Daehwa Pharm, a Kosdaq-listed drugmaker, said Friday it received orphan drug designation (ODD) from the European Medicines Agency (EMA) for Liporaxel Solution, an oral paclitaxel, for the second-line treatment of gastric cancer on Feb. 26.Daehwa explained that the orphan drug designation for Liporax
GC Medical Science (GC MS) said Friday that it has signed an agreement for the long-term supply of hemodialysis solutions with Baxter Korea’s Kidney Business Division.GC MS has supplied hemodialysis solutions to Baxter for the past five years, from 2019 to 2023. With the latest agreement, GC MS will
Genexine and Handok said Friday that GX-H9 (HL2356), a long-acting growth hormone for pediatric use under co-development by the two, has been designated as an orphan drug in the developmental stage by the Ministry of Food and Drug Safety (MFDS).According to the companies, the designation of GX-H9 as
Medytox posted a significant year-over-year drop in profits last year. The company attributed it to ongoing litigation and other reasons while predicting its performance will improve this year.On Thursday, Medytox released its preliminary consolidated operating results for 2023 through a public disc
The second-generation bruton tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib), developed by BeiGene, has cleared the threshold of the Pharmaceutical Reimbursement Evaluation Committee (PREC) after a second attempt at expanded coverage.At the same meeting, AstraZeneca's asthma drug Fasenra (be
Samsung Pharm has received approval from the Ministry of Food and Drug Safety (MFDS) to change the investigative new drug (IND) application for its phase 3 clinical trial of GV1001 for Alzheimer's disease.The MFDS accepted Samsung Pharm's application to simplify GV1001's dosing regimen, approving a
In a significant milestone marking the ten-year collaboration between SK bioscience and Sanofi, a global leader in healthcare, the two companies have embarked on an ambitious expansion of the L HOUSE, SK bioscience’s vaccine manufacturing plant in Andong, North Gyeongsang Province.This expansion aim
HLB Group has announced the acquisition of domestic rights to Jiangsu Hengrui Pharmaceuticals' immunotherapy, camrelizumab, facilitating the path towards commercializing the combination therapy of camrelizumab and its novel drug candidate riboceranib in Korea.The group's subsidiaries -- HLB Life Sci
Binex, a Kosdaq-listed biopharmaceutical CDMO, has been subjected to a two-month suspension of sales operations for Bimo 5mg (ingredient: minoxidil), a hair loss treatment, for failing to submit necessary documents for the 2023 drug equivalence reevaluation.The product in question will not be availa
MSD's 15-valent pneumococcal conjugate vaccine (PCV), Vaxneuvance, will be used in Korea in earnest next month as part of the government’s pediatric national immunization program (NIP).MSD Korea said it had secured sufficient batches of Vaxneuvance to prepare for its full-scale launch.Vaxneuvance is
ProEn Therapeutics, which develops antibody-drug conjugates (ADCs), said Monday that it has completed attracting a strategic investment from Kolmar Korea Holdings.The investment amount was not disclosed per the agreement between the two companies.The investment is part of an open innovation program
GSK Korea's inhalation-type triple combination asthma medicines Trelegy 100 Ellipta (fluticasone furoate/umeclidinium/vilanterol) and Trelegy200 Ellipta will get health insurance benefits starting this month.According to a notice by the Ministry of Health and Welfare and the Health Insurance Review
Samjin Pharmaceutical announced a strategic investment of 1 billion won ($751,371) in Neurophet, a company specializing in AI solutions for brain disorder imaging, to fight dementia and stroke.Under the accord, the two companies seek to leverage Samjin’s extensive research resources, infrastructure,
The Korea Drug Research Association held the 25th Korea New Drug Development Award Ceremony in Seoul last Thursday.At the ceremony, Yuhan Corp., which developed the non-small cell lung cancer (NSCLC) treatment Leclaza, and GC Biopharma’s immune disease treatment Alyglo co-won the grand prize in the
Hugel said it received approval from the U.S. FDA for its botulinum toxin product, Letybo, in 50-unit and 100-unit dosages.This FDA approval marks a significant development for Hugel, following its third attempt to gain approval for Letybo.The company's journey to this point involved addressing feed
Pharmbio Korea will exclusively sell Clipper (beclomethasone dipropionate), an original ulcerative colitis treatment from Italian pharmaceutical company Chiesi, in Korea.Clipper is a steroidal ulcerative colitis treatment, a long-acting extended-release tablet that provides the anti-inflammatory ben
Biologic agent Dupixent (dupilumab) has emerged as a new treatment option for moderate-to-severe nodular pruritic rash (prurigo nodularis), for which existing treatments, such as topical steroids and systemic immunosuppressants, have shown little treatment effects.On Wednesday, Sanofi Korea held a n
Kolon Life Science said it has decided to appeal to the Supreme Court against the revocation of the manufacturing and sales license for its knee osteoarthritis cell and gene therapy, Invossa-K Inj.This move comes after the company faced defeats in both the district and appellate courts.Most recently
Celltrion said Thursday that it has completed submitting a marketing authorization application for CT-P47, a biosimilar to Actemra (tocilizumab) for treating autoimmune diseases, to the Ministry of Food and Drug Safety (MFDS).Celltrion has applied for the marketing authorization of CT-P47 for the fu
PARP (poly ADP-ribose polymerase) inhibitors have recently emerged as a new treatment option for metastatic castration-resistant prostate cancer (mCRPC) with a poor prognosis and are expected to contribute significantly to improving survival rates.However, they remain far beyond the reach of most Ko