Novartis Korea aims to address the unmet needs of non-small cell lung cancer (NSCLC) patients with MET exon 14 skipping mutation with the launch of Tabrecta, the company said Tuesday."Lung cancer is the third most common cancer in Korea, and NSCLC has a five-year relative survival rate of only 8.9 p
Yuyu Pharmaceutical said that it has received approval from the U.S. Food and Drug Administration to conduct phase 2 clinical trials for YP-P10, a new dry eye treatment.YP-P10 is a new biopharmaceutical using synthetic peptides and aims to relieve signs and symptoms of dry eye syndrome caused by inf
Zuellig Pharma Korea fell to full-scale capital erosion for the second year as its liabilities exceeded assets due to continued losses in 2021.Complete capital erosion refers to a situation in which the total amount of capital for a company goes below zero as the company's deficit widens, surplus ru
Yuhan Corp. said that its U.S. partner Spine Biopharma has received approval from the U.S. Food and Drug Administration for the phase 3 clinical trial of YH14618, a degenerative disc treatment candidate.Spine Biopharma plans to start trials in June and obtain results by the first half of 2024.YH1461
Roche Korea’s profits aggravated last year as sales dropped and expenses increased.According to Roche Korea, the company posted 343.9 billion won ($278.9 million) in sales last year, down 22.53 percent from 443.9 billion won in 2020. It also registered annual sales of below 400 billion won for the f
SK Chemicals said it has agreed to develop new drugs with inCerebro, a local artificial intelligence (AI) drug development company based on quantum mechanics technology.Under the accord, inCerebro will derive new drug candidate substances for specific diseases based on its quantum mechanics-based mo
Hugel said a complete response letter (CRL) from the U.S. FDA on botulinum toxin (BTX) Letybo requires supplementary documents, but it would not have a significant impact on the drug approval.News reports said that Hugel received the FDA’s CRL on Letybo (brand name in Korea: Botulax) on March 31.Hug
The U.S. health insurance authorities finalized the policy for coverage of aducanumab and future monoclonal antibodies against Alzheimer’s disease as it had planned earlier this year.The decision is likely to hurt Biogen, which recently released Aduhelm (aducanumab), and other drugmakers who plan to
HK inno.N said it completed a phase 1 study of K-Cab (ingredient: tegoprazan), a gastroesophageal reflux disease (GERD) treatment, in the U.S.In a public disclosure on Thursday, HK inno.N said it finished the phase 1 trial in 30 healthy adults. The study was randomized, double-blind, placebo-control
AbClon said that it has partnered with the National Cancer Center (NCC) to develop a CAR-T (Chimeric Antigen Receptor-T) cell therapy for solid cancer and target Claudin (CLDN)-18.2 antigen.According to the company, the recent breakthrough success of CAR-T cell therapy for blood cancer has accelerat
Pfizer’s Lorviqua (ingredient: lorlatinib), a third-generation anaplastic lymphoma kinase (ALK) targeted therapy, passed the review for health insurance coverage for the treatment of adult patients with ALK-positive advanced non-small-cell lung cancer (NSCLC).On Thursday, the Health Insurance Review
Affyxell Therapeutics, a joint venture between Daewoong Pharmaceutical and Avacta Life Science, said that it would conduct more efficient preclinical trials through a three-party joint project with Biocytogen, Korea Non-Clinical Technology Solution Center (KNTSC)In drug development, preclinical tria
BeiGene’s Brukinsa (ingredient: zanubrutinib), a next-generation BTK inhibitor, passed the Health Insurance Review and Assessment Service’s (HIRA) Cancer Drugs Benefit Appraisal Committee review just 40 days after winning marketing approval in Korea.Merck’s anti-PD-L1 immunotherapy Bavencio (aveluma
Processa Pharmaceuticals said it began to conduct a U.S. phase 2 study of YH12852 (PCS12852), an investigational gastrointestinal treatment Yuhan Corp. licensed out two years ago.On Wednesday, Yuhan said its technology transfer partner Processa Pharmaceuticals enrolled the first patient of the phase
Humedix said Wednesday that it would cooperate with Exostemtech to develop exosome-based therapeutics and cosmetics.Under the accord, Humedix plans to discover areas that can use exosome therapeutics and promote joint research by considering both companies' technologies, capabilities, and business a
The Supreme Court has dismissed the appeal filed by the Ministry of Food and Drug Safety’s Seoul office, maintaining a lower court's decision to suspend the ban on selling and making Botulax, Hugel's botulinum toxin.According to Hugel, the ministry’s order to ban the sales and manufacture of Botulax
In 2021, Boehringer Ingelheim’s R&D investment hit 4.1 billion euros ($4.46 billion), a new high in its 137-year history. Among them, R&D investment in human pharmaceuticals was 3.7 billion euros for over 100 products. The company aims to release up to 15 new products by 2025.Boehringer Ingelheim he
Shares of Korea United Pharm plummeted just before the Tuesday marketing closing, possibly affected by foreign investors’ recent sell-off of Korean stocks, industry sources said.The stock price of Korea United Pharm closed at 30,450 won ($24.99) on Tuesday, plunging by the daily limit of 30 percent
Therapeutic cancer vaccines are emerging as candidate drugs for major combination therapy with immune checkpoint inhibitors, and the attention is also on Korean developers of such vaccines, an industry report said.The Korea Health Industry Development Institute (KHIDI) released a report on the statu
Medytox Korea, a subsidiary of Medytox, said Tuesday that it has completed the phase 3 trial of MBA-P01, a next-generation botulinum toxin (BTX).The company has been conducting comparative studies on the efficacy and safety of MBA-P01 on 318 adults in need of moderate to severe forehead wrinkle trea