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Daewoong Pharmaceutical acquires cGMP approval of Nabota factory from US FDA

Daewoong Pharmaceutical(CEO Seung-Ho Jeon) received an establishment inspection report(EIR) which mentioned approval for the Nabota(prabotulinumtoxin A, DWP-450) manufacturing facility from the US Food and Drug Admini...

KPA & KPBMA discuss about counteractions on pharmas noncooperative to returns

The Korea Pharmaceutical Association(President Chan-Hwi Cho, KPA) and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association(Chairman Sun-Hye Cho, KPBMA) created a consultative group to strengthen cooperati...

‘Bio-Health Big Data’ to be established of 50 million people from 39 hospitals for personalized new drugs

Medical data of 50 million people from 39 hospitals will be established as virtual big data by 2020, which will empower tailored new drugs, developed of medical devices and personalized healthcare services. The Minis...

1 of 3 listed pharmas with SG&A ration higher than 40%

1 of 3 listed pharmaceutical companies reportedly have a SG&A expense/sales ratio higher than 40%. Yakup Shinmoon(www.yakup.com) analyzed 2018 1st quarter business performances that 62 listed pharmaceutical companies...

MOHW, MSIP and MOTIE carry out ‘National New Drug Development Support Project’

The 3 government bodies, Ministry of Health and Welfare(MOHW), Minister of Science, ICT and Future Planning(MSIP) and Ministry of Trade, Industry and Energy(MOTIE), will study proprietary of the ‘National New Drug Dev...

1st group of the pharma industry to complete ‘ISO 37001’ process by this June

The ‘ISO 37001’ certification program that the Korea Pharmaceutical and Bio-Pharma Manufacturers Association(KPBMA) decided to take to raise the Korean pharmaceutical companies’ ethical management into the global leve...

Samil Pharmaceutical signs co-sales agreement of ‘Lastacaft Soln’ with Allergan

Samil Pharmaceutical(CEO Seung-Beom Huh) announced on 14 Mary that the company signed a distribution and co-sales agreement of Lastacaft Ophthalmic Solution 0.25% 5mL(alcaftadine), an allergic conjunctivitis therapy, ...

Celltrion Healthcare’s ‘Herzuma’ had first prescription in Germany

‘Herzuma(generic name: trastuzumab),’ an antibody biosimilar for the treatment of breast cancer and stomach cancer, Celltrion Healthcare is actively selling in the world had the first prescription in Germany as it did...

Pharmas are able to manufacture only 1% for small-packaged medicines with low demands

The government will revise regulations which allow pharmaceutical companies to manufacture only 1% if having low demands for small packaging. The Ministry of Food and Drug Safety recently held the small packaging com...

Average settlement rate for drug price negotiations for 12 years is 91%

The average settlement rate of all the drug price negotiations after the drug price negotiation system is 91.2%, but for the past 2 years were 98.8% in 2016 and 98.6% in 2017, showing a higher rate. The total 455 new...

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