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Pink Sheet
By Brenda Sandburg 03 Jul 2019
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
Pink Sheet
By Brenda Sandburg 03 Jul 2019
'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.
Scrip
By Brenda Sandburg 02 Jul 2019
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
Scrip
By Brenda Sandburg 28 May 2019
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
Pink Sheet
By Brenda Sandburg 15 May 2018
US FDA revises draft guidance issued in 2013 to allow research targeting cognition as single endpoint and studies solely evaluating biomarkers; document offers 'potential for multiple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
Pink Sheet
By Brenda Sandburg 15 May 2018
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.
Pink Sheet
By Brenda Sandburg 08 Nov 2017
House IP Subcommittee Chair Issa suggests legislation may address sovereign immunity.
Pink Sheet
By Brenda Sandburg 02 Nov 2017
Pharma is criticized for aggressive marketing, but the report also seeks industry help in research on innovative medication.
Topic FDA
Pink Sheet
By Brenda Sandburg 27 Oct 2017
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
Pink Sheet
By Brenda Sandburg 17 Oct 2017
Research centers are collaborating on projects to find causes of disease
Pink Sheet
By Brenda Sandburg 01 Oct 2017
Agreement with AbbVie allows Amgen to launch its Humira biosimilar in Europe in 2018 and in the US in 2023.
Topic Biosimilars
Pink Sheet
By Brenda Sandburg 21 Sep 2017
Janssen, Teva, Allergan, Endo, and Purdue – as well as several distributors
Pink Sheet
By Brenda Sandburg 16 Sep 2017
Commissioner Gottlieb says FDA is looking to work with provider groups to set dosage based on indication.
Pink Sheet
By Brenda Sandburg 14 Sep 2017
US FDA's preclinical policies should be 'more closely matched to the complexion of modern technologies,' commissioner explains.
Topic Clinical trials
Pink Sheet
By Brenda Sandburg 12 Sep 2017
As state attorneys general and Department of Justice move against generic manufacturers, plaintiffs’ firms have filed more than 90 antitrust suits.
Pink Sheet
23 Aug 2019
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23 Aug 2019
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20 Aug 2019
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19 Aug 2019
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12 Aug 2019
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11 Aug 2019
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11 Aug 2019
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09 Aug 2019
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07 Aug 2019
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06 Aug 2019
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01 Aug 2019
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26 Jul 2019
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18 Jul 2019
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18 Jul 2019
Pink Sheet
18 Jul 2019
