Request for CMS to provide a Bayh-Dole Section 202 license and a 28 USC 1498 authorization and consent to use three patents listed in the FDA Orange Book for the cancer drug enzalutamide

Letter from KEI, UACT and UAEM to Chiquita White Brooks-Lasure, Administrator of the Office of the Administrator, Centers for Medicare and Medicaid Services, at HHS, asking that CMS to provide a Bayh-Dole Section 202 license and a 28 USC 1498… Continue Reading

NGO Letter to Biden Administration in Support of Xtandi Appeal

Today, eight non-governmental organizations sent the Biden Administration a letter of support for the administrative appeal of the request for the Department of Health and Human Services (HHS) to use its rights in the patents on the prostate cancer drug… Continue Reading

25 Members of Congress Ask HHS Secretary to Act on Xtandi Request

On January 10, 2023, twenty-five Members of Congress sent a letter to HHS Secretary Xavier Becerra urging him to act on the Xtandi request, and to use the Bayh-Dole Act to lower the price of Xtandi (enzalutamide) for US patients.… Continue Reading

Letter to Secretary of HHS Xavier Becerra regarding Xtandi march-in case from Robert Sachs and Clare Love

SecBecerra-18Nov2022-Sachs-Love-Xtandi November 18, 2022 Xavier Becerra Secretary Department of Health & Human Services Washington, DC Via Email: xavier.becerra@hhs.gov Dear Secretary Becerra: Today marks the one-year anniversary since the undersigned prostate cancer patients petitioned the Department of Health & Human Services… Continue Reading

Senators Warren and King, and Representative Doggett ask HHS Secretary Becerra to Move Forward on Xtandi March-in and Government Use Rights (Existing Bayh-Dole Safeguards)

Senators Elizabeth Warren (D-MA) and Angus King (I-ME) and Representative Lloyd Doggett (D-TX) wrote Secretary of HHS Xavier Becerra on February 17, 2022, urging him to move forward with the march-in petition by Robert Sachs, Clare Love and Eric Sawyer,… Continue Reading

Eric Sawyer December 13, 2021 Petition to HHS on Xtandi March-in Case

On December 13, 2021, Eric Sawyer filed this petition with the Department of Health and Human Services, asking to join an outstanding march-in petition on the patents for the prostate cancer drug enzalutamide, sold under the brand name Xtandi by… Continue Reading

HHS Asked to Take Up March-in Request of Prostate Cancer Drug Xtandi

(Update: On December 15, 2021 KEI hosted a press briefing regarding the Xtandi march-in request. Video and details available here: https://www.youtube.com/watch?v=KwqUl7NLMXo) On November 18, 2021, Robert Sachs and Clare Love submitted a petition to the Secretary of Health and Human… Continue Reading

KEI Submission to WHO Essential Medicines List – Enzalutamide / Abiraterone Acetate

The WHO Essential Medicines List is a major WHO tool used to expand access to medicines.  In 2017, the WHO issued the 20th Essential Medicines List (EML) which was the 40th anniversary of the list.  The WHO is currently in… Continue Reading

Biolyse Pharma offers to supply enzalutamide (Xtandi) for $3 per pill to Medicare and developing countries

On April 22, 2016, the President of Biolyse Pharma — a Canadian pharmaceutical company that specializes in the manufacture of oncology drugs — offered to supply the prostate cancer drug enzalutamide (Xtandi) to the Centers for Medicare & Medicaid Services (CMS) for $3 per pill ($12 per day; $4,383 per year). The Biolyse price for enzalutamide is 4-percent of the 2014 Medicare price, $69.41 ($277.64 per day; $101,408.01 per year), and lower than any other price in the world.

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