Inequitable conduct and invalidation of patents related to FDA regulated products

13 November 2023 - Median brand name drug launch prices increased from $2,115 in 2008 to $180,007 in 2021. ...

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Ancillary product patents to extend biologic patent life

13 November 2023 - In 2021, 46% ($260 billion) of all gross prescription drug spending in the US was on biologic ...

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In shocking reversal, CMS wants to allow Medicare Part D plan sponsors to substitute non-interchangeable biosimilars

10 November 2023 - On November 6, 2023, CMS announced a proposed Rule that would permit Medicare Part D plan sponsors ...

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MHRA joins global regulatory partners in celebrating ten years of international medicines regulatory cooperation

9 November 2023 - As a founding member and former chair of the International Coalition of Medicines Regulatory Authorities (ICMRA), the MHRA ...

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Getting ready for EMA’s website relaunch on 5 December 2023

9 November 2023 - The EMA is relaunching its corporate website on 5 December 2023. ...

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HHS considers removing J&J’s Stelara from Medicare drug price negotiations

7 November 2023 - The Department of Health and Human Services in a supplemental court filing posted late last week ...

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FDA’s Califf wants to get the public as excited about life expectancy as cures

8 November 2023 - It’s easy to get people worked up about cures, but they don’t seem to be bothered ...

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First electronic product information published for selected human medicines

8 November 2023 - The Heads of Medicines Agencies (HMA), the European Commission and EMA have published for the first time ...

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FDA finalises guidance on real-time review of oncology drugs

7 November 2023 - The US FDA has finalised its guidance that outlines the eligibility and submission requirements for applicants interested ...

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How should the FDA evaluate psychedelic medicine?

4 November 2023 - Drug companies are spending millions of dollars to incorporate psychedelic agents into health care. Working with ...

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Key Senate panel to consider PBM, drug pricing reform package

2 November 2023 - A key Senate panel announced it will consider more policies to regulate pharmacy middlemen and ensure ...

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Medicare is urged to consider Amgen patent manoeuvres when negotiating the price for a drug

31 October 2023 - As Medicare prepares to negotiate prices for its first batch of medicines, an advocacy group argues ...

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The FDA and Moderna’s cosy relationship: how lax rules enable a revolving door culture

1 November 2023 - After holding oversight roles for covid vaccines, two regulators from the US FDA went to work for ...

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FDA notes “continued growth” of Orbis collaborative review program, adds EMA as observer

1 November 2023 - There has been “continued growth” in the number of applications submitted to Project Orbis, and the ...

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Landmark listing of first three countries as WHO listed regulatory authorities

31 October 2023 - The Health Sciences Authority, Singapore; the Ministry of Food and Drug Safety, Republic of Korea; and ...

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