Development

Company launches new services dedicated to emerging biotech and biopharma companies.

New platform technologies, advanced modeling tools, and addressing patient needs are important developments.

Solentim and ATUM have announced a technology collaboration agreement that will focus on the creation of an efficient cell line development solution for biotherapeutic drug developers.

The agreement gives Sanofi access to Biomunex’s proprietary bi- and multi-specific-antibody-generating platform.

Orphan and cancer drugs continue to lead, but treatments for many common diseases were also approved in 2018.

A new plasma B cell antibody discovery workflow launched by Berkeley Lights enables the shortening of antibody drug discovery from month to a day.

The new reagents are designed to support clinical-phase and commercialization stages of cell and gene therapy production and to enhance DNA transfection.

Compensation and professional challenges are key pieces to solving the biopharma employee satisfaction puzzle.

Bio/pharma companies are successfully launching novel therapies; however, the industry still needs to work on manufacturing innovation.

The agency is looking to leverage real-world health data to support drug development.

The companies aim to advance research into inflammatory bowel disease.

Bioconjugation requires aseptic manufacturing and containment for cytotoxic payloads.

Advances in single-use technologies, sensors, and cell retention systems facilitate processes designed for the long run.

The acquisition will give Genentech full rights to Jecure’s preclinical portfolio of NLRP3 inhibitors.

The contract research organization has increased its US-based early phase clinical capacity and doubled its specialty lab space.

The new center will integrate biologics drug discovery, development, clinical manufacturing, and commercial manufacturing.

ADC Biotechnology will invest downstream formulation, fill/finish capabilities, and Lock-Release conjugation technology.

More-and earlier-interaction between R&D and payers will be essential if innovative therapies are to become more accessible for patients, and more profitable for manufacturers, said panelists at the 2018 Galien Foundation Forum.

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

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.

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.

New data highlights ability of the SQZ cell therapy platform to preserve cellular functions.

Survey results and record attendance may show positive signs for established and emerging biopharma regions.

Bioconjugation requires aseptic manufacturing and containment for cytotoxic payloads.

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