Year in Review: Biosimilars
In November 2020, the FDA released its most recent draft guidance for industry on biosimilarity and interchangeability
Drug Pricing
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Read more: Year in Review: Biosimilars -
Read more: AbbVie Wins First Round in Humira Antitrust Lawsuit AbbVie Wins First Round in Humira Antitrust Lawsuit
The purpose of the secondary patent filings was to assemble a thicket of patents, 132 in all, to prohibit competition from biosimilar companies.
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Read more: Issuing the Most Favored Nation Interim Final Rule Was a Mistake Issuing the Most Favored Nation Interim Final Rule Was a Mistake
Procedurally, the Trump administration’s issuance of the Most Favored Nation Interim Final Rule was a mistake.
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Read more: Monthly Round-Up of What to Read on Pharma Law and Policy Monthly Round-Up of What to Read on Pharma Law and Policy
Selections feature topics ranging from political pressures facing the FDA, to the financial incentive structure for antibiotic development.
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Read more: Monthly Round-Up of What to Read on Pharma Law and Policy Monthly Round-Up of What to Read on Pharma Law and Policy
Interesting empirical studies, policy analyses, and editorials on pharma, health law, and policy issues from August 2020.
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Read more: Monthly Round-Up of What to Read on Pharma Law and Policy Monthly Round-Up of What to Read on Pharma Law and Policy
Interesting empirical studies, policy analyses, and editorials on health law and policy issues from July 2020.
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Read more: To Cut Prescription Drug Spending, Stop Delays for Generic Competition To Cut Prescription Drug Spending, Stop Delays for Generic Competition
While generic competition is crucial for reducing drug prices, brand-name drug manufacturers can utilize several strategies to delay such competition.
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Read more: Monthly Round-Up of What to Read on Pharma Law and Policy Monthly Round-Up of What to Read on Pharma Law and Policy
Topics include the association between the clinical benefit of cancer drugs and their prices, and whether to include children in COVID-19 therapy trials.
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Read more: New HarvardX Course on the FDA and Prescription Drugs New HarvardX Course on the FDA and Prescription Drugs
Interested in learning more about pharmaceutical policy? Curious about the role of the FDA in ensure safe and effective drugs reach the market? Wondering why drug prices are so high in the US? Readers of my prior posts may enjoy learning more about these topics! Check out a free HarvardX online course, “The FDA and…
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Read more: Healthcare Already Taking Center Stage in 2020 Democratic Primary Race Healthcare Already Taking Center Stage in 2020 Democratic Primary Race
While many issues are likely to play a prominent roles in this campaign, healthcare is likely to play an outsized role.
