
Navigating key news stories in pharma
Featured Stories
As pharmaceutical packaging evolves to incorporate more patient-centric designs, overcome increasingly complex formulations, and undergo a digital transformation, safety and compliance remain non-negotiables.
As pharmaceutical packaging evolves to incorporate more patient-centric designs, overcome increasingly complex formulations, and undergo a digital transformation, safety and compliance remain non-negotiables.
With an increasing spotlight on sustainability, it is increasingly important for industry-wide sustainability practices to be implemented to ensure transformative change is achieved.
In this white paper, Chris Gilmore, Director of Sales, Sanner America, introduces the company’s new packaging platform, TabTec® CR, which is a convenient solution for oral solid dosage products with integrated desiccant and child-resistant opening.
Dealmaking
This partnership will leverage BioDuro’s expertise and Atombeat’s in silico modeling know-how to launch an AI-powered platform that allows for accelerated development of next-generation peptides.
The companies will work together, leveraging Syntekabio’s AI prediction platform for virtual screening to uncover new, high-potential indications for MetaVia’s DA-1241 oral therapy.
The strategic collaboration will also provide GSK with an exclusive worldwide license for Hengrui’s potential best-in-class PDE3/4 inhibitor, which is in clinical development as an add-on maintenance treatment for COPD.
The strategic collaboration and license agreement is potentially worth more than USD 1 billion and offer patients less burdensome treatment regimens through sustained ocular delivery of therapies.
Future Biopharma
With an increasing spotlight on sustainability, it is increasingly important for industry-wide sustainability practices to be implemented to ensure transformative change is achieved.
While biomanufacturing has ample capacity, a funding downturn and workforce shortages have created a paradoxical situation, putting pressure on sponsors’ decisions when it comes to choosing their manufacturing partners.
While there have been promising advances in terms of technologies to help the development and manufacture of next-gen therapies, limitations remain; but, it is likely that AI will be revolutionary for development in the near future.
Advanced technologies, while important for the successful development and manufacture of next-gen therapies, are still a long way off being impactful, meaning more investment is needed to reap the rewards of these promising treatments.
R&D
The grant money will be used by the biotechs to develop innovative targeted lipid nanoparticles that contain novel immune-silent DNA constructs for in vivo CAR T therapy.
The company’s research in a well-established rodent model has shown that EB-003 has potential as an effective treatment for post-traumatic stress disorder, representing an opportunity in an underserved market.
Business Finland is providing Nanoform with a EUR 5 million R&D loan to be used to accelerate the clinical development of the nanoformulated version of apalutamide through to the pivotal bioequivalence study.
The latest studies on the mechanism of action for LIB-01 have demonstrated that the drug targets the underlying nerves and vascular structures that are involved in penile erections.
Expansion
The strategic investments by the CRDMO, which are aligned with its long-term strategy, will strengthen its integrated oligonucleotide platform and capabilities to delivery ADC solutions.
The location of the facility has been purposefully chosen to be as central as possible to cell and gene therapy companies located across the U.S. and will allow the company to meet growing demand for pDNA development and manufacturing services.
Through this acquisition, ESTEVE will expand its contract development and manufacturing services for small-molecule APIs from pre-clinical through to commercial manufacturing within the U.S.
Marking a strategic move for the company, the expansion will enable acceleration of pre-clinical development of the circVec circular RNA expression data platform.
Strategy
As pharmaceutical packaging evolves to incorporate more patient-centric designs, overcome increasingly complex formulations, and undergo a digital transformation, safety and compliance remain non-negotiables.
D’Herve has succeeded Dr. Singh, bringing a wealth of industry experience to the position, having previously served in senior positions at Evonik.
Recent fatalities in clinical trials for gene therapies have led to greater regulatory scrutiny and concerns over safety, particularly in relation to the use of viral vectors, leading industry to question whether a potential therapeutic reinvention is needed.
In efforts to position itself for long-term growth, Rocket is reducing its company headcount, undergoing a structural reorganization, and prioritizing late-stage AAV cardiovascular programs.
Regulatory
FDA has granted approval to Viatris for its generic intravenous iron replacement product as a treatment of iron deficiency anemia in adult and pediatric patients with chronic kidney disease.
If the oral antibiotic gains regulatory approval, patients who are 12 years of age and older in the U.S. suffering from urogenital gonorrhea will have an alternative, non-invasive treatment option.
This latest FDA leadership appointment comes as the agency focuses on balancing regulatory challenges with opportunities for accelerated patient access.
Pegcetacoplan (EMPAVELI), which was shown to be safe and effective in a Phase III clinical trial, is now approved for the treatment of U.S. patients 12 years and older with C3G and primary IC-MPGN.
Upcoming Events
The goal of this Symposium is to provide a forum for the discussion of recent developments in capillary electrophoresis (CE) analysis of protein, nucleotide, and small molecule pharmaceuticals.
This September in Philadelphia, the brightest minds in marketing, commercialization, medical affairs, and PR & communications are coming together for one unmissable week of insight, innovation, and industry-shaping strategy.
Join the 26th Precision in Drug Discovery & Preclinical Summit (Barcelona, Spain, Europe) PDDP for a two-day journey into the insightful world of drug discovery and preclinical drug development.