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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

1 For use as prescription drugs, a botanical product must be approved by the FDA: to date, only two have gained this approval. The MA pathway is applicable for herbal medicines designed to treat more serious health conditions and require a medical prescription or the supervision of a medical practitioner. 2012/1916).

Marketing 103
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Navigating the Challenges of Biopharma Product Launches: A Blueprint for Success

PM360

The landscape is highly competitive with new prescription medications launching worldwide each year. Early shaping of the label during clinical trial design, risk mitigation, and avoiding approval delays are crucial for seizing a competitive advantage.

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Exforge antitrust settlement caps Novartis’ year of legal disputes

Pharmaceutical Technology

The alleged actions violated the Hatch-Waxman Act, formally known as the “Drug Price Competition and Patent Term Restoration Act of 1984,” which allows generic manufacturers to market their generic versions of previously approved generic medications. These actions allegedly led to the extension of Novartis’ patents.

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Humira biosimilars set the stage for long-awaited 2023 US launches

Pharmaceutical Technology

Others are made by big pharma giants like Boehringer Ingelheim , Novartis , or Pfizer , which has raised the expectations for a competitive market. . Although AbbVie will now face competition from these products, it has built a strong market for Humira, says Hlávka, adding that it will likely continue reporting significant revenues.

Marketing 104
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Fixed-dose combination: Considerations for design, formulation, manufacturing and analysis

Pharmaceutical Technology

Understanding both the significant competitive advantages that FDC products can offer, and the difficulties and potential pitfalls associated with development and manufacturing of FDC drugs in oral solid dosage forms is a critical first step for companies exploring this approach. Of those 131 approved FDCs, 98 were oral dosage forms.

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The Witty Answer to GSK’s Future

Pharmaceutical Technology

PT: How do you think GSK is placed competitively? Important elements within this expectation are the build up of strong contributions from Rotarix, Cervarix and Tykerb, while the outlook for GSK’s important asthma franchise becomes less clear beyond 2010. PD: We believe that GSK has the strongest pipeline in the industry.

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Breaking through the forecasting fog – 3 trends that will impact critical medicine supply in 2023

pharmaphorum

Demand has also increased due to changes in prescribing protocols, leading to a higher underlying number of prescriptions for certain antibiotic medicines. He previously held regional leadership roles at Sandoz between 2005 and 2010. The impact is two-fold.

Medicine 105