Don’t Give Probiotics To Preterm Babies, FDA Warns After A Death
The risk comes from potentially invasive and fatal infections or disease carried by live organisms in the probiotics. Among other news, the FDA gave approval for a treatment for Duchenne muscular dystrophy; the agency also approved an ulcerative colitis treatment from Eli Lilly.
AP:
FDA Warns About Giving Probiotics To Preterm Babies After Infant Death, Other Injuries
The U.S. Food and Drug Administration is warning health care providers and the public about injuries and at least one death in premature infants who were given probiotic products in the hospital. The products, which supplement regular feeding and contain live organisms such as bacteria or yeast, can lead to invasive, potentially fatal infections or disease, the FDA said Thursday. (Aleccia, 10/26)
In other pharmaceutical news —
Reuters:
Santhera's Drug Gets US FDA Nod For Rare Muscular Dystrophy
Catalyst Pharmaceuticals said on Thursday that U.S. health regulators have approved its partner Santhera Pharmaceuticals' drug to treat Duchenne muscular dystrophy (DMD) in patients aged two years and older. (10/26)
Stat:
FDA Approves Eli Lilly Ulcerative Colitis Treatment Omvoh
The Food and Drug Administration on Thursday approved an Eli Lilly drug that takes a new approach to treating ulcerative colitis, a chronic inflammatory disease that can cause intense gastrointestinal pain and distress. (Wosen, 10/26)
Stat:
ALS Patients Lend Support To Rare Diseases Bill
A month after advisers to the Food and Drug Administration overwhelmingly voted against the experimental ALS drug NurOwn, a Senate committee is considering a bill that would allow provisional approvals of the drug and other investigational treatments for rare, incurable diseases. (Wilkerson, 10/26)
Reuters:
Bristol Myers Says It Needs Another Year To Hit Target For New Drugs
Bristol Myers Squibb on Thursday pushed back by a year the time frame for its new-product portfolio to hit $10 billion in revenue as the sales ramp-up of medicines such as psoriasis treatment Sotyktu and multiple sclerosis drug Zeposia takes longer than initially projected. (Erman and Roy, 10/26)
The Wall Street Journal:
Sanofi Plans To Spin Off Consumer-Healthcare, Pharma Businesses
Sanofi said it plans to spin off its consumer-healthcare business, making it the latest major drugmaker to sharpen its focus on prescription medicines. The French pharmaceutical company outlined the plan on Friday as part of a strategic update that also detailed plans to increase investment in its drug-development pipeline and cut costs. (Calatayud and Hopkins, 10/27)
Stat:
Can Americans Learn From Europe’s Plan To Stem Drug Shortages?
European drug regulators are updating regulations to stem drug shortages. Are there lessons for Americans? Drug shortages are not solely an American problem. Last winter, European supplies of common antibiotics were critically low, especially for children, due to the surge of respiratory infections that followed two years of laying low to avoid Covid-19. There were also shortages of heart drugs. (Wilkerson, 10/25)
