Celltrion said on Wednesday that it received approval from the FDA for its 80 mg and 20 mg dosage forms of Yuflyma, a biosimilar referencing Abbvie's Humira (ingredient: adalimumab), adding to the existing approval for the 40 mg dose. Humira, the original medicine, is prescribed primarily for autoim
Roche Korea said on Wednesday that its oral treatment for spinal muscular atrophy (SMA), Evrysdi (ingredient: risdiplam), obtained health insurance coverage from Oct.1.Accordingly, Evrysdi will be covered for patients with 5q SMA with a confirmed genetic diagnosis of a deletion or mutation in the 5q
Handok said on Wednesday that it submitted an IND plan for a global phase 2/3 clinical trial of HDB001A, a biliary tract cancer drug candidate, to the Ministry of Food and Drug Safety (MFDS). The global phase 2/3 study of HDB001A will enroll 150 patients at more than 35 sites in Korea and overseas.
Bridge Biotherapeutics announced on Tuesday that it will discontinue the development of BBT-176, a drug candidate for non-small cell lung cancer (NSCLC), and BBT-212, another candidate for fundus disease.Instead, the company stated it would focus on BBT-877 and BBT-207, candidates for idiopathic pul
Daewon Pharmaceutical said Monday the company has signed a contract with PT Interbat, an Indonesian pharmaceutical company, for the exclusive export and supply of finished products of non-steroidal anti-inflammatory drugs (NSAIDs), Pelubi SR Tab (pelubiprofen).The contract's total value is $3 millio
AbClon said Monday the company would expand its phase 2 clinical trial for its chimeric antigen receptor T-cell (CAR-T) therapy candidate, AT101. to seven sites.In addition to Asan Medical Center, Ajou University Hospital, Ulsan National University Hospital, and Dong-A University Hospital, where the
Dongkook Pharmaceutical is drawing the industry’s attention by completing the phase 3 clinical trial of its new therapy for benign prostatic hyperplasia (BPH), which combines dutasteride and tadalafil.Dongkook Pharm said Monday that it has confirmed the efficacy and safety of DKF-313, an improved co
Janssen, which will launch the first generic version of prostate cancer treatment Zytiga (abiraterone acetate) with insurance benefit, has introduced Akeega, a prostate cancer therapy combining the existing abiraterone and PARP inhibitor niraparib, in Korea.On Monday, the Ministry of Food and Drug S
Pinotbio, a local biotech specializing in antibody-drug conjugates (ADC), said it has been selected for a major ADC development project sponsored by the Korea Drug Development Fund (KDDF).The initiative, named the "Global Blockbuster ADC Anticancer Drug Component Development Project," aims to suppor
EyeGene said on Friday in a public filing that its phase 2 clinical trial of EG-Myocin, a drug candidate for the treatment of myocardial ischemia and reperfusion injury, failed to show statistically significant changes in myocardial infarction size. The study explored the effectiveness and safety of
Starting in October, the reimbursement standards for the spinal muscular atrophy (SMA) drugs Spinraza (nusinersen) and Evrysdi (risdiplam) will be expanded and newly established.The Ministry of Health and Welfare (MOHW) issued an administrative notice on the “Partial amendment to the details (pharma
Celltrion Healthcare said on Monday it won bids in major European countries for three of its anti-cancer biosimilars, Truxima (ingredient: rituximab), Herzuma (ingredient: trastuzumab), and Vegzelma (ingredient: bevacizumab), since switching to direct sales. On the same day, Celltrion also announced
EuBiologics said on Friday that it signed a memorandum of understanding (MOU) with South African vaccine manufacturer, Biovac, to supply its meningococcal pentavalent vaccine to the local market and transfer technology to produce finished doses. EuBiologics' meningococcal pentavalent conjugate vacci
Viatris Korea announced results from a survey involving 963 diabetic patients with neuropathic pain (NeP) from Korea, Italy, Spain, Malaysia and Mexico, during a press conference on Thursday.The survey was designed to learn more about the impact of NeP and the unmet needs of people living with diabe
EuBiologics said on Thursday that it received an award letter from the United Nations Children's Fund (UNICEF) for the delivery of 49.3 million doses of its oral cholera vaccine in 2024, valued at approximately $99 million. This order surpasses the company's 51.2 billion won in cholera vaccine sales
Organon Korea, a spin-off from MSD Korea entering its third year, takes the lead in raising awareness and improving the environment for women's health issues, including contraception and infertility, establishing itself as a company specializing in women's health.On Wednesday, Organon Korea held the
Biogen, maker of the spinal muscular atrophy (SMA) drug Spinraza (nusinersen), and Roche, maker of Evrysdi (risdiplam), recently reached a dramatic agreement with the government by even extending drug price negotiations.Now, the patients are also shifting their attention to dosing standardsAccording
Alteogen, a company specializing in next-generation biobetters, said on Tuesday that it obtained a U.S. patent regarding its proprietary antibody technology.In particular, the patent covers the technology of the antibody which specifically bind to the folate receptor alpha (FOLR1). The patent was gr
Novartis Korea said it held the seventh emotional support program, CHEERYOU, for patients with rare and intractable diseases in collaboration with the Korean Organization for Rare Diseases (KORD) at the Pine Valley Glamping Site in Pocheon, Gyeonggi Province, last Friday.The CHEERYOU campaign, a fla
ST Pharm said it has taken its first step towards becoming the global leader in the oligonucleotide contract development and manufacturing organization (CDMO) domain with the groundbreaking ceremony for its second oligonucleotide facility on Monday.The new plant will be located in Ansan, Gyeonggi Pr