Drug Development

With ingredients sold to multiple markets, excipient manufacturers must understand the different regulatory requirements for pharma vs. food.

As COVID-19 rapidly spreads, the bio/pharma industry is committing significant efforts to fast track development of therapies.

The new molecules entering the development pipeline are bringing forth exciting challenges in drug delivery.

Pre-clinical immunization studies of iBio’s SARS-CoV-2 VLP candidates are being performed by Texas A&M.

Johnson & Johnson announces clinical trial plans for COVID-19 vaccine candidate, as well as plans to produce 1 billion vaccine doses.

AstraZeneca has revealed that it will collaborate with Silence Therapeutics on the discovery, development, and commercialization of small interfering RNA (siRNA) therapeutics for the treatment of cardiovascular, renal, metabolic, and respiratory diseases.

Grifols has entered into a formal collaboration with US Federal public health agencies, including the Biomedical Advanced Research Development Authority (BARDA) and the Food and Drug Administration (FDA), to produce a treatment that specifically targets COVID-19.

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.

FDA is offering advice and added flexibility to help sponsors adjust ongoing and planned clinical research programs during the COVID-19 outbreak.

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

Synairgen, a respiratory drug discovery and development company, has announced that it has received expedited approvals to conduct a trial of its inhaled formulation of interferon-beta-1a, SNG001, in COVID-19 patients.

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.

Thermo Fisher Scientific launched the ALPS 5000 Plate Sealer to simplify the plate sealing process and provide enhanced dependability and productivity for stand-alone and integrated robotic projects.

Assays can provide a useful tool in determining the potential toxicity of drugs throughout the development cycle.

The huge potential of biopharma is presenting an important epoch for outsourcing partners that can support the development and manufacture of biologics in an efficient way.

Can investing in early formulation studies drive a new therapy successfully across the commercialization finish line?

Formulating fixed-dose combination drugs proves more complex than simply adding one ingredient to another.

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

Eurofins DiscoverX partners with VelaLabs to enable VelaLabs to perform highly reproducible potency lot release assays under GLP/GMP conditions.

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.