Fewer than two dozen cell and gene therapies have been approved in the US, and Orchard Therapeutics founder and CEO Bobby Gaspar says it's important to work with regulatory authorities throughout the development and commercialization process. "The industry is stepping into new territory as we tackle clinical, scale-up, and commercial challenges, and so are the regulatory agencies," Gaspar says.
The pharmaceutical industry standards-setting body US Pharmacopeia and Phlow will collaborate at Virginia Commonwealth University's Medicines for All Institute to develop quality standards for drugs made using continuous manufacturing. The US FDA references USP standards, and the new standards might encourage drugmakers, including makers of generic drugs, to invest in new equipment in the US.
A site 70 miles east of Moscow where biological weapons were developed now houses Generium Pharmaceutical's high-tech facility mass-producing Russia's COVID-19 vaccine. Engineers have scaled up to produce several million doses a month and are heading toward 10 million to 20 million a month, says Chief Science Officer Dmitry Poteryaev. At least 30 countries have ordered nearly 2.5 billion doses, but one scientist says less than 2% of Russians have received at least one dose.
GlaxoSmithKline is closing antibiotics manufacturing plants in Barnard Castle and Ulverston, England, and selling its cephalosporin business to Novartis' Sandoz unit, and Integral Pharma Services consultant Keith Plumb says the closure is a sign "the UK is missing out on the move to bioprocesses, with a subsequent significant loss of manufacturing skills." However, startup contract drugmaker Lakes BioScience is building a monoclonal antibody facility at a GSK site in Ulverston.
The Biovac Institute's planned expansion and Aspen Pharmacare's agreement to produce Johnson & Johnson's COVID-19 vaccine will relieve South Africa's reliance on other countries for vaccines. Biovac started making a pediatric vaccine licensed from Sanofi Pasteur last year, will start making pneumococcal vaccines licensed from Pfizer this year and could start making a COVID-19 vaccine within a year, says CEO Morena Makhoana.
A woman died after receiving a transplant of lungs that carried the novel coronavirus, according to a case study in the American Journal of Transplantation. Tests for the virus were negative before the procedure "We would absolutely not have used the lungs if we'd had a positive COVID test," study co-author Dr. Daniel Kaul said.
A midstage trial assessing the chimeric antigen receptor T-cell therapy idecabtagene vicleucel, developed by bluebird bio and Bristol Myers Squibb, found adults older than 65 with relapsed or refractory multiple myeloma had higher response rates than the overall study group. The findings were presented at the Transplantation & Cellular Therapy Meetings.
A study in the American Journal of Infection Control found people who received the flu vaccine had 24% lower odds of testing positive for COVID-19 compared with those who were not vaccinated. The findings, based on data from 27,201 people, showed flu-vaccinated patients who contracted COVID-19 also had shorter hospital stays and were less likely to need mechanical ventilation and require hospitalization.
The FDA and the American Association for Cancer Research have released new guidance developed during a joint workshop to address the issue of African Americans being underrepresented in multiple myeloma clinical trials. The recommendations, published in the journal Blood Cancer Discovery, aim to eliminate racial bias through the inclusion of more African Americans in clinical trials and encourage the use of real-world data to gain a better understanding of antimyeloma agents' effects among African Americans.
- Page 1