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The current pharma business model is unsustainable

World of DTC Marketing

In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. They relied so much on a new drug that they tried to market a product with bad science behind it. The pharma industry is a giant behemoth that needs new drugs to survive and grow.

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Pharma is in acquisition mode but small biotechs hurting for money

World of DTC Marketing

It seems that pharma is only interested in drugs that have the potential to sell hundreds of millions as opposed to small products that may only sell to a limited audience. A study in 2020 estimated that the median cost of getting a new drug into the market was $985 million, and the average price was $1.3 5 drugs) ranged from $765.9

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GSK and Spero enter licence deal for cUTI antibiotic

Pharmaceutical Technology

Since 2009, Meiji has marketed tebipenem HBr in Japan. Following receipt of encouraging regulatory feedback from the US Food and Drug Administration (FDA) on the proposed trial design, the company intends to commence the Phase III trial next year. In July, GSK acquired Sierra Oncology for $1.9bn in cash.

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FDA sketches a path for patient-focused drug development

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has released the fourth and final chapter in a series of guidance documents designed to support patient-focused drug development. The guidance also touched upon clinical trial design elements that must be explained, described, or rationalised to the FDA.

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Bringing the patient voice into clinical trials with clinical outcome assessments

Clarivate

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. Patient focused drug development in alopecia areata clinical trials.

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How clinical outcome assessments can help us understand the patient experience

Clarivate

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. All data were collated in FDA COA Evidence Dossiers. Mainland China and Japan.

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Centinel Spine® Completes Enrollment in First-of-its-Kind 2-Level IDE Trial Evaluating prodisc® C Match-the-Disc™ Cervical TDR System

Legacy MEDSearch

Food and Drug Administration. ” The pro disc C Vivo system has been in clinical use internationally since 2009 and is currently one of the most frequently implanted TDR devices in the world. The study includes 431 Subjects at 29 sites throughout the U.S. and with oversight from the U.S.