The U.S. Food and Drug Administration placed a clinical hold on Gilead Sciences’ use of injectable lenacapavir in borosilicate vials in all ongoing clinical studies for HIV and HIV pre-exposure prophylaxis (PrEP).
Novartis agreed to expand the company’s fill-and-finish support for the Pfizer/BioNTech Covid-19 vaccine by using manufacturing facilities in Ljubljana, Slovenia, to fill at least 24 million doses in 2022, the Swiss drugmaker said on Oct. 21.
The U.S. drug regulator gave Moderna Inc. clearance to speed up output of the company’s Covid-19 vaccine by letting it fill a single vial with up to 15 doses, with the United States banking on rapid immunization to stem the spread of the deadly virus.
Drugmaker Baxter International Inc. will help fill in vials and package about 60-90 million doses of Moderna Inc.’s Covid-19 vaccine in 2021, the companies said.
Moderna Inc. proposed filling vials with additional doses of the Covid-19 vaccine to ease a crunch in manufacturing as the company approaches the manufacturing of almost a million doses a day.
Moderna Inc. asked the U.S. Food and Drug Administration for permission to fill the company’s Covid-19 vaccine vials with up to five additional doses to ease a crunch in manufacturing, CNBC reported.
Pfizer’s partner BioNTech boosted the 2021 delivery target for their Covid-19 vaccine to 2 billion doses, up from 1.3 billion previously, as they bring new production lines on stream and as more doses can be extracted per vial.
During this webinar, learn more about benefits and risks of changing primary components during product development and how a design of experiments approach can be used to address issues and risks.
Gilead Sciences set the price of the only approved treatment for COVID-19, remdesivir, at $2,340 per patient for a 5-day treatment.
With Moderna on the precipice of launching a Phase III trial of 30,000 people for the COVID-19 vaccine mRNA-1273, the company is ramping up manufacturing capabilities and is partnering with Catalent.
