Development

Transdermal patch design, materials, and manufacturing variables, as well as drug formulation and interactions between the API and the adhesive, can affect adhesion and drug delivery.

Virpax’s Patch-in-a-Can technology delivers pain medication using a metered-dose spray film.

Using training devices may ease patient anxiety about using autoinjectors and prefilled syringes, potentially leading to improved patient adherence.

FDA Commissioner Scott Gottlieb has been promoting drug market competition in recent months that includes new guidance documents and targeted advisories to support R&D of complex drugs and combination products.

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

Charles River Laboratories has announced a data expansion in its compendium of tumor models for oncology drug R&D.

A new, high-throughput microplate reader cuts down on screening time and works faster than standard ultra-high-performance liquid chromatography processes.

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.

The testing of raw materials is essential as raw material quality determines the outcome of biologic product quality.

Experts believe that the contract development and manufacturing organization market will reach $17.38 billion by 2022, with disruptive business models using Industrial Internet of Things (IIot) and single-use technologies proving more profitable and efficient in the long term.

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.

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.

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