REGULATORY
Japan Might Approve 1st Eylea Biosimilar by June, but Not AMD Use
By Shinya Sato April 15, 2024
Japan is expected to soon approve the first biosimilar version of the VEGF inhibitor Eylea (aflibercept), albeit for limited indications. If all goes without a hitch, it could land approval by June and join the…

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April 15, 2024
Japan’s Ministry of Health, Labor and Welfare (MHLW) has announced a list of 14 companies that will be eligible for grants under its emergency subsidy project for stable drug supply systems. The roster includes the…
April 15, 2024
Fujifilm said on April 12 that it is investing an additional 180 billion yen in a facility currently under construction in North Carolina with the aim of expanding its North American CDMO business targeting biologics.The company’s US subsidiary Fujifilm Diosynth…
April 15, 2024
Astellas Pharma on April 12 downwardly revised its consolidated profit outlook for the fiscal year ended March 2024 as it faces a big impairment charge associated with its gene therapy program, AT808, and some other headwinds.While leaving sales guidance unchanged…
By Ken Yoshino

On March 5, Japan unveiled new NHI prices for the FY2024 drug price revision. A Jiho survey found that Tsumura, a specialist in Japanese Kampo herbal medicines, received an astonishing raise of over 24% in its drug prices on a…

By Philip Carrigan

Too often, recruiters are more clear on what a position will “do” rather than what it will “achieve”.Outlining tasks and responsibilities takes priority over goals and impact.But to attract top talent, you need to define and explain what success looks…

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

By Izuru Ando

Generic manufacturers in Japan will be required to disclose supply-related information from this June under a new company indicator rule…

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…

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