Vivozon Pharmaceutical, which was punished for making drugs in unauthorized methods earlier this year, has been recently ordered to recall and discard medicines due to the same GMP violation.The Ministry of Food and Drug Safety said on Monday that it would urgently request a recall of two medicines
An increasing number of Korean pharmaceutical and biotech companies are collaborating with the Coalition for Epidemic Preparedness Innovations (CEPI) to tap the global vaccine market.CEPI is an international private organization established in 2017 to support vaccine development to fight infectious
CancerRop held an extraordinary general meeting of shareholders on Thursday and decided to change the company name, appoint new board directors, and change some of the articles of incorporation.During the extraordinary general meeting of shareholders, the company specializing in molecular diagnosis
SK bioscience said that it has expanded its collaboration and license agreement with Novavax concerning the latter's NVX-CoV2373, a recombinant nanoparticle protein-based Covid-19 vaccine.Under the expanded contract, SK bioscience will reserve additional manufacturing capacity to produce an antigen,
AstraZeneca’s booster dose of the Covid-19 vaccine and an antibody combination therapy Evusheld (tixagevimab/cilgavimab) effectively prevented infection with the Omicron variant, studies showed.The research team of University College Oxford, U.K., and Washington University School of Medicine, St. Lo
inno.N said the company has licensed out its gastroesophageal reflux disease (GERD) therapy, K-CAB, to Braintree Laboratories, a subsidiary of Sebela US, a U.S.-based pharmaceutical company.The total contract size is 640 billion won ($540 million), the largest single contract achieved by the company
Korean vaccine developers are racing to develop a vaccine against the Omicron variant, which is likely to be the dominant variant within a few months in the nation.Rep. Lee Kwang-jae and Shin Hyun-young of the Democratic Party held a meeting with officials from local vaccine developers on Wednesday
Amgen said its oral PDE4 inhibitor Otezla (ingredient: apremilast) obtained FDA’s approval for expanded indication to treat mild to moderate plaque psoriasis. With the latest nod, Otezla became the only oral systemic treatment that can be used for all stages of plaque psoriasis.Amgen acquired owners
LG Chem said it completed recruiting participants for a phase 1 clinical trial of non-alcoholic steatohepatitis (NASH) treatment in the U.S.According to clinicaltrials.gov, LG Chem updated the status of the phase 1 trial of TT-01025 on Nov. 24.The updates displayed that the status of participant enr
In January every year, all eyes of global biopharmaceutical companies are on the J.P. Morgan Health Conference, the largest healthcare conference in the world that draws institutional investors’ attention worldwide.For the same reason, many Korean drugmakers will participate in the 2022 conference d
GI Innovation said it has entered a clinical collaboration agreement with AstraZeneca to develop a combination therapy of GI-101 and Imfinzi.Under the accord, GI Innovation and AstraZeneca will conduct clinical trials assessing a combination regimen between GI-101 and Imfinzi to treat small cell lun
Novartis said ligelizumab, a new treatment for chronic spontaneous urticarial (CSU), failed to prove superiority to the company’s existing CSU treatment Xolair (omalizumab) in phase 3 clinical trials.On Monday, Novartis released top-line results from phase 3 PEARL 1 and PEARL 2 studies, saying ligel
After Merck released the results of its phase 3 clinical trial for molnupiravir, an oral Covid-19 treatment, investors are focusing their attention on how the results will affect related stocks in the Korean market.Merck is known as MSD outside of the U.S. and Canada.The phase 3 clinical trial resul
Korean pharmaceutical and biotech companies are planning a year-end issue of bonus shares and cash dividends to raise shareholder value, industry officials said.As of Monday, Yuhan Corp., Chong Kun Dang, and Hanmi Pharmaceuticals said they determined the issue of new shares for free.Yuhan and Chong
MedPacto, University of California San Francisco (UCSF), and MSD have teamed up to conduct investigator-initiated clinical trials to develop therapies for colon cancer.Professor Chloe Atreya at the UCSF Helen Diller Family Comprehensive Cancer Center will lead the study to check the efficacy of Vact
LG Chem said that Transthera Bioscience, its Chinese partner, has received approval from the Chinese National Medical Products Administration (NMPA) to conduct a phase 2 clinical trial into LC510255, an autoimmune disease treatment candidate.LG Chem will receive an undisclosed milestone from Transth
Biogen’s first attempt to sell its Alzheimer drug Aduhelm (aducanumab) in Europe has failed.On Thursday, the European Medicines Agency said it refused to grant marketing approval for Aduhelm, reflecting the November voting results of the Committee for Medicinal Products for Human Use (CHMP).“Althoug
The International Vaccine Institute (IVI) said that it has signed a memorandum of understanding with Sweden’s Ministry for Foreign Affairs to establish its regional office in Stockholm.With the opening of the new office, IVI aims to create an international hub for global health research, innovation,
Hanmi Pharmaceutical said that the European Medicines Agency (EMA) has granted the orphan drug designation (ODD) to its LAPS Triple Agonist (HM15211) for treating primary sclerosing cholangitis.The ODD designation comes after the company received the ODD designation for HM1521 for treating primary b
Hugel, a medical aesthetic company, said Friday that the Ministry of Trade, Industry and Energy (MOTIE) has approved its cross-border merger and acquisition (M&A) in the form of changes in its largest shareholder.On Aug. 24, the company announced that Leguh Issuer Designated Activity Company, its la
