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Driving QbD as a quality standard in drug development

European Pharmaceutical Review

Reviewing implementation of QbD in the pharmaceutical industry To compile the review of Quality by Design in the context of MAAs in Europe, the researchers analysed the implementation of the QbD methodology for all MAAs approved by the European Medicines Agency (EMA) since the ICH Q8(R2) guideline was adopted in 2009.

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The current pricing of cancer treatments is unsustainable

World of DTC Marketing

From 2009 to 2019, the median monthly treatment costs for new drugs at launch reached $11,755 in the U.S… From 2009-10 to 2018-19, the lowest average monthly costs for new cancer drugs approved by the U.S. SUMMARY: The U.S. needs to take substantial steps to address the high costs of cancer drugs.

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The current pharma business model is unsustainable

World of DTC Marketing

While that sounds encouraging, most cancer drugs launched between 2009 and 2014 cost more than USD 100,000 annually. COVID-19 has not impacted the number of launches in the oncology space, as 2020 and 2021 have seen similar rates of drug launches as in 2019. ASH Clinical News takes it a step further.

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Cognitive decline in early Alzheimer’s could stem from serotonin loss

PharmaTimes

Scientists recruited 49 volunteers with mild cognitive impairment (MCI) and 45 healthy adults aged 55 years and older who had previously undergone an MRI to measure changes in brain structure and two positron emission tomography (PET) scans of their brains at Johns Hopkins between 2009 and 2022.

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Now alcohol is a direct cause of cancer

World of DTC Marketing

Endpoints recently wrote, “between 2009 and 2020, prices increased — with one exception — within and across all 12 cancer drug classes studied in the U.S., Employers who, for example, pay for employee gym memberships should be reimbursed, provided there is proof employees are using them.

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Biogen’s $900 million settlement signals scrutiny on speaker fees

Pharmaceutical Technology

In 2009, former Biogen employee Michael Bawduniak filed a lawsuit claiming that Biogen had violated the False Claims Act and the Anti-Kickback Statute by providing millions of dollars to healthcare providers (HCPs) as an incentive to prescribe three of its multiple sclerosis (MS) drugs.

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The PM360 Trailblazer Awards 2022 Finalists

PM360

The Trailblazer Awards were established in 2009 to recognize and honor outstanding companies, marketers, marketing teams, brand managers, and initiatives that have demonstrated innovation and achieved incredible results in the life sciences. The finalists are in for PM360’s 14 th annual Trailblazer Awards.

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