HLB’s U.S. affiliate, Verismo Therapeutics and GC Cell’s U.S. affiliate, Artiva Biotherapeutics announced this week that they obtained phase 1 IND approval from the FDA for their respective next-generation chimeric antigen receptor (CAR-T) treatments.Accordingly, Verismo will evaluate the safety, re
The U.S. Food and Drug Administration (FDA) on Tuesday raised concerns over the safety and efficacy of poziotinib, a non-small cell lung cancer (NSCLC) licensed out by Hanmi Pharmaceutical to Spectrum Pharmaceuticals. Poziotinib aims to treat NSCLC with locally advanced and metastatic HER2 Exon 20 i
Celltrion said on Tuesday that it won a patent invalidation lawsuit against Roche (Genentech) in Taiwan for the Rheumatoid Arthritis (RA) indication of Truxima, a biosimilar of the original drug Rituxan (ingredient name: rituximab).Celltrion had previously invalidated the related patent in Korea in
SillaJen said it inked a deal with Basilea Pharmaceutica, a Switzerland-based biopharmaceutical company, to license in the latter's BAL0891, an anticancer drug candidate.Under the agreement, Basilea will receive an upfront payment of $14 million and can receive up to $335 million for milestones acco
Drugmakers are gearing up to race in the development of a denosumab biosimilar to treat various bone diseases. Sandoz, a subsidiary of Novartis handling off-patent medicines, said on Monday that it confirmed positive results from a study of a proposed biosimilar denosumab (original brands: Prolia, X
Domestic industry executives are watching closely when the regulator will release the result of their review of Envlo Tab. (ingredient: enavogliflozin, development name: DWP16001), a new diabetes treatment drug under development by Daewoong Pharmaceutical.The Ministry of Food and Drug Safety publish
Takeda Korea said on Monday that its PARP inhibitor, Zejula (niraparib), has confirmed the continuous and long-term progression-free survival (PFS) and disease resolution in the primary maintenance treatment of newly diagnosed patients with progressive ovarian cancer.The median follow-up period was
Yuhan Corp. has recently acquired AtoGen, a subsidiary of the cosmetics company, Tonymoly, attracting the industry’s attention to its background. Yuhan said it would expand its microbiome business by acquiring AtoGen, which researches and develops microbiome treatments.Yuhan announced its equity acq
Dx&Vx said it acquired Korea Bio Pharm for 15 billion won ($10.7 million) to begin the contract development and manufacturing organization (CDMO) business.Korea Bio Pharm, established in 1995 and located in Jincheon, North Chungcheong Province, is a health functional food manufacturer of 120 product
Cash reserves of Korean biopharmaceutical companies are shrinking, causing concerns that several companies may go bankrupt in the worst-case scenario.According to industry watchers, Korean biopharmaceutical companies are facing headwinds in attracting investments because the financial markets nearly
Dong-A ST said it signed a global licensing agreement with NeuroBo Pharmaceuticals, a U.S. pharmaceutical company.Under the accord, Dong-A ST plans to accelerate the global development and commercialization of DA-1241, a type 2 diabetes and nonalcoholic steatohepatitis (NASH) treatment, and DA-1726,
Daehwa Pharmaceutical said Wednesday that it had been notified of the acceptance of the application for new drug approval for Liporaxel/RMX3001, oral paclitaxel (DHP107/RMX3001) drug, from China’s National Medical Products Administration.The indication of Liporaxel/RMX3001 seeking the Chinese permit
Lilly Korea said it released Retevmo (selpercatinib), the first RET (rearranged during transfection) targeted therapy, in Korea on Wednesday.The market release follows Retevmo’s winning the regulatory nod in March to treat adult patients with metastatic RET fusion-positive non-small cell lung cancer
The Ministry of Food and Drug Safety has added tumor lysis syndrome (TLS) to the adverse effects of sorafenib-based treatments for liver cancer.On Tuesday, the Drug Safety Assessment Division of the ministry made public changes in permitted contents – directions for use of medicine – of sorafenib dr
Qurient said it entered into a joint development agreement with MSD (Merck in the U.S.) for clinical research on the combination therapy of Q901, a selective CDK7 inhibitor, and MSD’s Keytruda, an anti-programmed cell death protein1 (PD-1) immunotherapy.Under the accord, the two companies will condu
MedPacto said Tuesday that it has presented a poster study on the interim clinical data of the Vactosertib combination therapy related to pancreatic cancer during the American Association for Cancer Research (AACR) Special Conference on Pancreatic Cancer.The study is an investigator-initiated clinic
The Ministry of Food and Drug Safety imposed a three-month manufacturing suspension on two nutritional injection products of Samsung Pharm, GC Wellbeing Amino Inj. And GC WellBbing Neuramin Inc., last Thursday.The reason for the disposition is the “violation of the regulations on management responsi
Dx&Vx said it succeeded in raising 17.8 billion won ($12.9 million) by issuing convertible bonds (CB).According to the company, it will use the new fund for operating use and acquiring shares of other corporations. DA 1st Company Limited, a special purpose company, will acquire all CBs.The maturity
It has become almost certain that the government would cancel the licenses of all brain function-improving drugs using acetyl-L-carnitine as the main ingredient.Faced with a crisis of losing the annual 50 billion won (36.2 million) prescription market, domestic drugmakers called for the Ministry of
A year has passed since Organon & Co. spun off from MSD, vowing to be a company specializing in the field of female healthcare.Over the past year, Organon has made positive efforts to promote female health. For instance, it acquired companies producing postpartum solutions to treat postpartum hyster