Drug Development

This paper explores the legal and regulatory framework around 3D drug printing, particularly for personalized medicine, considering regulatory compliance, business concerns, and intellectual property rights.

Novartis will in-license PTC's PTC518 program, which has the potential become the first oral disease-modifying therapy for Huntington's disease.

Centogene NV and ROPAD consortium publish data from a landmark study identifying genetic variants that may respond to innovative cell and gene therapies.

Automation technologies provide real potential to improve responsiveness and decision-making in drug development.

LNPs have gained solid ground as a drug delivery system for mRNA due to their success in the vaccines arena.

Through the agreement, Cambrex will provide accelerated access to clinical development capabilities to Lilly’s biotech collaborators.

EXO Biologics and ExoXpert, an EXO Biologics subsidiary, have received GMP certification of a European manufacturing facility for exosomes and have successfully loaded mRNA and DNA payloads into GMP-grade exosomes for drug delivery.

With its new offering, Lonza can tailor services to support smart capsule companies with its bi-layer capsule manufacturing technology.

Datwyler has launched new coated plungers in its NeoFlex line that are suitable for large volume biologics.

The companies will collaborate to create and test circVec DNA–LNP formulations for use in potential therapeutic applications.

Webinar Date/Time: Fri, Dec 13, 2024 11:00 AM EST

CHMP has granted Eisai Europe and Biogen a positive opinion for the use of their monoclonal antibody therapy in treating early Alzheimer’s disease.

Avantor's newly launched expanded Innovation Center in Bridgewater, NJ, is designed for integrated workflows and features purpose-built collaboration spaces.

Executives at Avantor talk about the future of the biopharmaceutical industry and the anticipated impact that a wave of next-generation biotherapeutics will bring.

Pharmaceutical Technology® caught up with Brittany Hayes, PhD, Highly Potent & Oncology Platform Director at CordenPharma, after AAPS PharmSci 360 to talk about the challenges and quality requirements involved in the development and manufacture of peptide-based oral dosage forms.

Webinar Date/Time: Wed, Dec 4, 2024 11:00 AM EST

Webinar Date/Time: Tue, Dec 3, 2024 11:00 AM EST

The new Institute for Cell Therapy Discovery and Innovation will utilize expertise to develop cell therapies for cancer, autoimmune diseases, and infections.

The companies will work to create climate-friendly pMDIs using Orbia’s low global warming potential propellant.

In the collaboration, the new company, Oblenio Bio, has been granted an exclusive option to license LBL-051, a tri-specific T-cell engager antibody, from Leads Biolabs.

A genetic medicines customer has selected the company’s binders for commercial development of the customer’s product.

Automation, miniaturization, and new software algorithms are improving throughput and accuracy.

Synaffix, a Lonza company, has licensed its ADC technology to BigHat Biosciences to be combined with the latter's ML design platform to develop new ADCs

CDER Director Patrizia Cavazzoni and CBER Director Peter Marks provided an update on the rare disease innovation hub in a new FDA Voices blog post.

The partnership will use ViaNautis’ proprietary polyNaut technology platform to develop genetic medicines that can precisely target tissue types.