- Company
- Biktarvy’s indication expanded to patients 6yrs and older
- by Whang, byung-woo Oct 24, 2024 05:52am
- The indication for the HIV-1 treatment Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide, B/F/TAF) has been expanded to include children and adolescents aged 6 years and older. Gilead Sciences Korea announced on the 23rd that its Biktarvy has been approved by the Ministry of Food and Drug Safety for the treatment of HIV-1 infectio
- Company
- Reimb of the dyslipidemia drug Leqvio at a halt?
- by Eo, Yun-Ho Oct 24, 2024 05:52am
- The dyslipidemia drug that received industry attention as a first-in-class siRNA drug is facing difficulties in obtaining insurance reimbursement coverage in Korea. According to Dailpharm’s coverage, Novartis Korea's Leqvio (inclisiran) applied for new drug reimbursement after receiving approval from the Ministry of Food and Drug Safety
- Company
- Moderna’s keyword for post-COVID vaccination is ‘RWE’
- by Whang, byung-woo Oct 23, 2024 05:50am
- With the COVID-19 pandemic transitioning to the post-COVID-19 era, Moderna is putting forward ‘real-world evidence (RWE)’ as the keyword for its vaccines. As the seasonal vaccination of COVID-19 vaccines has become the norm, the company has been promoting the accumulated effectiveness and safety of its vaccines. Since the pandemic,
- Company
- "Multiple myeloma dynamics require changes to reimb strategy
- by Whang, byung-woo Oct 22, 2024 05:51am
- "Multiple myeloma is a cancer type that has a great ripple effect depending on new drugs provided in a certain environment. Reimbursement of multiple myeloma treatment requires discussion following a thorough evaluation of the impact of the treatment depending on the treatment environment." Multiple myeloma is one of the cancer types wit
- Company
- Will combination therapies for cancer be reimbursed in KOR?
- by Whang, byung-woo Oct 21, 2024 05:49am
- As the government has begun to prepare the principles for the reimbursement review of combination therapies that use new anticancer drugs, attention is being paid to whether the discussion will progress further. According to industry sources, the Health Insurance Review and Assessment Service recently held a Cancer Disease Deliberation C
- Company
- Therapeutic device 'improves OS for lung cancer patients'
- by Son, Hyung Min Oct 21, 2024 05:48am
- The first therapeutic device has been approved for use in non-small cell lung cancer (NSCLC). Novocure's therapeutic device, in combination with an NSCLC medication, demonstrated to improve patients' overall survival and won the approval of the U.S. regulatory authority. In South Korea, Nu Eyne is researching the potential of oncology therapeuti
- Company
- Oxlumo receives orphan drug designation in Korea
- by Eo, Yun-Ho Oct 21, 2024 05:48am
- The primary hyperoxaluria treatment Oxlumo received orphan drug designation in Korea. The Ministry of Food and Drug Safety (MFDS) recently announced the designation through an orphan drug designation notice. Oxlumo (lumasiran) was also recently designated a Global Innovative products on Fast Track (GIFT) by the MFDS. The drug is an
- Company
- RNAi therapeutic 'Givlaari' receives the ODD in KOR
- by Eo, Yun-Ho Oct 21, 2024 05:48am
- RNAi therapeutic 'Givlaari' has been designated as an orphan drug following its designation as the GIFT. The Ministry of Food and Drug Safety (MFDS) recently announced this through the posting of the Orphan Drug Designation (ODD). Givlaari (givosiran) had previously been designated as the 'Global Innovative products on Fast Track (GIF
- Company
- Bladder cancer drug Balversa offers new treatment option
- by Whang, byung-woo Oct 18, 2024 05:49am
- The introduction of the targeted therapy Balversa (erdafitinib) in urothelial carcinoma has attracted attention for its potential to address unmet needs. In particular, the emergence of FGFR inhibitors has highlighted the importance of genetic mutation diagnostics to quickly detect the presence of such mutations. Inho Kim, professor o
- Company
- 'Vorasidenib' receives Orphan Drug Designation in KOR
- by Eo, Yun-Ho Oct 18, 2024 05:49am
- 'Vorasidenib,' an anticancer drug targeting brain cancer, has been designated an orphan drug in South Korea. The Ministry of Food and Drug Safety (MFDS) announced this on October 8th through the Orphan Drug Designation (ODD) notice. Vorasidenib is an orally administered dual inhibitor of isocitrate dehydrogenase (IDH) 1/2 that selectiv
