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STAT+: Medicare may test policy of paying less for accelerated approval drugs

STAT

The Food and Drug Administration uses accelerated approvals to make promising drugs for serious conditions available to patients sooner. Continue to STAT+ to read the full story…

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2022 spells change for EU pharmaceutical legislation

European Pharmaceutical Review

The review was impacted by Brexit and the COVID-19 pandemic, which compounded existing issues surrounding high drug pricing and patient access that had been brewing since 2016 and highlighted several shortcomings in the EU’s pharmaceutical system. It is too early to say because we have not seen the whole package of measures yet.

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Rare Disease Spotlight – tracing the rise of orphan drug designations over almost 40 years

Pharmaceutical Technology

Orphan drug designations provide financial incentives for companies and developers, including “tax credits for qualified clinical testing”, “a Waiver of the Prescription Drug User Fee” that is currently at almost $3 million for a new drug, and “potential seven years of market exclusivity”.

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Achieving scale up success under economic uncertainty

European Pharmaceutical Review

Market uncertainty Rising operational costs, stiffening competition, ongoing patent expirations, evolving environmental and social governance requirements and increasing pressure on drug prices mean the industry will have to navigate thoughtfully to be successful amid this complicated mix of financial and strategic risks.

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Three strategies for managing loss of exclusivity successfully

pharmaphorum

Drug prices to plummet in wave of expiring patents”. Price decay after loss of brand exclusivity”. These are just three headlines that come up when you Google “drug patent expiry”. AstraZeneca’s patent for its top-selling gastroesophageal reflux disease drug was due to expire in 2001. billion in 2004.14

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Preliminary Injunction Decision in Chambers of Commerce Case Provides First Insights Into Merits of Medicare Negotiations Cases

FDA Law Blog: Biosimilars

By Faraz Siddiqui — Last week, a federal court in Ohio denied a preliminary injunction motion by four Chambers of Commerce in their lawsuit against the Medicare Drug Price Negotiation Program. Engler , a 2001 decision by the Sixth Circuit Court of Appeals.

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Opinion: Global freeloading: Americans shouldn’t bear the brunt of drug development costs

STAT

in 2001 to 27.2% Chronic diseases, such as diabetes, cancer, and cardiovascular disease, pose one of the most significant health threats to Americans today. The share of Americans with multiple chronic conditions increased from 21.8% In 2022, these illnesses claimed the lives of 1.9 Read the rest…