Axcan Helicide amendment
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Axcan submits Helicide amendment addressing manufacturing issues in response to "not approvable" letter from FDA, announced in August. An NDA for the H. pylori eradication agent (subcitrate/metronidazole/tetracycline) was submitted Sept. 30, 200
You may also be interested in...
Axcan Helicide, Photofrin Barrett’s Approvals Expected By Year-End
Axcan plans to position its Helicobacter pylori treatment Helicide as more effective than a clarithromycin-based regimen in antibiotic-resistant patients.
Second EU MDR Notified Body Designated In France
Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has been named too.
Takeda, Astellas Found New JV To Support Japanese Bioventures
Major Japanese companies Takeda, Astellas and SMBC are joining hands to establish a new joint venture with $3.9m capital and based in Japan’s largest biocluster Shonan iPark to help incubate local biopharma start-ups.