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BioWorld - Monday, March 30, 2026
Breaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sector
Home » Topics » BioWorld, Regulatory

BioWorld, Regulatory
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Regulatory actions for Sept. 1, 2020

Sep. 1, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arch, Astrazeneca, Athenex, BMS, GSK, Inmune, Mirum, Nkmax, Novo, Plus, Vertex.
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Skin, tissue layer illustration

After AU$45M IPO, Aroa rakes in two new approvals as it ramps up commercial presence

Aug. 31, 2020
By Tamra Sami
PERTH, Australia – After its initial public offering on the Australian Securities Exchange, soft tissue regeneration company Aroa Biosurgery Ltd. has received new clearances in the U.S. and Europe and is focusing on building up its commercial and manufacturing capacity.
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FDA icons

Seeking transparency: COVID-19 vaccine adcom first of more?

Aug. 31, 2020
By Mari Serebrov
In a bid to build public confidence and demonstrate its transparency in determinations about potential COVID-19 vaccines, the FDA will convene its Vaccine Advisory Committee for a virtual meeting Oct. 22 to discuss the general development of the vaccines for the U.S. market.
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Regulatory front for Aug. 31, 2020

Aug. 31, 2020
The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory actions for Aug. 31, 2020

Aug. 31, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biocryst, Can-Fite, Cormedix, Cstone, FDS, Gilead, Lipocine, Mustang, Omeros, Oncopeptides, Revive, Sound, Spero, Velosbio, Xortx.
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Winlevi’s FDA approval for acne is a big win for Cassiopea

Aug. 27, 2020
By Lee Landenberger
With the FDA approval of Cassiopea SpA’s Winlevi (clascoterone cream 1%) to treat acne in patients 12 years and older, the European company hailed it as the first acne drug in 40 years with a new mechanism of action.
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Prescription drug bottle, pills shaped in $ sign

Final offer? Or will U.S. drug pricing negotiations continue as election looms?

Aug. 27, 2020
By Mari Serebrov
“Maybe this is not their final offer and maybe they’re not digging as deep as they perhaps could or should,” Michael Abrams, managing partner and co-founder of Numerof & Associates, said of the biopharma industry’s counteroffer to U.S. President Donald Trump on drug pricing. But the offer “is not inconsequential,” he told BioWorld, noting that it reportedly could deliver $100 billion in savings over 10 years. The proposal also offers the president the opportunity to say he delivered on his promise to lower prescription drug prices as he campaigns for re-election, whereas his threatened executive order granting Medicare and other federal programs “most favorable nation pricing” for prescription drugs would still be in the rulemaking process when voters head to the polls or their mailboxes in November.
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Regulatory front for Aug. 27, 2020

Aug. 27, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Biomarin, Genentech.
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Regulatory actions for Aug. 27, 2020

Aug. 27, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biomark, Cassiopea, Galecto, Glaxosmithkline, Laurent, Rocket, Sirtex, Taysha Gene Therapies.
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Regulatory front for Aug. 26, 2020

Aug. 26, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Apotex, Auspex, Glenmark, Johnson & Johnson, Sandoz, Teva, Taro.
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