Clinical Trial Materials

FDA officials and their scientific advisors have come down hard on clinical development programs that rely on study results from a single foreign country, instead of from multi-regional trials following harmonized R&D standards.

Recipharm will build up its biologics service offering with the acquisition of GenIbet.

Pfizer invested $68.5 million in a facility in Durham, NC.

The authors review some of the monoclonal antibody candidates that reached Phase III clinical trials but were discontinued at later stages.

Lonza plans to establish drug product manufacturing capabilities at is site in Guangzhou, China, to produce clinical trial and commercial supply in the country.

Selexis and KBI Biopharma will use integrated services to advance Immatics’ TCR bispecifics drug development program to the IND stage.

The guidance provides recommendations for including premenopausal women in breast cancer clinical trials.

Sanofi and GlaxoSmithKline reported that their adjuvanted recombinant COVID-19 vaccine candidate demonstrated strong immune responses across all adult age groups in a Phase II trial.

Best practices can help ensure supply chain flexibility and viability for biologic drugs in clinical trials.

Sterling Pharma Solutions and OncoTEX have entered into a clinical development agreement for the manufacturing of OncoTex’s novel platinum-resistant oncology drug candidate, OxaliTEX, for use in clinical trials.

Sandoz will soon begin enrolling patients with neovascular age-related macular degeneration in a Phase III study with its proposed biosimilar to aflibercept.

Packaging materials, kit design, and cold-chain handling should be optimized for each study.

A task force details its findings of the risks associated with using convalescent plasma using failure mode and effects analysis

Best practices can help ensure supply chain flexibility and viability for biologic drugs in clinical trials.

After a hectic 2020, biopharma looks to deliver on COVID-19 vaccines and move other promising therapies forward.

CDMOs strive for flexible, adaptable processes and fast tech transfer for manufacturing investigational drug products, including COVID-19 treatments and vaccines

The Phase III clinical trial of NVX-CoV2373 is expected to be fully enrolled in the UK and will begin in the US and Mexico by the end of November 2020.

The much-anticipated meeting of FDA’s vaccine advisory committee this week is slated to address a number of critical issues related to testing and approval of vaccines to prevent COVID-19 infection.

Manufacturers and the US government are investing heavily in traditional and non-traditional forms and materials to ensure supplies of containers and delivery devices for COVID-19 treatments and vaccines.

The COVID-19 pandemic has led to increased demand for direct-to-patient shipments, challenging cold-chain specialists to become more agile and to strengthen their global distribution networks.

Previous investments set a foundation for later efficiency improvements.

Achieving herd immunity will require testing, data, a vaccine, and public support.

Therapies for early and late treatment and passive immunization of COVID-19 are needed and can be developed using antibodies from recovered patients.

Hitachi Chemical Advanced Therapeutics Solutions and apceth Biopharma entered into long-term development and manufacturing services agreements for the clinical and commercial supply of multiple bluebird bio therapies.

Catalent will manufacture a mRNA-based COVID-19 vaccine for clinical trials and potential commercialization.