BUSINESS

Fycompa Approved for Monotherapy for Partial Epilepsy in US

July 28, 2017
Eisai announced on July 27 that the US FDA has approved its antiepileptic drug Fycompa (perampanel) for monotherapy in patients with partial epilepsy aged 12 years and older. The regulatory pathway announced by the FDA in September 2016 permits the…

To read the full story

Related Article

BUSINESS

By Shinya Sato

Six years have passed since the so-called “G1” rule and associated market withdrawal scheme were introduced for long-listed products (LLPs). As initially planned, a batch of LLPs saw their NHI price brought down to the generic levels for the first…

By Korkut Bilgin Minoura and Leen Helsloot

In today’s dynamic pharmaceutical landscape, the relationships between Field Medical representatives and physicians are fundamental in all markets for disseminating…

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…