“I’m excited by the strength of these positive results from the AFFINE trial that show giroctocogene fitelparvovec was generally well tolerated, and demonstrate the transformative potential of this gene therapy candidate to provide superior bleed protection compared with routine FVIII prophylaxis, while helping relieve the treatment burden for people living with hemophilia A,” states study lead investigator Andrew Leavitt M.D.
Tag Archive for: Pfizer
After nixing a twice-daily version of its oral GLP-1 agonist, Pfizer is hoping to break into the weight-loss space with a once-daily version, but experts question its outlook.
The company made the announcement based on results from the ongoing pharmacokinetic study (NCT06153758), selecting its preferred once-daily modified release formulation for danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist. Pfizer plans to conduct dose optimization studies in the second half of 2024 evaluating multiple doses of the preferred modified release formulation to inform the registration enabling studies.
“After more than 15 years as the architect of Pfizer’s exceptional scientific and research and development resurgence, Mikael and I recently discussed starting the process to look for his successor,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.
Unlike the current commercially available pneumococcal vaccines—including its top competitor, Pfizer’s Prevnar 20—Capvaxive covers eight unique serotypes that together account for around 27% of IPD cases in patients 50 years and older, and approximately 30% of cases in seniors 65 years and older.
A committee of outside experts to the U.S. CDC are set to vote on whether to expand the age group of adults who should receive respiratory syncytial virus (RSV) vaccines this year, as GSK battles rival Pfizer and new entrant Moderna to keep its top position in the market.
The pharma industry is staring down the barrel of a widespread loss of exclusivity, with more than 190 products going off-patent between 2022 and 2030. Here are some strategies company are employing to manage the drop in revenue.
Sarepta Therapeutics’ gene therapy Elevidys will be available to Duchenne muscular dystrophy (DMD) patients who are at least 4 years old, regardless of whether they can walk, the FDA said Thursday.
The FDA on Monday greenlit Merck’s 21-valent pneumococcal conjugate vaccine to prevent invasive pneumococcal disease and pneumococcal pneumonia in adults.
Pfizer’s investigational Duchenne muscular dystrophy gene therapy, fordadistrogene movaparvovec, failed in a late-stage study to significantly improve motor function in patients versus placebo.