Roche Korea said Monday that the Ministry of Food and Drug Safety has approved Evrysdi (Ingredient: Risdiplam), the world’s first oral drug for treating spinal muscular atrophy (SMA).The ministry gave its nod based on Roche Korea’s results from various clinical trials, such as Firefish and Sunfish,
The Ministry of Food and Drug Safety has recently cleared GC Pharma’s investigational plasma therapy to treat Covid-19 in three local hospitals.However, observers said the company would have to address the plasma supply issue to commercialize the treatment.On Friday, the MFDS granted Ajou University
Celltrion said Monday that its affiliate, Celltrion Pharma USA, has signed an agreement with Prime Healthcare Distributors to supply 210 billion won ($185 million) worth of rapid Covid-19 testing kits, Sampinute.The contract signing came after Celltrion obtained emergency use approval (EUA) from the
Apparently affected by fatalities related to influenza vaccination in Korea, the Singaporean and Malaysian health authorities recently recommended local medical institutions to halt inoculation using vaccines in question.The two vaccines are SK Bioscience's SKYCellflu Quadrivalent and Sanofi Pasteur
AbbVie has released the results of a study that confirmed the efficacy of Skyrizi to improve the skin of patients with moderate to severe plaque psoriasis and their quality of life.The company said it published the outcome of the phase-3, open-label extension LIMMitless study at the European Academy
HK inno.N's K-CAB recorded prescription sales of 50.8 billion won ($44.9 million) in the first three quarters of this year, maintaining its leading position in the domestic gastroesophageal reflux disease (GERD) treatment market.According to UBIST, a drug market surveyor, K-CAB marked a three-fold s
A recent advertisement claiming that AstraZeneca Korea will pay 10 million won ($8,830) to people participating in its Covid-19 vaccine clinical trial turned out to be false.According to the ad, which recently appeared on various online communities, people aged 19 or more who could visit the clinic
LegoChem Biosciences said Thursday it signed a global technology transfer contract with China’s Cstone Pharmaceuticals. According to the contract, LegoChem Bio will license out the development right, and worldwide sales right (except for Korea) of its antibody-drug conjugate (ADC) anticancer drug ca
Macrogen, a company specializing in genomic precision medicine, said Thursday that it has signed a business agreement with Avatamed for a joint project to make tailored cancer precision medicine.Under the accord, the two companies will build a cancer precision medical platform, prepare for joint adv
The Ministry of Food and Drug Safety on Tuesday ordered Huons Medicare, a subsidiary of Huons Global, to suspend manufacturing a peptic ulcer drug for three months due to poor packaging.the administrative order, Huons Medicare cannot produce Eprazole Tab. 40mg (esomeprazole magnesium dihydrate), a p
Daiichi Sankyo's Lixiana (ingredient: edoxaban) retained its leading position in the domestic new oral anticoagulants (NOAC) market in the third quarter, chased by Korean competitors’ generic drugs.According to UBIST, a drug market survey firm, the NOAC market recorded 138.5 billion won ($123 millio
“The introduction of Janus kinase (JAK) inhibitors, following biological agents, was an ‘entirely new wave’ in rheumatoid arthritis (RA) treatment area over the past two decades.Unlike existing JAK inhibitors, upadacitinib (brand name: Rinvoq) not only improved side effects by inhibiting JAK1 select
The bullying at some local offshoots of global pharmaceutical companies has gone too far, a lawmaker said during the National Assembly's audit of the Ministry of Employment and Labor on Monday.Rep. Lee Soo-jin of the ruling Democratic Party presented such companies' names and their bullying behavior
Hugel said Tuesday that it has recently gained approval for its botulinum toxin (BTX) product, Letybo, from the Chinese regulator, vowing to carve out the largest share of the Chinese market in three years.In an online news conference, the company also said it plans to grow into a global pharmaceuti
The U.S. Food and Drug Administration has temporarily postponed the approval for the novel long-acting neutropenia drug, Rolontis (ingredient: eflapegrastim), which Hanmi Pharmaceutical licensed out to Spectrum Pharmaceuticals.Hanmi Pharmaceutical said that FDA found it necessary to inspect the comp
Celltrion has presented the results of phase 3 clinical trials that confirmed the efficacy and non-inferiority of subcutaneous (SC) formulation of Remsima (ingredient: infliximab) compared to the intravenous (IV) injection for rheumatoid arthritis.The company introduced its study results at the 22nd
GC Pharma’s recent deal with an international alliance to reserve Covid-19 vaccine capacity is drawing more attention to the company’s manufacturing facility, called “W&FF.”On Friday, GC Pharma said it signed an agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) to produce som
MSD Korea’s labor union said it would shortly launch a collective action against the management, which plans to announce the list of employees moving to the new spinoff company Organon Korea at the end of this month.The trade union said it informed the management of the breakdown of talks on Oct. 12
Local biopharmaceutical companies are turning toward spinoffs and mergers as a new business model to ensure their future growth.For example, Celltrion, a bio and chemical drug developer, acquired the business rights for 18 brands of Takeda Pharmaceutical in the Asia-Pacific region for 332 billion wo
Hugel said that it has received approval from the Chinese regulator to sell Letybo, its botulinum toxin (BTX) product, in Asia’s largest market.Hugel is Korea’s first and the world’s fourth company that won the sales nod for BTX products in China. The company has marketed the same product in Korea w