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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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Japanese approval of Dinagest for dysmenorrhea

Jan. 23, 2020
Green traffic light

FDA greenlights Ra Medical’s DABRA atherectomy trial

Jan. 22, 2020
By Meg Bryant
Ra Medical Systems Inc., of Carlsbad, Calif., reported that the U.S. FDA has granted investigational device exemption (IDE) approval to study its DABRA excimer laser system as an atherectomy device to treat peripheral vascular stenosis.
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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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Tepezza approved in the U.S. for thyroid eye disease

Jan. 22, 2020

China promotes real-world evidence in R&D and approval with new guidelines

Jan. 21, 2020
By Elise Mak
BEIJING – China has released guidelines to promote the use of real-world evidence (RWE) in drug development and reviews.
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Horizon wins FDA approval for thyroid eye disease drug Tepezza

Jan. 21, 2020
By Michael Fitzhugh
About a month-and-a-half earlier than expected, Horizon Therapeutics plc has won FDA approval for teprotumumab in thyroid eye disease (TED), a progressive autoimmune condition that disproportionately affects women.
Read More

Regulatory front for Jan. 21, 2020

Jan. 21, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
Read More
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