.
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