News About: Pharm. Affairs
Late entry of 10 year old constipation drug into domestic market
A Takeda Pharmaceutical’s chronic idiopathic constipation therapy is expected to land in Korea after the 10th anniversary for its global approval.
On the 18th, the Ministry of Food and Drug Safety(MFDS) announced ‘Lu...
“How come indications that are foreignly approved cannot be used in Korea?”
Patients have suffered from an incident where an indication was approved by the U.S. FDA, not in Korea. In other words, the rights to access new drugs have been restricted.
If myelodysplastic syndrome is not treated,...
Lantus and Tamiflu expired in patent on February
On February, Lantus and Tamiflu will expired in patent.
First of all, the Sanofi’s antidiabetic treatments, Lantus Inj Vial, Lantus Inj Solostar and Lantus Inj Cartridge, have been expired in their substance and use ...
Despite air shipment and full factory operation, Neodex is out-of-stock by March
The generic substitutes of Pfizer Pharmaceuticals Korea’s Terramycin Eye Oint have started to be out-of-stock again.
Despite the effort to increase their output by 5 times larger, the companies have only been able to...
First ‘NOAC’ antidote, Praxbind, counting down for domestic introduction
The first NOAC antidote is expected to be introduced in Korea.
According to the industry concerned on the 17th, Boehringer Ingelheim recently turned in the approval application of ‘Praxbind(idaruxizumab),’ an antibod...
Unlike other medical markets, urology market lacking medical students
As large erectile dysfunction treatments, such as Viagra and Cialis, were expired in patent, the urology market fluctuated. Thanks to them, sales of their domestic generics grew, and in addition, their complex market ...
“Price dualization for cervical cancer vaccines will be fully reviewed”
While cervical cancer vaccines will be included in the National Immunization Program(NIP) from the coming June, the Korea Centers for Disease Control and Prevention(KCDC) was known to consider the dualization of MSD’s...
Distribution companies careful on managing Tamiflu inventory
While influenzas have been widely spread lately, a part of pharmaceutical distribution companies have worried about the inventory management of Tamiflu.
This is because the Korea Centers for Disease Control and Preve...
Celltrion’s Remsima receives ‘approval recommendation’ for all indicationsOn the 9th of February(local time), Celltrion announced the first biosimilar antibody, ‘Remsima,’ received ‘approval recommendation’ for all the indications applied from the U.S...
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Hastened development and commercialization of ‘rare drugs’ for rare disease patients
The Ministry of Food and Drug Safety(Minister Seung-hee Kim, MFDS) announced it gave a administrative notice for 6 amendments, such as the ‘Regulation to Indicate Rare Drugs,’ containing the contents to establish acti...
