Eutilex said that it has agreed with Microuni to jointly research a next-generation mRNA expression system to develop an infectious disease and anticancer vaccine. Microuni is a bio venture established by a research team at Chungbuk National University Medical School.The two companies plan to utiliz
Hugel said that the European Medicines Agency (EMA) has granted good manufacturing practice (GMP) certification to its Geodu Plant that manufactures the company's botulinum toxin (BTX) product, Letybo.Geodu Plant, located in Chuncheon, Gangwon Province, is Hugel's second BTX factory with a productio
Bayer Korea said Thursday that Verquvo, its chronic heart failure treatment, obtained product approval from the Ministry of Food and Drug Safety on Nov. 30.Hospitals can use the treatment along with other heart failure medications on chronic heart failure patients who recently received intravenous d
Hyundai Bioscience said on Wednesday that it would expand the indication of its oral antiviral agent CP-COV03 (ingredient: niclosamide).The biotech company is repurposing niclosamide, an anti-parasitic drug, as a Covid-19 treatment. The investigational drug’s indication will also include influenza t
Roche Korea said it would actively expand new drugs in Korea at an online press conference, marking the 125th anniversary of the foundation of Roche Group.With the conference title, “We are Roche – The Future of Healthcare,” the company presented Roche Grou’s achievements in the past 125 years, visi
Pfizer Korea said that the Ministry of Food and Drug Safety has approved Mylotarc as the first-line treatment of newly diagnosed CD33-positive adult patients with acute myeloid leukemia (AML).The ministry based its approval on an open-label, randomized, multicenter, phase 3 ALFA-0701 clinical trial
Celltrion recently obtained Europe’s marketing approval for Regkirona (regdanvimab), a Covid-19 antibody treatment, but it met with a lukewarm response from the stock market.Investors do not anticipate Celltrion’s sales benefits from the Covid-19 pandemic anymore, so the company should restore inves
Celltrion Healthcare, negotiating the export of Regkirona with 56 countries, said Monday that it has signed a supply contract with nine European countries.The company did not provide details on the nine European countries that import Regkirona, citing a contractual term. Under the accord, the compan
Myongji Hospital said Monday that its Covid-19 home care support center is receiving requests for help from localities as the nation is experiencing a rapid increase in mild and asymptomatic Covid-19 patients under the “living-with-covid” system.Last Tuesday, the hospital in Goyang, a bed town just
Celltrion said that it plans to accelerate the development of an inhalable cocktail treatment combining Regkirona and CT-P63 to actively respond to variants that can develop into a dominant species.Cocktail therapy is a method of increasing efficacy by mixing two or more drugs.Celltrion has tried to
Helixmith said it has made 50-percent progress in recruiting patients for its clinical trial of TADIOS, a Covid-19 treatment, in India.The company plans to conduct a double-blind, placebo-controlled, multicenter clinical trial on 100 people at four medical institutions in India and has enrolled 50 p
SK Chemicals said it has agreed with Cimplrx, an artificial intelligence-based new drug development company, for joint research and development of new drugs using AI.Under the accord, the two companies plan to discover new drugs for specific indications and target proteins. Cimplrx intends to find n
A local court has accepted Hugel's application for suspending the execution of an administrative order to nullify the license of its botulinum toxin (BTX) product, withdraw and discard those already made.The Seoul Administrative Court cited Hugel's application for suspending the execution of the adm
Samsung Biologics will team up with Greenlight Biosciences, a U.S. mRNA vaccine maker, to supply a Covid-19 mRNA vaccine for Africa.The Korean biotech company said Thursday that it signed a contract manufacturing organization (CMO) deal to manufacture drug substance (DS) of GreenLight’s Covid-19 mRN
HLB Therapeutics said Friday that the U.S. Food and Drug Administration has approved the execution of an expanded access program (EAP) for its NHPN-1010, a treatment candidate for hearing loss and tinnitus.Upon winning the approval, the company began to administer the drug to a chronic tinnitus pati
The Ministry of Food and Drug Safety has ordered the recall of 12 drugs manufactured by Medica Korea after confirming various violations in their manufacturing processes.The 12 drugs comprise five Medica Korea's drugs – Lockpain, BAMBI, Salazine, and Arutec Crethicone – and seven consignment drugs –
Handok said that it has invested 3 billion won ($2.5 million) in Spark Biopharma, a local biopharmaceutical company, to co-develop SBP-101, an anticancer treatment candidate.The investment is part of Handok's open innovation initiative, and with the co-development contract, the company has secured p
HanAll Biopharma said on Wednesday that it started administering its dry eye disease treatment HL036 (tanfanercept) to patients in the second phase 3 VELOS-3 trial in the U.S.HL036, being developed in collaboration with Daewoong Pharmaceutical in the U.S., is a biologic treatment that inhibits tumor
Pfizer’s oral Janus kinase (JAK) inhibitor Cibinqo (abrocitinib) obtained the regulatory nod for the treatment of atopic dermatitis, joining competition against Lilly’s Olumiant (baricitinib) and AbbVie’s Rinvoq (upadacitinib) in Korea.On Tuesday, the Ministry of Food and Drug Safety authorized the
Toolgen said Thursday that it would become a global leader in gene editing platforms and gene and cell therapy products based on its superior technology after joining the secondary Kosdaq market.The company, now traded on the smaller Konex market, seeks to move to the bigger Kosdaq market by offerin