Japan’s Pharmaceuticals and Medical Devices Agency has traditionally been less than receptive to clinical data from other nations, but that aversion is slowly giving way. Ames Gross of Pacific Bridge Medical told BioWorld that a trial conducted in another nation with significant representation of those of Japanese ancestry can go a long way toward obviating the need for a trial conducted in Japan.
The first new U.S. FDA-approved therapeutic option for PTSD in more than 20 years will have to wait. A supplemental NDA seeking approval of Rexulti (brexpiprazole) combined with sertraline, filed by one of Japan’s biggest pharmas, Otsuka Pharmaceutical Co. Ltd., received a complete response letter (CRL) from the agency.
“The comment I hear a lot from scientists … is that science has no borders,” Arif Noorani, partner at Sidley Austin LLP, said while addressing the panel audience at Asia Bio 2025 in Singapore. “I agree, but the reality is, we do have a lot of borders.”
Japan’s Pharmaceuticals and Medical Devices Agency has traditionally been less than receptive to clinical data from other nations, but that aversion is slowly giving way. Ames Gross of Pacific Bridge Medical told BioWorld that a trial conducted in another nation with significant representation of those of Japanese ancestry can go a long way toward obviating the need for a trial conducted in Japan.
“The comment I hear a lot from scientists … is that science has no borders,” Arif Noorani, partner at Sidley Austin LLP, said while addressing the panel audience at Asia Bio 2025 in Singapore. “I agree, but the reality is, we do have a lot of borders.”
“The comment I hear a lot from scientists … is that science has no borders,” Arif Noorani, partner at Sidley Austin LLP, said while addressing the panel audience at Asia Bio 2025 in Singapore. “I agree, but the reality is, we do have a lot of borders.”
The Korea Pharmaceutical Traders Association said Aug. 26 that it signed a strategic agreement with Korea Trade Insurance Corp. to support South Korean companies exporting biopharmaceutical materials overseas.
The Korea Pharmaceutical Traders Association said Aug. 26 that it signed a strategic agreement with Korea Trade Insurance Corp. to support South Korean companies exporting biopharmaceutical materials overseas.
Ribomic’s umedaptanib pegol (RBM-007) looks to have some advantages compared to competitors in the achondroplasia space, and the company plans to progress the oligonucleotide-based aptamer that targets anti fibroblast growth factor 2 to phase III trials, Ribomic’s business development head, Kihei Yamashita, told BioWorld.
Ribomic’s umedaptanib pegol (RBM-007) looks to have some advantages compared to competitors in the achondroplasia space, and the company plans to progress the oligonucleotide-based aptamer that targets anti fibroblast growth factor 2 to phase III trials, Ribomic’s business development head, Kihei Yamashita, told BioWorld.
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