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.
Pfizer's LORBRENA® CROWN study shows majority of patients with ALK-positive advanced lung cancer living beyond five years without disease progression
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) today announced longer-term follow-up results from the Phase 3 CROWN trial evaluating LORBRENA® (lorlatinib, a third-generation ALK inhibitor, available in Europe under the brand name LORVIQUA®) versus XALKORI® (crizotinib) in people with previously untreated, anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
BlueRock Therapeutics receives FDA Regenerative Medicine Advanced Therapy designation for Parkinson’s disease cell therapy candidate bemdaneprocel
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- Category: Bayer
Bayer AG and BlueRock Therapeutics LP, a clinical stage cell therapy company and wholly owned independently operated subsidiary of Bayer AG, announced today that BlueRock's investigational cell therapy bemdaneprocel for the treatment of Parkinson's disease has been granted Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA).
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