Pfizer announces positive topline results From Phase 3 study of hemophilia A gene therapy candidate
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) today announced positive topline results from the Phase 3 AFFINE study (NCT04370054) evaluating giroctocogene fitelparvovec, an investigational gene therapy for the treatment of adults with moderately severe to severe hemophilia A.
The AFFINE study achieved its primary objective of non-inferiority, as well as superiority, of total annualized bleeding rate (ABR) from Week 12 through at least 15 months of follow up post-infusion compared with routine Factor VIII (FVIII) replacement prophylaxis treatment.
Darolutamide meets primary endpoint in Phase III ARANOTE trial
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- Category: Bayer
The Phase III ARANOTE trial, investigating darolutamide plus ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC), has met its primary endpoint of rPFS. Darolutamide plus ADT significantly increased rPFS compared to placebo plus ADT. The safety data were comparable between both treatment arms and reconfirm the established tolerability profile of darolutamide in advanced prostate cancer.
Pfizer advances development of once-daily formulation of oral GLP-1 receptor agonist danuglipron
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) announced that based on results from the ongoing pharmacokinetic study (NCT06153758), the company has selected 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.
AskBio receives FDA Fast Track and MHRA Innovation Passport designations for AB-1005 investigational GDNF gene therapy for Parkinson's disease
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- Category: Bayer
Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that the United States (U.S.) Food and Drug Administration (FDA) has granted Fast Track Designation for AB-1005, which is being developed for moderate Parkinson's disease. AB-1005 has also been awarded the Innovation Passport, the United Kingdom Medicines and Healthcare products Regulatory Agency (UK MHRA) innovative medicine designation, for the treatment of Parkinson's disease.
GSK and CureVac to restructure collaboration into new licensing agreement
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- Category: GlaxoSmithKline
GSK plc (LSE/NYSE: GSK) and CureVac N.V. (Nasdaq: CVAC) today announced they have restructured their existing collaboration into a new licensing agreement, allowing each company to prioritise investment and focus their respective mRNA development activities.
Since 2020, GSK and CureVac have worked together to develop mRNA vaccines for infectious diseases.
Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention
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- Category: AstraZeneca
AstraZeneca's Marketing Authorisation Application (MAA) for sipavibart has been accepted under an accelerated assessment procedure by the European Medicines Agency (EMA), for the pre-exposure prophylaxis (prevention) of COVID-19 in immunocompromised patients.
Sipavibart is an investigational long-acting antibody designed to provide COVID-19 protection for immunocompromised patients who often do not respond adequately to vaccination alone and remain at high risk of serious outcomes from COVID-19.
Berlin Center for Gene and Cell Therapies kicked off in Berlin
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- Category: Bayer
Bayer AG, together with Charité - Universitätsmedizin Berlin, presented plans for the construction of the Berlin Center for Gene and Cell Therapies. The project is being substantially financed and supported by Germany's Federal Government as well as the State of Berlin. The aim of the joint project is to bring these groundbreaking technologies to patients more quickly while creating a leading biotech ecosystem for innovative therapies in Berlin.
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