WHO Recommends Johnson & Johnson’s COVID-19 Vaccine for Booster Use

FDA Grants Priority Review to Roche’s COVID-19 Treatment  

FDA recently accepted Roche’s supplemental biologics license application (sBLA) and granted priority review for the company’s COVID-19 treatment, Actemra/RoActemra. 

The treatment is now available for hospitalized adults receiving systemic corticosteroids and requiring supplemental oxygen, a non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.  

“The high rate of unvaccinated people will continue to put a strain on hospitals and healthcare systems around the world, furthering the need for effective treatments for patients hospitalized with COVID-19,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche, said in the announcement.   

“More than one million people with severe or critical COVID-19 have already been treated with Actemra/RoActemra worldwide, demonstrating the important role of this medicine in the fight against the pandemic,” Garraway continued.  

Roche based its sBLA submission on four randomized, controlled studies evaluating Actemra/ RoActemra to treat COVID-19 in over 5,000 hospitalized patients. All four studies suggested that the treatment may improve outcomes in adults.  

In June 2021, FDA granted emergency use authorization to Actemra after the drug decreased the risk of death, hospital duration, and the likelihood of being placed on ventilators in clinical trials.  

Thermo Fisher Wins Award for Expediting COVID-19 Vaccine Approvals During Pandemic  

Thermo Fisher Scientific recently won a 2021 TOPRA Award for Regulatory Excellence, recognizing the critical role of its regulatory affairs team in accelerating COVID-19 vaccine approval during the pandemic.  

Novavax nominated Thermo Fisher in the “support” category based on its ongoing clinical research organization (CRO) partnership with PPD, a leading global CRO to the biopharma and biotech industry that Thermo Fisher acquired in December 2021 for $17.4 billion.  

PPD engaged with regulatory authorities to expedite the review and approval of Novavax’s innovative COVID-19 vaccine as part of its support for Novavax’s development program. 

“Our team worked tirelessly and seamlessly to guide Novavax through the procedures to ensure timely COVID-19 vaccine approval,” Cindy Elko-Simms, MD, senior vice president of pharmacovigilance, regulatory affairs, medical writing, and clinical research at Thermo Fisher, said in the announcement.   

“I am proud of our team for their expertise and professionalism, and we’re thankful to Novavax for their trust and close collaboration,” Elko-Simms continued.