- Company
- Strong dollar slows sales of Epis’s 3 biosimilars in Europe
- by Jul 22, 2022 05:53am
- The 3 autoimmune disorder biosimilars developed by Samsung Bioepis (Benepali, Imraldi, Flixabi) made slower sales in Europe in the first half of this year. Total sales fell by 4.7% compared to the previous year. Sales of the products had suffered a hard blow from the recent strong dollar and the continued pressure to cut prices. According
- Policy
- Drug e-labeling and abolition of PMS reexaminations...
- by Lee, Hye-Kyung Jul 22, 2022 05:53am
- The Ministry of Food and Drug Safety announced that it will refrain from making a unilateral announcement of regulations, and Suk-Yeol Yoon’s government announced that it would reform regulations by listening to the opinions of the industry. As part of such efforts, the MFDS had conducted 7 internal discussions since Yoon’s inauguration to
- Policy
- Billions of won in losses if applied retroactively
- by Lee, Tak-Sun Jul 22, 2022 05:53am
- The pharmaceutical industry is complaining about the retroactive application of detailed operation guidelines revised in April at this year's PVA. Although it has already officially proposed excluding retroactive application to the NHIS twice, the NHIS' position is firm. Analysts say that such an issue will be a hurdle to settle the negoti
- Company
- Takeda's anti-cancer drug Exkivity has been approved
- by Jul 22, 2022 05:53am
- A second targeted anticancer drug targeting EGFR Exxon 20 insertion mutation has emerged. Takeda Pharmaceutical Korea announced on the 20th that it has received approval from the Ministry of Food and Drug Safety for the EGFR Exxon 20 insertion mutant non-small cell lung cancer treatment Exkivity (Mobocertinib). Exkivity is a TKI that inhib
- Policy
- Negotiations for Pfizer Lorviqua have not been completed
- by Lee, Tak-Sun Jul 22, 2022 05:52am
- It was found that Lorviqua' a third-generation non-small cell lung cancer treatment that inhibits ALK (anaplastic lymphoma kinase), failed just before being listed. The HIRA announced the establishment of a standard next month, but the NHIS negotiations were not completed, leading to the deletion again. According to the industry on the 19th
- Company
- Imbruvica makes 4th attempt to extend reimbursement
- by Eo, Yun-Ho Jul 21, 2022 06:04am
- Already for the fourth time, Janssen is attempting to expand reimbursement for ‘Imbruvica’ as a first-line treatment. According to industry sources, reimbursement of Imbruvica (ibrutinib) as a first-line treatment for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Leukemia (SLL) will once again be deliberated by the Health Ins
- Policy
- “Pharma companies cannot conduct online product briefings"
- by Kim, Jung-Ju Jul 21, 2022 06:04am
- “Online product briefing sessions by pharmaceutical companies are clearly illegal, but we cannot directly warn the pharmaceutical industry by pressing charges or requesting investigations at the moment." With the prohibition temporarily lifted on the pharmaceutical and medical device companies’ support of online academic conferences,
- Company
- Tabrecta is scheduled to be introduced in August
- by Eo, Yun-Ho Jul 20, 2022 05:50am
- MET anticancer drugs will enter the first stage of registration of insurance benefits. According to related industries, Tabrecta will be introduced to the HIRA Cancer Disease Review Committee on August 10. Tabrecta was approved in Korea in November last year as a non-small cell Lung Cancer (NSCLC) treatment that confirmed MET Exxon 14 deficie
- Policy
- Companies receive mixed reimb results in urothelial cancer
- by Lee, Tak-Sun Jul 20, 2022 05:49am
- The changes made in the reimbursement standards for urothelial carcinoma brought joy or sadness to affected companies. A new reimbursement standard for urothelial carcinoma has been created for MSD’s ‘Keytruda inj (pembrolizumab),’ while the reimbursement standard for Roche’s ‘Tecentriq inj (atezolizumab)' has been removed from the li
- Company
- Moderna to soon release bivalent COVID-19 vaccine
- by Jul 20, 2022 05:49am
- Moderna is determined to promptly commercialize its new bivalent COVID-19 vaccine “mRNA-1273.214 (214)” in Korea. On the morning of the 19th, Moderna held a “Moderna’s mRNA technology and strategy in the endemic era” press conference at JW Mariott Hotel. At the conference, the company stated that it can “supply the 214 globally by the
