Oxford Vacmedix, a U.K.-based bio company specializing in cancer vaccines and partner of Korea’s CancerRop, said Tuesday it has won the regulatory approval to conduct a phase 1 trial of vaccine candidate OVM-200.The U.K. Medicines and Healthcare products Regulatory Authority (MHRA) gave the go-ahead
President Moon Jae-in on Tuesday vowed to provide full support for the phase 3 clinical trial of SK Bioscience’s Covid-19 vaccine candidate, GBP510.“The government will provide the full range of supports for SK Bioscience to proceed with the study so that the company can carry out domestic clinical
Celltrion said that it has received approval from the Therapeutic Goods Administration (TGA) of Australia to conduct a phase 1 clinical trial plan for the inhalational formulation of Regkirona, a Covid-19 treatment.Inhalon Biopharma, a U.S.-based bio-company that signed a contract with Celltrion to
Defying worries that the continued Covid-19 pandemic could discourage clinical trials, researchers are increasingly testing drugs in more trials than ever worldwide.Statistics show that the number of newly registered clinical trials led by pharmaceutical companies increased 14.3 percent on-year to 5
The U.S. Food and Drug Administration has approved Nexviazyme (ingredient: avalglucosidase alfa-ngpt) for intravenous infusion to treat patients aged one year or above with late-onset Pompe disease (LOPD).LOPD patients have mutated alpha-glucosidase (GAA) gene that reduces or eliminates essential en
Merck Biopharma Korea and Pfizer Pharma Korea said their immuno-oncology Bavencio (ingredient: avelumab) has won additional approval from the Korean regulator as the first-line maintenance therapy for locally advanced or metastatic urothelial cancer.The Ministry of Food and Drug Safety has expanded
Pfizer Korea said Monday that it also would support the vaccination of its employees, following reports last week on Pfizer headquarters’ decision to mandate the Covid-19 vaccination for its employees."It is difficult to obligate employees to receive vaccination in the Korean branch, but we are cond
The Korean branch of Eli Lilly said that it had gained additional reimbursement for its psoriasis treatment Taltz (Ingredient: ixekizumab) as first-line biologic therapy for patients with psoriatic arthritis.Under the latest revision, the government will reimburse the treatment for patients with act
The U.S. FDA rejected Spectrum Pharmaceuticals’ application for neutropenia treatment Rolontis (ingredient: eflapegrastim), notifying that the regulator would reinspect the manufacturing site. Spectrum is a U.S. partner firm for Hanmi Pharmaceutical.The latest decision is likely to delay approval fo
Sanofi-Aventis Korea said it would recall three types of hypertension treatments containing irbesartan due to impurity concerns raised in other countries.The three products sold 16.9 billion won ($14.7 million) in Korea in the first half. However, the recall could dent second-half sales of Handok an
AbbVie said its atopic dermatitis treatment Rinvoq (ingredient: upadacitinib) has proved its superiority over dupilumab in the phase 3b study on their safety and efficacy.Both were used as mono-therapy treatments on moderate to severe atopic dermatitis adult patients.The research paper was based on
The U.S. Health and Human Services (HHS) Office of Inspector General said Wednesday that it would investigate the U.S. Food and Drug Administration’s process in approving Aduhelm (ingredient: aducanumab), Biogen’s Alzheimer’s disease treatment.The FDA recently approved Aduhelm with an accelerated ap
Vigencell, a company specializing in immune cell treatments’ research and development, said it plans to go public in the Kosdaq stock market next week. Ahead of its IPO, the company presented its major pipelines, competitiveness, visions, and strategies in a news conference on Thursday.Vigencell aim
Maria Trading, the platinum sponsor of MISS Iraq 2021 with the crowned beauty (Maria Frhad) as its official brand ambassador, seeks to grow into a top company that provides medical aesthetics products in the Arabian Gulf region.The company, a leading player in dermatology and aesthetic sectors in th
PharmaResearch said Friday that its polynucleotide (PN)-based medical device, Rejuran HB Plus, has won approval from the Ministry of Food and Drug Safety and plans to begin marketing from the second half of the year.The company has upgraded Rejuran HB Plus by adding hyaluronic acid (HA) and lidocain
Novartis Korea said Monday its interleukin-17a (IL-17a) inhibitor Cosentyx (ingredient: secukinumab) began receiving reimbursement as a first-line biologics for progressive psoriatic arthritis (PsA) patients who had an inadequate response to existing disease-modifying antirheumatic drugs (DMARDs).Wi
ViiV Healthcare, the HIV specialist owned by GlaxoSmithKline plc. (GSK), presented Dovato’s 48-week data of the phase 3 SALSA and 144-week data of TANGO at the 2021 International AIDS Society.The 2021 International AIDS Society was held online from July 18-21. Dovato, HIV treatment, is a two-drug re
GC Pharma has signed a joint research and license agreement to develop orally administered chaperone therapy of gangliosidosis (GM1) with Japans’ Tottori University.A neurodegenerative disease, GM1 is a recessively inherited genetic defect that leads to a lack of enzymes in the body. It happens to o
Korea marked the first trade surplus in pharmaceutical products last year since the nation began compiling related data in 1998, the government said.On Sunday, the Ministry of Food and Drug Safety released the data of Korea’s output, export, and import of medicines in 2020.The data showed that the n
Large domestic pharmaceutical companies are likely to continue their growth pattern as they increased sales in the second quarter despite slight drops from the first three months.Hanmi Pharmaceutical, Daewoong Pharmaceutical, Samsung Biologics, GC Pharma, and Hanmi Pharmaceutical began to release th