Helixmith said it has made 50-percent progress in recruiting patients for its clinical trial of TADIOS, a Covid-19 treatment, in India.The company plans to conduct a double-blind, placebo-controlled, multicenter clinical trial on 100 people at four medical institutions in India and has enrolled 50 p
SK Chemicals said it has agreed with Cimplrx, an artificial intelligence-based new drug development company, for joint research and development of new drugs using AI.Under the accord, the two companies plan to discover new drugs for specific indications and target proteins. Cimplrx intends to find n
A local court has accepted Hugel's application for suspending the execution of an administrative order to nullify the license of its botulinum toxin (BTX) product, withdraw and discard those already made.The Seoul Administrative Court cited Hugel's application for suspending the execution of the adm
Samsung Biologics will team up with Greenlight Biosciences, a U.S. mRNA vaccine maker, to supply a Covid-19 mRNA vaccine for Africa.The Korean biotech company said Thursday that it signed a contract manufacturing organization (CMO) deal to manufacture drug substance (DS) of GreenLight’s Covid-19 mRN
HLB Therapeutics said Friday that the U.S. Food and Drug Administration has approved the execution of an expanded access program (EAP) for its NHPN-1010, a treatment candidate for hearing loss and tinnitus.Upon winning the approval, the company began to administer the drug to a chronic tinnitus pati
The Ministry of Food and Drug Safety has ordered the recall of 12 drugs manufactured by Medica Korea after confirming various violations in their manufacturing processes.The 12 drugs comprise five Medica Korea's drugs – Lockpain, BAMBI, Salazine, and Arutec Crethicone – and seven consignment drugs –
Handok said that it has invested 3 billion won ($2.5 million) in Spark Biopharma, a local biopharmaceutical company, to co-develop SBP-101, an anticancer treatment candidate.The investment is part of Handok's open innovation initiative, and with the co-development contract, the company has secured p
HanAll Biopharma said on Wednesday that it started administering its dry eye disease treatment HL036 (tanfanercept) to patients in the second phase 3 VELOS-3 trial in the U.S.HL036, being developed in collaboration with Daewoong Pharmaceutical in the U.S., is a biologic treatment that inhibits tumor
Pfizer’s oral Janus kinase (JAK) inhibitor Cibinqo (abrocitinib) obtained the regulatory nod for the treatment of atopic dermatitis, joining competition against Lilly’s Olumiant (baricitinib) and AbbVie’s Rinvoq (upadacitinib) in Korea.On Tuesday, the Ministry of Food and Drug Safety authorized the
Toolgen said Thursday that it would become a global leader in gene editing platforms and gene and cell therapy products based on its superior technology after joining the secondary Kosdaq market.The company, now traded on the smaller Konex market, seeks to move to the bigger Kosdaq market by offerin
Daiichi Sankyo Korea said its hypertension drug Sevikar HCT (ingredient: amlodipine, olmesartan medoxomil, hydrochlorothiazide) showed promising long-term efficacy and safety profile for Korean patients with essential hypertension in RESOLVE-PRO clinical trial.RESOLVE-PRO trial is a real-world study
Celltrion said Wednesday that it would supply Covid-19 antibody treatment, Regkirona (ingredient: regdanvimab), to more facilities treating patients with lighter symptoms to help curb its spread. “Following the decision by Korea Disease Control and Prevention Center (KDCA) to expand the supply of Re
Novartis’ anticancer drug targeting MET mutation in non-small cell lung cancer obtained approval in Korea.On Tuesday, the Ministry of Food and Drug Safety authorized the use of Tabrecta (ingredient: capmatinib), an oral MET inhibitor, for the treatment of patients with locally advanced or metastatic
SillaJen said on Tuesday that it started administering Pexa-Vec, an oncolytic virus therapy, in a phase 1b/2 trial to patients with melanoma in China. The Korean biotech firm is conducting the study jointly with its Chinese partner, Lee’s Pharm.The phase 1b study in China will be on 46 patients with
FedEx Express said it has been selected as “Asia’s best third-party logistics (3PLs) for vaccines” at the Asia Pacific Vaccine Excellence Awards 2021.The award was attributed to the transportation company’s protection of shipment integrity and the supply of vaccines across the globe.FedEx has transp
Aduhelm (ingredient: aducanumab), developed by Biogen and authorized by the FDA as the first treatment for Alzheimer’s disease, is engulfed in controversy.The new Alzheimer’s drug recently reported the death of a patient who died of amyloid-related imaging abnormalities (ARIA), the most common side
Three Korean pharmaceutical companies are in a fierce race to develop a biosimilar of Stelara (ustekinumab), a treatment for autoimmune diseases.Samsung Bioepis, Celltrion, and Dong-A ST have received authorization to conduct global phase 3 trials of Stelara biosimilars.Recently, Dong-A ST finished
As the Covid-19 pandemic continues, there are growing calls to increase the self-sufficiency of pharmaceutical raw materials in Korea.The call for self-sufficiency of pharmaceutical raw materials has recently increased after the nation has been making a flurry of diplomatic efforts to secure urea an
Genexine said Friday that the company expects its Covid-19 vaccine candidate, GX-19N, to prevent infection for a long time as it uses T cell immune response instead of antibodies.GX-19N, a DNA vaccine, is a next-generation vaccine with nucleocapsid antibody added to the existing spike protein protec
Sanofi’s Dupixent (dupilumab), a severe atopic dermatitis (AD) treatment covered by health insurance in people aged 18 or more, should become reimbursable for adolescents, too, a petition on Cheong Wa Dae said.Dupixent is the only biologic agent that can treat severe AD. In addition, it proved thera