A recent series of development over Medytox’s botulinum toxin is making it quite difficult to predict whether or not the government will revoke the BTX license, industry watchers said on Monday.The company recently won a court’s ruling to stop the Minister of Food and Drug Safety Ministry’s Daejeon branch from proceeding with the ministry’s plan to suspend making and selling Meditoxin. The dec
Local drug companies are making an all-out effort to increase sites for clinical trials on potential Covid-19 treatments, as the declining new confirmed cases of Covid-19 might frustrate patient recruitment.As of midnight Thursday, Korea had 11,122 confirmed cases of Covid-19 and 10,135 of them were cured, according to the Korea Centers for Disease Control and Prevention (KCDC). The other 987
The Thai government not only suspended the sale of Meditoxin, a botulinum toxin product by Medytox, but recalled all the Meditoxin products distributed in the market.The recall is expected to take a heavy toll for Korea’s leading BTX maker, as Meditoxin sales in Thailand bring in 20 billion won ($16.2 million) annually.According to a document of the FDA Thailand obtained by Korea Biome
Plastic surgeons and dermatologists have asked the regulator to reconsider its decision to revoke the license of Meditoxin, a botulinum toxin product made by Medytox allegedly using unauthorized ingredients. Last Friday, the Korean Society for Aesthetic and Dermatologic Surgery (KSDS) submitted a petition to Minister of Food and Drug Safety Lee Eui-kyung, requesting leniency in the regulator
With the world’s collaboration to fight the new coronavirus pandemic, researchers have successfully entered clinical trials on a Covid-19 vaccine in just four months, an expert said in an online biotech conference. He noted that the speed of the vaccine development is unprecedentedly fast. Jerome Kim, director-general of International Vaccine Institute, said so during his keynote speech at the
Medytox, the nation’s largest botulinum toxin maker by market share, suffered a nosediving operating margin last year, amid an ongoing lawsuit against Daewoong Pharmaceutical over the ownership of a BTX strain.Medytox’s operating profit turned to an operating loss in the fourth quarter last year, and the operating loss even grew larger in the first quarter. Analysts expect the company’s earnin
Hanmi Pharmaceutical’s diabetes drug candidate efpeglenatide, which had led to a massive licensing deal with Sanofi, is on the brink of being discarded in the middle of the phase-3 trial. On Thursday, the company announced that the French multinational drugmaker abruptly decided to return all rights concerning efpeglenatide to Hanmi. In 2015, Hanmi licensed-out three diabetes pipelines – e
Prosecutors have revealed Kolon Life Science had to change contract manufacturing organization (CMO) for Invossa-K, gene therapy for knee osteoarthritis, from Wuxi to Lonza.The revelation came when the Seoul Central District Court held the second trial on Kolon Life Science CEO Lee Woo-sok and company executives on Wednesday. The company initially wanted Wuxi to manufacture Invossa samples for
Daewoong Pharmaceutical has said it would promote sarpogrelate, which reportedly has a lower risk of bleeding than aspirin and prevents cardiovascular disease, to fight the popular notion that aspirin is synonymous with an antiplatelet drug. The company also plans to market it as a preventive therapy for high-risk groups with cardiovascular diseases such as elderly diabetic patients, it added.
Shares of two Korean pharmaceutical companies have shot up since the first outbreak of Covid-19 in Korea on Jan. 20, because of the potentials of their drugs as a Covid-19 treatment.Shinpoong Pharmaceutical’s stock price surged 168 percent to close at 19,050 won ($15.67) Friday, compared with 7,120 won recorded on Jan. 20. Shinpoong shares reached a peak of 25,000 won over the past 52 weeks. S
Daewoong Pharmaceutical earned 13.6 billion won ($11.1 million) by exporting its botulinum toxin Nabota in the first quarter. However, all of the revenue was offset by expenses for its ongoing lawsuit against Medytox over the origin of BTX strain in the United States.Daewoong said on Thursday that Nobota sales in the first quarter amounted to 15.1 billion won in the first quarter, up 174 perce
“A global pharmaceutical company is conducting a verification test on therapeutic delivery technologies (of four biotech firms). I’m sure we will beat the three other biotech firms and clinch a licensing deal.”So said Jo Dae-woong, CEO of Cellivery Therapeutics, at a news conference in Yeouido, Seoul, Wednesday.Since last year, the protein-based drug discovery company has been receiving a
The pharmaceutical industry is closely watching whether a Korean botulinum toxin (BTX) product will win approval in the Chinese BTX market, five times larger than the Korean one, this year. Industry sources said Wednesday Medytox, Hugel, Daewoong Pharmaceutical, Pharma Research Bio, and Huons are preparing to enter the Chinese market.Among them, Medytox and Hugel are hoping to obtain a Chi
Leading domestic pharmaceutical companies recorded robust earnings in the first quarter despite the new coronavirus outbreak, industry data showed. According to each company’s public disclosure as of Thursday, GC Pharma, Hanmi Pharmaceutical, Chong Kun Dang, and Dong-A ST achieved improved earnings in the first three months, compared to a year earlier. However, Yuhan Corp. suffered
Kolon Life Science said it would return 15 billion won ($12.3 million) upfront payment it had received from Mundipharma for licensing-out its gene therapy Invossa-K, as the U.S. firm decided to exercise the right of pledge amid the issue of Invossa’s ingredient mislabeling. Despite the FDA’s recent approval to resume the phase-3 trial on Invossa in the U.S., Mundipharma requested Kolon to
A local court has turned down Medytox’s appeal for suspending the execution of the government’s order to stop making and selling its botulinum product, Meditoxin. The Daejeon District Court recently dismissed Medytox’s application for suspending the execution of the administrative order to that effect issued by the head of the Daejeon branch of the Ministry of Food and Drug Safety, according t
SillaJen said a combination of its oncolytic viral therapy Pexa-Vec (JX-594) with immune check inhibitor Libtayo (ingredient: cemiplimab) has reduced tumor in 12 out of 16 kidney cancer patients. It also shrank the size of the tumor more than 30 percent in nine out of the 12 patients, the company added.The company released the interim results of the Phase-1b trial at the meeting of the America
Genexine said its investigational DNA vaccine for cervical cancer has improved the response rate of immunotherapy Keytruda significantly.The company released interim results of the local phase-1b/2 clinical trial on the combined therapy of GX-188E and MSD’s immunotherapy Keytruda (ingredient: pembrolizumab) at the online meeting of the American Association for Cancer Research (AACR) on Monday.
Kolon Life Science said Monday it has started the administration of an experimental gene therapy KLS-2031 to the first patient to treat neuropathic pain in the phase-1/2a trial in the U.S.KLS-2031 is a candidate for the first-in-class drug for the treatment of lumbosacral radiculopathy, a pain syndrome caused by compression or irritation of nerve roots in the lower back. The U.S. Food and Drug
The government had planned to phase out “consigned bioequivalence test system,” which allows incompetent drugmakers to sell generic drugs by relying on another company to conduct bioequivalence tests.The tentative decision came after the controversy over Chinese-made valsartan recall due to carcinogen risk in 2018.However, the Regulatory Reform Committee, chaired by Prime Minister Chung Sy