Sillajen's shares shot up a daily limit of 30 percent to trade at 5,590 won ($4.3) on Monday afternoon, after filing on Friday results of a phase 1b/2a clinical study on Pexa-Vec, a thymidine kinase-deactivated vaccinia virus, combined with Regeneron's checkpoint inhibitor, Libtayo (cemiplimab), for
The Ministry of Food and Drug Safety (MFDS) said it has appealed against the first-instance court decision that canceled the sales suspension of Meditoxin, Medytox's botulinum toxin (BTX) product.The MFDS decided to appeal under the direction of the Ministry of Justice, believing that further respon
Kwangdong Pharmaceutical said Friday that it has signed a co-promotion agreement with MSD Korea on the human papillomavirus (HPV) vaccine Gardasil and Gardasil 9.Under the agreement, the two companies will jointly market and distribute Gardasil and Gardasil 9 in Korea starting January 1, 2024.Gardas
A petition has been posted to call for providing insurance benefits for Lilly's CDK 4&6 inhibitor Verzenio (abemaciclib) for early-stage breast cancer.Verzenio is the first CDK 4&6 inhibitor to have its indication expanded to include HR+ (hormone receptor positive)/HER2- (human epidermal growth fact
Novartis' PI3K-inhibiting breast cancer drug Piqray (alpelisib) has been struggling in the Korean market, failing to gain access to health insurance coverage.In the meantime, AstraZeneca recently launched a process to win approval in Korea with its FDA-approved AKT inhibitor, capivasertib (Truqap in
Bukwang Pharmaceutical said that the Ministry of Food and Drug Safety has approved Latuda Tab. (ingredient: Lurasidone Hydrochloride), a treatment for schizophrenia and major depressive episodes associated with bipolar I disorder developed by Japan's Sumitomo Pharma.Latuda acts as an antagonist by b
GC Biopharma said Thursday that its flu vaccine, GCFLU, has been awarded an order worth about $10 million (about 13 billion won) in a 2024 tender by Thailand's Government Pharmaceutical Organization (GPO), a state-owned pharmaceutical company.This is the largest contract GC Biopharma has won since e
Handok’s Vyxeos liposomal Injection, a combination of cytarabine and daunorubicin for therapy-related acute myeloid leukemia (t-AML) and acute myeloid leukemia with myelodysplasia-related change (AML-MRC), has crossed the first threshold for reimbursement in its second attempt.Gilead Sciences’ Trode
Hanmi Pharm said it has overhauled its R&D center’s structure to make it a disease-oriented research organization.The reorganization focuses on maximizing synergies and convergence of expertise by integrating teams previously divided into bio and synthetic areas. The move aims to speed up the develo
Bukwang Pharmaceutical’s headquarters in Sangdo-dong, southwestern SeoulBukwang Pharmaceutical has entered the single representative system of Lee Woo-hyun, chairman of its largest shareholder, OCI Holdings. With the end of the separate representative system, which has continued even after OCI Holdi
BeiGene Korea said on Tuesday it obtained the Ministry of Food and Drug Safety’s approval for Tevimbra Inj. 100mg (ingredient: tislelizumab) to treat esophageal squamous cell carcinoma (ESCC). Specifically, anti-PD-1 immunotherapy Tevimbra has been authorized as monotherapy in adults with unresectab
Sam Chun Dang Pharmaceutical said Tuesday it has signed a contract with an unidentified distributor to supply SCD411 (ingredient aflibercept), a macular degeneration biosimilar referencing Eylea, in five European countries: Germany, Spain, Italy, Switzerland, and Austria.According to the public disc
MSD Korea held a press conference on Monday to celebrate the launch of Vaxneuvance, a 15-valent pneumococcal protein conjugate vaccine, in Korea.The event underscored the need for collaborative efforts and policies to swiftly introduce and implement the new vaccine in Korea's medical sector.Pneumoco
GC's Hunterase, a treatment for Hunter syndrome, has finally obtained full approval, 11 years after receiving conditional approval, the company said on Friday. After being designated as an orphan drug in September 2011, Hunterase, the world's second treatment for Hunter syndrome, received conditiona
AbbVie Korea's interleukin-23 (IL-23) inhibitor Skyrizi (risankizumab) has expanded its indications to treat moderate-to-severe active Crohn's disease in adult patients (18 and older) following psoriasis and psoriatic arthritis.Skyrizi has won approval and received insurance benefits for treating mo
AbbVie Korea announced Thursday that Aquipta(atogepant), a calcitonin gene-related peptide (CGRP) receptor antagonist, has been approved by the Ministry of Food and Drug Safty (MFDS) for the prevention of migraine in adults. This approval makes AQUIPTA the first once-daily oral CGRP receptor antagon
HanAll Biopharma said Thursday that the monthly sales of its hair loss treatment, Hairgrow (finasteride), have exceeded 1 million tablets.It marked the largest sales volume since its launch in 2007. In 2022, the sales volume of Hairgrow has grown 20 percent on annual average for about five years. In
The supply shortage of Sudafed (ingredient: pseudoephedrine hydrochloride), used for cold and sinus congestion relife, is likely to be resolved in November.An official from the Ministry of Health and Welfare's Pharmaceutical Affairs Division said so at a meeting with journalists covering the ministr
Huons Biopharma, a company specializing in botulinum toxin (BTX), announced Thursday that it has received approval from the Ministry of Food and Safety (MFDS) for the phase 3 Investigational New Drug (IND) clinical trial of its HU-045, a BTX, treating frown lines.HU-045 was developed to address mode
Daewoong Pharma said it has signed a comprehensive memorandum of understanding (MOU) with China Meheco International, a Chinese pharmaceutical import and export company, to export Daewoong's treatment to China.Daewoong expects that through this MOU, the company will be able to accelerate the entry o
