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The rising impact of biomarkers in early clinical development

Drug Target Review

As our understanding of the underlying biology of disease grows more sophisticated, emerging therapies operate on increasingly complex biopathological systems and mechanisms. Safety biomarkers account for adverse effects of a therapy under study. For use as endpoints, biomarkers must be correlated to a valid clinical outcome.

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Vamorolone

New Drug Approvals

Corticosteroid therapy is the current standard of care for DMD despite relatively high rates of adverse effects. Example 2: Synthesis of the present invention Scheme C: Route of Synthesis of Vamorolone from 8-DM Vamorolone was synthesized in three synthetic steps from commercially available 8-DM. 77 Readily available steroid 9.1

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Landiolol

New Drug Approvals

Treatment of phenol 143 with bromo epoxide 144 in the present of K2CO3 afforded ether 145 in 76% yield. “Pharmacokinetics of landiolol hydrochloride, a new ultra-short-acting beta-blocker, in patients with cardiac arrhythmias” Clinical Pharmacology and Therapeutics. New Drug Therapy Approvals 2024 (PDF).

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Shaping drug development success: how does artwork play a role?

Drug Target Review

The pharmaceutical industry is undergoing a major shift towards the development of breakthrough medicines and advanced therapies. However, making informed labelling decisions during preclinical stages is complex and requires expertise in a variety of areas, including clinical pharmacology, toxicology, regulatory affairs and medical writing.

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Biomarker identification in the realm of rare diseases

Drug Target Review

Small patient populations often result in difficulty in determining a significant effect of a therapy, given the low confidence power associated with the statistics. However, some biomarkers may only be present in a minority of patients, requiring a large patient population to identify such markers.

Disease 59
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Astellas and Seagen Announce Initial Results of PADCEV® (enfortumab vedotin-ejfv) in Patients with Muscle-Invasive Bladder Cancer Not Eligible for Cisplatin Chemotherapy

The Pharma Data

– La te-breaking data from Cohort H of EV-103 trial to be presented at the 2022 ASCO Genitourinary Cancers Symposium –. Data from this late-breaking abstract will be included in an oral presentation (Abstract 435) at the 2022 ASCO Genitourinary Cancers Symposium (ASCO GU) on February 18. Astellas Pharma Inc. Astellas”) and Seagen Inc.

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Bristol Myers Squibb Data at the EADV 30th Anniversary Congress Highlight the Growing Body of Evidence on Deucravacitinib and Scientific Advancements for Patients with Serious Dermatologic Diseases

The Pharma Data

Deucravacitinib demonstrated efficacy no matter baseline characteristics, including weight , disease severity and former treatment with biologic or non-biologic therapies. These data (Presentation #2857) are being presented today during the Late Breaking News Session from 3:45 – 4:45 p.m.

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