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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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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.

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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.

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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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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.

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NEW FEXOFENADINE over the counter – Allevia tablets

Druggist

The Government recently announced the reclassification of fexofenadine 120mg, which will be available as General sale Medication (GSL), sold as branded products – Allevia 120mg tablets. Fexofenadine is known as generic product ‘fexofenadine’ and branded as Telfast. Summary of the post: What is fexofenadine?

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Gamida Cell Provides Regulatory Update on Biologics License Application for Omidubicel

The Pharma Data

The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. Specifically, the FDA requested that Gamida Cell demonstrate analytical and clinical comparability from the company’s planned commercial manufacturing sites.