Korean pharmaceutical and biotech companies are introducing a new standard for a compliance management system, ISO 37301, to enhance internal monitoring and prepare for ethical management of ESG (environmental, social, and corporate governance).Their move came mainly after the embezzlement case earl
Kukje Pharma said Thursday it rolled out Kukje Hyal Inj. (ingredient: sodium hyaluronate), treatment for knee arthritis and frozen shoulder.The treatment comes in a pre-filled syringe, administered to the intra-knee joint or shoulder joint for five consecutive weeks.The company said the product has
Pfizer, which dominated the global pneumococcal vaccine market with 13-valent Prevnar 13, said it won approval for a 20-valent vaccine in Europe.On Tuesday, the European Medicines Agency authorized the use of Apexxnar (brand name in the U.S.: Prevnar 20) for immunization and prevention of invasive d
Janssen’s Rybrevant (ingredient: amivantamab) obtained marketing approval for the treatment of non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations in Korea.On Tuesday, the Ministry of Food and Drug Safety (MFDS) approved Rybrevant to treat pati
Daewoong Pharmaceutical posted a record-high revenue in 2021 on the back of botulinum toxin export to the U.S. and a licensing-out deal over the nation’s 34th drug Fexuclue Tab. (fexuprazan hydrochloride), a treatment for gastroesophageal reflux disease (GERD). As a result, operating income jumped 4
Pfizer has changed the form of Ibrance (palbociclib), a CDK4/6 inhibitor, from capsules to tablets, making it easier for cancer patients to take the medication.The Ministry of Food and Drug Safety approved Ibrance Tab. 75 mg, 100 mg, and 125 mg on Monday.Ibrance is used as the standard treatment, al
A court dismissed local drugmakers’ appeal to nullify the government’s push to negotiate the recollection of health insurance coverage for choline alfoscerate (CA).The Ministry of Health and Welfare said the Seoul Administrative Court ruled in favor of the ministry on Friday.The ruling was against 2
SK Bioscience said Monday it signed a deal with the Pan American Health Organization to supply chickenpox vaccine to the Latin American market. It is the first time the company won bidding from PAHO, an international health agency under the United Nations.The Korean vaccine maker said it received PH
Amgen’s Lumakras (ingredient: sotorasib), the world’s first KRAS mutation inhibitor developed over 40 years, arrived in the Korean market.The treatment is indicated for non-small cell lung cancer (NSCLC). However, as it recently showed anticancer effects in pancreatic cancer, the marketing approval
The nation is experiencing a shortage of acetaminophen-containing cold medicines amid the surge of the Omicron variant and increased at-home treatment.Local pharmaceutical companies have begun running an emergency production system to cope with the shortage of such drugs.On Monday last week, the gov
HK inno.N and AbClon said they would work together to develop and commercialize CAR-T therapy, and their collaboration will continue through a contract development manufacturing organization (CDMO) deal.On Monday, the two signed a memorandum of understanding for the joint development of AT-101, a ty
Korean pharmaceutical companies recently obtained marketing approval for generic drugs of MSD’s Bridion (sugammadex), a muscle relaxation antagonist.As the original drug’s patent expires in April, local drugmakers are expected to engage in fierce competition to sell generic copies, observers said.Th
Medpacto said that it has signed a business agreement with HITS, specializing in artificial intelligence-based drug development.Under the accord, the two companies will jointly secure and share technology and experimental data for new drug development, establish new business models and projects for
inno. N said that the Ministry of Food and Drug Safety has approved K-CAB orally disintegrating tablet (ODT) 50mg, a gastroesophageal reflux therapy.The company plans to launch the new K-CAB formulation in the first half of this year, further spurring its share in the Korean peptic ulcer solvent mar
“In 2021, Hugel’s sales recorded 245.2 billion won ($204.4 million), the largest since the company’s foundation. In 2022, the company will go beyond the leading botulinum toxin (BTX) maker in Korea and tap the world’s three largest BTX markets – China, Europe, and the U.S.”Hugel CEO Sohn Ji-hoon sai
Handok said that it has signed a local joint promotion and sales contract with Sanofi-Aventis Korea for Renvela, the latter’s hyperphosphatemia treatment, from March.The drug is a non-calcium-based phosphorus binder that can more effectively control serum phosphorus in chronic kidney disease patient
In recent years, Korean biopharmaceutical companies have been actively licensing out drug technology in the global market. Therefore, industry watchers are now paying attention to which companies will show notable achievements this year.The domestic drugmakers showed remarkable results last year, co
CKD Bio said it obtained approval for exporting Tyemvers, a botulinum toxin (BTX) product.The company plans to ship the product to some countries that do not require a separate registration process in the Middle East and Central and South America.The Ministry of Food and Drug Safety said it granted
Samyang Biopharm USA, a global biotech subsidiary of Samyang Holdings Corp., said on Thursday that it appointed Ryu Eun-ju as its new CEO.Ryu is a new drug business strategist and marketing expert with more than 30 years of experience in global clinical trial management and drug approval, business d
Daewon Pharmaceutical said it has won approval from the Ministry of Health of the Russian Federation for Pelubi, its non-steroidal anti-inflammatory drug (NSAID), and will launch it under the brand name Pelubio.Daewon will produce Pelubi at its plant in Gyeonggi Province and export it to Russia. Pha