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New FDA head needs to examine the accelerated approval program

World of DTC Marketing

SUMMARY: Medicare spent nearly $600 million over a three-year period to pay for four cancer drugs with no clinical benefit an analysis published Monday by JAMA Internal Medicine found.

FDA 234
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AbbVie sucks

World of DTC Marketing

AbbVie, Humira’s manufacturer, kicked off 2020 with a price increase in excess of 7 percent on its mega-blockbuster brand-name treatment. The cost of Humira, which is injected via syringe, was more than $72,000 a year on prescription drug websites this week and is not expected to come down until at least 2023.

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AbbVie continues to be what’s wrong with big pharma

World of DTC Marketing

prices on seven of the 10 costliest prescription drugs in 2020 without justification, increasing drug spending by $1.67 group that reviews the value of medicines said on Tuesday. According to Reuters “drugmakers hiked U.S. billion, a U.S. leading to an almost $1.4 billion increase in U.S. leading to an almost $1.4

Pharma 202
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“Game-changing” obesity drug over-promising?

World of DTC Marketing

Novo Nordisk has admitted that it would not be able to keep up, adding that it would likely take until early 2022 for the supply to stabilize and that some patients “are experiencing an approximate one month or longer delay in filling prescriptions for Wegovy.” Nearly 3% of the overall U.S. The reasons are complex.

Insurance 271
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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. 2 Approach taken by regulators in the UK The Medicines and Healthcare products Regulatory Agency regulates herbal medicines in the UK. 2012/1916). 2012/1916). 2012/1916).

Marketing 103
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Inflation threatens supply of life-saving generics to Europe

Pharmaceutical Technology

On November 16, 2022, Medicines for Europe (MFE), the generics and biosimilars body, called for EU and national reforms to improve the security of medicine supplies, including tackling the impact of inflation on the security of essential medicine supplies with smart procurement guidelines for medicine.

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GAMP 5 update: computerized system expectations for pharma manufacturers

European Pharmaceutical Review

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.”