CrystalGenomics said Monday that its Ivaltinostat has won orphan drug status from the U.S. Food and Drug Administration for treating acute myeloid leukemia (AML).With the orphan drug designation, CrystalGenomics can receive up to a 50 percent tax cut for conducting clinical trials and exemption from
Roche’s Avastin, targeted therapy for various types of cancer that arrived in Korea 15 years ago, has shown strong sales performance in recent years, government data showed.Avastin’s robust sales growth stemmed from its efficacy when used in combination with other anticancer medicines against many t
The Ministry of Food and Drug Safety has asked the Supreme Court to step in and overturn a lower court's decision to dismiss its suspension order for revoking the sales license of Medytox's botulinum toxin drugs.The regulator's appeal will open a new round for the legal brawl between the two parties
HLB said Friday that its Chinese partner, Jiangsu Hengrui Medicine, has received marketing approval for its Rivoceranib, locally branded as Apatinib, as a second-line treatment for liver cancer from the China National Medical Products Administration.The company expects Rivoceranib to expand its mark
Despite the prolonging Covid-19 pandemic, about 20 local biopharmaceutical companies will participate in the 2021 J.P. Morgan Healthcare Conference, the largest healthcare industrial event globally.The JP Morgan Healthcare Conference, which celebrates its 39th conference, will hold its program onlin
Shinpoong Pharmaceutical said it was aggressively working on global trials of Pyramax (ingredient: pyronaridine/artesunate), an antimalarial drug, for Covid-19 treatment. The company began two studies this month alone.Shinpoong obtained approval from the FDA Philippines to go ahead with the Phase-2/
Biobetter developer Alteogen said Thursday it has signed a contract with Intas Pharmaceutical, an India-based multinational pharmaceutical company, to transfer technology that converts intravenous (IV) injections into subcutaneous (SC) injections.Alteogen will transfer its ALT-B4 technology to Intas
LG Chem said Thursday that it will supply $80 million worth of Eupolio, its Sabin inactivated polio vaccine (IPV), to the U.N. International Children’s Education Fund for two years.The accord comes amid the global resurge of polio infections. According to the company, most of the recent polio occurr
Daewoong Pharmaceutical received approvals for eight phase 3 clinical trials last year, beating all other Korean companies, according to a Ministry of Food and Drug Safety website.Phase 3 clinical trials that won the regulator’s nod in 2020 included those on the additional studies on its Covid-19 tr
Hanmi Pharmaceutical has come up as one of the possible candidates to sign a deal with Moderna to produce Covid-19 DNA vaccines for the domestic market.Industry watchers are paying attention to whether Hanmi will seize the opportunity to run its Bio Plant sufficiently as a contract manufacturing org
The domestic pharmaceutical industry has announced the start of business in 2021 with opening ceremonies and New Year’s messages.In their New Year’s messages, heads of drugmakers emphasized that they needed bold innovations and challenges such as open innovation strategy to overcome the unprecedente
Medytox said Monday that it has recruited legal experts Lee Doo-sik as its new vice president to put an early end to the ongoing legal battle over its botulinum toxin products. On Dec. 22, the Ministry of Food and Drug Safety said it would take administrative steps to suspend the manufacture, sale,
The Ministry of Food and Drug Safety said Monday that it would complete the approval process of AstraZeneca’s Covid-19 vaccine in 40 days to start vaccination in late February.The ministry aims to shorten the existing licensing process for AstraZeneca's vaccine from the conventional 180 days for rap
The Korean government’s deal with Moderna to purchase 40 million doses of Covid-19 vaccines has raised the question of which drugmaker will manufacture them.On Thursday, the government said it inked the deal with Moderna for the supply of 40 million doses, double the initial plan. Deliveries will st
Daewoong Pharmaceutical said that China's National Medical Products Administration (NMPA) has approved its phase 3 clinical trial of Fexuprazan, a novel gastroesophageal reflux disease agent.Daewoong plans to proceed with the phase 1 trial on about 30 people in the first half of next year and comple
GemVax & KAEL (GemVax) said that the government has selected its Alzheimer’s treatment, GV1001, as a state research and development project for dementia.The project, jointly promoted by the Ministry of Science and ICT and the Ministry of Health and Welfare, aims to develop treatments and technologie
Novartis said it has won the regulatory approval for three-in-one combination treatment for asthma. The formulation combines the bronchodilation of indacaterol acetate (a LABA) and glycopyrronium bromide (a LAMA) with mometasone furoate (ICS).The Ministry of Food and Drug Safety granted the license
Samsung Pharmaceutical said Monday that it has confirmed the efficacy and safety profile of Riavax, a pancreatic cancer drug, in phase 3 clinical trials.Samsung Pharm conducted the study for five years, from November 2015 to April 2020, on 148 patients with locally advanced and metastatic pancreatic
Huons Lab said Monday that its development of a long-lasting dual agonist peptide for short bowel syndrome (SBS) has gained additional momentum, as it was chosen as a state-subsidized project for growth technology.The Ministry of SMEs and Startups runs the project to encourage and support startup co
Celltrion Group has prohibited employees and their family members from trading company stocks, following a series of stock sales by executives.Industry sources said Monday the group sent text messages to employees, saying they will not be able to trade stocks of Celltrion, Celltrion Healthcare, and