FDA approves Pfizer's LITFULO™ (ritlecitinib) for adults and adolescents with severe alopecia areata
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved LITFULO™ (ritlecitinib), a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata. The approved recommended dose for LITFULO is 50 mg. It is the first and only treatment approved by the FDA for adolescents (12+) with severe alopecia areata.
Pfizer's TALZENNA® in combination with XTANDI® receives U.S. FDA approval
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- Category: Pfizer
Pfizer (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved TALZENNA (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI (enzalutamide), for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
Real-world evidence highlights the urgent need to act on the growing global burden of chronic kidney disease
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- Category: AstraZeneca
AstraZeneca, a leader in cardiorenal diseases, presented new real-world evidence (RWE) data at the European Renal Association (ERA) 2023 Congress in Milan, Italy, demonstrating the staggeringly low rate of diagnosis in chronic kidney disease (CKD). These data show that an urgent need exists for improved screening which can lead to earlier diagnosis.
Results from the REVEAL-CKD multinational study showed that the prevalence of undiagnosed Stage 3 (moderate) CKD was 85% to 97% across Spain, Australia, Canada and Brazil.
Bayer to acquire exclusive license from Cedilla Therapeutics on selective inhibitors in pre-clinical precision oncology
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- Category: Bayer
Bayer and Cedilla Therapeutics, a biotechnology company bringing a new dimension to precision oncology, announced an exclusive license agreement to develop and commercialize Cedilla Therapeutics' CyclinE1/CDK2 complex inhibitors which selectively address oncogenic drivers.
Overexpression or genetic activation of Cyclin Dependent Kinase 2 (CDK2) binding partner cyclin E is a key oncogenic process in several cancers.
AstraZeneca announces agreement with Quell Therapeutics to develop, manufacture and commercialise engineered T-regulatory cell therapies for autoimmune diseases
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- Category: AstraZeneca
AstraZeneca has entered into an exciting collaboration, exclusive option and license agreement with Quell Therapeutics to develop multiple engineered T-regulator (Treg) cell therapies that have the potential to be curative in Type 1 Diabetes (T1D) and Inflammatory Bowel Disease (IBD) indications.
Under the terms of the agreement, Quell's proprietary toolbox of Treg cell engineering modules, including its innovative Foxp3 Phenotype Lock will be leveraged to develop autologous multi-modular Treg cell therapy candidates for major autoimmune disease indications.
Bayer strengthens gene therapy portfolio with lipid nanoparticle technology from Acuitas Therapeutics
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- Category: Bayer
Bayer AG is joining forces with Acuitas Therapeutics, Inc., a biotechnology company specializing in the development of lipid nanoparticle (LNP) delivery systems for molecular therapeutics. Acuitas' LNP technology will support Bayer's in vivo gene editing and protein replacement programs by specifically delivering RNA payloads to the desired target organ, the liver.
New England Journal of Medicine publishes results from Phase 3 induction and maintenance programs evaluating upadacitinib (RINVOQ®) in Crohn's disease
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- Category: AbbVie
AbbVie (NYSE: ABBV) announced the New England Journal of Medicine (NEJM) published results from the pivotal Phase 3 clinical trials - U-EXCEL, U-EXCEED and U-ENDURE - evaluating upadacitinib (RINVOQ®) in adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to conventional therapy or a biologic agent.
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