AskBio receives FDA Fast Track Designation for AB-1002 investigational gene therapy program in congestive heart failure
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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, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the AB-1002 program. AB-1002 is an investigational one-time gene therapy that is administered to the heart with the intention of helping to promote the production of a constitutively active form of protein inhibitor 1 (I-1c) designed to block the action of protein phosphatase 1.
European Commission approves Pfizer's EMBLAVEO® for patients with multidrug-resistant infections and limited treatment options
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for EMBLAVEO® (aztreonam-avibactam) for the treatment of adult patients with complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), and complicated urinary tract infections (cUTI), including pyelonephritis. It is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options.
AskBio presents 18-month Phase Ib trial results of AB-1005 gene therapy for patients with 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, on Sunday April 14 presented results from the 18-month Phase Ib clinical trial for AB-1005, an investigational gene therapy for treating patients with Parkinson's disease (PD).(1,2) The data were presented at the American Academy of Neurology 2024 Annual Meeting in Denver, Colorado, USA.
The study met its primary objective, which was to evaluate the safety of a one-time bilateral delivery of AB-1005 directly to the putamen.
Bayer and Thermo Fisher Scientific collaborate to increase patient access to precision cancer medicines
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- Category: Bayer
Bayer AG and Thermo Fisher Scientific Inc. today announced a collaboration to develop next-generation sequencing (NGS)-based companion diagnostic assays (CDx) together. These will help identify patients who may benefit from Bayer's growing portfolio of precision cancer therapies by offering decentralized genomic testing and rapid turnaround time.
Bayer and Aignostics to collaborate on next generation precision oncology
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- Category: Bayer
Bayer and Aignostics GmbH announced a strategic collaboration on several artificial intelligence (AI)-powered approaches with applications in precision oncology drug research and development. Aignostics is a spin-off from one of the world's leading hospitals, Charité-Universitätsmedizin Berlin, and a global leader in using computational pathology to transform complex biomedical data into biology insights.
AstraZeneca to acquire Amolyt Pharma, expanding late-stage rare disease pipeline
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- Category: AstraZeneca
AstraZeneca announced that it has entered into a definitive agreement to acquire Amolyt Pharma, a clinical-stage biotechnology company focused on developing novel treatments for rare endocrine diseases.
The proposed acquisition will bolster the Alexion, AstraZeneca Rare Disease late-stage pipeline and expand on its bone metabolism franchise with the notable addition of eneboparatide (AZP-3601), a Phase III investigational therapeutic peptide with a novel mechanism of action designed to meet key therapeutic goals for hypoparathyroidism.
European Commission approves Pfizer's PREVENAR 20® to help protect infants and children against pneumococcal disease
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for the company's 20-valent pneumococcal conjugate vaccine, marketed in the European Union under the brand name PREVENAR 20®, for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age.
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- Acquisition of Icosavax completed
- First patient randomized in AskBio Phase II gene therapy trial for congestive heart failure
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