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March 20, 2020
Emergent BioSolutions will help develop and manufacture an oral vaccine candidate and will develop plasma-based antibody therapeutics.
March 19, 2020
The partners have initiated an observational case-control study of siltuximab in patients with COVID-19 who have developed serious respiratory complications.
March 06, 2020
The new center expands the company’s R&D capabilities and will help it advance its portfolio of rare disease gene therapy programs.
March 05, 2020
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.
FDA issued a notice to drug compounders regarding the transition of licensure of biologics to the Public Health Service Act.
A guidance document answers questions regarding the transition of biologics applications from under the FD&C Act to the PHS Act.
March 02, 2020
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.
February 21, 2020
As the date for transitioning the approval of biologic drug to a new pathway comes closer, FDA publishes a final rule and answers questions on the pathway changes.
February 06, 2020
The two agencies are collaborating to support a robust biologics marketplace by taking steps to deter anti-competitive business practices.
FDA published draft guidance for applicants seeking licensure of a proposed biosimilar or proposed interchangeable biosimilar.