The fiasco over carcinogen-containing valsartan drugs that broke out three years ago changed the prescription market for valsartan-based antihypertensive single and combination drugs.In July 2018, the Ministry of Food and Safety had prohibited sales of 174 valsartan-based hypertension treatments aft
The outpatient prescription of sodium-glucose cotransporter 2 (SGLT2) inhibitors in the first half of 2021 in Korea increased 12 percent from the same period of last year to reach 64.3 billion won ($55.9 million).According to the outpatient prescription report of UBIST, the gap between AstraZeneca’s
Korea’s Covid-19 diagnostic kit makers are shifting from detecting the virus to confirming the formation of virus-neutralizing antibodies among vaccinated people as the pandemic prolongs, industry insiders said Friday.The biggest reason is the uncertainty of generating the antibodies, as people test
JW Pharmaceutical said Friday that the Ministry of Food and Drug Safety has approved two Livalozet products – 2/10 mg and 4/10 mg -- pitavastatin-based combination drugs for dyslipidemia.The ministry based its approval on phase 3 clinical trial of Livarozet in 25 hospitals, including Gangdong Sacred
Pfizer Korea said that its ALK (anaplastic lymphoma kinase)-positive non-small cell lung cancer (NSCLC) treatment Lorviqua 25mg and 100mg had received approval from the Ministry of Food and Drug Safety.While the ministry approved the drug to treat adult patients with ALK-positive advanced NSCLC, hos
Pharmaceutical companies manufacturing novel oral anticoagulants (NOAC) showed contrasting results in outpatient prescriptions in the first half of 2021, a market surveyor said Thursday.Some domestic NOAC generic makers have been expelled from the market, while original NOAC developers absorbed the
The prescription of chronic disease drugs Celltrion acquired from Takeda Pharmaceuticals decreased in the first half of this year from a year ago.According to UBIST, a drug market research firm, the total prescription amount of drugs Celltrion took over from Takeda Pharmaceutical stood at 33.4 billi
The Ministry of Food and Drug Safety has suspended the manufacturing of six drugs produced by Samyang Holdings for one month due to the violation of drug production management obligations and consignee management responsibilities.The ministry suspended six drugs -- three nicotine patches (Nicostop-1
GC Pharma applied for building and running a Biosafety Level 3 (BL3) research facility to the Korea Disease Control and Prevention Agency (KDCA) on Wednesday.The company said it is the first Korean drugmaker attempting to construct a BL3 facility.The biosafety level is an administrative standard use
Daewoong Pharmaceutical said Wednesday that the company and Hanall Biopharma would expand their “open collaboration” by jointly investing in the U.S. biopharmaceutical industry.Daewoong and Hanall have invested in NurrOn Pharmaceuticals' Series A round for developing novel therapies for Parkinson's
The Ministry of Food and Drug Safety said MSD withdrew all three of its Sinemet lineup of Parkinson's disease treatment -- Sinemet, Sinemet 25/100, and Sinemet-CR -- from Korea on Tuesday.According to industry experts, however, the withdrawal’s impact will be minimal as MSD had not marketed the prod
inno.N said Wednesday that its IPO subscription competition rate for institutional investors reached 1,871 to 1, marking the highest level among biopharmaceutical companies listed on the Kosdaq market in the past 10 years. The company forecasted the demand for domestic and foreign investors between
GC Wellbeing said it has failed to meet the primary endpoint in phase 2a clinical trial of GCWB204, a drug candidate for cancer cachexia, but confirmed the development potential as a medication.The company aimed to license out its drug candidate, but the recent study results have might have pushed b
Daewoong Pharmaceutical said Wednesday that the company would speed up the entry into the Chinese market with its botulinum product, Nabota while releasing the topline results of its phase 3 clinical trials conducted in China.In the trial, researchers administered the same dose of Nabota or control
Prestige Biopharma, a company focusing on novel antibody therapies, said its trastuzumab biosimilar candidate, HD201 (Tuznue), showed an equivalent pharmacokinetic (PK) profile to Roche’s original drug Herceptin (ingredient: trastuzumab).The rate of treatment-emergent adverse events after administer
The FDA recently authorized Keytruda to be used as adjuvant therapy before and after surgery in patients with early triple-negative breast cancer (TNBC), defying the oncology drug advisory committee’s (ODAC) advice to reject MSD’s application.However, the controversy over whether the FDA made the ri
The Ministry of Food and Drug Safety said GC Pharma, the distributor of Moderna’s Covid-19 vaccine in Korea, sought expanded vaccine approval for children aged 12 to 17 on Tuesday.To obtain broader authorization, the company submitted data from a U.S. clinical trial in 3,732 adolescents aged 12 to 1
GC Pharma said Tuesday that it has signed a monopoly license agreement with Mirum Pharmaceuticals to develop and commercialize Maralixibat, a new drug to treat rare liver diseases in children.Mirum is conducting clinical trials and applying for permits in the U.S. and Europe for the Maralixibat indi
MSD’s anti-PD-1 immunotherapy Keytruda (ingredient: pembrolizumab) won local approval for breast cancer indication.On Friday, the Ministry of Food and Drug Safety granted the use of Keytruda in combination with chemotherapy to treat patients with locally recurrent unresectable or metastatic triple-n
Daewoong Pharmaceutical said that it has failed to reach the primary endpoint in the topline result of its phase 2b clinical trial for Coviblock (ingredient: camostat mesylate), an oral Covid-19 treatment candidate.The company conducted a clinical trial at 24 institutions in Korea from February to J