Bridge Biotherapeutics has passed the regulatory agency’s preliminary review to be listed on the Kosdaq market. The Korea Exchange (KRX)’s Kosdaq Market Committee decided on the passage of the biotech firm at a meeting on Thursday.The company will submit the registration statement to the KRX and go public in December. The lead underwriters of the initial public offering (IPO) are Daishin Secur
KangStem Biotech said it has failed to prove the efficacy of Furestem-AD, an investigational stem cell therapy for atopic dermatitis, in a local phase-3 clinical trial.The biotech firm said Thursday it could not secure statistical significance in the evaluation of Eczema Area and Severity Index-50 (EASI-50), the primary endpoint result, in the phase-3 study on 197 patients at 11 medical instit
Experts are raising the need to establish tools to calculate the value of new anticancer medicines due to the rising costs of national health insurance. However, industry officials express concerns that such devices could be used for “post-assessment,” which could remove existing drugs.Korean Cancer Study Group held a public hearing titled “Analysis on Value Assessment Tools for Anticancer Dru
PharmAbcine said it would speed up the development of a new anticancer drug by establishing a subsidiary in the U.S.The developer of antibody drugs said Tuesday it would set up a U.S. offshoot, tentatively named WINCAL, in Delaware. The Korean firm will invest 100 percent in the U.S. subsidiary, with a base capital of $10 million.Through the U.S. unit, PharmAbcine will support phase-2 clin
Physicians generally recommend inhaled corticosteroids as the first drug for treating asthma. Inhaled corticosteroids, reaching the lungs quickly, have shown to be more effective than orally administered agents that are absorbed by the entire body. However, a recent study pointed out that inhaled steroids might not be the best medicine for elderly patients with asthma. Inhalers are difficult t
Dong-A ST is voluntarily giving up its membership of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), 66 years after joining the group.The company decided so to take responsibility for receiving a sentence in an illegal rebate case, industry sources said. The drugmaker revealed its intention to leave the association at a meeting of the KPBMA’s boardroom on Tuesday.
Korea’s large pharmaceutical companies are expected to have yielded good earnings in the third quarter, analysts said. Local drugmakers will begin to announce their quarterly performances, starting from Samsung BioLogics on Wednesday this week.Yuhan Corp., which had unsatisfying earnings in the first quarter, will receive royalties from a licensing-out deal in the third quarter. Brokerages for
The Ministry of Food and Drug Safety ordered Medytox to recall and discard mandatorily some of the company’s Meditoxin (export name: Neuronox) products sold overseas due to poor quality.The ministry issued the order after some of the botulinum toxin (BTX) products failed the regulator’s quality test. Medytox has exported 3.3 billion won ($2.79 million) worth of defective items, the ministr
U.S. sales of Remicade (ingredient: infliximab), the autoimmune disease treatment by Johnson & Johnson (J&J), plunged after facing fierce competition with biosimilar drugs such as Celltrion’s Remsima.According to J&J’s third-quarter earnings announced on Tuesday, the U.S. sales of Remicade declined to $749 million, a 24.1 percent on-year drop.It was the worst sales record for Remicade sinc
The Samsung Group has admitted that a Samsung-affiliated company failed to develop a Rituxan (ingredient: rituximab) biosimilar. It is unclear whether Archigen Biotech, a subsidiary of Samsung BioLogics, could continue the global clinical trial on the experimental drug. Such admission came at the Seoul Central District Court’s fourth trial Tuesday on the eight executives and employees of Samsu
Shares of Kolon Life Science shot up after the regulator decided to delay the decision on the delisting of Kolon TissueGene, a subsidiary of Kolon Life Science, by one year.The stock price of Kolon Life Science went up by a daily limit of 30 percent to hit 29,250 won ($24.73) as of 2:24 p.m., Monday.On Friday, the Korea Exchange’s Kosdaq Market Committee said it decided to defer its decisi
HLB said it would merge with its subsidiary Elevar, a U.S.-based developer of a targeted anticancer therapy rivoceranib. Elevar is the new name of LSK BioPharma.HLB USA, a subsidiary of HLB, clinched a deal on Friday to acquire a 100 percent stake of Elevar. HLB USA is a wholly-owned subsidiary of HLB. Upon the completion of the merger, HLB will achieve a triangular merger as HLB Chairman Jin
About 80 percent of companies listed on the Kosdaq stock market using the regulator’s “technology exception policy” was in the biotech industry. Still, only six firms turned from red to black last year, a lawmaker found.A couple of companies are under the suspicion that their executives and affiliated people used insider information to increase their wealth, he said, calling for the regulator’
Samsung executives said Samsung BioLogics and Samsung Bioepis workers were responsible for deleting data excessively, during a trial over the alleged window dressing of Samsung BioLogics. They ordered data deletion to “prevent unnecessary misunderstandings” about Samsung, but the two companies unexpectedly replaced servers, they claimed. The Seoul Central District Court on Wednesday held t
In the wake of the recall of cell gene therapy Invossa-K, the Ministry of Food and Drug Safety conducted a special inspection of six cell therapy developers. The raid came less than a year since the regulator made an urgent inspection in October last year.According to industry sources, the ministry started the inspection in early September to enhance the regular monitoring after the cancellati
The National Assembly’s Health and Welfare Committee is expected to focus on two key issues – mislabeled gene therapy Invossa-K and Allergan’s recalled breast implant – in the 20th parliamentary audit for the pharmaceutical and biopharmaceutical sector starting from Wednesday.People related to the suspension of Invossa took up the largest share of the general witnesses that the committee decid
Pharmaceutical companies are expected to suffer massive losses due to the regulator’s order to kick heartburn treatment ranitidine drugs out of the market. The recall order came after the authorities detected a potentially cancer-causing chemical N-Nitrosodimethylamine (NDMA) in ranitidine medicines.Unlike the valsartan recall last year, the regulator is likely to ban ranitidine for good, and
The Ministry of Food and Drug Safety Thursday offered a briefing to pharmaceutical firms over the suspension of ranitidine-containing heartburn treatments, explaining why it had to ban the manufacturing, importing, and selling of ranitidine drugs. Earlier, the regulator said it found that NDMA levels in seven ranitidine raw materials exceeded the provisional standard, following the U.S. F
Executives of Samsung BioLogics and affiliated companies claimed that they did not engage in any window dressing, although they deleted evidence which was an obstruction of justice. They argued that such acts were not serious enough, and therefore they cannot be charged with criminal destruction of evidence. However, prosecutors countered that their acts violated the law by tampering with
Helixmith used to be one of the promising biotech firms with its market capitalization ranking second on KOSDAQ.However, the company failed to complete the global phase-3 trial on a gene therapy due to its drug mix-up between the placebo and the treatment, and it is blaming others for its own mistake.Helixmith on Tuesday said it detected data contamination for its gene therapy Engensis, al