Development

The strategic alliance provides an integrated product offering around drug discovery and development.

The transgenic mouse R&D platform will support the discovery of fully-human monoclonal antibodies.

Emergent BioSolutions will help develop and manufacture an oral vaccine candidate and will develop plasma-based antibody therapeutics.

USP technical advisors will offer assistance to drug developers to ensure material quality and testing.

The partners have initiated an observational case-control study of siltuximab in patients with COVID-19 who have developed serious respiratory complications.

An NIH study of a COVID-19 vaccine is enrolling Seattle-based healthy adult volunteers.

With some FDA inspections on hold, will the US drug supply maintain its quality standards?

The company is using its LEAPS peptide technology to develop the immunotherapy, which may be able to reduce COVID-19 viral load and tissue damage.

The new center expands the company’s R&D capabilities and will help it advance its portfolio of rare disease gene therapy programs.

Research from data and analytics company GlobalData shows that CAR-T cell therapy innovations across APAC will make the global market for these therapies more competitive.

Contract service organizations can offer biopharma companies early insight into dangers that may hinder a drug’s later development.

The partners will use ProBioGen’s DirectedLuck transposase technology to support development and large-scale manufacturing of ImmunOs’ biologics.

Under the agreement, ERS Genomics will license its gene-editing technology to Aelian Biotechnoloy to support its commercial functional genomic screening platform.

An evaluation by USP indicates bovine heparin is a potential alternative to porcine heparin.

FDA’s Center for Biologics Evaluation and Research is planning on publishing nine specific guidance documents on gene therapies in 2020.

The agency is taking steps to monitor the supply chain and assist in the development of treatments.

The knockout CHO K1 cell line will be used to support biotherapeutic R&D across a range of therapeutic indications.

Bio/pharma researchers mobilize to diagnose and treat patients in pandemic threat.

Biologics raise unique formulation and development challenges, and industry is still on a learning curve to get the best out of these diverse and complex therapies.

The partners will collaborate on developing scale-up chip-based technology to enable commercial-scale production of a third-generation DNA synthesis platform.

Otsuka will use PhoreMost’s phenotypic screening platform to identify new targets for drug development, with a focus on gene therapy.

The license gives Daiichi Sankyo access to ERS Genomics’ genome-editing technology for internal R&D initiatives.

The agreement centers around the development of new stem-cell derived allogeneic T-cell therapies for the treatment of cancer.

While the US public and law makers push for price controls, pharma’s venture capitalists have other ideas for balancing innovation and affordability.

Under the agreement, Almirall will leverage WuXi Biologics’ proprietary WuXiBody platform to develop bispecific antibodies for dermatological diseases.

Roche will apply ProBioGen’s proprietary GlymaxX technology to boost the antibody-dependent cellular cytotoxicity activity of antibodies.

The joint venture will develop next-generation cell and gene therapies incorporating Affimer proteins.

While falling short of the 2018 record levels, US drug approval numbers continue to set the pace globally.

Achieving effective manufacturing processes and sufficient capacity remains a top priority across a diversified biologic drug pipeline.

While cell and gene therapies differ in many ways, some of the best practices for process development and validation are similar.