Drug Development

Formulation issues cause significant drug project delays and project failures, according to a 2018 survey conducted by Informa Pharma Intelligence, Rentschler Biopharma, and LEUKOCARE.

The decision follows an FDA request for additional information to complement the company’s submission for biosimilar rituximab.

AbbVie will grant Momenta license to launch a biosimilar to AbbVie’s Humira.

The multi-year collaboration will incorporate NextCure's proprietary FIND-IO platform, a technology designed to identify novel cell-surface molecular interactions that drive functional immune responses in the tumor microenvironment and other disease sites.

Demand for highly potent APIs continues to rise.

Survey results and record attendance show positive signs for various bio/pharma regions.

Experts share best practices, and war stories, for a crucial but often underappreciated part of drug development.

Thermo Fisher Scientific has entered into a collaboration with Symphogen to deliver validated, platform workflows for simplified characterisation and quality monitoring of complex therapeutic proteins.

This new partnership provides access to Distributed Bio’s antibody discovery platforms.

The company has expanded its operations in the United States with the opening of a new 45,000-ft2, early-phase formulation and manufacturing facility located in Garnet Valley, PA.

Dr C. Frank Bennett, has been announced as a recipient of the Breakthrough Prize in Life Sciences in recognition of his contribution to the discovery and development of the first drug approved for the treatment of spinal muscular atrophy (SMA).

To achieve a more dynamic marketplace, FDA is issuingguidance documents and targeted advisories to support R&D on complex generics and combination products.

The companies will work together to develop Ionis-FB-LRx for the treatment of complement-mediated diseases, including Geographic Atrophy (GA), the advanced stage of dry age-related macular degeneration (AMD), in a deal worth $760 million.

Novartis plans to acquire Endocyte, a biopharmaceutical company, to accelerate the development of innovative radioligand technology for treating cancer.

The agency is developing technology- and disease-specific regulatory frameworks for innovations that may not have previously had a clear development pathway.

The guidance describes the agency's recommendations on how to group patients with different molecular alterations and approaches for evaluating the benefits and risks of targeted therapies where some molecular alterations may occur at low frequencies.

The new guidance, Rare Diseases: 2 Early Drug Development and the Role of Pre-IND Meetings Guidance for Industry, discusses the planning of pre-IND meetings with FDA and sponsors.

The company will collaborate with GlycoBac to offer an insect cell line for the development of viral vaccines and gene therapies.

Novartis’ Sandoz has reached a global patent resolution for Hyrimoz (adalimumab), its biosimilar to AbbVie’s Humira (adalimumab).

A new investigational vaccine, LASSARAB, shows promise for use against Lassa fever and rabies.

Biotechnology developers should be aware of subtle differences between the way that European and United States patent authorities approach monoclonal antibodies.

Advances in biologic drug development require increased methodological and technological innovation from the biopharma industry. Learn more at the new bioLIVE launching this year adjacent to CPhI Worldwide 2018.

Innovative technologies, such as drug-loaded devices and 3D printing, enable advances in implantable devices and other novel dosage forms.

Lipid-based formulations offer a means of addressing the physicochemical and biological challenges of poorly soluble APIs.

Integration of new modeling and analytical tools with flow chemistry are notable trends.