A Seoul court turned down Kolon Life Science’s appeal for stopping the government’s decision to nullify the license of Invossa-K.The Seoul High Court ruled on Tuesday against Kolon’s petition, after reviewing whether the ministry should stop the process to revoke the permit of Invossa on Sept. 9.Kolon filed the administrative suit against the Ministry of Food and Drug Safety to invalidate
The U.S. Food and Drug Administration has recommended Kolon TissueGene to remanufacture the second fluid of Invossa-K if the company wishes to resume the phase-3 trial on the drug. Invossa-K, a genetic treatment for osteoarthritis, was suspended in Korea due to the mislabeling of the ingredient in the second fluid.Kolon TissueGene said the remanufacturing was not a requirement for the trial re
As the 2019-2020 flu season approaches, pharmaceutical firms are engaging in an invisible war to set the price of their flu vaccines.Last year, the supply price of a flu vaccine went below 10,000 won ($8.4) per shot due to severe competition. Drug companies said they would not focus only on price competition this year.The Ministry of Food and Drug Safety said the government authorized the
The labor union of Galderma Korea, the local offshoot of a skin healthcare company affiliated with Nestle, said the company was deliberately sabotaging activities of unionized employees by secretly running a background check on them.According to the Korea Democratic Pharmaceutical Union’s Galderma Korea branch, the management investigated into the labor union head’ history of student movements
The Korea Exchange said it has delayed its decision whether to delist Kolon TissueGene.The KRX’ Kosdaq Market Committee said it would extend the deadline of its review on Kolon TissueGene by 15 more business days from Sept. 18, under Paragraphs 2 and 10 of the Article 33 of the Kosdaq Listing Regulations.The delay pushed the deadline to Oct. 11.The KRX reportedly decided to delay the d
An increasing number of biotech companies are eyeing on the Korea Exchange’s “growth potential exception policy” to avoid rigorous requirements in an initial public offering (IPO) and secure stronger protection for investors.Olipass, Bridge Biotherapeutics, and Syntekabio are planning to go public using the growth potential exception policy, industry sources said.The growth potential excep
Chong Kun Dang said it has won the lawsuit against Novartis over the patent of Novartis’ immunosuppressant Certican (ingredient: everolimus).The Supreme Court struck down Novartis’ appeal on Aug. 30, which claimed that Chong Kun Dang’s Certirobel, a generic drug of Certican, infringed upon Certican’s patent. In July 2017, Chong Kun Dang sought a lawsuit against Novartis to recognize it
Daewoong Pharmaceutical said it would conduct a clinical trial on botulinum toxin Nabota for the treatment of hair loss.The Ministry of Food and Drug Safety on Monday approved the phase-2b study on Nabota in patients with male pattern baldness.Park Byung-cheol, a professor at the Dermatology Department of Dangook University Hospital, plans to evaluate the efficacy and safety of Nabota
Novartis canceled its lawsuit against Ahngook Pharmaceutical’s anti-diabetic treatment, a copy of Novartis’ dipeptidyl peptidase 4 (DPP-4) inhibitor Galvusmet (ingredient: vildagliptin, metformin). The move relieved pressure on Ahngook which has been preparing to release Galvusmet’s generic drug.Industry sources said Novartis withdrew last Thursday from the second trial to determine the sc
“We’ve never heard when and how they would do a long-term follow-up. Kolon Life Sciences said it held a meeting with patients for better communication, but the meeting was for 10 people only. What kind of communication is that?”So said a patient who received the treatment of Invossa-K, now-suspended gene therapy for osteoarthritis by Kolon Life Sciences, venting his anger.Other patients tr
Professor Tasuku Honjo of Kyoto University said he was expecting a good outcome out of more than 1,000 clinical trials on combination therapies to improve the effectiveness of immunotherapies. He won the 2018 Nobel Prize in Physiology or Medicine for his identification of programmed cell death protein 1 (PD-1). “Soon, cancer will be regarded as a chronic disease,” he said. Professor Honjo
“We will broaden open innovation toward the academic sector and expand our business scope to central nervous system diseases so that we can become an innovative drug developer.”So said Yuhan Corp. CEO Lee Jung-hee on the company’s vision for R&D during an industry event on Thursday.Lee spoke on Yuhan’s achievements since 2015 and business plans at 2019 Seoul Bioeconomy Forum, held in Yeoui
SK Holdings is integrating three pharmaceutical production subsidiaries around the world to pursue advanced contract development and manufacturing organization (CDMO) business.SK Biopharmaceuticals, a subsidiary of SK Holdings, is also set to release new sleep disorder drug soliamfetol in the U.S., taking steps to become a multinational pharmaceutical firm.SK Holdings, the holding firm
Hanmi Pharmaceutical and Daewoong Pharmaceutical were included in the top 20 list of most innovative large pharmaceutical companies in the Asia-Pacific region, according to industry data. Biotech firms such as Genexine and Huons also came in 15 most innovative small and medium-sized enterprises (SME).Clarivate Analytics, a provider of global academic information, released “Pharmaceutical i
JW Pharmaceutical said more countries have recognized that its cholesterol-lowering drug Livalo (ingredient: pitavastatin) did not increase the risk of new-onset diabetes.The drugmaker said on Friday the number of countries recognizing Livalo’s safety against diabetes has increased from 10 to 21.Livalo is the only statin-class medication that won such a recognition based on post-market
Intron Biotechnology said the conditions for last November’s deal with a multinational drugmaker to license out SAL200, a novel biologic to combat super bacteria, have been changed. Observers said the size of the deal went up, but the conditions for receiving milestone payments turned against the Korean biotech firm.Intron Biotechnology said in a public filing Wednesday that the conditions of
Inhibitors of dipeptidyl peptidase 4 (DPP-4), used to treat diabetes, have recorded a robust sales expansion in the domestic market last month with homemade drugs leading the growth.According to data from UBIST, the total sales of DPP-4 inhibitors amounted to 48.9 billion won ($40.2 million) in July, up 12.4 percent from a year earlier.Among the DPP-4 inhibitors, those by LG Chem, Handok,
CJ HealthCare’s K-Cab Tab., the nation’s 30th novel drug, recorded over 10 billion won ($8.2 million) outpatient prescription sales this year, becoming a blockbuster drug in just five months of the market release. According to UBIST data, accumulated sales of K-Cab, a treatment for the gastroesophageal reflux disease, reached 10.2 billion won in the first seven months of the year. If the momen
After the Korea Exchange’s Corporate Review Committee decided to delist Kolon TissueGene, patients who used mislabeled gene therapy Invossa-K and shareholders of Kolon demanded a heartfelt apology of the company and compensation for damages.Oh Kims, the law firm pursuing a lawsuit against Kolon TissueGene on behalf of Invossa-treated patients and minority shareholders of the company, said in a
HLB said it would test a combination therapy using rivoceranib with Lonsurf for the treatment of metastatic colon cancer.The company said it received approval for its investigational new drug (IND) application from the U.S. Food and Drug Administration to conduct the phase-1b/2 trial on rivoceranib. The drug is being developed by U.S. subsidiary LSK BioPharma, in combination with Lonsurf by Ja