- Company
- Trodelvy approved for reimbursement with the ICER value
- by Whang, byung-woo Jun 12, 2025 06:06am
- As Trodelvy (sacituzumab govitecan), the first antibody-drug conjugates (ADC) for treating Triple-Negative Breast Cancer (TNBC) available in South Korea, becomes reimbursed, a paradigm shift in the treatment is expected. Experts assess that the metastatic TNBC treatment, which has been challenging due to a high risk of metastasis and relapse
- Company
- Tevimbra seeks to add 6 indications in Korea
- by Eo, Yun-Ho Jun 12, 2025 06:05am
- The use of the immuno-oncology drug Tevimbra is set to be extended further in Korea. The Ministry of Food and Drug Safety is in the final stages of reviewing and approving the additional indications for BeOne Medicines Korea’s Tevimbra (tiselizumab). The drug is expected to be approved for the extended indications within the month. Sp
- Policy
- Measures to reduce industry burden for stronger GMP
- by Lee, Hye-Kyung Jun 12, 2025 06:04am
- With the Ministry of Food and Drug Safety set to enforce the revised GMP standards for aseptic drugs reflecting the international Pharmaceutical Inspection Co-operation Scheme (PIC/S) standards from December, measures are being prepared by the industry to reduce its burden. Ahead of its rejoin into PIC/S in 2023, the MFDS announced the “Regu
- Opinion
- [Reporter's View] Fostering BD talent requires tech·strateg
- by Whang, byung-woo Jun 12, 2025 06:04am
- Recently, the role of business development (BD) in the pharmaceutical and biotech industry has been rapidly advancing. Previously regarded simply as a sales task, BD changed to one of the core strategic teams that oversees the success of new drug development. BD is responsible for key discovery and execution of various opportunities for n
- Policy
- Qlaris starts Phase II trial for its glaucoma drug in KOR
- by Lee, Hye-Kyung Jun 12, 2025 06:03am
- Qlaris Bio, a US biotech company, is conducting a Phase II clinical trial in Korea for 'QLS-111,' a drug candidate for primary open-angle glaucoma (POAG) and ocular hypertension (OHT). On the 5th, the Ministry of Food and Drug Safety approved a randomized, active-controlled, multicenter, double-blind, preliminary study to evaluate the saf
- Company
- 'Ocrevus' for multiple sclerosis available at hospitals
- by Eo, Yun-Ho Jun 11, 2025 06:03am
- The new drug 'Ocrevus' for treating multiple sclerosis is becoming available at general hospitals. According to sources, Roche Korea's Ocrevus (ocrelizumab), the treatment for relapsing multiple sclerosis (RMS), has passed drug committees of tertiary general hospitals, including Samsung Medical Center, Seoul National University, Asan Medic
- Company
- Janssen Korea to cut distribution margins… sparks pushback
- by Son, Hyung Min Jun 11, 2025 06:03am
- i1 Janssen Korea, which has announced a 2% reduction in distribution margins, is expected to engage in dialogue with individual pharmaceutical distribution companies rather than the Korea Pharmaceutical Distribution Association (KPDA) to resolve the current issue. The KPDA has sent two official letters to Janssen Korea, demanding negotiations
- Company
- Korean pharmas to make strong presence at BIO USA
- by Son, Hyung Min Jun 11, 2025 06:02am
- The domestic pharmaceutical and biotech industry will showcase its contract development and manufacturing (CDMO) and new drug candidate technologies at Bio USA, the world's largest biotech convention. Various Korean companies have also set out to participate in BIO USA 2025, which will be held in Boston, USA, for four days from the 16th of t
- Company
- EU revises pharma package law for the first time in 20 years
- by Kim, Jin-Gu Jun 11, 2025 06:02am
- The European Union (EU) is pushing for revisions to its “Pharmaceutical Package” law on major drugs for the first time in 20 years. The core of the revision, which is now awaiting final approval by the European Parliament, can be summarized as expanding the exclusivity of innovative drugs and strengthening supply obligations within Euro
- Company
- Pfizer launches 'Prevenar 20' for adults aged 18 years+
- by Whang, byung-woo Jun 11, 2025 06:01am
- Pfizer Korea (CEO and President Dong-wook Oh) announced on June 10 that its 'Prevenar 20,' a 20-valent pneumococcal conjugate vaccine for adults, was launched in early June, and it is now available for vaccination for individuals aged 18 years and older. Prevenar 20 will be supplied to the Korean market for adults through a co-promotion a
