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.
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.
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.
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.
“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.
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.
The latest global regulatory news, changes and updates affecting biopharma, including: Apotex, Auspex, Glenmark, Johnson & Johnson, Sandoz, Teva, Taro.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 3Sbio, Alimera, Hansa, Hifibio, Catalyst, Kye, Revive, TLC.