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Policy
IMD-generic drug price differential regulation is revised
by
Lee, Jeong-Hwan
Jan 16, 2020 06:07am
Expectations are growing in the news that the Ministry of Health and Welfare is announcing the reform of the generic drug price regulation, which recognizes the value of IMD and maintains the premium pricing clause. In particular, the revised plan will postpone the regulation of IMD next year instead of this year, and if there are not man
Policy
Atozet generic¡¯s gold rush unaffected by new regulation
by
Lee, Tak-Sun
Jan 16, 2020 06:07am
The Korean pharmaceutical industry is keeping a close eye on a series of generics following MSD Korea¡¯s blockbuster combination drug for hyperlipidemia, Atozet (ezetimibe/atorvastatin calcium hydrate), in development with individual bioequivalence test, as the government has enforced new regulation on joint bioequivalence test. Despite
Company
Zejula indicated for late-line therapy on ovarian cancer
by
Eo, Yun-Ho
Jan 16, 2020 06:06am
Anticancer treatment Zejula is now available for a monotherapy prescription on patient with ovarian cancer, who has been treated with fourth-line or later treatment. Takeda Pharmaceuticals Korea (CEO Moon Hee-seok) official stated Ministry of Food and Drug Safety (MFDS) has additionally indicated Zejula¡¯s (niraparib) on Dec. 24 for trea
Policy
Daewoong-Merck faces new contender with metformin ER
by
Lee, Tak-Sun
Jan 16, 2020 06:06am
Once almost dominated by Daewoong Pharmaceutical and Merck, the high-dose (1000 mg) metformin extended-release (ER) tablet market has a new competitor. Dalim Biotech has joined the race with newly approved ER tablet. With extensive individual drug portfolio, Dalim Biotech has well-prepared for the competition, sources say. On Jan. 9, Kor
Policy
IMD, virtually confirmed without drug price restrictions
by
Lee, Jeong-Hwan
Jan 15, 2020 06:44am
The drug price reform plan, which excludes 'proven advancement IMD' from the scope of generic drug price regulation, has been virtually confirmed. The decision was made to maintain some of the existing provisions for drug price benefits, with the difference between IMD and general generics. According to the pharmaceutical industry and t
Policy
Diverse response for premium pricing policy for IMD
by
Lee, Jeong-Hwan
Jan 15, 2020 06:37am
The Ministry of Health and Welfare has virtually confirmed the premium pricing policy of excluding incrementally modified drugs(IMD) from generic drug price regulations, and since then, subtle airflow has been detected in the domestic and overseas pharmaceutical industry. The expression of the reform of the Ministry of Health's Welfare on
Policy
Company executives were accused of vaccine bidding bribe
by
Lee, Jeong-Hwan
Jan 15, 2020 06:32am
Foreign pharmaceutical company executives who received &8361; billions from drug wholesalers for trials of vaccine distribution such as bidding, supply, and price setting are tried. Employees of a large domestic pharmaceutical company accused of committing the same type of crime were also prosecuted. Both employees are accused of rece
Company
Recommending ezetimibe, ¡°The lower the LDL-C, the better¡±
by
Eo, Yun-Ho
Jan 15, 2020 06:30am
With robust evidences of efficacy, ezetimibe is now one of major options for treating dyslipidemia. ¡°The lower the better.¡± The result of clinical trial IMPROVE-IT, with the slogan claiming the lower the low-density lipoprotein cholesterol (LDL-C) is the better the health benefit, earned its recognition when it was announced in 2015. N
Opinion
[FOCUS] 10 ¡®global new drugs¡¯ promised 10 years ago
by
Chon, Seung-Hyun
Jan 15, 2020 06:28am
In 2011, the government formed Korea Drug Development Fund (KDDF) to provide inter-ministerial level support for developing new drug. Ministry of Science and ICT (MSIT), Ministry of Trade, Industry and Energy (MOTIE) and Ministry of Health and Welfare (MOHW) laid down a plan to develop more than ten global-level new drugs by investing on R&D
Policy
What criteria does the Pharmaceutical Committee judge?
by
Lee, Hye-Kyung
Jan 14, 2020 08:49am
12 of 24 new drugs were successful in listed drugs, Unfortunately, there are four drugs that have failed the reimbursement challenge. The HIRA evaluates the adequacy of a drug through a review by the Pharmaceutical Benefits Evaluation Committee in accordance with Article 11 (2) of the Rules on National Health Insurance Benefits. Daily
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