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- 2026-04-16 21:14:34
- Company
- The KDPU joined the memorial against racism
- by An, Kyung-Jin Jun 15, 2020 06:16am
- A performance scene in honor of George Floyd The domestic pharmaceutical industry gathered to honor memory of George Floyd, a black man who died from the abuse of public power by the American police. On the afternoon of the 11th, Lundbeck Korea branch of the Koea Democratic Pharmaceutical Union held a memorial performance for George Floyd during a protest rally in front of the Lundbeck headquarters in Songpa-gu, Seoul. This was the union's response to the request for participation by the Uni Global Union (UNI) to commemorate George Floyd's sad death. On this day, participants of the Lundbeck Picket protest in Korea knelt down and shouted the protests, "Black Lives Matter," and "We Against Racism." UNI is an industrial group consisting of trade unions of white-collar/financial workers around the world, and has been in exchange with the KDPU since 2018. Floyd's neck was pressed against the police's knee last month in Minneapolis, Minnesota, USA. Floyd was taken to the hospital, but he died. Protests against Floyd's death are spreading beyond the United States to the world. Chairman Dong-Hee Joo of the Fresenius Kabi Korea Union branch said, "We have been participating in the commemoration of George Floyd, who has unfortunately died according to the request of an international UNI organization that has exchanged for nearly two years." "We plan to continue solidarity and cooperation with international UNI organizations." The protest rally by the Lundbeck Korea union continues on the 51st day. In the process of dismissal of former union member A, the Lundbeck union is conducting picket protests during morning time and lunch breaks about the company's unfair labor practices. The union has a policy of continuing the outside struggle until there is a sincere apology from the company.
- Policy
- 18 Champix IMD suspected of selling before patent expiration
- by Lee, Tak-Sun Jun 15, 2020 06:16am
- Pfizer 18 incrementally modified drugs (IMDs) of Champix (varenicline) are undergoing administrative measure for selling the products before the original’s patent was expired. Some of their item approvals have been revoked by the related administrative measure. Before the Champix’ patent expires next month, the follow-on drug market would fluctuate depending on the administrative measures. Korea’s Ministry of Food and Drug Safety (MFDS) announced on June 11, the ministry’s regional offices are reviewing 18 IMDs (nine 0.5 mg products and nine 1 mg products), which have been accused of going on sale before the original extended the patent term. The licenses on Korea Prime Pharm’s Champion in 0.5 mg and 1 mg tablets have been revoked by related statutes. Administrative measures on other items would be finalized when the regional offices complete respective reviews. Apparently, these items are suspected of going on sale before Champix extended the patent, although they stated the sale would be withheld until the expiration date as they were approved by the health authority. Champix’ substance patent expiration date before extension was on Nov. 11, 2018. And extended term would expire on July 19, 2020. Based on the Korean court’s ruling, most of the IMDs have gone sale from Nov. 14, 2018, when the original’s patent expired. But when the Supreme Court overruled the preceding decision and disapproved of IMDs evading patent infringement during the extended patent term, all IMDs have ceased manufacturing and sales. Instead, they are to resume the sale starting from July 19, when the extended patent term expires. The items receiving the administrative measure were supposed to resume the sale from next month. But, the sales plan could be scrapped as they are suspected of selling the products before the patent expiration. Relevant pharmaceutical companies would be affected as the item approval on an IMD selling before the patent expiration is immediately revoked, according to the highest level of administrative measure.
- Policy
- The packaging unit of self-injectable medicine is improved
- by Lee, Tak-Sun Jun 15, 2020 06:15am
- The packaging unit of self-administered injections such as Saxenda, which is used for appetite suppression, is expected to be subdivided. In order to prevent misuse, it was decided to put one in one package. In addition, safety information is produced for patients to use it correctly, and educational program development and medication guidelines are prepared. The MFDS announced on the 11th that it is pursuing a comprehensive measure to support the safe use of self-administered injections, which the patients themselves directly inject. It is said that this measure was prepared to strengthen the safe use and to eliminate medicine’s abuse as the product launch and use expanded due to the convenience of self-administered injection. First, the safety use information that the patient participates in is produced. The intention is to construct a patient panel for self-administered injections to produce safety use information that reflects consumer opinions from the planning stage to delivery and provision. In addition, the existing promotional materials will be reviewed. Patient education programs are also established through consultation with groups of doctors or pharmacists. The doctors' association decided to develop an education program and practice training for patients using self-administered injections. In addition, it was decided to form a consultative body with the pharmaceutical assiociation to prepare a method for strengthening medication guidance for patients and a medication guide. In order to prevent abuse, the product packaging unit is also reduced. The plan is to improve the current packaging unit, which is packed up to five per product, to one. In addition, it was decided to add 'self-administered injection' to the subject of risk management plan submission and to describe in detail how to use it in containers, packaging, and attached inserts The MFDS also plans to promote the use of self-administered injections at home and abroad and research on the current education status. An official from the MFDS said, “We are looking forward to creating an environment where patients can safely use self-administered injections without fear of misuse through this measure. And, we will do our best to continue to communicate with patients, experts, and the industry to expand the foundation for safety commercial use.”
