Daewoong Pharmaceutical has won the approval for a phase 2 investigational new drug (IND) clinical trial of DWN12088, its treatment candidate for idiopathic pulmonary fibrosis (IPF), in Korea following the nod in the U.S.The Ministry of Food and Drug Safety gave the go-ahead to Daewoong’s treatment
Allergan Aesthetics Korea said it has identified four key themes that will drive consumer behavior change in the global aesthetics market. The four key themes are beauty empowerment, aesthetic fluency, untabooing treatments, and a desire to move back to nature.The company has published the four them
Boryung said it obtained local marketing approval for finasteride-containing spray treatment for hair loss. Attention is on whether the new product could enlarge its presence in the hair loss treatment market dominated by MSD’s Propecia tablet. On Tuesday, the Ministry of Food and Drug Safety author
The European Medicines Agency (EMA) refused a rolling review of SK Bioscience’s Covid-19 vaccine, SKYCovine, due to “changing pandemic conditions,” a senior official at SK Bioscience said.A rolling review speeds up the evaluation of a drug or a vaccine during a public health crisis.The SK Bioscience
The growth of Alvogen Korea's obesity treatment Qsymia, which had been competing for a top market share with Novo Nordisk's Saxenda, is slowing down.Industry watchers attribute the relatively weaker performance of Qsymia to the absence of indications for obese adolescents aged 12 or older.Saxenda ob
The drug regulator ordered Korea Pharma to suspend manufacturing of medicines including steroid cream, saying the drugmaker violated the Good Manufacturing Practices (GMP). On Aug. 30, the Ministry of Food and Drug Safety ordered Korea Pharma’s manufacturing suspension due to the company’s violation
LG Chem is accelerating efforts to develop a new gout treatment.The company recently submitted applications for phase 3 investigational new drug (IND) clinical trials to the Chinese regulator, following the U.S., drawing attention to its future development process.In a public notice on Monday, LG Ch
Bridge Biotherapeutics said that it signed a cooperation agreement with Brainomix, a U.K.-based artificial intelligence (AI) medtech firm, to efficiently conduct phase 2 clinical trials of BBT-877, an idiopathic pulmonary fibrosis (IPF) treatment candidate.Under the accord, Bridge Biotherapeutics wi
“The message given to us is clear. We shortened the vaccine development period from 10 years to two years, but we have to reduce it to 100 days. This is impossible with traditional methods and technology. We need innovative frameworks and technology.”So said Chey Chang-won, vice president of SK Disc
Despite Korean biopharmaceutical companies’ sales growth by 20 percent on-year in the first half, their stock prices plunged, resulting in a significant loss in their market capitalizations.According to the Electronic Disclosure System of the Korea Exchange, the total sales of the top 25 biopharmace
Dongwha Pharmaceutical said it joined hands with Animuscure, a Korean biotech startup, to co-develop a sarcopenia treatment.Under the accord, the two companies will conduct joint research to identify and develop innovative candidates for the new synthetic drug treatment for muscle disease that Dongw
The five-year survival rate of breast cancer in Korea is 86.6 percent, higher than that of the Organisation for Economic Co-operation and Development (OECD) average at 84.5 percent.However, the five-year relative survival rate when diagnosed with advanced or metastatic breast cancer is only 30 perce
Janssen Korea said its ulcerative colitis Stelara (ustekinumab) won health insurance benefits as the primary treatment for ulcerative colitis in adults in Korea as of Thursday.The reimbursement for Stelara will be recognized for moderate-to-severe ulcerative colitis adult patients who do not respond
Amgen said Repatha (evolocumab) reduced the low-density lipoprotein (LDL) cholesterol to desirable target levels in 80 percent of patients with atherosclerotic cardiovascular disease (ASCVD) in a long-term trial.The U.S. biotech firm disclosed the results of the phase 3 FOURIER open-label extension
GC and its U.S. partner Speragen participated as co-sponsors in the externally-led patient-focused drug development (EL-PFDD) conference, attended by the U.S. Food and Drug Administration (FDA).The EL-PFDD meeting is one of the major processes in developing treatments for rare diseases, an occasion
SK Bioscience, a subsidiary of SK Chemicals, said it failed to develop an injection-type, homegrown, trivalent rotavirus vaccine.In a public filing on Monday, the company said it would give up on a multinational phase 3 trial of P2-VP8, an injection-type rotavirus vaccine.The interim results of the
Hanmi Pharmaceutical and its U.S. partner Spectrum have completed preparations to launch Rolontis in the U.S. market by confirming the product’s American name and beefing up local sales and marketing personnel.They expect Rolontis, or Rolvedon in U.S., will win the FDA’s approval on Sept. 9.“The FDA
Pfizer Korea submitted an application to the Ministry of Food and Drug Safety (MFDS) for authorization for a Covid-19 vaccine booster that fights the Omicron variant.On Monday, the MFDS said it started reviewing Pfizer Korea’s application for an import of Comirnaty 2 Inj. 0.1 mg/mL.Comirnaty 2 Inj.
Chong Kun Dang presented the preclinical research results of CKD-510, confirming the possibility of developing it as atrial fibrillation treatment at the 2022 European Society of Cardiology (2022 ESC) in Barcelona, Spain, from Aug. 26-29.According to the company, CKD-510 is a next-generation drug
BARCELONA, Spain – AstraZeneca’s SGLT-2 inhibitor Forxiga (ingredient: dapagliflozin) proved its effectiveness in reducing cardiovascular death or heart failure (HF) in patients with a mildly reduced or preserved ejection fraction (EFmrEF or HFpEF) in phase 3 DELIVER study.Forxiga created new clinic