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Luye claims its first FDA approval, for bi-weekly schizophrenia drug

pharmaphorum

China’s Luye Pharma has claimed its first FDA approval, getting a green light for Rykindo, an injectable formulation of the antipsychotic risperidone given every two weeks. ” The post Luye claims its first FDA approval, for bi-weekly schizophrenia drug appeared first on.

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Considerations for Neuroscience Trials with Intrathecal Delivery and Other Methods of Direct CNS Administration

XTalks

Clinical research experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. Why is it Difficult to Develop CNS Therapeutics?

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Boehringer Ingelheim; Roche demonstrated new analyses of their drugs in patients with ILDs during the American Thoracic Society (ATS) Virtual conference

Delveinsight

Boehringer Ingelheim is worth mentioning here, as it is presenting key posters and studies on Ofev’s SENSCIS Trial and INBUILD Trial. Nintedanib is an orally bioavailable, small-molecule tyrosine kinase inhibitor (TKI) developed for the treatment of IPF and SSc-ILD. Ofev (Nintedanib) Facts. Esbriet (Pirfenidone) Facts.

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Lilly Announces Details of Presentations at 2021 American Association for Cancer Research (AACR)

The Pharma Data

Retevmo was approved under the FDA’s Accelerated Approval regulations based on the LIBRETTO-001 Phase 1/2 trial’s endpoints of overall response rate (ORR) and duration of response (DoR). LY3484356, an oral SERD, is currently being studied in a Phase 1/2 clinical trial. Pipeline Highlights.

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Monday 17 April at AACR Annual Meeting 2023

Drug Discovery World

DDW’s Megan Thomas rounds up highlights from Monday 16 April at AACR 2023, from promising trial results for colorectal cancer patients to updates on Biden’s Cancer Moonshot initiative. Read more here. overall response rate. Read more about AACR award winners here.

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Systemic Lupus Erythematosus Treatment Market: How the Leading Companies are Countering the Rising Prevalence?

Delveinsight

Hydroxychloroquine and BENLYSTA are the FDA-approved therapies for SLE treatment. With the approval of these therapies, the outlook for SLE patients improved from a 4-year survival rate of ~50% in 1950 to a 15-year survival rate of ~85% by 2013. The average annual drug cost is USD 38,000 per year. Baricitinib (INCB-028050).