- Company
- KARS and Galderma to run first rosacea campaign in Korea
- by Eo, Yun-Ho Jun 12, 2020 06:12am
- Korean Acne and Rosacea Society (KARS) and Galderma Korea are conducting a campaign to raise awareness in early symptoms and diagnosis of rosacea. From May 6, Galderma Korea has been disseminating rosacea diagnostic checklist, developed with the board of KARS, to private dermatology clinics for the visiting patients and doctors to use. As rosacea usually relapses and needs differential diagnosis, it is crucial for patients to quickly notice the symptoms of the disease and see a specialist. However, a report by Korean Dermatological Association found most of the patients have not heard of the disease name ‘rosacea,’ and most of the survey participants did not recognized the disease to require early attention. Moreover, it is integral for the patients to receive accurate diagnosis from a dermatologist and treatment as the disease show ambiguous symptoms similar to that of acne, perioral dermatitis, seborrheic dermatitis, demodicidosis and systemic lupus erythematosus. In fact, surveying 554 patients and 710 doctors in six countries, 29 percent of patients felt even their doctors does not consider the disease to be serious, and 37 percent of them said their family and friends were not familiar with the disease. The findings showed the patients need understanding and support from doctors and surrounding people. And one third of the survey participants said rosacea has impacted their quality of life either significantly or extremely. The rosacea checklist for the patient provides information on the disease and a list of symptoms to review by themselves. Early symptoms of rosacea includes regularly expressed severe erythema in the center of face, dilated capillaries, itching, hot flush, dried skin, irritated swollen and red eyes, piercing pain and acne-like pimples. People finding these symptoms should seek for dermatologist’s attention. The checklist for doctors provides the latest rosacea treatment standard, factors worsening the disease, and early symptoms for the doctors to refer when accurately diagnosing and treating the patients. According to the latest rosacea diagnosis standard, a person with a symptom either regularly expressed severe erythema in the center of face or rhinophyma-like change in nose can be diagnosed as a patient with rosacea. President Lee Jee-bum of KARS commented, “After missing the time for early treatment, a rosacea patient is most likely to fail to recover completely. But so many of patients not recognizing or ignoring the early symptoms as a disease, but they rely on folk remedy. Because fast and accurate diagnosis and treatment are the most important steps of rosacea treatment, people seeing red spots in the center of face with itching and dried sensation should visit a dermatologist for more details.” CEO Rene Wipperich of Galderma Korea explained, “We anticipate the campaign to better inform specialists and patients visiting dermatologists about rosacea and provide an opportunity to treat it from early stage.”
- InterView
- Why is Metformin’s investigation expanded?
- by Lee, Tak-Sun Jun 12, 2020 06:11am
- Namsu Kim, the chief explains the progress of NDMA in Metformin investigation in a briefing with reporters held at the MFDS in Osong on the 9thThe "detection of NDMA in metformin preparations" published by the MFDS is different from the previous cases. In particular, the difference is that NDMA was not detected in the raw materials. ertain raw materials were a problem in the case of Valsartan or Nizatidine. And, NDMA was also detected in raw materials in the case of Ranitidine. However, in the case of Metformin, Nothing was found among 970 commercially available raw materials. Nevertheless, the MFDS prohibits the manufacture and sale of 31 drug products that have been detected in excess of NDMA by investigating the drugs. In response, a briefing with reporters held at the Osong headquarters on the 9th, Nam-soo Kim, the chief of the Food and Drug Administration, said, "We inevitably tested imported products that had no raw materials in the country and expanded our investigation to domestic finished products due to cases of substandard NDMA detection." He said, "In fact, in the case of finished drugs, it was difficult to investigate all because the number of lots reached almost 15,000," he added, "Once we screened (exactly inspected) about 970 raw materials on the market, there were no major problems with the raw materials." However, there were no raw materials for imported pharmaceuticals in Korea. Moreover, it was difficult to import raw materials from overseas. For this reason, it was inevitable to conduct a test inspection on imported finished products, not raw materials. "NDMA in imported finished products is within the standard, but it has been partially detected, and accordingly, domestic pharmaceutical products have been investigated," said Kim. "Singapore authorities and the United States FDA also investigated both raw materials and finished products." He said that the investigation had to be expanded. If the investigation was stopped on raw materials, NDMA would not have been detected in the finished drugs. However, this decision confirmed the detection in the finished product, which made it possible to estimate that Metformin was incorporated into NDMA in the manufacturing process of finished drugs. However, it was not a complete investigation of the entire lots of the drug product. According to Kim, the total number of finished pharmaceutical products in circulation was 15,000. The MFDS collected three lots of 228 items on the market and conducted an investigation. Some critics pointed out that the accuracy of the survey results is not as good as some. In response, Kim explained, "If three items of finished products were collected and investigated, NDMA was detected uniformly by lot for the same item. "There was a so-called border line, and I think it would be better if it was managed more." However, Metformin's NDMA detection is only an estimate that it will be incorporated in the drug product manufacturing process. No specific cause has been identified. "If you submit data about the parts that companies think would be the cause of their own, we will discuss with external experts and consider improving the process for reshipment," said Kim. "In the case of metformin preparation, we had to do a lot of screening, so the inspection agency had a lot of trouble testing it for 5 months," said Kim. "FDA also screened all distribution items as quickly as the results detected in the finished product, not raw materials."
