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Merck has scored US Food and Drug Administration (FDA) approval for its next-generation pneumonia vaccine Vaxneuvance that covers 15 different strains of the pneumococcal bacteria that causes the infection. Both next-gen shots offer enhanced protection against bacteria that can cause pneumonia, blood infections and meningitis.
After receiving US Food and Drug Administration (FDA) approval for Fabhalta (iptacopan) last week for the treatment of the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH), Novartis presented trial data yesterday showing the drug’s promise in another indication.
In 2023, Vaxneuvance, which was approved in 2021, netted $665 million in sales. Last year, sales of Pfizer’s pneumococcal vaccines reached $6.4 However, Vaxneuvance has contributed to slowing down Prevnar 20’s sales growth from 20 percent in 2022 to two percent last year.
The company says that these four serotypes represent roughly 10–15% of bacteria causing pneumococcal disease in adults. While the first pneumococcal polysaccharide vaccine was approved in the US in 1977, the first conjugate shot Prevnar was greenlighted only in 2000. VAX-24 has forecasted sales of $21 million in the same year.
The settlement requires Totality to take several specific corrective actions, which include refraining from making any statements that suggest the spa’s products are genuine, FDA-approved Lilly products, and stopping the use of Eli Lilly branding in promoting any of the products.
CDIs usually develop after treatments with antibiotics as they can kill off healthy bacteria in the gut in the process of targeting the pathogenic bacteria. As part of the deal with Nestlé, Seres will receive license payments of $175 million up front with an additional $125 million upon FDAapproval of the drug.
BONESUPPORT received market authorization from the FDA for Cerament G, the first and only bone graft with antibiotic elution that is approved for the US market. Osteomyelitis is a bone infection caused by fungi or bacteria. What was special about this latest FDAapproval from the company’s (BONESUPPORT’s) commercial perspective?
Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDAapproval on May 25, 2023. billion in pharmaceutical sales from 2021. billion in 2022, a 23.43
Under the terms of the new deal, Nestle’s Health Sciences unit will pay Seres another $125 million if the FDAapproves the drug – called SER-109 – and is also line for up to $225 million in commercial milestones tied to sales targets. diff infection. diff, which can germinate and grow after the course is completed.
The FDA has accepted for review Seres Therapeutics’ Biologics License Application (BLA) for SER-109, an investigational oral microbiome therapeutic for the prevention of recurrent Clostridium difficile infection (rCDI). If approved, SER-109 would be the first-ever FDA-approved oral microbiome therapeutic.
In September, Corbus Pharmaceuticals Holdings announced topline results from its 52-week Phase III RESOLVE-1 study of lenabasum in patients with diffuse cutaneous systemic sclerosis (SSc), a rare life-threatening multi-system autoimmune disease for which there are no FDA-approved treatments. Anti-CD40L Antibody. Patient Recruitment.
As companies navigate a complex environment shaped by emerging pathogens, evolving regulatory frameworks and shifting market demands, sales data offers valuable insights into which drugs are setting the pace and why. Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) Biktarvy 2023 sales: $11.85
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