Japan

Nichi-Iko says that remediation activities at its Toyama plant in the wake of a suspension over GMP violations mean that there may be delays to supply.

Japanese generics giant Sawai appears to be turning a corner, but the impact of National Health Insurance pricing revisions continues to hold the firm – and the rest of the country’s generics industry – back.

Neuraxpharm has expanded its footprint outside of Europe with the launch of its first product in Japan, in the form of the Buccolam value-added midazolam product gained through a deal with Takeda.

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Non-Japanese firms without offices in the country may submit documents for approval filings in English, subject to certain conditions.

The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers.

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

After 10 years of promised investment following its Nobel Prize for iPS cell research, Japan is cautiously narrowing regulations around the conditional approval of cell therapies and cutting reimbursement prices. How has the sector panned out over the last decade?

After 10 years of promised investment following its Nobel Prize for iPS cell research, Japan is cautiously narrowing regulations around the conditional approval of cell therapies and cutting some reimbursement prices. Commercial success remains mixed and some products have been withdrawn from the market.

After a transformative last fiscal year, Sawai presented its financial first quarter results for its 2025 year, with slight disappointment among analysts due to missed revenue forecasts.

Mentholatum says two line extensions made with 2% salicylic acid and its "Oxy for Every Kind of Ne" campaign reinforce the brand’s “commitment to tackling every type of acne—from face-ne and chin-ne to body-ne.”

Following Towa’s reveal of its medium-term business plan earlier this year, the company has shared its financial first quarter results, which were positively received by select analysts.

A Japanese approval for Lilly's Alzheimer's drug donanemab is expected soon following a positive recommendation from the MHLW. The ministry has also announced reimbursement prices for 12 new products including Fabhalta, along with price cuts for Tezspire, Dupixent and competitors following a review.

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Several major Japanese firms, including Takeda, are planning layoffs at home and elsewhere as they make efforts to streamline their business and costs and cope with R&D and commercial challenges. 

Following past fiscal challenges, Chemiphar unveiled its results for the first quarter of the 2024 financial year while also forecasting to remain profitable in the 2024 fiscal year.

Results from the top Japanese pharma firms in the fiscal first quarter were marked mainly by strong global performances for mainstay products and significant currency effects due to the continued weakness of the yen, although forex concerns are rising. Eisai's Alzheimer's drug Leqembi also gained momentum, particularly in the US. 

Otsuka Pharma’s acquisition of Jnana seems like a win for its pipeline, but the Japanese major faced a setback in a Delaware District Court where the judge’s opinion put challenger Lupin closer to a generic to its Jynarque (tolvaptan)

Ahead of its impending financial Q1 results call, Towa disclosed its near-future plans and goals that are expected to see the company emerge out of Japan’s generic drugs crisis.

Despite it’s initial promise, a novel autologous cell transplant therapy for severe heart failure has faced multiple challenges gaining full approval in Japan, potentially offering lessons for other regenerative medicine developers.