- Company
- Prompt review is urgent for COVID-19 treatment
- by Nho, Byung Chul Jun 12, 2020 06:11am
- It is noteworthy that industry consensus is demanding a fast track clinical trial approval process for autoimmune therapies that have been proven to be safe, as countries around the world are eager to develop vaccines and treatments related to the COVID-19 infection pandemic. The MFDS is also actively sympathizing with this situation, and is conducting consultations with individual pharmaceutical companies, but it is showing a difference of position in approving the clinical trial of the effect of COVID-19 on autoimmune treatment. Recently, autoimmune preparations, such as Sod. Cridanimod, have products that are effective in HIV, hepatitis B/C, viral encephalitis, and encephalomyelitis and are sold globally in Korea and abroad. This product has already entered clinical trial procedures related to the effect of COVID-19 in some countries, including Russia, but the MFDS is delaying the review on this grounds for 'no protocol and guidelines'. In response, the MFDS is requesting in vitro results on the growth and reproduction inhibition of COVID-19. The difference between the opinions of the health authorities and the industry is interpreted as a difference in understanding and perspective on the mechanism. In the case of other drugs, the focus of treatment and development is based on the mechanism of suppressing the growth and reproduction of viruses, but in the case of autoimmune drugs, it has the advantage of enhancing the safety while minimizing side effects by increasing the resistance to viruses through white blood cells in the human body. For example, Sod. Cridanimod, one of autoimmune therapy, has a clinical design that kills the virus by increasing leukocytes following stimulation of interferon alpha/beta. Despite the absence of COVID-19 clinical trial protocols and guidelines for autoimmune preparations, the basis for the need for a fast track is that there are two-sided results of 'positive and negative' of malaria, HIV, and Ebola virus treatments such as Hydroxychloroquine, Kaletra, and Remdesivir. Although Hydroxychloroquine had a prophylactic administration effect and reduced virus amount and extinction effect, it had a similar prognosis similar to the standard treatment group, and had side effects such as increased mortality and induction of neuralgia, mental illness, and hypoglycemia. Kaletra showed a decrease in the amount of detection of virus and improved symptoms of pneumonia, but did not express specific treatment efficacy, and had side effects such as hepatotoxicity, diabetes, and kidney disease. Remdesivir also gained indicators of increased production and improved mortality in North America, Europe, and Japan, but failed to obtain meaningful data, and caused side effects such as kidney damage, hypotension, and stomach paralysis. An industry official said, "Autoimmune preparations are a mechanism for activating a universal and innate endogenous interferon system. It is time to find various methods for the development of therapeutics in which no drug has proved the efficacy associated with COVID-19."
- Policy
- 13 COVID-19 global clinical trials were approved
- by Kim, Jung-Ju Jun 11, 2020 06:53am
- Global clinical trials for the development of COVID-19 vaccines and treatments have increased 15 fold more than in three months. There are 858 cases worldwide and 13 cases approved in Korea, and clinical trials are actively underway. The KONECT (Chairman Byung-Joon Bae) announced on the 9th that it updated the domestic and foreign clinical trial trend information for the development of COVID-19 vaccines and treatments. As of the 8th, there were 858 drug interventional clinical trials that were newly registered in the National Institutes of Health (NIH) ClinicalTrials.gov. The total number of clinical trials increased by 15.3 times from 56 cases to 858 cases as of March 11th. In particular, the number of sponsor-investigator trials increased by 17.7 times from 32 to 565, and it was analyzed that the clinical trials of researchers aimed at the public interest in responding to the national public health crisis are driving clinical research. Of the 858 clinical trials, 825 clinical trials related to treatment and 33 clinical trials related to vaccines. Among clinical trials related to treatment, 546 clinical trials by researchers, 264 clinical trials by pharmaceutical companies, NIH and U.S. Fed-sponsored clinical trials were 15 cases, and the proportion of researchers' clinical studies was 66.2%. Among clinical trials related to treatment, 546 clinical trials by researchers, 264 clinical trials by pharmaceutical companies, NIH and U.S. Fed-sponsored clinical trials were 15 cases, and the proportion of researchers' clinical studies was 66.2%. Korea has 13 clinical trial plans related to COVID-19 approved by the MFDS as of 8th. Of these, 12 clinical trials related to treatment and 1 clinical trial related to vaccines were conducted, and 7 sponsor-investigator trials (53.8%) were reported to be in progress. Meanwhile, information on the current status of clinical trials related to COVID-19 can be viewed and downloaded from the Korean Clinical Trial Portal (K-CLIC).
