Morning Briefing
Summaries of health policy coverage from major news organizations
Dupilumab Improves Covid Outcomes; Xofluza Approved For Treating Flu In Kids 5 And Older
ScienceDaily: Eczema Treatment Cuts Risk Of Death From COVID-19, Study Suggests
A monoclonal antibody used to treat asthma and eczema can improve survival for patients with moderate to severe COVID-19, a clinical trial suggests. (University of Virginia Health System, 8/16)
CIDRAP: FDA green-lights baloxavir use for flu in kids as young as 5
Roche recently announced that the FDA has approved the use of baloxavir marboxil (Xofluza) for treating flu in children ages 5 to 12. Also, the FDA approved the drug for postexposure prophylaxis (prevention) in kids ages 5 to 12 who had contact with someone with flu. (8/15)
ScienceDaily: Old Drug, New Trick: Researchers Find Combining Antiviral Drugs And Antibody Therapy Could Treat Seasonal Flu And Help Prevent Next Flu Pandemic
Researchers have found a class of well-known antiviral drugs could be part of a one-two punch to treat seasonal influenza and prevent a flu pandemic when used in combination with antibody therapies. (McMaster University, 8/16)
Stat: BrainStorm To Seek FDA Approval For ALS Drug, Despite Agency Objections
Last year, the Food and Drug Administration issued a rare public statement to inform the ALS community that a negative clinical trial involving an experimental stem-cell therapy from Brainstorm Cell Therapeutics did not support the filing of a marketing application. (Feuerstein, 8/15)
CIDRAP: BD, Accelerate Announce Collaboration On Rapid ID, Susceptibility Tests
Under the agreement, BD will market and sell through its global sales network the Food and Drug Administration–approved Accelerate Pheno system, which delivers rapid pathogen identification and antibiotic susceptibility test results from blood cultures 1 to 2 days faster than traditional laboratory methods. The agreement also covers the Accelerate Arc module. (8/16)
FiercePharma: Pharma Exec Misled FDA In Hopes Of Marketing Sanorex, DOJ Says
After being charged with deceiving the FDA last fall, purported New Jersey pharma CEO Alain Bouaziz had his day in court. Now, the 69-year-old French citizen faces up to five years in prison—plus a maximum fine of $250,000—over a plot to get his hands on Novartis’ former weight loss med Sanorex. Bouaziz submitted forged documents and made false statements to the FDA in a bid to “fraudulently gain control of Sanorex,” a stimulant-based weight loss drug that Novartis pulled from the market more than 10 years ago, the DOJ says. (Kansteiner, 8/15)
Stat: Sales From Controversial Drug Discount Program Rose To $44 Billion Last Year
Prescription medicines purchased in the U.S. under a controversial government discount program amounted to $44 billion in 2021, a nearly 16% increase from the previous year, according to the Health Resources & Service Administration, which oversees the program. (Silverman, 8/15)
Stat: Novartis Reports Two Children Died From Acute Liver Failure After Treatment With Zolgensma Gene Therapy
Two children have died from acute liver failure after being administered Zolgensma, a pricey gene therapy sold by Novartis to treat a rare disease. (Silverman, 8/11)
