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.
Bayer receives Breakthrough Therapy designation in China for BAY 2927088
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- Category: Bayer
Bayer announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China has granted Breakthrough Therapy designation for BAY 2927088, a potential new targeted therapy for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC), whose tumors have activating HER2 (ERBB2) mutations, and who have received a prior systemic therapy. The CDE's designation for BAY 2927088 follows the Breakthrough Therapy designation granted by the U.S. Food and Drug Administration (FDA) in February 2024 for the same patient population.
GSK accelerates oligonucleotide platform and pipeline medicines with acquisition of Elsie Biotechnologies
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- Category: GlaxoSmithKline
GSK plc (LSE/NYSE: GSK) today announced that it has acquired Elsie Biotechnologies, a San Diego-based private biotechnology company dedicated to unlocking the full potential of oligonucleotide therapeutics, for up to $50 million (approximately £39 million).
Oligonucleotides have a unique ability to modulate gene expression, making them an attractive modality to address a significant proportion of therapeutic targets that are not amenable to traditional small molecules or biologics.
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- AstraZeneca sets ambition to deliver $80 billion Total Revenue by 2030
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- U.S. FDA approves Pfizer's BEQVEZ™ (fidanacogene elaparvovec-dzkt), a one-time gene therapy for adults with Hemophilia B
- AskBio receives FDA Fast Track Designation for AB-1002 investigational gene therapy program in congestive heart failure