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BioWorld, Regulatory
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Regulatory front for Jan. 14, 2020

Jan. 14, 2020
The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory front for Jan. 13, 2020

Jan. 13, 2020

The latest global regulatory news, changes and updates affecting biopharma.


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GIST kissed ahead of V-Day PDUFA, Blueprint design plan for Ayvakit goes ‘fourth’

Jan. 10, 2020
By Randy Osborne
Cambridge, Mass.-based Blueprint Medicines Corp.’s price tag and label for Ayvakit (avapritinib) caused some chagrin on Wall Street as observers continued to weigh the drug’s odds against ripretinib, the competing drug for which Deciphera Pharmaceuticals Inc. awaits regulatory action.
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Regulatory front for Jan. 10, 2020

Jan. 10, 2020
The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory front for Jan. 9, 2020

Jan. 9, 2020
The latest global regulatory news, changes and updates affecting biopharma.
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As bushfires continue to burn, Australia’s regulators don’t anticipate delays

Jan. 8, 2020
By Tamra Sami
PERTH, Australia – Although Australia’s deadly bushfires continue to burn, and conditions are expected to worsen later this week as temperatures rise, Australia’s Therapeutic Goods Administration (TGA) is not anticipating any effect on business operations.
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Regulatory front for Jan. 8, 2020

Jan. 8, 2020
The latest global regulatory news, changes and updates affecting biopharma.
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Drug vials and syringe

CDER approval numbers show biosimilar advance, steady pace of novel BLAs

Jan. 7, 2020
By Mari Serebrov
For the first time since Congress opened the door to biosimilars in 2010, the FDA approved nearly as many biosimilars in 2019 as it did new biologics. As the first decade of biosimilars came to a close, the agency’s Center for Drug Evaluation and Research (CDER) approved 10 biosimilars referencing seven blockbuster biologics, bringing the total number of approved biosimilars to 26.
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Regulatory front for Jan. 7, 2020

Jan. 7, 2020
The latest global regulatory news, changes and updates affecting biopharma.
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Australia implements opioid reforms to deal with 150 hospitalizations per day

Jan. 6, 2020
By Tamra Sami
PERTH, Australia – Australia’s Therapeutic Goods Administration is putting in place a number of opioid reforms to clamp down on the use of opioids to deal with increasing deaths and hospitalizations from the use of those drugs.  
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