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BioWorld - Saturday, February 28, 2026
Home » Topics » Regulatory, BioWorld

Regulatory, BioWorld
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Regulatory front for Jan. 29, 2020

Jan. 29, 2020
The latest global regulatory news, changes and updates affecting biopharma.
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FDA continues to map out the regulatory road for gene therapies

Jan. 28, 2020
By Mari Serebrov
With four gene therapies already approved and more than 900 in development, the FDA has finalized six guidances and issued a draft guidance to clarify the rules of the road for developing and manufacturing the treatments. 
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Regulatory front for Jan. 28, 2020

Jan. 28, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Johnson & Johnson, Insys Therapeutics Inc.
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Regulatory front for Jan. 27, 2020

Jan. 27, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Emmaus Life Sciences Inc., Global Blood Therapeutics Inc., Novartis AG and Vyera Pharmaceuticals LLC
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FDA Approved stamp

Tazemeto, stat: Accelerated win for Epizyme in ES could ‘reFLect’ well in bigger indication

Jan. 24, 2020
By Randy Osborne
Matthew Ros, chief strategy and business officer for Epizyme Inc., said the company is “not providing specific guidance at the moment” about the sales force that will be deployed to market Tazverik (tazemetostat) in follicular lymphoma (FL), an indication for which U.S. regulators are considering the oral, first-in-class EZH2 inhibitor. “But I can assure you we’ve planned very thoughtfully” about the effort, he said. “That's always been a part of why we thought epithelioid sarcoma [ES] was such a strategically important component of the overall business strategy to get on-the-ground experience.” The sales force numbers 19 for now.
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Regulatory front for Jan. 24, 2020

Jan. 24, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Sage Therapeutics
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Gavel and scales

Securities class action suits a growing fact of life for life sciences

Jan. 23, 2020
By Mari Serebrov
Whether large or small, or based in the U.S. or abroad, life sciences companies are an increasingly attractive target for shareholder suits. The number of securities fraud class action suits filed in the U.S. in 2019 across all industries totaled 404, just one more than the 403 cases filed in 2018 and down from the peak of 412 in 2017, according to a new Dechert LLP report.
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Australia’s TGA proposes fee increases to implement recent drug, device reforms

Jan. 23, 2020
By Tamra Sami
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking input from industry stakeholders on a proposal to increase its fees to cover projected deficits this year. The proposal outlines three options.
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Regulatory front for Jan. 23, 2020

Jan. 23, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Insys
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Regulatory front for Jan. 22, 2020

Jan. 22, 2020
The latest global regulatory news, changes and updates affecting biopharma: Aegerion Pharmaceuticals Inc., Alexion Pharmaceuticals Inc., Insys Therapeutics Inc.
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