Senate Investigation: Flovent Discontinuation Profited GSK, Harmed Kids
Pulling Flovent from the market in 2024 resulted in GSK profits and harm to pediatric asthma patients, according to a US Senate investigation reported by CNN.
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Senate Investigation: Flovent Discontinuation Profited GSK, Harmed Kids
Pulling Flovent from the market in 2024 resulted in GSK profits and harm to pediatric asthma patients, according to a US Senate investigation reported by CNN.
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RSV Vaccine Arexvy Gets Expanded Approval for At-risk Adults 18-49
The expanded approval means Arexvy is now indicated for all adults aged 60 and older, and adults aged 18–59 at increased risk for LRTD caused by RSV.
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FDA Approves First Flovent Generic for Asthma
The generic Flovent HFA (fluticasone propionate) inhalation aerosol is approved as a maintenance therapy for asthma in patients aged 4 years and older.
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FDA Approves Ultra-long-acting Biologic Depemokimab for Severe Asthma
Depemokimab is a twice-yearly administered monoclonal antibody approved for patients with severe asthma with an eosinophilic phenotype.
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GSK, Trump Administration Sign Agreement on Lower Drug Prices, Access to Respiratory Drugs
GlaxoSmithKline agreed to reduce costs for certain prescription drugs in the United States, after a direct request from the Trump administration.
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FDA Approves Mepolizumab for Adults with COPD
The US FDA has approved mepolizumab (Nucala) as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype.
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AAFA Applauds Senate Investigation into Asthma Inhaler Pricing
AAFA says the investigation opens an opportunity to address what patients report as the primary reason why people don’t adhere to their asthma treatment: the cost of prescribed asthma medication.
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Promising Data for Arexvy RSV Vaccine for Adults 50-59
GlaxoSmithKline announced positive preliminary results from its phase III trial of its Arexvy RSV Vaccine in adults aged 50 to 59.
Read MoreGeneric Fluticasone-Salmeterol as Effective as Brand-name Version for COPD
A study of patients treated for COPD found the inhaler, Wixela Inhub, is a substitutable version of the dry powder inhaler Advair Diskus.
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FDA Approves First RSV Vaccine
In clinical trials, the vaccine significantly reduced the risk of developing RSV-associated lower respiratory tract disease by 82.6% and reduced the risk of developing severe RSV-associated lower respiratory tract disease by 94.1% in adults age 60 and older.
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Five RSV Articles for the Week
FDA panel favors approval for two RSV vaccines, ‘Tripledemic’ hits US households, and a monoclonal antibody may be ready for next season—here are five RSV stories you should check out this week.
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Mepolizumab Reduced Asthma Attacks in Urban Youth
A monoclonal antibody, mepolizumab, decreased asthma attacks by 27% in Black and Hispanic children and adolescents who have a form of severe asthma.
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Positive Phase III Data for GSK RSV Vaccine Candidate
A phase III trial investigating the GSK RSV vaccine candidate for adults aged 60 years and above exceeded its primary endpoint with no unexpected safety concerns observed, the company announced.
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Monoclonal Antibody Sotrovimab No Longer Authorized in Northeastern US
The FDA revoked the emergency use authorization for the monoclonal antibody Sotrovimab in the Northeastern US due to its ineffectiveness against the Omicron BA.2 subvariant.
Read MoreGSK and Medicago’s Plant-based Covifenz Vaccine Approved in Canada
Health Canada has approved GlaxoSmithKline and Medicago’s Covifenz COVID-19 vaccine, a plant-based virus-like particles, recombinant, adjuvanted vaccine, for adults age 18-64.
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Sanofi-GSK Vaccine 100% Effective in Preventing Against Severe COVID-19, Hospitalizations
Sanofi and GSK will submit data from both their booster and Phase 3 efficacy trials to the FDA and other international regulatory agencies for authorization of their Sanofi-GSK COVID-19 vaccine.
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Philip Morris’ Battle to Buy Asthma Drugmaker Vectura
Philip Morris is competing with a US private equity firm to buy the asthma medicine company Vectura.
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FDA Approves Nucala for Hypereosinophilic Syndrome
The approval makes Nucala the first and only targeted biologic treatment to be approved for patients with Hypereosinophilic Syndrome in the US.
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FDA Approves Trelegy Ellipta for Asthma
The US FDA has approved a new indication for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for the treatment of asthma in patients aged 18 years and older.
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GSK Recalls Children’s Cough Syrup
GSK recalled several cough syrup products after the company discovered a flaw on the dosing measuring cups.
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GSK Says There’s No Link Between Pandemic H1N1 Flu Vaccine and Sleep Disorder
GSK told Reuters that its previous flu pandemic vaccine, which used some of the same ingredients as COVID-19 vaccines currently under development, was not linked to a rise in cases of narcolepsy, suggesting the link is to the H1N1 flu virus itself, not the vaccine.
Read MoreGSK Grants Will Support ATS COVID-19 Crisis Fund
GlaxoSmithKline has issued two grants totaling $380,000 to the American Thoracic Society’s COVID-19 Crisis Fund.
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Mepolizumab Approved for Kids 6-11 with Eosinophilic Asthma
The US FDA has approved Nucala (mepolizumab) for use in children as young as six years old who are living with severe eosinophilic asthma.
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FDA Approves Nucala for Patient Self-administration
The US FDA has approved two new methods for administering Nucala (mepolizumab), including an autoinjector and a pre-filled safety syringe that can be self-administered by patients or caregivers.
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