Early Phase Development

The contract research organization (CRO) has acquired Xenometrics, a non-clinical CRO specializing in preclinical assessment of new drug candidates.

Despite GxP and data-management challenges, pharma is moving toward new models for clinical trial logistics.

As part of the $900-million deal, Incyte will pay $150 million upfront to develop and commercialize an anti-PD-1 drug candidate from biopharmaceutical company, MacroGenics.

AbbVie will pay a $205-million upfront payment and have the option to develop and commercialize two antibody targets globally.

The collaboration aims to improve the pharmacokinetics of anti-C3 proteases developed by Catalyst to develop therapeutics for severe eye disorders.

Inovio has reported results from a study with non-human primates that showed 100% effectiveness with a DNA vaccine the company is developing with the US Army.

NIH has entered a five-year, $215-million collaboration with leading biopharmaceutical companies to advance the development of cancer immunotherapies.

BARDA has entered a $12-million contract with biopharmaceutical firm Achaogen for the late-stage development of an antibiotic against resistant bacteria, and as a potential treatment for biowarfare agents.

J&J’s Janssen ends a 2015 collaboration with Achillion Pharmaceuticals with a strategic decision to discontinue further development of a hepatitis C therapy in favor of pursuing hepatitis B therapeutics.

Catalent expands the scope of the OptiForm Solution Suite to bridge gap from late-stage discovery to Phase I trials.

A new study predicts a potential disconnect between regulatory science and biotechnology product development, unless regulators scan the horizon for new developments and consider new potential risk pathways.

Andrew Bulpin, head of Process Solutions Strategic Marketing & Innovation at MilliporeSigma spoke with BioPharm International about the requirements of expression systems in biosimilar development.

Developers of CAR-T cell therapies with products showing successful early-stage clinical results are currently seeking manufacturing capacity that will enable the production of the larger quantities of material needed for Phase III trials and eventual commercialization.

FDA says it is “weighing the appropriate regulatory approach” to handle the tasks outlined by President Obama’s new Precision Medicine Initiative.

EMD Millipore receives recertification of GMP compliance for Biodevelopment Centre in Martillac, France.

Therapeutics targeting epigenetic mechanisms of disease will change the pharmaceutical marketplace.

AET BioTech and BioXpress Therapeutics have entered into an agreement to codevelop a biosimilar version of Abbott's tumor necrosis factor inhibitor monoclonal antibody adalimumab.

How does working in a virtual biotech environment affect biosimilar development? Anjan Selz outlines target and partner selection in this first of a two part article.

MorphoSys AG (Munich, Germany) and Galapagos NV (Mechelen, Bengium) have launched a long-term co-development alliance aimed at discovering and developing antibody therapies based on novel modes of action in bone and joint disease, including rheumatoid arthritis, osteoporosis, and osteoarthritis.