FDA OKs Injectable Antibiotic for Three Different Uses
The FDA approved the injectable drug ceftobiprole medocaril sodium (Zevtera) to treat adults with Staphylococcus aureus bacteremia (SAB), the agency announced Wednesday. The antibiotic prodrug is indicated for people with right-sided infective endocarditis, those with acute bacterial skin and skin structure infections (ABSSSI), and adult and pediatric patients 3 months to less than 18 years […]
Weight-Loss Drug Zepbound Faces Supply Issues
Another popular weight-loss drug is in short supply. Doses of tirzepatide (Zepbound) are few and far between, experts told MedPage Today, although the injectable has not been listed in the FDA Drug Shortage Database as of today. Another version of tirzepatide, for type 2 diabetes (Mounjaro), has been on the FDA shortage list since December […]
Former FDA Chief Says COVID-19 Variant May Cause Surge In States With Low Vaccination
Scott Gottlieb, the former head of the Food and Drug Administration, warned Sunday that an infectious variant of the coronavirus could lead to a new surge in COVID-19 infections in the fall, particularly in states with low vaccination rates. Gottlieb made the comments on CBS’s “Face the Nation,” saying that while the White House should […]
Once-Weekly ART Showed Similar Efficacy for HIV as Daily ART
DENVER — A once-weekly oral antiretroviral therapy (ART) regimen of the investigational drug islatravir, a nucleoside reverse transcriptase translocation inhibitor, with lenacapavir (Sunlenca) showed similar efficacy to daily oral ART in people with HIV, a phase II randomized study showed. The virologic suppression rate was 94.2% in both the patients who received the weekly regimen […]
Oral Drug Gains Steam as On-Demand Option for Hereditary Angioedema Attacks
WASHINGTON — The investigational oral drug sebetralstat provided on-demand relief during tissue swelling attacks from hereditary angioedema (HAE), a phase III study showed. Following self-administration, time to the beginning of symptom relief was reduced from a median 6.7 hours with placebo to 1.6 hours with a 300-mg dose of the plasma kallikrein inhibitor (P<0.0001) and […]
Common hair loss and prostate drug may also cut heart disease risk in men and mice
The drug finasteride, also known as Propecia or Proscar, treats male pattern baldness and enlarged prostate in millions of men worldwide. But a new University of Illinois Urbana-Champaign study suggests the drug may also provide a surprising and life-saving benefit: lowering cholesterol and cutting the overall risk of cardiovascular disease. The study, published in the […]
Opinion | The Sackler Family Can Act Today to Compensate Opioid Overdose Victims
LaBelle is an expert in addiction policy and drug control law. Fields is a legal fellow. In March 2022, three members of the Sackler family listened as more than two dozen people on Zoom addressed them in a federal bankruptcy court in New York. For over 2 hours, the speakers talked about their own struggles […]
Combination Shows Promise in Metastatic ESR1-Mutant Breast Cancer
A novel drug combination led to clinically meaningful antitumor activity in metastatic ESR1-mutated, estrogen receptor-positive (ER+)/HER2-negative breast cancer that had progressed on CDK4/6 inhibition, a small prospective study showed. Adding the selective estrogen receptor modulator (SERM) lasofoxifene to abemaciclib (Verzenio) resulted in a median progression-free survival (PFS) of 56 weeks, and a 24-week clinical benefit […]
Biden Administration Announces Moves to Cut Drug Prices
The Biden administration announced several actions Thursday aimed at lowering prescription drug costs, including decreasing some drug copays for Medicare beneficiaries and getting pricing concessions for COVID treatments developed in part with federal funding. “I have no problem with companies making reasonable profits, but not on the backs of seniors and working people,” President Biden […]
FDA Inspections of Foreign Drug Manufacturers Haven’t Bounced Back After Pandemic
The FDA hasn’t recovered from its pause in foreign drug manufacturer inspections during the COVID-19 pandemic, with inspections in 2022 remaining “well below” pre-pandemic surveillance levels, a study found. Researchers tracking a decade of FDA inspections observed an expected decline in inspections in 2020, but 2 years later foreign inspections remained 79% lower than 2019, […]