
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.
The company has decided to voluntarily withdraw obeticholic acid from the U.S. market after the FDA issued a request for the withdrawal and put a clinical hold on trials involving the drug.
The global healthcare company is expecting that its efforts to streamline operations will allow it to improve the speed of decision making and reinvest savings into pertinent growth opportunities.
The latest multi-asset licensing and option agreement between Argos and Novartis, will grant the Swiss pharma giant rights to key siRNA molecules, building on the companies’ partnership.
Dealmaking
The latest multi-asset licensing and option agreement between Argos and Novartis, will grant the Swiss pharma giant rights to key siRNA molecules, building on the companies’ partnership.
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.
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
In a financial report webcast, the Norwegian biotech presented breakthrough circVec-AAV data showing up to 40x higher protein expression than traditional mRNA-AAVs.
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.
Expansion
Located in Hopewell, N.J., the new facility signifies the first major manufacturing investment for Enzene within the U.S., strengthening the company’s commitment to supporting innovation and supply chain resilience in the country.
This latest funding will bolster the additional investment and private capital and will allow Delpharm to modernize its Boucherville facility to be able to meet the growing demand for injectable drugs.
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.
Strategy
The global healthcare company is expecting that its efforts to streamline operations will allow it to improve the speed of decision making and reinvest savings into pertinent growth opportunities.
Industry leaders delve into the latest biopharma supply chain disruptions and provide insights into approaches that can help to reduce vulnerabilities and ensure greater resilience in the future.
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.
Regulatory
The company has decided to voluntarily withdraw obeticholic acid from the U.S. market after the FDA issued a request for the withdrawal and put a clinical hold on trials involving the drug.
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.
Upcoming Events
Returning for its 7th year, the RAS-Targeted Drug Development Summit remains the only industry-focused meeting dedicated to targeting all RAS mutations in the fight against a wide array of cancers.
The 15th Annual DPHARM® offers an unparalleled opportunity to hear senior clinical operations executives and innovative thought leaders unveil the latest innovations on modernizing clinical trials.
Ilmac is where the life sciences industry meets, moves, and makes deals. Ilmac has its origins in the Swiss trade fair for laboratory, measurement technology and automation in the chemical industry, which was held for the first time in Basel in 1959.