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Pfizer settles 12-year-old lawsuit in alleged pay-for-delay scheme for $39M

Fierce Pharma

In a case so old that it predates Pfizer’s 2009 acquisition of Wyeth, the companies and a class-action group of direct drug purchasers have agreed to

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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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Impact of IFM 2009 and DETERMINATION Studies

Pharmacy Times

Panelists discuss how the introduction of triplet therapy prior to transplant in studies like IFM 2009 and DETERMINATION shifted the clinician mindset toward more intensive induction regimens, leading to a focus on achieving deeper responses and longer progression-free survival as primary goals of therapy for newly diagnosed multiple myeloma patients. (..)

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470% price increases

World of DTC Marketing

Humira’s net price—which subtracts discounts and rebates—increased by 110% between 2009 and 2018, from $16,663 per year to $35,041 per year. billion in “Humira Research & Development” expenditures between 2009 and 2018—approximately 4.2% of the company’s Humira worldwide net revenue over that period. The post 470% price increases.

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Pharma is in acquisition mode but small biotechs hurting for money

World of DTC Marketing

This study included 63 of 355 new therapeutic drugs and biologic agents approved by the US Food and Drug Administration between 2009 and 2018. 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

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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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FDA Publishes Two Guidance Documents, One in Final Version

PharmaTech

The final guidance is a revision of a policy that has existed in some form since at least 2009, while a separate, draft guidance will accept public comment for consideration for its final version through April 8.

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