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Glaxosmithkline

All articles tagged with #glaxosmithkline

health2 years ago

"Cameroon Initiates Groundbreaking Malaria Vaccine Program for Children"

Cameroon has launched the world's first major malaria vaccine program for children, using the RTS.S vaccine developed by GlaxoSmithKline. The vaccine is meant to work with other preventive measures to fight the disease, and the country aims to vaccinate about 250,000 children this year and next. The campaign is seen as a major step in the fight against malaria in Africa, where the disease accounts for about 95 percent of the world's malaria deaths. The World Health Organization has approved two malaria vaccines, with hopes that their use could sharply reduce severe infections and hospitalizations.

health2 years ago

GSK's RSV Vaccine Demonstrates Promising Protection for Adults 50-59

GlaxoSmithKline's RSV vaccine, Arexvy, has shown potential in protecting adults aged 50 to 59 from respiratory syncytial virus (RSV) in a late-stage clinical trial. The vaccine elicited an immune response in this age group without any adverse effects, and the safety data was consistent with that of adults aged 60 and above. GSK plans to submit the final trial results for regulatory review and expects a decision on expanding the vaccine's label in 2024. Currently, Pfizer is the only other company with an approved RSV vaccine, but it is unclear if they will present data for adults aged 50 to 59. RSV causes thousands of hospitalizations and deaths among older Americans each year.

pharmaceuticals2 years ago

GSK Files Lawsuit Against Pfizer for RSV Vaccine Patent Infringement

GlaxoSmithKline (GSK) has filed a lawsuit against Pfizer, alleging that Pfizer's RSV vaccine, Abrysvo, infringes on GSK's patents for its own RSV shot, Arexvy. GSK claims that Pfizer knowingly used vaccine ingredients developed by GSK without permission, including recombinant RSV antigens and RSV F protein compositions. GSK also noted that its vaccine was in development seven years prior to Pfizer's. Both Pfizer and GSK's vaccines were approved for patients 60 years or older by the FDA in May.

healthcare2 years ago

GSK Anticipates Slower Uptake of RSV Vaccine Compared to Shingles Shot

GlaxoSmithKline CEO Emma Walmsley expects the uptake of the company's new RSV vaccine to start slower than its shingles shot, but believes it will drive future sales. The RSV vaccine recently received approval in the US and EU for adults 60 and older, and GSK plans to roll it out this fall. While the company has not provided revenue estimates for the RSV shot, it expects overall vaccine revenue to increase by a "mid-teens" percentage from last year. GSK's shingles shot, called Shingrix, has been a top-selling drug for the company and gained over 90% of the US market share for shingles vaccines within five months of its launch. Investors are hopeful that both the shingles and RSV shots will help offset patent expirations for GSK's HIV drugs in the future.

health2 years ago

CDC recommends new vaccines for adults and kids.

The CDC advisory panel has recommended two RSV vaccines for adults aged 65 and above, as RSV can lead to serious infections like pneumonia or bronchitis, particularly in older adults. The FDA approved Pfizer and GlaxoSmithKline shots for adults aged 60 and above last month, and the CDC's director is expected to endorse them soon. The goal is to have the vaccines available in the fall.

health2 years ago

Pfizer's RSV vaccine cleared for use in seniors by FDA.

The FDA has approved Pfizer's Abrysvo vaccine to prevent respiratory disease RSV in older adults, marking the second authorized RSV shot for older adults in the US this month after GlaxoSmithKline's Arexvy. The vaccine is expected to be available before the start of next RSV season. RSV causes severe illness in older adults, resulting in hospitalizations and deaths. Pfizer's vaccine was found to be more than 85% effective in preventing severe lower respiratory tract illness in older adults.

pharmaceuticals2 years ago

SCOTUS decision on 'skinny' label generic drugs sparks concerns for future carve outs.

The US Supreme Court has declined to take up a case involving "skinny" label generic drugs, which could have implications for the generic drug industry. The industry has been able to bring generic drugs to market by carving out the label to avoid certain indications that are still under patent protection. The case in question involved a court battle between Teva and GlaxoSmithKline over GSK’s beta-blocker Coreg (carvedilol), which Teva launched a generic of in 2007.

health2 years ago

FDA approves first-ever RSV vaccine for older adults.

The FDA has approved the first-ever vaccine to combat severe respiratory syncytial virus (RSV), called Arexvy, developed by GlaxoSmithKline, for adults aged 60 and older. The vaccine was 82% effective at preventing lower respiratory tract illness caused by RSV and 94% effective in those with underlying medical conditions. RSV is the leading cause of hospitalizations among newborns and younger children and causes more than 177,000 hospitalizations and 14,000 deaths among older adults each year. Other RSV vaccines and treatments are also under review by regulatory agencies.

health2 years ago

FDA approves first-ever RSV vaccine for older adults.

The FDA has approved the first-ever vaccine to prevent respiratory disease RSV in adults aged 60 and older. Developed by GlaxoSmithKline, the vaccine is expected to be available before the start of next RSV season. Pfizer's vaccine aimed at the same demographic is expected to be approved by the end of the month. RSV causes between 60,000 and 160,000 hospitalizations annually for adults older than 65 in the U.S. and 6,000 to 13,000 deaths, according to federal statistics.

pharmaceuticals2 years ago

Biden administration pushes for Supreme Court to hear Teva vs. GSK 'skinny labels' case.

The Biden Administration has urged the US Supreme Court to hear a patent appeal over drug labels involving Teva Pharmaceuticals and GlaxoSmithKline that could have significant ramifications for the generic-drug industry. The case involves "skinny labels" that allow generic drugmakers to launch their products earlier while avoiding liability for infringing brand-name drugmakers' patents. The US Solicitor General said Teva's generic version of GSK's heart drug Coreg could not have violated GSK's patent rights because Teva omitted the infringing use of the drug from its labeling.

pharmaceuticals2 years ago

Biden administration pushes for Supreme Court to hear Teva vs. GSK 'skinny labels' case.

The Biden Administration has urged the US Supreme Court to hear a patent appeal over drug labels involving Teva Pharmaceuticals and GlaxoSmithKline that could have significant ramifications for the generic-drug industry. The case involves "skinny labels" that allow generic drugmakers to launch their products earlier while avoiding liability for infringing brand-name drugmakers' patents. The US Solicitor General said Teva's generic version of GSK's heart drug Coreg could not have violated GSK's patent rights because Teva omitted the infringing use of the drug from its labeling.