Biologic Drugs in Development

As biologics continue to push boundaries, the industry needs to take a holistic approach to formulation to ensure success.

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

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

Janssen and MeiraGTx will collaborate on the development and commercialization of gene therapies for treating inherited retinal diseases.

Biosimilars, pricing strategies, and technology investments will influence growth in spending on drugs.

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

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

Moving forward with gene therapy development requires a “quantum leap” in manufacturing capabilities.

The new program will provide cell and gene therapy companies a more efficient way to ensure quality compliance across collection center networks and to minimize quality system audit burden on these centers.

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.

While food, shelter, and clothing are the primal essentials for life, hope-as embodied by modern medicine-has now become part of that human expectation.

The CHF 400-million (US$416-million) investment in Lonza's biopark in Visp, Switzerland, will expand Ibex Solutions with two new offerings, drug substance development and drug substance and drug product manufacturing.

The drug particle engineering and nanotechnology company offers a nanotechnology platform that can revive failed drugs in the pharma pipeline.

Colin Clarke, from the National Institute for Bioprocessing Research and Training, will lead a four-year European Industrial Doctoral Program for enhancing upstream biopharmaceutical manufacturing process development through single cell analysis.

Andrew Bulpin, head of Process Solutions, MilliporeSigma, shares insights on characterizing CQAs in biopharmaceutical development and the different tests that should be carried out when assessing an investigational drug.

Protagen Protein Services, a CRO, now offers quicker and more accurate characterization of biomolecular stability using differential scanning calorimetry (DSC).

Frustrated by slow market adoption, Gottlieb maps out new plan for biosimilar competition.

The National Science Foundation grant will be used to commercialize a synthetic biology platform for cancer drug development.

In launching FDA’s Biosimilar Action Plan, Gottlieb takes innovator companies to task for delaying competitive biosimilar products.

CELLforCURE will produce cancer CAR-T treatments for Novartis at a manufacturing facility in Les Ulis (Essonne), France.

The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.

After 30 years of biologic-drug advances, the industry and patients still have a lot to learn.

The company has completed the first phase of expansion at its headquarters in Freiburg, Germany, in anticipation of increasing demand as cell and gene therapies approach commercialization.

MilliporeSigma targets emerging biotechs with US development center and global grants.