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Senior Editor
New York, USA
+39 year(s) experience
Pink Sheet
Suit against agency reveals internal discussions to approve Jacobus' Ruzurgi despite Catalyst's orphan exclusivity for the same drug; Sen. Bernie Sanders urged FDA to address price of Catalyst's Firdapse (amifampridine).
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An interactive timeline shows the news of the past decade and the evolution of US FDA policies. Click on each year for a full list of events and see the accompanying article.
Topic FDA Policy and regulation
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Rising Pharmaceuticals agrees to pay $3.1m, admits to conspiring to fix prices for hypertension drug, and enters into deferred prosecution agreement. Pfizer asks court to be removed from complaint by state AGs.
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Fallout from Supreme Court's Escobar decision and Department of Justice memos could impact types of healthcare fraud complaints in which the government intervenes.
Topic Drug approval Strategy
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'Number of different initiatives' coming in next several months to make drugs more affordable, including for PrEP prophylaxis, HHS Assistant Secretary for Health Giroir says. Multi-agency approach is key strategy.
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Xtandi use in early prostate cancer, lorlatinib as second-line treatment for non-small cell lung cancer and dacomitinib for first-line NSCLC have upcoming user fee dates.
Topic Cancer
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Bernstein analyst looks into J&J's average net price decline in 2017 and notes average sales price hikes for growth products Darzalex and Imbruvica are offset by price cuts for drugs facing competition. All products had single digit increases, though.
Topic Biosimilars
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US FDA revises draft guidance issued in 2013 to allow research targeting cognition as single endpoint and studies solely evaluating biomarkers; document offers 'potential for multiple advances,' Alzheimer's Association says.
Topic Alzheimers
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Allergan's novel tactic to derail inter partes review of Restasis patents ends for now as Patent Trial and Appeal Board denies Tribe's request to terminate proceeding; Board sets June 6 deadline for final written decision on IPR petition.
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House IP Subcommittee Chair Issa suggests legislation may address sovereign immunity.
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Pharma is criticized for aggressive marketing, but the report also seeks industry help in research on innovative medication.
Topic FDA
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In 8-7 vote, Advisory Committee on Immunization Practices recommends GSK's Shingrix as preferred shingles vaccine given its higher efficacy compared to Merck's Zostavax.
Topic BioPharmaceutical
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Research centers are collaborating on projects to find causes of disease
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Agreement with AbbVie allows Amgen to launch its Humira biosimilar in Europe in 2018 and in the US in 2023.
Topic Biosimilars
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Janssen, Teva, Allergan, Endo, and Purdue – as well as several distributors
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15 May 2020
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07 May 2020
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06 May 2020
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05 May 2020
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03 May 2020
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28 Apr 2020
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23 Apr 2020
Generics Bulletin
22 Apr 2020
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19 Apr 2020
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19 Apr 2020
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16 Apr 2020
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13 Apr 2020
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02 Apr 2020
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01 Apr 2020
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30 Mar 2020
