Biogen’s first anti-amyloid antibody, Alzheimer’s disease treatment Aduhelm (ingredient: aducanumab), is suffering a series of setbacks.According to the annual securities filing by Biogen on Thursday, the U.S. Federal Trade Commission (FTC) and the Securities and Exchange Commission (SEC) started se
Immunomic Therapeutics, a subsidiary of HLB, said it has received U.S. Food and Drug Administration’s approval to conduct the phase 1 clinical trial of ITI-3000, a Merkel cell carcinoma treatment.ITI-3000 is an anticancer vaccine made by combining LAMP1 (lysosomal-associated membrane protein) with t
SK Bioscience said Turkey’s health authorities granted GMP certification to its vaccine plant, raising the chance of exporting self-developed vaccines.On Friday, the company said that the Turkish Medicines and Medical Devices Agency renewed GMP certification on the L House’s vaccine facility, manufa
Shinpoong Pharmaceutical has completed an overseas clinical trial of antimalarial treatment Pyramax (ingredient: artesunate/pyronaridine), drawing attention to the study results.According to clinicaltrials.gov, the status of the Phase 2/3 study NCT05192265 for malaria indication has been updated as
The Korean pharmaceutical industry rolled out four home-grown new medicines in 2021. Industry watchers are paying attention to which company will introduce a new drug in 2022.Observers said companies conducting or finishing phase 3 trials to finalize the safety and efficacy might release new drugs t
Yuyu Pharmaceutical has launched Nagran Oral Disintegrating Tablet (Ingredient: Naratriptan), the first generic drug for GSK’s Naramig, a migraine treatment.Patients can use orally disintegrating tablets to relieve migraine headaches rapidly. The company has increased convenience by allowing patient
inno.N said Thursday that it has signed a contract with Malaysia’s Pharmaniaga Logistics to export its gastroesophageal reflux disease (GERD) therapy, K-CAB, to the Southeast Asian country.Under the accord, Pharmaniaga will have the exclusive right to distribute K-caps in Malaysia for five years. Th
Hugel said it obtained product approval from the French drug ministry (Agence Nationale de Sécurité du Médicament) for Letybo, its botulinum toxin formulation, for treating forehead wrinkles last Thursday.The approval follows Hugel receiving a recommendation for approval of the product approval for
SK Plasma said that it has signed a contract with Khairi S.A., a South American pharmaceutical sales company, to export 38.4 billion won ($31.8 million) of blood products.Under the accord, Khairi will have the right to supply SK Plasma's blood products, such as LIV-r Inj. and albumin, to eight count
Samsung Biologics said Friday that it had decided to acquire all 10,341,852 shares of Samsung Bioepis owned by Biogen, a multinational pharmaceutical company, for $2.3 billion.After Biogen requested Samsung Biologics to buy out their shares, the two companies finalized the deal.Biogen had owned 50 p
The Korea Health Industry Development Institute (KHIDI) said Thursday that it would recruit companies to move into the C&D Incubation Center located in Boston CIC (Cambridge Innovation Center), the U.S., from Thursday to Feb. 11.It is part of the government’s “K-Blockbuster Support Project,” which a
A joint research team has released a short-term clinical result confirming the efficacy of Novartis' gene therapy Zolgensma (ingredient: onasemnogene abeparvovec) in treating Korean patients with spinal muscular atrophy (SMA).The real-world evidence (RWE) study, published in the online edition of Br
AbbVie said its drug Skyrizi (ingredient: risankizumab) obtained the U.S. FDA authorization to treat adults with active psoriatic arthritis (PsA).The FDA approval was based on the results of the KEEPsAKE-1 and KEEPsAKE-2 trials which tested Skyrizi in adults with PsA, including those who had respond
Hanmi Pharmaceutical is busy preparing for a market release of inhaled asthma medication, Glyterol Inhalation Cap. 110/50 μg.As the original drug's patent expired partially, industry officials are closely watching when Hanmi will release Glyterol.The Ministry of Food and Drug Safety said Hanmi’s Gly
After 14 months of collaboration, SK Chemicals and Dr. Noah Biotech succeeded in deriving three new drug candidates to treat nonalcoholic steatohepatitis (NASH) and idiopathic pulmonary fibrosis (IDF) using artificial intelligence.The two companies stressed that their results have proved AI technolo
Celltrion and Icure Pharmaceutical have registered a pharmaceutical patent on a “patch-type dementia treatment,” preparing to release the product in Korea within the first half of this year.The Ministry of Food and Drug Safety (MFDS) said the two companies registered the patent on the donepezil-cont
Hugel said that the EU's Heads of Medicines Agencies (HMA) has issued a positive opinion for the approval of Letybo, its botulinum toxin (BTX) product, for treating forehead wrinkles.HMA is an association of drug safety management organizations in each European country.The company expects to enter i
Eutilex signed an MOU with Medirama, specializing in clinical consulting, to develop and commercialize strategic new drugs.The two companies will maximize synergy in the overall development of new drugs, such as discovering additional candidates for Eutilex’s cell therapy and dual antibody therapy,
Kyongbo Pharm said Tuesday it recently obtained approval from the Ministry of Food and Drug Safety for DPP-4 antidiabetic drugs Vilda Tab. and Vildamet Tab.Four products got the marketing approval – one monotherapy using vildagliptin as the main ingredient and three doses of Vilda Tab. plus metformi
Ripretinib (brand name: Qinlock), developed by Deciphera Pharmaceuticals as a treatment for gastrointestinal stromal tumors (GIST), failed to improve progression-free survival (PFS) in advanced GIST patients, compared to sunitinib (brand name: Sutent).However, ripretinib showed favorable data in adv