The Ministry of Food and Drug Safety has decided to allow limited use of Gemvax & KAEL's Riavax, an Alzheimer's disease drug candidate, on Alzheimer's patients who had received the treatment in previous clinical trials.The ministry decided so after it discussed the appropriateness of using Riavax fo
Sillajen said that M2N has become the company's largest shareholder after acquiring 18.75 million new shares with 60 billion won ($52.2 million).M2N has set a three-year probationary period for all of its newly acquired shares after deciding to emphasize responsible management as the largest shareho
Experts from the Institute for Clinical and Economic Review (ICER), a U.S. non-profit organization, say Biogen's Alzheimer's disease treatment, Aduhelm (ingredient: aducanumab), is not cost-effective, putting a brake on its advance to the U.S. market.At a meeting last Thursday, the ICER experts revi
Celltrion said Friday that its Covid-19 antibody treatment, Regkirona, has shown efficacy in treating the Delta variant.The company injected Regkirona in 49 mice infected with the Delta variant. Compared to the control group that did not receive any drugs, researchers confirmed clinical improvement
Biogen's Alzheimer's drug Aduhelm (Ingredient: Aducanumab), which has recently received approval from the U.S. Food and Drug Administration, may soon be available in Korea.According to industry sources, the company's Korean offshoot recently applied for the approval of Aduhelm to the Ministry of Foo
Yuhan Corp.’s non-small cell lung cancer (NSCLC) treatment Leclaza (ingredient: lazertinib), which won reimbursement on July 1, quickly entered the prescription drug market.The lung cancer drug passed drug committee (DC) reviews at major tertiary hospitals in Seoul and regional general hospitals wil
The incumbent management of Helixmith has succeeded in defending its managerial rights from minority stockholders by winning a vote during an extraordinary shareholders’ meeting on Wednesday.As a result, Helixmith CEO Kim Sun-young and the company’s top management will continue to have control over
The global contract research organization (CRO) services market is undergoing rapid changes with a surge in clinical trials to develop Covid-19 vaccines and treatments.Major CROs are clinching merge and acquisition (M&As) deals, and remote clinical trials are expanding.Following the global trend, th
Bayer's Vitrakvi (ingredient name: larotrectinib) is leading a paradigm shift in cancer treatment designs tailored to treat tumors based on biomarkers rather than specific carcinomas, the company said Tuesday.Patients with NTRK (neurotrophic receptor tyrosine kinase) gene fusion can use Vitrakvi fro
The government has completed negotiations with 58 pharmaceutical companies to retrieve health insurance paid for choline alfoscerate, adjuvant treatment for dementia.Some companies accepted the National Health Insurance Service’s proposal to recollect 20 percent of health insurance covered for the d
Huons Biopharma said Tuesday that it has received approval to conduct a phase 3 clinical trial for its botulinum toxin Liztox, branded a Hutox in the global market, in treating upper limb spasticity after stroke.The company completed the phase 1 trial in November and submitted the plan to enter the
Celltrion said it presented the global phase 3 trial results of its antibody Covid-19 treatment, Regkirona, at a session of the European Congress of Clinical Microbiology & Infectious Disease (ECCMID) on Monday.Dr. Oana Sandulescu from Carol Davila University of Medicine and Pharmacy in Romania made
Genexine will conduct joint research with Phi Biomed and Pohang University of Science and Technology (POSTEC) to develop the next-generation mRNA vaccine that overcomes the limitations of existing mRNA vaccines.The three partners signed an agreement at Genexine headquarters in Seongnam, Gyeonggi Pro
Ferring Korea said Monday that it presented phase 3 clinical trial results of its fertility treatment, Rekovelle (follitropin delta), in Asian women at the European Society of Human Reproduction and Embryology (ESHRE) on June 28.The GRAPE study compared conventional dosing of follitropin alfa with i
Takeda Korea said Monday that it has confirmed the efficacy and safety profile of Kynteles (ingredient: vedolizumab) in Asian adults with moderate to severely active ulcerative colitis.The VARSITY study showed that Kynteles has superior efficacy and safety profile compared to adalimumab, meeting the
MSD’s Keytruda (ingredient: pembrolizumab), immunotherapy for lung cancer, is the company’s flagship item that sold $14.38 billion worldwide last year.However, MSD Korea is struggling with limited reimbursement for Keytruda in Korea.Keytruda was the first immunotherapy to obtain the regulatory nod a
LegoChem Biosciences said that it has signed a collaboration and option license agreement with Cellectar Biosciences, a U.S.-based biopharmaceutical company, in developing a PDC (phospholipid drug conjugates)-based anticancer treatment.Under the accord, the two companies will discover PDC candidates
Novartis said Friday that it would continue to discuss with the domestic regulators to receive reimbursement for its gene therapy Zolgensma, which has effectively reserved motor developments in infants diagnosed with spinal muscular atrophy (SMA).The company hosted an online conference on Friday and
The U.S. FDA revised the label of Biogen’s Aduhelm (ingredient: aducanumab), reducing the number of people eligible for the treatment.On Thursday, the regulator added the information in the label that Aduhelm should be used for “patients with mild cognitive impairment or mild dementia stage of the d
Vivozon Healthcare said Thursday that it has received approval from the Institutional Review Boards (IRBs) of Korea’s four major hospitals to conduct phase 3 clinical trials of its non-opioid analgesic injection, Opiranserin (VVZ-149).The company will conduct the phase 3 study in Seoul National Univ