BlueRock Therapeutics to incorporate wearable and invisible contactless digital health technologies from Rune Labs and Emerald Innovations in Parkinson's disease clinical trial
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- Category: Bayer
BlueRock Therapeutics LP, a clinical stage biopharmaceutical company and wholly-owned, independently operated subsidiary of Bayer AG, announced a collaboration with Rune Labs and Emerald Innovations focused on using wearable and invisible contactless digital health technology to improve monitoring and data collection for Parkinson's disease clinical trials.
Novartis Tafinlar + Mekinist approved by FDA for pediatric patients with BRAF V600E low-grade glioma
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- Category: Novartis
Novartis today announced the U.S. Food and Drug Administration (FDA) granted approval for Tafinlar® (dabrafenib) + Mekinist® (trametinib) for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. The FDA also approved liquid formulations of Tafinlar and Mekinist, marking the first time a BRAF/MEK inhibitor has been developed in a formulation suitable for patients as young as one year of age.
AstraZeneca launches call for entries to the 2023 global R&D Postdoctoral Challenge
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- Category: AstraZeneca
AstraZeneca has announced the launch of the 2023 R&D Postdoctoral Challenge, an initiative designed to accelerate ideas to transform the treatment of some of the world’s most complex diseases.
The R&D Postdoctoral Challenge has been designed to drive R&D productivity, promote diversity of thought and stimulate research opportunities across the globe.
Pfizer invests $43 billion to battle cancer
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) and Seagen Inc. (Nasdaq: SGEN) today announced that they have entered into a definitive merger agreement under which Pfizer will acquire Seagen, a global biotechnology company that discovers, develops and commercializes transformative cancer medicines, for $229 in cash per Seagen share for a total enterprise value of $43 billion.
Pfizer's ZAVZPRET™ (zavegepant) migraine nasal spray receives FDA approval
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) has approved ZAVZPRET™ (zavegepant), the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine with or without aura in adults. In its pivotal Phase 3 study, ZAVZPRET was statistically superior to placebo on the co-primary endpoints of pain freedom and freedom from most bothersome symptom at two hours post-dose.
US FDA Advisory Committee votes to support effectiveness and safety of GSK's respiratory syncytial virus older adult vaccine candidate
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- Category: GlaxoSmithKline
GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that the available data support the safety and effectiveness of GSK's respiratory syncytial virus (RSV) older adult vaccine candidate for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older.
Pfizer receives positive FDA Advisory Committee votes supporting potential approval for vaccine candidate to help combat RSV in older adults
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that available data is adequate to support the safety and effectiveness of its respiratory syncytial virus (RSV) bivalent vaccine candidate PF-06928316 or RSVpreF. The Committee voted 7 to 4 on safety and 7 to 4 on effectiveness.
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- AstraZeneca enters license agreement with KYM Biosciences for CMG901, a Claudin-18.2 antibody drug conjugate
- Pfizer's elranatamab receives FDA and EMA filing acceptance
- Pfizer announces The Lancet Neurology has published Phase 3 data for zavegepant for the acute treatment of migraine in adults
- Roche announces donation of essential medicines and diagnostic solutions to the people affected by the devastating earthquake in Türkiye and Syria
- Kerendia™ (finerenone) granted expanded indication in the EU for broad range of patients with chronic kidney disease and type 2 diabetes
- GSK announces results from 17-year retrospective study on US clinical trial diversity
- 2022 Otto Bayer Award goes to Professor Frank Glorius