- Opinion
- [Reporter’s View] 'all-comers' with strict criteria
- by Eo, Yun-Ho Jul 2, 2024 05:48am
- Drugs that are intended for use regardless of any conditions are strictly regulated. In the pharmaceutical industry, 'all-comers' refers to a drug indication that can be prescribed at any treatment stage, regardless of conditions. Drugs with all-comers indications have demonstrated their efficacy regardless of receptors or genetic mu
- Opinion
- [Reporter’s View] No innovation without failure
- by Son, Hyung-Min Jul 1, 2024 05:47am
- Korean biopharmaceutical companies are exchanging joy and sorrow over out-licensing agreements. Last month, three companies, including HK inno.N, have successfully signed agreements to out-licensing of their new drug candidates in addition to AprilBio and ISU Abxis. In contrast, there are instances where new drug candidates that have been
- Opinion
- [Reporter's View] No more exemptions, just deferrals
- by Eo, Yun-Ho Jun 24, 2024 05:47am
- The Korean government has set out to fix the pharmacoeconomic evaluation exemption system. Although the authorities coined it as an “improvement,” the direction seems to be near a “reduction.” A report on a study commissioned by the Health Insurance Review and Assessment Service was released at the end of last year. The study, titled
- Opinion
- [Reporter’s View] Reliability Verification Review Committee
- by Lee, Hye-Kyung Jun 20, 2024 05:48am
- The Ministry of Food and Drug Safety has formed a Reliability Verification Review Committee. In the 'Guideline for Drug Manufacturing, Sales, and Import Marketing Authorizations and Labeling Change Authorizations,' which was revised by the MFDS on the 17th, a procedure was added for the Reliability Verification Review Committee to verify the
- Opinion
- [Reporter’s View] Finances limit reimbursement of drugs
- by Eo, Yun-Ho Jun 7, 2024 05:51am
- &160;Insurance reimbursement standards and indications for a drug can differ. This is because the government’s pockets are not infinite under the National Health Insurance System. This is why there are always complaints in the field. Not all complaints can be resolved but there are some that evidently require resolution, that were made
- Opinion
- [Reporter's View] Expectations for new Alzheimer's drugs
- by Son, Hyung-Min Jun 5, 2024 05:47am
- Last month, a new drug for Alzheimer's disease, Leqembi, was approved in Korea. Leqembi, which was developed by Eisai and Biogen, targets the amyloid beta (Aβ) protein in the brain, which is considered one of the most likely causes of Alzheimer's disease. The industry welcomed Leqembi’s arrival because there had been no promising new dr
- Opinion
- [Reporter’s View] An open talk on improving the GMP system
- by Lee, Hye-Kyung Jun 5, 2024 05:47am
- Last month, CEOs of biopharmaceutical companies submitted a statement to the Ministry of Food and Drug Safety (MFDS) requesting an improvement to the 'Cancellation of the GMP compliance decision (GMP One strike-out).' They asked that if non-compliance with GMP has been unintentional, a different set of measures be applied instead of one st
- Opinion
- [Reporter’s View] We don’t know the fate of rivoceranib
- by Kim, Jin-Gu May 30, 2024 05:50am
- On the 17th, The US Food and Drug Administration issued a complete response letter (CRL) for HLB and Chinese Jiangsu Hengrui Pharmaceuticals’ frontline camrelizumab plus rivoceranib as a treatment for those with unresectable or metastatic hepatocellular carcinoma (HCC). Immediately after the news broke, HLB's stock price plummeted. The s
- Opinion
- [Reporter’s View] Lung cancer but also a 'rare disease'
- by Eo, Yun-Ho May 27, 2024 05:48am
- What appears to be the same 'cancer' type can be classified based on different numbers. Cutting-edge, targeted anticancer therapies are being developed to target an extremely small number of patients within a specific category of cancer. The cancer types we refer to as liver cancer, gastric cancer, and lung cancer are major categories,
- Opinion
- [Reporter’s View] Drug Review Coordination Council
- by Kim, Jin-Gu May 16, 2024 05:48am
- The Ministry of Food and Drug Safety (MFDS) has launched the Drug Approval and Review Coordination Council. The council will directly receive coordination requests from complainants when matters for supplemental measures arise during the drug approval and review process. With the Director-General of the Drug Safety Division heading the co
