- Policy
- Drug pricing nego start in earnest for Tagrisso·Leclaza
- by Lee, Tak-Sun Nov 9, 2023 05:43am
- With drug pricing negotiations ongoing for the reimbursement of Tagrisso (AZ, osimertinib) and Leclaza (Yuhan, lasertinib) as a first-line treatment for non-small cell lung cancer, whether the two drugs will be applied the initial treatment refund-type RSA (risk-sharing agreement system) remains a variable. Leclaza, which is being supp
- Policy
- MFDS approves P3T for talquetamab in MM patients
- by Lee, Hye-Kyung Nov 8, 2023 05:37am
- Janssen Korea received approval to initiate a Phase III trial for its first-in-class investigational bispecific antibody ‘talquetamab’ for multiple myeloma in Korea. The drug is ‘Talvey,’ which was approved by the US FDA in August. The FDA granted accelerated approval to Talvey based on its overall response rate and duration of respon
- Policy
- Daewoong starts developing XR formulation of tofacitinib
- by Lee, Tak-Sun Nov 8, 2023 05:37am
- Daewoong Pharmaceutical has begun developing a product that can rival Pfizer's oral JAK inhibitor 'Xeljanz XR 11mg'. Xeljanz XR (tofacitinib citrate) is Prizer's latest tofacitinib product approved in December 2020. Daewoong Pharmaceutical, like the original company Pfizer, is building a lineup of immediate-release and extended-release ta
- Policy
- PN injection benefit restriction suddenly halted
- by Nho, Byung Chul Nov 8, 2023 05:37am
- With the advent of the reevaluation period for selective coverage of intraarticular injections containing PN (sodium polynucleotide), health authorities are planning to adjust the patient copayment upward. Manufacturers and sellers have recently submitted opinions to HIRA, drawing attention to the future direction. The opinion is based on su
- Policy
- A draft for reevaluation of overseas drug prices
- by Lee, Tak-Sun Nov 8, 2023 05:37am
- Advantages and disadvantages depending on the re-evaluation method. The HIRA has prepared a draft plan for comparative and reevaluation of overseas drug prices and will begin collecting opinions in earnest with the pharmaceutical industry starting this month. As the HIRA plans to conduct re-evaluation sequentially starting next year, it is e
- Policy
- Drug price reduction delayed due to suspension of execution
- by Lee, Jeong-Hwan Nov 7, 2023 05:34am
- As the so-called 'Drug Price Reduction Litigation Recovery and Refund System' is about to be implemented in earnest from the 20th, it is expected that some pharmaceutical companies will be put on hold in their tricks to preserve the prices of their own drugs by nullifying or delaying the effect of the government's drug price reduction disposi
- Policy
- Lunsumio receives marketing authorization in Korea
- by Lee, Hye-Kyung Nov 6, 2023 05:27am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyoung Oh) announced that it had approved ‘Lunsumio (mosunetuzumab),’ which is used to treat follicular lymphoma, on the 3rd of this month. Lunsumio is used to treat adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. Lunsum
- Policy
- Pulmican & Pulmicort price increase discussed on the 9th
- by Lee, Tak-Sun Nov 6, 2023 05:26am
- The agenda to increase the prices of asthma drugs Pulmican and Pulmicort, suffering from supply and demand problems, will be discussed at the 12th Pharmaceutical Reimbursement Evaluation Committee held on the 9th. On this day, the appropriateness of the drug price increase will be reviewed. If it passes the Pharmaceutical Review Committee, i
- Policy
- Prevenar competitor Vaxneuvance is approved in KOR
- by Lee, Hye-Kyung Nov 3, 2023 05:32am
- MSD Korea’s 15-valent pneumococcal vaccine ‘Vaxneuvance Prefilled Syringe (Pneumococcal/diphtheria CRM197 Protein conjugate vaccine) has been granted marketing authorization in Korea. Vaxneuvance, which is expected to rise as a strong competitor to ‘Prevenar 13,’ is a 15-valent pneumococcal conjugate vaccine, that induces active immun
- Policy
- Tramadol classified as narcotics abroad but not in KOR
- by Lee, Hye-Kyung Nov 3, 2023 05:32am
- The Ministry of Food and Drug Safety stated that there is insufficient evidence to designate tramadol, a so-called narcotic painkiller, as a controlled narcotic in Korea. On the 1st, the MFDS submitted a written response to the written inquiry issued by Rep. Sun-Woo Kang of the Democratic Party of Korea regarding the need to designate tramado
