Positive Data for Merck’s Pneumococcal Conjugate Vaccine Candidate
Two Phase 3 studies of Merck's investigational 15-valent pneumococcal conjugate vaccine met their primary immunogenicity objectives.
Category: US Pharmaceuticals
US Pharmaceuticals
Latest
US Pharmaceuticals
Latest
FDA Approves Abbreviated NDA for Sedation Drug
The FDA approved an abbreviated new drug application for dexmedetomidine hydrochloride in 0.9% sodium chloride injection, which is used for patient sedation in some medical procedures.
US Pharmaceuticals
Popular
FDA Approves Nucala for Eosinophilic Granulomatosis with Polyangiitis
The FDA has approved Nucala (mepolizumab) as the first targeted treatment for eosinophilic granulomatosis with polyangiitis (EGPA), previously known as Churg-Strauss syndrome.
Industry Perspective: Inhaled Nitric Oxide Use for Patients with COVID-19
Two experts on inhaled nitric oxide explain the physiological effects and properties that make iNO a potential therapeutic agent in the battle against COVID-19.
Read More
COVID-19: Clinical Trial Starts for Remdesivir plus Interferon β1a
The National Institutes of Health has initiated a randomized, controlled clinical trial evaluating the safety and efficacy of the antiviral remdesivir (Gilead Sciences) plus the immunomodulator interferon beta-1a (Merck) in patients with COVID-19.
Read More
More Positive Results for Moderna’s COVID-19 Vaccine Candidate
Moderna’s mRNA-1273 induced neutralizing antibodies in mice when given as two intramuscular injections of a 1-microgram dose three weeks apart.
Read More
Cystic Fibrosis: Phase 1B Trial Begins for Arginase Inhibitor
Calithera Biosciences Inc has dosed the first patients in its Phase 1b clinical trial of the arginase inhibitor CB-280 in adult patients with cystic fibrosis and chronic airway infection.
Read More
COVID-19 Vaccine Candidate Protected Upper, Lower Airways in Primate Study
Two doses of Moderna’s experimental COVID-19 vaccine induced robust immune responses and rapidly controlled the coronavirus in the upper and lower airways of rhesus macaques exposed to SARS-CoV-2.
Read More
COVID-19 Vaccine Candidate Begins Phase 3 Testing
A Phase 3 clinical trial of Moderna Inc’s investigational COVID-19 vaccine mRNA-1273 will enroll approximately 30,000 adult volunteers who do not have coronavirus.
Read More
FDA Approves Triple Therapy Breztri Aerosphere for COPD
Breztri Aerosphere is a single-inhaler, fixed dose triple-combination of the ICS budesonide, the LAMA glycopyrrolate, and LABA formoterol fumarate.
Read More
HHS/DOD Deal with Pfizer would Provide COVID-19 Vaccine Free to All Americans
The US Department of Health and Human Services and the Department of Defense have signed a $1.95 billion agreement with Pfizer Inc and BioNTech SE for 100 million doses of the companies’ COVID-19 vaccine candidate, BNT162.
Read More
‘Rapid and Strong’ Immune Response from Moderna COVID-19 Vaccine Candidate
An interim analysis of Moderna’s vaccine candidate against COVID-19 found that mRNA-1273 induced rapid and strong immune responses against SARS-CoV-2.
Read More
Gilead Puts Multiple Price Tags on COVID-19 Therapeutic Remdesivir
Gilead announced Remdesivir drug prices vary based on US insurance coverage. Generics are also being manufactured for developing nations.
Read More
Self-administered Dupixent Pen Approved for Asthma, CRSwNP
FDA approved a 300 mg single-dose pre-filled pen for Dupixent (dupilumab) to treat atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP).
Read More
FDA Approves Zepzelca for Small Cell Lung Cancer
Clinical data showed that in patients with relapsed small cell lung cancer, Zepzelca demonstrated an overall response rate of 35% and a median duration of response of 5.3 months.
Read More