CKD Bio said it obtained approval for exporting Tyemvers, a botulinum toxin (BTX) product.The company plans to ship the product to some countries that do not require a separate registration process in the Middle East and Central and South America.The Ministry of Food and Drug Safety said it granted
Samyang Biopharm USA, a global biotech subsidiary of Samyang Holdings Corp., said on Thursday that it appointed Ryu Eun-ju as its new CEO.Ryu is a new drug business strategist and marketing expert with more than 30 years of experience in global clinical trial management and drug approval, business d
Daewon Pharmaceutical said it has won approval from the Ministry of Health of the Russian Federation for Pelubi, its non-steroidal anti-inflammatory drug (NSAID), and will launch it under the brand name Pelubio.Daewon will produce Pelubi at its plant in Gyeonggi Province and export it to Russia. Pha
Institutional and individual investors' views on pharmaceutical stocks sharply divided in the first month of 2022.Stock market pharmaceutical sector index companies’ net purchase and sales in January (Unit: 100 million)According to the Korea Exchange, institutional and foreign investors’ net sellin
SK Bioscience said that it has shipped out the first 840,000 doses of Nuvaxovid, Korea's first synthetic antigen-based Covid-19 vaccine, from its plant in Andong, North Gyeongsang Province, on Wednesday.The shipment follows the Ministry of Food and Drug Safety's approval for the vaccine on Jan. 12.
Boryung Biopharma said it acquired Forbio Korea’s research unit and established a subsidiary, BPgene, to develop mRNA drugs.Forbio Korea is a developer of biological substances. Since 2014, the company has been working on new drug development using its mRNA technology.Boryung Biopharma invested in F
NeoImmuneTech said on Monday it completed the administration of NT-I7 (efineptakin alfa), a new skin cancer drug, in combination with Roche’s Tecentriq (atezolizumab) to the first patient in a phase 2 trial in the U.S.The Korean biotech company gets all doses of Tecentriq for the trial from Roche.Th
Yuhan Corp.’s non-small cell lung cancer (NSCLC) treatment Leclaza (lazertinib) is likely to score the regulatory nod soon, observers said.The Ministry of Food and Drug Safety’s central pharmaceutical affairs advisory committee recently agreed to allow Yuhan to replace a confirmatory clinical trial
Gilead Sciences’ HIV treatment and prevention drug Truvada (ingredient: emtricitabine/tenofovir disoproxil fumarate) avoided the regulator’s revocation of approval for HIV treatment.According to the minutes of the Ministry of Food and Drug Safety (MFDS)’s central pharmaceutical affairs advisory comm
The Seoul Central District Prosecutors’ Office has acquitted Daewoong Pharmaceutical of charges that the company stole Medytox’s botulinum toxin (BTX) technology.“As a result of a search and seizure, digital forensic, and statements of related employees, there is no evidence to admit that Medytox's
Daewon Pharmaceutical said it held working-level negotiations with Cigala Healthcare Group, a Saudi healthcare company, to conduct joint clinical trials for TG Fenon (Ingredient: fenofibrate), an oral Covid-19 treatment.TG Fenon is a hyperlipidemia drug that Daewon repurposed as a Covid-19 treatment
Daewoong Pharmaceutical’s subsidiary iN Therapeutics said it raised 26 billion won ($21.6 million) bridge capital for new drug development.Last year, iN Therapeutics successfully attracted 14 billion won of Series A investment.The temporary funding came from new investors, Stic Ventures and Interves
Celltrion said Monday it has confirmed the safety of its inhaled Covid-19 antibody treatment through an Australian phase 1 clinical trial and plans to start global clinical trials for a cocktail version of the inhaled treatment.Inhalon Biopharma, Celltrion's global partner, proved the inhaled antibo
Biogen’s first anti-amyloid antibody, Alzheimer’s disease treatment Aduhelm (ingredient: aducanumab), is suffering a series of setbacks.According to the annual securities filing by Biogen on Thursday, the U.S. Federal Trade Commission (FTC) and the Securities and Exchange Commission (SEC) started se
Immunomic Therapeutics, a subsidiary of HLB, said it has received U.S. Food and Drug Administration’s approval to conduct the phase 1 clinical trial of ITI-3000, a Merkel cell carcinoma treatment.ITI-3000 is an anticancer vaccine made by combining LAMP1 (lysosomal-associated membrane protein) with t
SK Bioscience said Turkey’s health authorities granted GMP certification to its vaccine plant, raising the chance of exporting self-developed vaccines.On Friday, the company said that the Turkish Medicines and Medical Devices Agency renewed GMP certification on the L House’s vaccine facility, manufa
Shinpoong Pharmaceutical has completed an overseas clinical trial of antimalarial treatment Pyramax (ingredient: artesunate/pyronaridine), drawing attention to the study results.According to clinicaltrials.gov, the status of the Phase 2/3 study NCT05192265 for malaria indication has been updated as
The Korean pharmaceutical industry rolled out four home-grown new medicines in 2021. Industry watchers are paying attention to which company will introduce a new drug in 2022.Observers said companies conducting or finishing phase 3 trials to finalize the safety and efficacy might release new drugs t
Yuyu Pharmaceutical has launched Nagran Oral Disintegrating Tablet (Ingredient: Naratriptan), the first generic drug for GSK’s Naramig, a migraine treatment.Patients can use orally disintegrating tablets to relieve migraine headaches rapidly. The company has increased convenience by allowing patient
inno.N said Thursday that it has signed a contract with Malaysia’s Pharmaniaga Logistics to export its gastroesophageal reflux disease (GERD) therapy, K-CAB, to the Southeast Asian country.Under the accord, Pharmaniaga will have the exclusive right to distribute K-caps in Malaysia for five years. Th