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Policy
Bill to strengthen fines on rebates pass NA plenary session
by
Lee, Jeong-Hwan
Jun 3, 2021 06:11am
A bill to increase the upper limit of the penalty surcharge imposed on drugs caught doing illegal rebates, and allowing the use of the surcharge as a resource for catastrophic health projects passed the plenary session of the National Assembly on the 21st. In the session, the NA passed the bill for the partial amendment of the National He
Company
Tecentriq attempts reimbursement after Keytruda fails
by
Eo, Yun-Ho
Jun 2, 2021 06:11am
¡®Tecentriq¡¯ is attempting what ¡®Keytruda¡¯ had failed. Industry sources have said that Roche Korea had submitted an application for the reimbursement of its ¡®Tecentriq (atezolizumab),¡¯ as monotherapy in the first-line setting for non-small cell lung cancer (NSCLC) patients whose tumors have a programmed death ligand-1 (PD-L1) express
[Reporter's view]COVID-19 Vaccine Development in Asia
by
Jun 2, 2021 06:11am
The development of COVID-19 vaccine in Asian countries is on track. Currently, about 6 companies in South Korea, 4 in Japan, 3 in Taiwan, 2 in Thailand and 1 in Singapore are developing their own COVID-19 vaccine. All have just entered clinical trials or are preparing for large-scale clinical trials. Chinese vaccines whose clinical data ar
Policy
The new rheumatoid oral drug Smyraf was revoked after a year
by
Lee, Tak-Sun
Jun 2, 2021 06:10am
Astellas' Smyraf, which has drawn attention as a treatment for rheumatoid arthritis, withdrew the license in a year. Smyraf is the third domestically licensed inhibitor of Januskinase (JAK) after Xeljanz (Tofacitinib, Pfizer) and Olumiant (Baricitinib, Lilly). However, it failed to complete the registration process and withdrew from the Ko
Company
Improved reg. allow price succession of transfer products
by
Chon, Seung-Hyun
Jun 2, 2021 06:10am
Drug price succession in transferred pharmaceutical products has been increasing. As the stepped pricing system is no longer applied to drugs that are relisted due to change of licensees, companies have been actively engaged in the transfer of their products. Some products have seen a twofold increase in their price compared to when the stepped
Opinion
[Reporter's view] Tylenol is out of stock
by
Jun 2, 2021 06:10am
As vaccinations began in earnest, the Tylenol crisis broke out in pharmacies. The Tylenol crisis has become inevitable as vaccinations for people aged 75 or older and those aged 65-74 have been implemented following preferential vaccinations for essential social workers. The government and the media are instructing people to take Tyleno
Company
The FDA's final decision on Rolontis remains
by
An, Kyung-Jin
Jun 1, 2021 06:11am
The FDA's due diligence on the domestic manufacturing facilities of Rolontis, a drug that Hanmi exported technology, has entered the final stage. The final process for obtaining final FDA approval has been completed as scheduled. Hanmi's partner Spectrum is rushing to prepare to enter the U.S. market worth about &8361;3 trillion in prepa
Policy
Comparing Cellid with Janssen¡¤AZ¡¦ SK Bio with Novavax
by
Lee, Tak-Sun
Jun 1, 2021 06:11am
With the Ministry of Food and Drug Safety announcing lowered standards for conducting Phase III clinical trials to promote the development of domestically developed COVID-19 vaccines, commercialization of Korean COVID-19 vaccines is likely to happen sooner than expected. In particular, domestic vaccines that were not able to enter the Pha
Company
3-way race between ultra-expensive new orphan drugs to start
by
Jun 1, 2021 06:11am
With Novartis¡¯s gene therapy ¡®Zolgensma¡¯ approved, 3 new drugs have been introduced into the Korean spinal muscular atrophy (SMA) market, a market that previously had virtually no treatment available. The introduction of 3 new drugs in just 3 years marked the start of a full 3-way race between the new SMA treatments in Korea. In the U.S.
Company
Astellas notified distributors, Betmiga cannot be returned
by
Kim, Jin-Gu
Jun 1, 2021 06:11am
Confusion in pharmacies is expected to continue for a while over the lowering of the drug Betmiga (Mirabegron), an irritable bladder treatment. The pharmaceutical industry and the outpatient pharmacies predict that it will take at least a year for the drug price to be finalized. According to the pharmaceutical industry and pharmacies on th
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