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
BeiGene, a global biotech firm founded in 2010 in Beijing, is strengthening its global presence by expanding its workforce and boosting sales.The company is waiting for the U.S. Food and Drug Administration (FDA) to approve its anti-PD-1 immuno-oncology drug Tevimbra (tislelizumab) this year, drawin
Starting next month, biliary tract cancer patients can add the anti-PD-L1 immunotherapy Imfinzi (durvalumab) at their own expense to the existing gemcitabine/cisplatin (GemCis) chemotherapy regimen for the first-line treatment of locally progressive or metastatic biliary tract cancer.It was part of
Roche Korea hosted a two-day RISE (Roche Initiated Scientific Exchange) symposium on Thursday and Friday last week, shedding light on the clinical significance of the pioneering bispecific antibodies for blood cancer, Columvi (ingredient: glofitamap) and Lunsumio (mosunetuzumab).Comprising five sess
Medytox has encountered a significant setback as the U.S. FDA has declined the biologics license application (BLA) for its innovative non-animal liquid botulinum toxin product, MT10109L, aimed at reducing moderate to severe glabellar (forehead) and lateral canthal (crow's feet) lines.The refusal, da
The first FGFR inhibitor for bladder cancer, Balversa (erdafitinib), will soon be launched in Korea.According to industry sources on Monday, Janssen Korea is gearing up to release Balversa without reimbursement in late March.Balversa is an FGFR (fibroblast growth factor receptor) inhibitor approved
Celltrion once again demonstrated the competitiveness of its Remsima SC at the 2024 European Crohn's and Colitis Organization (ECCO) congress in Stockholm, Sweden, from last Wednesday to Saturday by receiving favorable reviews from overseas medical professionals.At the ECCO, attended by more than 8,
GC Cell has signed an agreement to transfer the processing technology of its flagship anticancer immune cell therapy, Immuncell-LC Injection, to BioCentriq, its U.S. affiliate, and a cell therapy CDMO company.Through this process technology transfer cooperation, GC Cell and Biocentriq expect to prov
JW Shinyak said Monday it has signed a collaborative research agreement with C&C Research Laboratories, a subsidiary of JW Pharmaceutical, to develop innovative anticancer cell therapies.Under the agreement, JW Shinyak will develop a new CAR-NK cell therapy targeting solid tumors with C&C Research L
CKD Bio said it has confirmed the non-inferiority of CKDB-501A, aimed at improving moderate to severe frown lines, compared to Botox through a phase 3 clinical trial's topline results.The analysis of the data revealed that the improvement rate for frown lines when frowning was 80.69 percent (117 out
LG Chem said Friday that the company opened an aesthetic “Solution Lab Center" in Caiting Hospital, which specializes in cosmetic surgery in Shanghai, to expand expand its educational support for YVOIRE (LG Chem's hyaluronic acid filler’s brand name) customers in China.LG Chem’s Executive Vice Presi
GC Cell said that its U.S. affiliate, Artiva Biotherapeutics, has received fast-track designation from the U.S. FDA for their investigational lupus nephritis treatment, AlloNK (development code name: AB-101).The fast track designation is intended to facilitate the development and expedite the review
AbbVie's oral migraine prophylaxis Aquipta (atogepant) met its primary endpoint in a phase 3 clinical trial of patients who failed prior oral prophylaxis, reducing the average number of migraine days per month.AbbVie Korea said Friday that the full results of the phase 3 ELEVATE study were published
A typhoid conjugate vaccine developed by SK bioscience has received the World Health Organization's (WHO) Pre-Qualification (PQ) certification, a green light to enter new overseas markets.SK bioscience said Friday that its typhoid conjugate vaccine, SKYTyphoid Multi-Injection (NBP618 in the project
Janssen has been delaying the Korean launch of its FGFR (fibroblast growth factor receptor) inhibitor Balversa (erdafitinib) for over a year, making many watchers wonder what's happening.Janssen received approval for Balversa on Nov. 24, 2022, from the Ministry of Food and Drug Safety (MFDS).Balvers
At a government-business meeting early this week, the Ministry of Food and Drug Safety (MFDS) announced its intention to support exporting Korean medical products based on regulatory harmonization. Welcoming the move, pharmaceutical companies made several requests to open the way for exporting their