REGULATORY

Novartis’ Fabhalta, Novo’s Awiqli, and More Up for PAFSC Review on May 31

May 20, 2024
Novartis Pharma’s paroxysmal nocturnal hemoglobinuria (PNH) treatment iptacopan and Novo Nordisk Pharma’s once-weekly insulin icodec will come up for approval review by a key health ministry advisory panel on May 31. Iptacopan, known as Fabhalta overseas, is among the four…

To read the full story

Related Article

REGULATORY

By Shinya Sato

Japan introduced a new health coverage scheme for long-listed products (LLPs) on October 1. A survey of generic drug makers…

By Philip Carrigan

It’s easy to spot motivated and engaged employees. They are more productive, they go the extra mile, and they display a sense of ownership in their work.But how do you replicate this culture throughout your organization? How do you encourage…

A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…

A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…

The Japanese health ministry on December 22 approved a batch of medicines for additional indications, including Otsuka Pharmaceutical’s atypical antipsychotic Rexulti (brexpiprazole) and Zenyaku Kogyo’s anti-CD20 antibody Rituxan (rituximab).Rexulti is now newly indicated for the treatment of depression and depressive…

Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…

By Yoshinori Sagehashi

The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…

A key Japanese reimbursement policy panel on December 16 approved the government-backed plan for the FY2023 “off-year” drug price revision.…

Authorized generic (AG) strategies taken by innovative drug makers might help soften the impact of generic competition in their businesses but such tactics might also accelerate the application of “G1”/“G2” price cuts for their off-patent brand-name medicines, a Jiho tally…

Japan’s health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4, with the earlier application of so-called “G1” price cuts to be implemented for the first…