Janssen Korea’s prostate cancer drug Zytiga (ingredient: abiraterone acetate) will get expanded insurance benefits for the first-line treatment in patients with metastatic hormone-sensitive prostate cancer (mHSPC).On Monday, the Health Insurance Review and Assessment Service (HIRA) said it would col
Sanofi has confirmed its PD-1 inhibitor Libtayo (ingredient: cemiplimab-rwlc) lowers mortality in patients with cervical cancer following skin cancer, leaving an impressive mark as a latecomer.Sanofi said Monday that it would end the phase 3 clinical trials of Libtayo for patients with recurrent and
Binex's illegal change of its drug-making process has led to vehement criticisms of the government by pharmaceutical groups.These organizations are criticizing the government for its lack of licensing and manufacturing control of generic drugs, stressing the need to rectify its authorizing and manag
Eone Diagnomics Genome Center (EDGC) said Tuesday that its rapid EDGC Covid-19 Ag Test has obtained Conformite Europeene certification.EDGC's coronavirus antigen diagnostic kit showed 93.8 percent sensitivity and a specificity of 100 percent in clinical performance evaluation. Sensitivity refers to
Samsung Bioepis said Monday it has signed a partnership agreement with Yuhan Corp. to sell Adalloce™, the biosimilar of AbbVie’s autoimmune therapy, Humira.Adalloce is the first biosimilar of Humira to be marketed in Korea. It treats autoimmune diseases, including rheumatoid arthritis, ankylosing sp
Recently, the government granted health insurance benefits for Takeda’s Ninlaro (ingredient: ixazomib), a second-generation oral proteasome inhibitor (PI), to treat relapsed and multiple refractory myelomas.The three-drug therapy using Ninlaro (IRd, ixazomib+lenalidomide+dexamethasone) has become a
Hanmi Pharmaceutical’s partner Spectrum Pharmaceuticals said Thursday that the U.S. Food and Drug Administration has designated its non-small cell lung cancer (NSCLC) treatment, Poziotinib, as FastTrack. Hanmi developed the drug candidate in 2019 and licensed it out to Spectrum.Spectrum added that i
Ildong Pharmaceutical faced a series of criticism over its advertisement of contraceptive pill Daon Tab. which it released last year.On Friday last week, the Ministry of Food and Drug Safety said it ordered Ildong to suspend the ad of Daon Tab. (ingredient: ethinyl estradiol/levonorgestrel) for one
MedPacto, a company developing anticancer drugs using biomarkers, said Wednesday it would present four study results of Vactosertib, at a conference of the American Association for Cancer Research (AACR) in April.At the meeting, the company will unveil the interim results of transforming growth fact
Binex's alleged manipulation of raw material capacity is spilling over to the entire generic drug industry after regulators announced the suspension of additional products made by Binex commissioned by other drugmakers.The Ministry of Food and Drug Safety announced Tuesday that it had temporarily su
Sanofi said Wednesday that Dupixent (ingredient: dupilumab) has won regulatory approval for children aged 6-11 with atopic dermatitis and adults with chronic rhinosinusitis accompanying nasal polyps.Dupixent, the only biological drug prescribed for atopic dermatitis, has expanded indications to trea
Hyundai Pharm said the name of the upcoming abortion drug it planned to supply in Korea would be “Mifegymiso.”Earlier on Tuesday last week, the company said it clinched an exclusive agreement with Linepharma International to sell an oral abortive drug in the domestic market.Mifegymiso is a combinati
Helixmith said that it has administered the first dose of VM202 to patients with amyotrophic lateral sclerosis (ALS) disease in the U.S. as part of its phase 2a clinical trial.Helixmith plans to conduct the clinical trial in 18 patients at four clinical trial centers in the U.S. and plans to proceed
AstraZeneca’s Lynparza (ingredient: olaparib) obtained additional indication for combination therapy with bevacizumab in the first-line maintenance treatment of ovarian cancer in Korea. Lynparza is the world’s first poly ADP (adenosine diphosphate)-ribose polymerase (PARP) inhibitor.The additional i
GC Pharma, which had been developing plasma therapy for Covid-19, said Monday that it would continue to commercialize its drug, although the U.S. National Institute of Health halted a similar process recently.According to the Korean company, the U.S. NIH has halted clinical trials evaluating the saf
Roche has voluntarily withdrawn its anti-PD-L1 (programmed death-ligand 1) immunotherapy drug Tecentriq (ingredient name: atezolizumab) as a secondary treatment for bladder cancer in the U.S.As Korea currently reimburses the drug as a second-line bladder cancer treatment, regardless of the PD-L1 exp
Genome & Company has signed the second clinical collaboration and supply agreement with Merck and Pfizer to develop the world’s first immunotherapy microbiome drug.The collaboration comes a year after the company signed its first agreement with the two multinational giants in December 2019 to conduc
A series of analyses have been released in the U.S. and Korea recently, which raised doubts about the efficacy of the new antiplatelet drug, ticagrelor. These studies said ticagrelor is far from superior to the existing antiplatelet medication, clopidogrel, and has a higher risk of side effects such
Korean Pharmaceutical Association (KPA) said Tuesday that the government should place pharmacists specializing in the vaccine at Covid-19 inoculation centers for safe immunization.KPA pointed out that the health authorities’ plan to station pharmacists at 250 regional vaccination centers nationwide
The Ministry of Food and Drug Safety has ordered a temporary suspension of making and selling six drugs by Binex, a local contract manufacturing organization (CMO), for its suspected manipulating of raw material amounts.The six drugs are Amorin, Xelectin and Xelectin 10 mg, Daxfen, Rofsin, and Cadil