Moderna Inc. reached a milestone of sorts Jan. 31 as the U.S. FDA fully approved its COVID-19 vaccine, Spikevax (elasomeran), for use in adults. Meanwhile, the Moderna and Pfizer Inc.-Biontech SE vaccines are in the sights of the U.S. Congressional Progressive Caucus, which is pushing the Biden administration to do more to ensure global vaccination.
With COVID-19 taking a toll on the U.S. FDA’s inspection program, warning letters stemming from drug facility inspections have been few and far between for the past two years. Aurobindo Pharmaceutical Ltd., of Hyderabad, India, was one of the exceptions.
Should the U.S. government be in the business of manufacturing COVID-19 vaccines? Several prominent Democratic senators and representatives would say yes.
With Omicron spreading rapidly, U.S. COVID-19 vaccine producers are facing increasing pressure to up their production and to do more to ensure their vaccines are accessible globally.
Even as it strives for self-reliance, India is struggling to wean itself off a reported 75% increase in med-tech imports from China. China led the contribution to India’s med-tech imports with ₹91.12 billion (US$1.2 billion) worth of goods in the 2021 fiscal year (April 2020 to March 2021), according to an analysis of data from India’s Department of Commerce by the Association of Indian Medical Device Industry (AIMED).
While biopharma companies across the world pulled out all the stops in 2021 to develop and manufacture COVID-19 vaccines and therapies, the pandemic highlighted supply chain weaknesses, spurring demands in many countries for more domestic manufacturing and less reliance on production in other countries.
With 2021 coming to a close in just a few weeks, the U.S. FDA is racing to release the guidances it planned to get out the door this year. The regulator issued two draft guidances Dec. 7 detailing key clinical and production considerations to support applications for “N of 1,” or single-subject, clinical trials and drug development programs for severely debilitating or life-threatening diseases.
PERTH, Australia – Australian health technology company Planet Innovation is expanding its footprint into the U.S. with the acquisition of the North American operations of Germany’s medical device manufacturer BIT Analytical Instruments GmbH.
Emergent Biosolutions Inc.’s Bayview facility in Baltimore passed its manufacturing inspection with international regulators, clearing the way for shipment of batches of Johnson & Johnson’s (J&J) COVID-19 vaccine containing drug substance made at the plant.
As if it were needed, Amicus Therapeutics Inc.’s spin-off of its gene therapy work and PDUFA VII’s provisions to increase the capacity of the FDA’s Center for Biologics Evaluation and Research offered further proof this week of the global explosion that’s happening in the regenerative medicine field.
