Daewoong Pharmaceutical said that the U.S. Food and Drug Administration had granted fast-track designation to its idiopathic pulmonary fibrosis (IPF) therapy, DWN12088.IPF is a lung disease in which the lungs gradually harden and lose their function due to excessive fibrous tissue. It is a rare and
Celltrion received approval from the Polish Pharmaceutical and Medical Equipment Registration Office (URPL) on Monday for the phase 3 clinical trial (IND) of its Actemra biosimilar, "CT-P47," which treats rheumatoid arthritis treatment.Celltrion won the investigational new drug (IND) approval two mo
Hanmi Pharm released the second-quarter earnings report on Monday, earlier than expected, to refute an analyst report’s prediction of the drugmaker’s operating profit.In a regulatory filing on Monday, Hanmi announced that it recorded 316.5 billion won ($240.3 million) in sales, 29.6 billion won oper
CanariaBioM, a parent company of CanariaBio, signed a contract on Friday to take over Sejong Medical by acquiring a 100 percent share of the latter’s equity jointly with foreign financial investors.Through this acquisition, CanariaBioM will secure Sejong Medical’s medical device business and new dru
Technology transfers concerning new drug candidates made by Korean biopharmaceutical companies this year fell from a year ago.The license-out deals of Korean biopharmaceutical companies grew from 10.14 trillion won ($7.7 billion) in 2020 to 11.44 trillion won last year. The number of contracts also
The Ministry of Food and Drug Safety has suspended importing three Viatris Korea’s eye drop products for one through Aug. 14.The suspension of import business was due to the company’s failure to report the changes in the manufacturing client after the merger of the Upjohn division of Pfizer and Myla
The American Society of Clinical Oncology recently (ASCO) issued a “rapid recommendation” to use Kimmtrak (ingredient: tebentafusp) to treat uveal melanoma.Kimmtrak won FDA approval early this year as the first uveal melanoma treatment.With the latest ASCO’s recommendation, Kimmtrak became the stand
HLB Therapeutics said Monday that it would simultaneously start clinical trials for neuroparalytic keratitis treatment in the U.S. and Europe, signing related contracts with a global contract research organization (CRO).Eye disease drugs usually require two repetitive clinical outcomes. However, HLB
New Korean pharmaceutical companies are racing to develop botulinum toxin (BTX) to sell them in the U.S. and Europe instead of the saturated Korean market, industry officials said. Such companies include BioPlus, CKD Bio, Jetema, EuBiologics, and ATGC.On Thursday, BioPlus announced a 2.3 billion won
Kangstem Biotech said Friday it reapplied for a phase 1/2a IND of Furestem-OA Kit Inj. for osteoarthritis treatment to the Ministry of Food and Drug Safety.The company reapplied for a phase 1/2a clinical IND about a month after it voluntarily withdrew its original investigational new drug applicatio
Japanese pharmaceutical companies’ Korean offshoots recorded low growth in 2021, according to their audit reports.The audit reports showed that the combined sales of the nine Japanese drugmakers’ Korean offshoots stood at 1.44 trillion won ($1 billion) last year, marking an increase of a mere 1.4 pe
GC Wellbeing said on Friday that it signed a technology transfer contract with Japan's Healthy Navi for its functional raw material Green Cera-F, a honey suckle bud extract.Green Cera-F is a raw material that has been recognized by the Ministry of Food and Drug Safety for its functionality that can
The government is wielding excessive power to lower drug prices without recognizing the values of innovative medicines, an expert said.Kim Sung-ju, an expert advisor for Lee & Ko’s Healthcare Practice Group, published an article in the Korea Pharmaceutical and Bio-Pharma Manufacturers Association’s
Bayer Korea said it would continue marketing Nebido, its long-acting injectable for males with testosterone deficiency, in the country, although its headquarters handed over the drug’s global rights to Grünenthal, a German pharmaceutical company.Grünenthal has picked up the global rights for the dru
Korea saw a trade surplus in vaccines for humans for the first time in the first half of this year, raising expectations for further growth of the vaccine industry.According to a report on exports and imports of human vaccines and diagnostic agents, published by the Korea Biotechnology Industry Orga
GenScript ProBio signed a memorandum of understanding with DAAN Bio Therapeutics to cooperate to discover and develop innovative drugs on Thursday.Through this MOU, GenScript ProBio and DAAN agreed to strengthen their cooperation, specifically in the cell and gene therapy (CGT) and biologics field.T
The U.S. FDA put off a decision on whether to approve tislelizumab, anti-PD-1 immunotherapy developed by BeiGene and Novartis, due to Covid-19-related travel restrictions.BeiGene, the Chinese pharmaceutical firm, said on Thursday that the FDA deferred a decision on approval for tislelizumab as a sec
The Research Investment for Global Health Technology Fund (RIGHT Fund) committed an additional 4 billion won ($3 million) to support four newly selected research projects concerning infectious diseases in the first half of 2022.The four recipients of the additional grants are CHA Vaccine Institute,
GC Biopharma said Thursday it has received an investigational new drug (IND) approval from the Ministry of Food and Drug Safety for the researcher-led administration of Neulapeg on the same day after anticancer chemotherapy.The company said it is the first such clinical trial to be held in Korea.Neu
Study results to be presented at the WCLC in August will influence the direction of Yuhan Corp's Leclaza (Ingredient: lazertinib), the nation's 31st novel drug for NSCLC, and the corporate's value, a local analyst said."Yuhan will present three abstracts concerning its non-small cell lung cancer (NS