Development

The companies have entered into a manufacturing agreement to supply leronlimab, an investigational new drug currently being used in clinical trial protocols for COVID-19.

Will moving at “warp speed” to develop a vaccine impact efficacy or safety?

Next-generation therapeutics and regulatory requirements create demand for complex, fit-for-purpose tests.

AstraZeneca and the University of Oxford have announced that they will collaborate on the global development and distribution of the university’s potential recombinant adenovirus vaccine aimed at preventing COVID-19 infection.

NIH trial shows remdesivir accelerates recovery; Gilead study shows similar efficacy for 5- and 10-day dosing.

A new strategic plan from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, details the institute’s plan for accelerating research to diagnose, prevent and treat COVID-19.

US government and industry partners will coordinate to bring the most promising COVID-19 vaccine and treatment candidates to clinical trials.

This milestone achievement will allow the companies to move forward with developing a GMP-compliant manufacturing process for clinical testing.

With the acquisition, Orgenesis will combine TamirBio’s ranpirnase antiviral platform with its Bioxome technology.

The partners have formed a joint venture to produce muscle-derived mesenchymal stem cells as a source of exosomes and other cellular products to develop related therapies and advance clinical trials.

Industry opportunities are increasing for biosimilars, but companies should pay close attention to delivery device design to facilitate success.

Horizon Discovery has announced that it has expanded its cell-based clustered regularly interspaced short palindromic repeats (CRISPR) screening services to include primary human B cells, which complements the T cell screening service.

The partnership, led by Takeda and CSL Behring, will focus on developing a hyperimmune immunoglobulin against COVID-19.

Biopharma companies responding to the COVID-19 outbreak think accelerating the development of vaccines is safe.

Experience, communication, collaboration, transparency, planning, and prioritization contribute to success.

As the coronavirus pandemic unfolds, the bio/pharma industry must practice science over hype.

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.

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.

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.

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.