The delayed approval and price setting of Novartis Pharma’s Zolgensma (onasemnogene abeparvovec), a gene therapy for spinal muscular atrophy (SMA) listed in May, has raised questions about how the sakigake designation system should be operated. Despite being designated for the…
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- Sawai Ponders Possible Delay in Rollout of 4 Generic Brands After June Listing
May 26, 2020
- Takeda’s NSCLC Med Alunbrig Nabs Frontline Nod in US
May 26, 2020
- 90% of Drug Promotion Shifted to Remote Tools; Prudent Attitude Needed for New Launches amid COVID-19: IQVIA Official
May 25, 2020
- Enhertu Gets US FDA’s Orphan Status for Gastric Cancer
May 25, 2020
- US FDA Approves Sunovion’s Apomorphine Sublingual Film for Parkinson’s
May 25, 2020
- Bayer Files Japan NDA for Larotrectinib in NTRK-Positive Solid Tumors
May 25, 2020
- Daiichi Sankyo Launches PI for DS-6157 for GIST; 5th ADC Entered in Clinical Stage
May 25, 2020
- As Beovu Debut Nears, Novartis Set to Push Longer Dosing Interval, Pivotal Data in Battle against Eylea
May 22, 2020
- GSK Japan Looking to Develop Otilimab for COVID-19; President Stresses Efforts on Vaccines, Disease Management Too
May 22, 2020
- No. of Ambulatory Patients Sags 6% in March amid COVID-19, Greater Drop in Special Alert Prefectures: Survey
May 22, 2020
- EMA Accepts Roxadustat for Review
May 22, 2020
- Nippon Shinyaku’s DMD Drug Now Available in Japan; AZ’s Lokelma, Ono’s Velexbru Too
May 21, 2020
- Zolgensma Hits Japan Market with Stringent Conditions Attached
May 21, 2020
- Nipro to Roll Out Symbicort Copy in June with Stable Supply System in Place
May 21, 2020
- Suzuken to Exclusively Distribute Novartis’ Zolgensma in Japan
May 21, 2020
- JCR Chief Delays Global Licensing Timeline for Lysosomal Storage Disorder Therapies
May 20, 2020
- Astellas Confident of Hitting 3-Year Biz Goals on Xtandi, Full Backing of New Products
May 20, 2020
- Stella Pharma Launches New Cancer Radiation Therapy Steboronine
May 20, 2020
- Sawai, Nichi-Iko Hint at Delay in Edirol Generic Debut
May 20, 2020
- Astellas Eases Work-from-Home Policy in 39 Prefectures after Partial COVID-19 Emergency Lift
May 20, 2020
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