WHO Recommends Regen-COV for COVID-19 Patients at High Risk of Hospital Admission
A WHO panel of international experts and patients has recommended Regeneron's Regen-COV (casirivimab and imdevimab) for two groups of COVID-19 patients.
Tag: pharmaceuticals
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Moderna Booster Vaccine Induced Antibody Responses Against Delta Variant
Moderna's COVID-19 vaccine booster (mRNA-1273 50µg dose level) induced robust antibody responses of more than 40 times against the Delta variant (B.1.617.2), according to Phase 2 clinical data reported by the company.
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FDA Expands Authorized Use of Regen-Cov as Preventative Treatment
The FDA expanded authorization of Regen-Cov to include post-exposure prophylaxis in people at high risk for progression to severe COVID-19, who are not fully vaccinated or are not expected to mount an adequate response to vaccination.
FDA Approves Astepro Antihistamine for OTC Use
The FDA approved Bayer’s Astepro (azelastine hydrochloride nasal spray, 0.15%) for nonprescription use agaiseasonal and perennial allergic rhinitis
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Regen-Cov Reduced COVID-19 Hospital Mortality by 20% in Seronegative Patients
Regen-Cov (casirivimab and imdevimab) added to usual care reduced the risk of death by 20% in hospitalized patients who had not mounted a natural antibody response on their own against SARS-CoV-2.
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Novavax COVID-19 Vaccine 90% Effective Overall in Ph3 Trial
Novavax Inc’s COVID-19 vaccine NVX-CoV2373 demonstrated 90.4% overall efficacy against SARS-CoV-2 infection, and 100% protection against moderate and severe disease, according to a Phase 3 PREVENT-19 clinical trial.
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HHS to Purchase 1.7M Supply of Molnupiravir Antiviral for COVID-19
The US government will procure approximately 1.7 million courses of an investigational COVID-19 antiviral molnupiravir (MK-4482) from Merck, pending EUA or approval from the FDA.
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Moderna Vaccine Submitted to FDA for EUA in Kids 12 to 17
Moderna Inc has requested an emergency use authorization for its COVID-19 vaccine in adolescents age 12 to 17 with the FDA. The vaccine has been authorized for adults age 18 and older since December 2020.
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FDA Approves First Targeted Therapy for Specific Lung Cancer Mutation
The FDA approved sotorasib (Lumakras, Amgen Inc) as the first treatment for adult patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation called KRAS G12C.
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FDA Approves Rybrevant for Certain NSC Lung Cancer Patients
The FDA has approved Janssen Pharma’s Rybrevant (amivantamab-vmjw) as the first treatment for adult patients with non-small cell lung cancer whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
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Tezepelumab Significantly Reduced Asthma Exacerbations Requiring Hospitalization
Tezepelumab significantly reduced exacerbations requiring hospitalization and ED visits for adults and adolescents with severe, uncontrolled asthma.
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Cancer Drug Topotecan Reduced Morbidity, Mortality in Mice
A chemotherapy drug Topotecan, which targets inflammatory genes, reduced morbidity and mortality in mice infected with SARS-CoV-2.
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Long-term Data Shows Safety, Effectiveness of Fasenra for Severe Eosinophilic Asthma
A five-year trial found at least 75% of Fasenra-treated asthma patients with elevated blood eosinophil levels had zero exacerbations each year of the open-label period.
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Pfizer Vaccine Authorized for Adolescents Ages 12-15
The FDA has expanded its emergency use authorization for the Pfizer/BioNTech COVID-19 vaccine to children ages 12 to 15 years old. The vaccine had been authorized for individuals ages 16 and older.
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How Effective Is COVID-19 Vaccine for Immune Deficient Patients?
A study assessing how people with immune system deficiencies or dysregulations respond to COVID-19 vaccination has begun enrolling participants at the National Institutes of Health
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