Development

Merck KGaA opened a collaborative bio/pharma development facility in Molsheim, France and announced an investment plan through 2025 for its Darmstadt, Germany headquarters.

Findings from the Los Angeles Biomedical Research Institute could enable a new generation of anti-infectives.

Procarta Biosystems has received investment from Novo Holdings REPAIR Impact Fund to the tune of €1.5 million, which will be used to develop a new class of antibiotics to tackle AMR.

Iksuda Therapeutics and Femtogenix, have signed a license agreement aimed at progressing Iksuda’s lead ADC to clinic, with the aim of targeting difficult-to-treat solid tumors.

The acquisition will establish a clinical pipeline for Biogen of gene-therapy candidates in ophthalmology.

Jessica Rousset, chief operating officer, CURE Pharmaceutical, highlights some key regulatory considerations developers should keep in mind when approaching alternative dosage forms.

The technology uses a silica nanoparticle to deliver vaccines and cancer treatments.

FDA expects more than 200 investigational new drug applications for cell and gene therapies by 2020, causing the agency to strengthen its regulatory program.

Optimizing the patient experience and technological advances can positively impact adherence.

Both empty and filled syringes must pass a range of tests to meet quality standards for biopharmaceutical drugs.

A properly designed validation program will detect variation and ensure control based on process risk.

Valitacell and Solentim, have announced a collaboration aimed at the acceleration of discovery and development of biologic drugs and advanced cell therapies.

Mustang intends to combine an oncolytic virus with an interleukin-13 Rα2-(IL13Rα2)-specific chimeric antigen receptor to potentially enhance efficacy in treating glioblastoma multiforme.

The partners will collaborate on the development and commercialization of a B-cell maturation antigen-targeting immunotherapeutic for treating multiple myeloma.

Pathios Therapeutics and Sygnature Discovery have signed a strategic and innovative partnership agreement aimed at accelerating Pathios’ drug discovery and development programs.

The multi-year agreement will give Novartis access to AbCellera’s expertise and state-of-the-art antibody discovery technology for up to ten clinically-relevant disease targets.

The companies will jointly develop and commercialize an investigational bifunctional fusion protein immunotherapy currently in clinical development for cancer treatment.

PDA survey and conference discussion will generate information to guidance on technology transfer.

In a deal potentially worth up to $460 million, Genentech and Xencor will develop and commercialize novel cytokine therapeutics.

A solid lipid excipient from ABITEC is designed for multiple dosing forms.

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.