Articles
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3 days ago |
biospace.com | Heather McKenzie
Since Donald Trump took office in January, the National Institutes of Health has seen its funding cut for numerous HIV studies, alarming researchers and likely reducing the chances of achieving the president’s own 2019 goal of ending HIV in the U.S. by 2030. Against this backdrop, biopharma companies such as Gilead Sciences and Immunocore are pursuing the holy grail—a cure. Medicine has made considerable strides against HIV since the advent of the epidemic in 1981.
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1 week ago |
biospace.com | Heather McKenzie
Novavax’s updated COVID-19 vaccine has been in limbo after the FDA missed its PDUFA deadline and subsequently requested another trial—though it’s unclear if that trial needs to happen before approval. But today, the company gave investors some good news, reporting a massive year-over-year increase in sales for the original product on a first-quarter earnings call Thursday.
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1 week ago |
biospace.com | Heather McKenzie
Last week, the Department of Health and Human Services revealed new requirements for the approval of vaccines in what it called a “radical departure” from past practices. Vaccine experts were largely underwhelmed by the new policy and are seeking greater clarity from HHS. In short, the agency will require all new vaccines to be tested in placebo-controlled trials before they are approved, several publications reported on April 30.
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1 week ago |
biospace.com | Heather McKenzie |Jef Akst |Annalee Armstrong |Dan Samorodnitsky
> Listen on Spotify> Listen on Apple Products> Listen on Amazon Music> Listen on iHeartIn his effort to onshore manufacturing, President Donald Trump issued an executive order on Monday afternoon ordering the FDA to ease permitting processes for new and expanded U.S. facilities. The announcement comes as more and more Big Pharma companies commit billions to expanding their U.S. footprints.
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1 week ago |
biospace.com | Heather McKenzie
Five weeks after Peter Marks suddenly resigned as director of the FDA’s Center for Biologics Evaluation and Research, the division has a new boss. Tuesday, FDA Commissioner Marty Makary named Vinay Prasad as CBER’s next director, according to several news sources. Prasad will take over for Scott Steele, who has been running CBER on an interim basis since Marks was reportedly given the choice to resign or be fired at the end of March.
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RT @RWPUSA: As I told Heather McKenzie here: “There’s objective truth in science, and the extreme left and extreme right have always wanted…
RT @BowTiedBiotech: 🧠 HUGE NEWS - $AZN out of Neuro!!!! Big loss for patients….disappointing “CNS really is probably better managed by ot…
#biopharma conference season is in full swing, and our very own @JefAkst and @Slabodkin will be at hashtag#ASGCT24 in Baltimore next week. https://t.co/WgYSWHxOtb