Human Trials Of BioNTech’s MRNA Malaria Vaccine Begin
Bloomberg reports that the breakthrough technology behind some covid vaccines is now in human trials to combat another illness: BioNTech's MRNA malaria vaccine was given to the first patient Dec. 21. Separately, the FDA has approved a long-acting HIV drug from Gilead.
Bloomberg:
Malaria Vaccine Trials Start By BioNTech In New Test For MRNA Vaccines
BioNTech SE has begun human trials on a vaccine for malaria, a fresh test for the messenger RNA technology that powered the most successful immunizations against Covid-19. The first patient was dosed on Dec. 21, Chief Executive Officer Ugur Sahin said in an interview. The Phase 1 study will enroll 60 patients and use three different doses for a single vaccine candidate, the BioNTech CEO said. The Mainz, Germany-based company plans to evaluate different versions of the shot to see which one works best. (Kresge, 12/23)
On HIV therapies —
Reuters:
U.S. FDA Approves Gilead's Long-Acting HIV Drug Sunlenca
The U.S. Food and Drug Administration on Thursday approved Gilead Sciences Inc's Sunlenca therapy for HIV infections, paving the way for a drug that requires less frequent dosing than existing treatments. Sunlenca injection and tablets are expected to cost $42,250 in the first year of therapy and $39,000 annually after that, the company told Reuters. (Mahobe, 12/22)
In other pharmaceutical news —
NPR:
A Common DNA Test Can Find Cancer In Bodies Of Seemingly Healthy Pregnant People
When Kathleen Aukstikalnis was expecting her first baby, she turned to a common prenatal test that a lot of her friends had gotten done during their pregnancies. The simple blood test looks at DNA that's floating freely in a pregnant person's bloodstream. It searches for bits released by cells in the placenta, which should have the same genetic make-up as the fetus. (Greenfieldboyce, 12/23)
CIDRAP:
Trial Results Show Superiority Of Shorter, All-Oral Treatment For Drug-Resistant TB
Clinical trial results published today in the New England Journal of Medicine show that a shorter, all-oral treatment regimen for drug-resistant tuberculosis (TB) is more effective and safer than standard care. (Dall, 12/22)
Bloomberg:
ALS Patients Seek Access To Experimental Drug That Hasn't Been Proven To Work
For years, a family tree spanning two pages of blueprint paper gathered dust at the back of Cynthia Weber’s closet. Going back to a family matriarch born in 1812, it detailed the relationships and causes of death of more than 350 ancestors. (Langreth, 12/23)
CBS News:
Biotech Company Aims To Treat Sudden Hearing Loss With Early-Stage Drug
Chris Sopuch has taught at Oakcrest High School in New Jersey for 25 years. But in 2017, Sopuch was almost forced to walk away from his life's work at the age of 48. "I woke up Jan. 5 to realize I could not hear properly out of my left ear," he told CBS News. Immediately, Sopuch knew something was wrong. (Duncan and Knox, 12/22)
Stat:
Eisai And Biogen’s Latest Alzheimer’s Drug Needs To Be Cheaper Than The Last One, Analysts Say
The latest Alzheimer’s disease treatment from Eisai and Biogen needs to be cheaper than $20,000 a year to be cost-effective, according to a draft analysis from an influential nonprofit organization published Thursday. The Institute for Clinical and Economic Review, or ICER, dug into the evidence for lecanemab and concluded that the drug’s demonstrated benefits, a modest but statistically significant delay in the advance of Alzheimer’s, are worth between $8,500 and $20,600 per year. (Garde, 12/22)
Reuters:
U.S. Baby Formula Shortage Leads To Boom In Advertisements
It's not your imagination if you feel like you're seeing more ads for baby formula than ever before. ... The number of viewers of TV and streaming ads for formula skyrocketed to roughly 562 million this year, up from just 200,000 last year, according to data from media measurement firm ISpotTV. Some ads came from new brands the U.S. government approved to ease the shortage. Others came from already approved brands stepping up marketing. (DiNapoli, 12/22)