Idience said Tuesday that venadaparib, the company’s novel drug candidate for targeted agents, has been designated as an orphan drug by the U.S. Food and Drug Administration.Idience is a subsidiary of Ildong Holdings, the holding company of Ildong Pharmaceutical Group, specializing in novel drug dev
Hanmi Pharmaceutical said it was ready to lead the local dyslipidemia treatment market with Rosuzet (rosuvastatin 10mg+ezetimibe 10mg) because of the treatment’s “distinguished evidence for therapeutic benefits.”At a news conference in Seoul Monday, Hanmi disclosed the results of the RACING trial, s
Pharmaceutical experts repeatedly said SK Bioscience’s Covid-19 vaccine SKYCovione needed additional safety review during the regulator’s marketing approval process, minutes of a drug review panel showed.The Ministry of Food and Drug Safety recently disclosed the minutes of the Central Pharmaceutica
SK Biopharmaceuticals’ epilepsy drug Cenobamate will soon be reviewed for approval in Canada and Israel.Paladin Labs, a subsidiary of SK Biopharma’s partner company Endo International, sent new drug submission (NDS) for the innovative novel drug for epilepsy to Health Canada in June.If the Canadian
Genematrix said Monday that it obtained the Conformité Européene In-vitro diagnostic (CE-IVD) device certification for its new Neoflex TB/NTM-5 detection kit, a new respiratory diagnostic product.The kit can identify one type of mycobacterium tuberculosis (TB) and five different types of non-tubercu
Pangen Biotech announced Monday that it signed a joint development agreement with Moogene Medi to develop a protein treatment using lipid nanoparticles (LNPs).The two companies also applied for a patent on “LNPs for protein transfer” in July.LNPs are transmitter substances of mRNA Covid-19 vaccine d
MedPacto announced Monday that it received green light from the U.S. FDA to test Vactosertib as a solo therapy for recurrent and intractable osteosarcoma patients in a phase 1/2 trial.The study will be on 54 patients aged 14 or older who suffer from recurrent or intractable osteosarcoma and carried
Cellid, a Korean bio-venture, will conduct a Covid-19 vaccine study in Kenya and Tanzania, a company official said.“In the near future, we will apply for an investigational new drug (IND) clinical trial in Kenya and Tanzania, jointly with the International Vaccine Institute (IVI),” the official told
Novo Nordisk is facing difficulties to replace the existing drug Saxenda (liraglutide) with a new drug Wegovy (semaglutide) in the obesity treatment market due to manufacturing issues.On Thursday, the Danish multinational drugmaker said in an IR meeting for second-quarter earnings that it would be d
Macrogen, a company specializing in precision medicine biotechnology, said on Monday that it is expanding its multiomics business by providing domestic and foreign protein analysis services.Multiomics is a high-level analytical technique that integrates genomic, transcriptome, and proteome data, and
Bukwang Pharmaceutical its subsidiary Dyna Therapeutics obtained a composition patent for SOL-804, a prostate cancer drug candidate, in Korea and Japan.With the additional two patent registrations, Dyna has completed the patent registration in 32 countries including the U.S., Australia, Mexico, and
HLB Life Science, which owns rights to market Jiangsu Hengrui Medicine’s anticancer drug pyrotinib in Korea, said it would expand new pipelines on the back of the recent success of a phase 3 pyrotinib trial.Jiangsu Hengrui announced that the phase 3 clinical trial of pyrotinib met the primary endpoi
SillaJen announced Thursday that it tapped Kim Jae-kyung, a former head of LabGenomics, as the new CEO.With Kim taking the helm, SillaJen said it would be able to normalize stock trading and strengthen corporate transparency.Kim was a founding member and CEO of LabGenomics. He also served as an adju
ATGC said Thursday that it signed a strategic partnership license and supply agreement with RELIFE, an Italian biopharma firm, for its botulinum toxin type A (ATGC-100) as part of its strategic entry into Europe.Under the agreement, ATGC will grant RELIFE exclusive rights to develop, register, promo
Bridge Biotherapeutics announced that it would release non-clinical data of idiopathic pulmonary fibrosis (IPF) treatment candidates BBT-301 and BBT-209 at the IPF summit 2022 to be held at Boston from Aug. 29 to Sept. 1.According to the company, BBT-301 is a novel drug candidate which fights the di
Medytox’s plan to enter the Chinese botulinum toxin (BTX) market is suffering a setback as Bloomage Biotechnology, its Chinese partner, announced that it would terminate its deal with Medytox.According to Chinese media outlets, Bloomage has hired a lawyer to issue an official notice to exercise its
Biogen’s Alzheimer’s disease treatment Aduhelm (ingredient: aducanumab) may not be able to obtain marketing approval in Korea due to “insufficient data.”According to the minutes of the Central Pharmaceutical Advisory Committee’s meeting disclosed by the Ministry of Food and Drug Safety, the committe
Reyon Pharmaceutical said it would expand business partnerships at the Bioplus-Interphex Korea 2022, Korea’s largest biotech convention held at COEX, Seoul.At the BIX 2022, Reyon Pharmaceutical will seek partners for co-development and CDMO/CMO business by promoting its cGMP biologic drug factory lo
The government approved Takeda’s human protein C to treat severe congenital protein C deficiency, an extremely rare disease with only 13 Korean cases reported so far.On Tuesday, the Ministry of Food and Drug Safety authorized the use of Ceprotin (ingredient: human protein C) to prevent and treat ven
GC Biopharma announced on Monday that operating profit for the second quarter of 2022 jumped by 18 percent on year recording 13.1 billion won ($10 million).Sales stood at 423.2 billion won in the second quarter, up 9.2 percent year-on-year. Net profit jumped 45.3 percent to 10.9 billion won in the s