Remove Branding Remove Generic Drugs Remove Trials
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Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. Types of Drug Applications The PMDA accepts three main types of drug applications: Investigational New Drug (IND) : Required for conducting clinical trials in Japan.

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Compliance Challenges in Generic Drug Development: Lessons Learned

Drug Patent Watch

The Unseen Hurdles of Generic Drug Development: Lessons Learned As the pharmaceutical industry continues to evolve, one thing remains constant: the pursuit of affordable, high-quality medications for patients worldwide. However, the journey to bringing a generic drug to market is often fraught with challenges.

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Expanding ketamine’s horizons to treat rare neurological disorders

Pharmaceutical Technology

The company now plans to move this approach into a Phase III trial. The treatment, sold under the brand name Spravato by Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson , is also indicated for the treatment of depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal thoughts.

Research 275
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Sweeping changes in leaked EU pharma law draft reignite profit vs access conflict

Pharmaceutical Technology

The overhaul will address drug marketing exclusivity length, pricing, patient access, innovation incentives, antimicrobial resistance, clinical trials, supply chain security and shortages, and environmental impact. The EU is planning a sweeping revision of its pharma legislation in March, the largest change in 20 years.

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Katie Porter attacks pharma

World of DTC Marketing

So where to start… Congresswoman Porter may want to look at the percentage of generic drugs available virus branded (89%). I have been recruited by these companies who promise huge payouts when they are acquired if their drug shows promise in clinical trials. In pharma R&D returns have declined to 1.8

In-Vivo 187
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Leading API chemical companies in contract marketing

Pharmaceutical Technology

Various factors have contributed to the need and growth of API chemical suppliers such as rising healthcare expenditure, increasing disposable incomes, growing geriatric population, increasing incidence of chronic diseases, patent expiration of blockbuster drugs, increased consumption of generic drugs, and intervention of the new generation APIs.

Marketing 100
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Quality by design with a focus on biosimilars

Pharmaceutical Technology

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug.