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How to Identify Branded Drugs with a Low Likelihood of Generic Entry as Targets for In-Licensing

Drug Patent Watch

Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. In this comprehensive guide, we’ll explore the intricacies of identifying such drugs and leveraging them for successful in-licensing opportunities.

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China’s NMPA grants priority review status for Ocumension’s Zerviate NDA

Pharmaceutical Technology

The NDA is supported by the data package licensed to Ocumension by Nicox as well as the Phase III clinical trial in China. Zerviate, 0.24% was compared to emedastine difumarate ophthalmic solution, 0.05%, an antihistamine, which is marketed under undeb Emadine brand name.

Licensing 162
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Sourcing Blockbuster Oncology Products for Clinical Trial Supply

XTalks

This is relevant for clinical trials as more regulators require evidence of efficacy in comparison to the standard of care, which is likely to be one of the blockbuster products. This means that sponsors are having to fork out for these blockbuster products in order to run their trials more often.

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Current and future players in the lupus market

Pharmaceutical Technology

Furthermore, similar to GSK’s strategy with Benlysta, AstraZeneca initiated the Phase III TULIP subcutaneous (SC) trial in SLE using subcutaneous delivery of Saphnelo in June 2021. However, the 2021 approval of AstraZeneca’s Saphnelo in the US will mean increasing competition for Benlysta in the coming years.

Marketing 278
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How to Ensure Patient Safety During a Clinical Trial

Cloudbyz

Monitoring patient safety during a clinical trial is one of the founding principles to be followed throughout the drug development life cycle. It can be defined as a collaborative relationship between sponsors, sites, researchers, and everyone involved in the clinical trial phases. Regulatory bodies governing clinical trials.

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Ultimate Guide To Clinical Trial Costs

Clinical Trial Podcast

Have you been tasked to develop a clinical trial budget? Well, you’re in luck because I’m going to share everything you need to know about clinical trial costs. Clinical trial budgets are often put together in haste. Developing a clinical trial budget can be a confusing exercise for sponsors and CROs. Patient Grant.

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Setanaxib by Calliditas Therapeutics for Primary Biliary Cholangitis (Primary Biliary Cirrhosis): Likelihood of Approval

Pharmaceutical Technology

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The company’s pipeline products include Busulipo which is under Phase II clinical trials and Nefecon for IgA Nephritis which is under Phase II clinical trials.