Respiratory Biologics Have Significantly Reduced Asthma Exacerbations
A large-scale study finds that the introduction of asthma biologics in 2015 has led to immediate and sustained reductions in exacerbations at the population level.
Category: US Pharmaceuticals
US Pharmaceuticals
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Respiratory Biologics Have Significantly Reduced Asthma Exacerbations
A large-scale study finds that the introduction of asthma biologics in 2015 has led to immediate and sustained reductions in exacerbations at the population level.
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FDA Accepts NDA for Apnimed Sleep Apnea Pill
The FDA will review a New Drug Application for Apnimed’s AD109, an investigational oral pill for the treatment of adults with obstructive sleep apnea with a target action date of Feb 28, 2027.
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Microneedle Patch for Peanut Allergies Begins Clinical Trials
A phase 1 study is testing the safety of a microneedle device designed to deliver peanut protein through the skin for desensitization.
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Alpha-1 Antitrypsin Deficiency Drug Enters Ph3 Trial
Grifols enrolled the first patient in its Phase 3 SWIFT-SC clinical trial to evaluate its subcutaneous Alpha1-Proteinase Inhibitor for the treatment of alpha1-antitrypsin (AAT) deficiency.
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RSV Antiviral Zelicapavir Enters Late-stage Clinical Trials
Enanta Pharma advanced zelicapavir into a registrational Phase 2b/3 clinical trial for adults at high risk of severe RSV outcomes.
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Ai-Generated Drug Rentosertib Trialed for Idiopathic Pulmonary Fibrosis
Insilico Medicine initiated a Phase 3 clinical trial for Rentosertib, an oral medication discovered using artificial intelligence to treat idiopathic pulmonary fibrosis (IPF).
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7 Pharma Companies Chosen for FDA PreCheck Pilot Program
The FDA’s PreCheck Pilot Program will expand domestic pharmaceutical manufacturing, increase production capacity, and strengthen US drug supply chain resilience.
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HHS Ends COVID-19 Emergency Use Authorizations
HHS secretary Robert F Kennedy, Jr signed determinations to end COVID-19 emergency use authorizations for drugs, biological products, and medical devices because the emergency circumstances no longer exist.
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FDA Expands Casgevy for Children 2+ with Sickle Cell Disease
The FDA approved the first gene therapy for children as young as 2 years old with sickle cell disease or transfusion-dependent beta thalassemia.
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Same-Day COVID-19 and Flu Vaccines Are Safe for Adults
Research involving 2.5 million patients found no increase in serious adverse events when receiving both COVID-19 and influenza vaccinations during the same visit.
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Positive Ph3 Data for Aspergillosis Antifungal Treatment
Phase 3 trial results indicate a new antifungal medication olorofim is as effective as current standard treatments for invasive aspergillosis with fewer side effects.
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CFTR Modulator Use Linked to Lower Anxiety in Children and Parents
New research suggests cystic fibrosis transmembrane conductance regulator (CFTR) modulators may provide mental health benefits for pediatric patients and their caregivers early in treatment.
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FDA Approves Capvaxive Pneumococcal Vaccine for Children 2-17
The USFDA approved an expanded indication for Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) to include children and adolescents aged 2 through 17 years, according to Merck.
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FDA Approves Generic Xofluza
The FDA approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment for acute uncomplicated influenza and prophylaxis in patients 5 years of age and older.
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FDA Approves OTC Rextovy for Opioid Overdose
Rextovy, a 4 mg naloxone medication, will be available for purchase without a prescription at retail stores and online.
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ENA Respiratory Secures Two US Patents for COPD Therapy
ENA Respiratory received notices of allowance for two US patents covering its innate immune modulators and their application in preventing COPD exacerbations.
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Unique Attack Method for New Antibiotic
Researchers discovered manikomycin, a soil-derived peptide that attacks bacteria in a unique way to bypass existing antibiotic resistance.
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Maternal RSV Vaccine Cuts Infant Hospitalizations Nearly 70%
Real-world data published in JAMA Network Open confirm the effectiveness of the RSVpreF vaccine in protecting newborns from respiratory syncytial virus.
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Certain Flu Drugs May Reduce Cognitive Decline
Researchers found that sialidase inhibitors—a class of flu drugs including oseltamivir (Tamiflu)—protected against degradation of protective sugar molecules tied to cognitive decline and premature aging in people living with HIV.
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Factors That Influence Parent Decisions on Pediatric COVID-19 Vaccination
Researchers found that five core values—safety, knowledge, trust, humanity, and autonomy—shape how minority parents approach pediatric vaccination.
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Combination CF Drugs Formoterol + Methacholine May Improve Mucus Clearance
Combining formoterol and methacholine significantly improves mucociliary clearance in animal models of cystic fibrosis, compared to using either drug alone.
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Nanoparticles Increase Lung Cancer Drug Delivery 30-fold
Researchers at Adelaide University developed a lipid-polymer vehicle that improves drug bioavailability and reduces systemic toxicity in preclinical models of lung cancer.
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New Data on Childhood Flu Vaccine Efficacy
For every 100 children vaccinated against influenza, between nine and 14 cases are prevented, according to Harvard Medical School data.
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Long-Term Data for Recurrent Respiratory Papillomatosis Therapy
Updated clinical data demonstrates that Papzimeos for adults with Recurrent Respiratory Papillomatosis (RRP) can maintain complete responses for more than four years.
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