A year has passed since the Ministry of Health, Labor and Welfare (MHLW) announced its package strategy to fuel the early commercialization of software as a medical device (SaMD) in November last year. A growing number of drug makers are…
BUSINESS
Aducanumab Gets “Negative Trend Vote” in Europe: Biogen/Eisai
Biogen has received a “negative trend vote” from a key European regulatory panel on its controversial Alzheimer’s treatment aducanumab, signaling that the drug could face a rejection in the region after the US FDA’s polarizing decision to grant it accelerated…
To read the full story
Related Article
- Aducanumab Submitted in Japan, but Decision Unlikely to Come Until Next Autumn
December 11, 2020
- Biogen Files Japan NDA for Aducanumab
December 10, 2020
- European Regulators Accept Aducanumab for Review: Biogen/Eisai
November 2, 2020
- Aducanumab Filed in Europe: Biogen/Eisai
October 22, 2020
BUSINESS
- Takeda Seeks Japan Approval for Low-Dose Revestive
November 29, 2021
- Sanofi’s Pompe Disease Drug Nexviazyme Now Available in Japan
November 29, 2021
- AbbVie Japan Rolls Out New Dosage Forms for Rinvoq, Skyrizi
November 29, 2021
- Daiichi Sankyo Sets Up New Subsidiaries in 3 Countries
November 29, 2021
- Takeda’s GI Biz Poised for Growth with 3 Products Now in Its Lineup
November 29, 2021
Remember what it was like back in March, when we all started working from home? There was a distinct change in the air - a sense of freedom and excitement about the novelty of being able to work from home.…
The average ratio of female employees at managerial posts stood at just 12.5% at pharmaceutical companies operating in Japan, a Jiho survey revealed. While foreign drug makers had an average 25.0%, the ratio came to as low as 9.8% for…
Biogen’s controversial Alzheimer’s drug aducanumab was filed for Japanese regulatory approval in December. If approved, it will be the first…
Japan’s key reimbursement policy panel on December 20 approved an outline of its FY2020 drug pricing reform next April, with…
Japan will go ahead with the introduction of a cost-effectiveness assessment (CEA) scheme for drugs and medical devices in April…