Academy of Physicians
in Clinical Research

Academy of Physicians
in Clinical Research




News from SCRIP

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Pharma intelligence | informa
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Bristol Approached Celgene Nearly Two Years Ago, Got A Better Deal Later

Fri, 02/01/2019 - 1:41pm

Documents detailing negotiations over the proposed Bristol/Celgene merger show Bristol’s offer decreased over time, but Celgene may still come out...

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Novo Nordisk Using Priority Review Voucher To Propel Oral Semaglutide To Market

Fri, 02/01/2019 - 8:11am

Danish diabetes fighter will file oral semaglutide with FDA within months using a priority review voucher to reduce the time...

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Natco-Alvogen Claim First Filer ANDA Status For Imbruvica Tablet Form

Thu, 01/31/2019 - 8:36pm

Natco and Alvogen Pine Brook have entered the arena for a potential generic version of AbbVie/Johnson & Johnson’s Imbruvica through...

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No More Rebates: HHS Proposed Rule Revises Anti-Kickback Safe Harbor

Thu, 01/31/2019 - 4:00pm

Proposed US rule would establish two new safe harbors against anti-kickback enforcement, one covering price reductions at the point of...

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No More Rebates: HHS Proposed Rule Closes Most Anti-Kickback Safe Harbors

Thu, 01/31/2019 - 4:00pm

Proposed US rule would establish two new safe harbors against anti-kickback enforcement, one covering price reductions at the point of...

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MeiraGTx Signs J&J To Develop Gene Therapies For Rare Retinal Diseases

Thu, 01/31/2019 - 12:38pm

While it wants to keep other programs for diseases with larger patient populations in house, MeiraGTx believes J&J offers the...

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Orphazyme Steams Ahead With Registration in Niemann Pick, Despite Endpoint Misses

Thu, 01/31/2019 - 10:24am

Even with numerous endpoint misses, such is the demand for treatment options for the ultra-rare disease Niemann Pick, Orphazyme is...

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Erleada Keeps Pace With Xtandi After Positive TITAN Study

Thu, 01/31/2019 - 8:01am

Metastatic castration-sensitive prostate cancer could see a marketing race following positive top-line clinical data for Janssen’s apalutamide in the Phase...

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Strides Exits Australia To ‘Double-Down’ On US Market

Wed, 01/30/2019 - 11:15pm

Strides founder Arun Kumar says he’s succeeded in putting the company back on the road to health after it shocked...

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Cellid IPO To Fund First-In-Class Cancer Immunotherapeutic Vaccines

Wed, 01/30/2019 - 9:17pm

After using government financial support to fund its early-stage clinical trials, Korean bioventure Cellid aims to further progress its first-in-class...

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Surprising SanBio/Sumitomo Stroke Stumble Slams Stocks

Wed, 01/30/2019 - 8:26pm

Mesenchymal stem cell-based therapy's missed Phase IIb endpoint in stroke prompts both an assessment of future development plans and a...

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Eyenovia's Positive Phase III Data Support Its Topical Microdosing Platform

Wed, 01/30/2019 - 3:04pm

Company envisions pricing branded drug/device on par with the standard of care to speed adoption and lay the groundwork for...

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