- Company
- Online seminar for Physicians & pharmacists is approaching
- by Eo, Yun-Ho Jun 11, 2020 06:23am
- Example of simultaneous connection of 3 participants and Japanese speakerThe trend of physicians-pharmacists online seminar (webinar), which is attracting attention due to the spread of COVID-19, is rapidly changing from 2D to 3D, and from one person to multiple. Online seminars are regarded as the advantages of non-face-to-face, COVID-19 accessibility and re-viewing regardless of location/time, and have established themselves as a new tool in pharmaceutical marketing. The Dailypharm's Webinar 2.0' system has recently attracted attention as it successfully connected to 2,500 doctors and successfully completed a real-time connection and lecture transmission with Japanese society speaker. It was difficult to emphasize the branding of the company name, product name, and symposium in the existing 2D-style online seminar with a fragmented composition centered on lecture materials. In addition, it was difficult to emphasize the branding of the symposium, and the visual of the lecturer was not emphasized, and to switch screens for each situation leading to opening and lecture, Q&A, and discussion. On the other hand, this system, which stands for 'Webinar 2.0', ▲ is a two-way live broadcast that connects overseas and domestic (local) in real time. ▲It can be used for both live and recorded transmission.▲ It is evaluated as overcoming the existing system because it can be viewed on any device with a url address sent via text and e-mail without installing a separate access program. Example of screen composition for each situation such as opening, lecture, Q&A, discussionWebinar 2.0 makes it possible to effectively insert a company, product, and symposium by constructing a virtual stage using 3D Max. In addition, screens for each situation are organized according to opening, lecture, Q&A, discussion, etc., so that the satisfaction of speakers and viewers is high, and the concentration of lectures is increased. The limitations of the existing webinar method, in which only one person appeared due to technical limitations, were solved. Webinar 2.0 provides free discussion and case sharing by assigning individual responsibilities sessions as small group meetings depending on the number of participants. Dailypharm's Webinar 2.0 is based on its own system and is conducted by its own manpower, and it is possible to configure various screens with up to 5 people instead of 1, based on a 3D virtual studio. An official from the Daily Farm webinar team said, “This year, more than 2,500 people attended and conducted a two-way live broadcast linking foreign F companies and Japan-domestic regions, and confirmed the system safety and technology. We are providing various types of solutions to pharmaceutical companies at home and abroad at this time when non face-to-face marketing is required." He added, "It is possible to emphasize both lecture materials and lecturer's visuals as if it were offline, and the picture quality of HD cameras is excellent. The web conversion of various seminars will be accelerated." 3D Studio
- Opinion
- [Editor’s View] Adjustment on choline alfoscerate coverage
- by Nho, Byung Chul Jun 11, 2020 06:23am
- Korea’s National Institute of Dementia (NID) found that 43 percent of senior citizens aged 60 to 69 fear dementia the most as far as disease goes. The number of patients with dementia in Korea has rapidly surged to date, and it is projected to exceed one million by 2024 and two million by 2039. And the cost of state-led dementia management is projected to see 15-fold jump from 8.7 trillion won in 2010 to 134.6 trillion in 2050. Due to the surge in dementia patient population and raised awareness of the disease, many of middle-aged people started demanding prescription by healthcare providers to prevent developing dementia. Accordingly, the prescription volume of cognitive function improving choline alfoscerate, used on patients with mild cognitive impairment (MCI), soared exponentially and claimed reimbursement of 325.5 billion won in 2019, making it a major prescription drug market. Noticing the sharp increase in choline alfoscerate reimbursement claim, however, Ministry of Health and Welfare (MOHW) has started reevaluating the adequacy of National Health Insurance (NHI) reimbursement on the medicine, while Health Insurance Review and Assessment Service (HIRA) is to convene Drug Reimbursement Evaluation Committee (DREC) to discuss the issue. The pharmaceutical industry sources report the government bodies are leaning towards designating the use of choline alfoscerate in a person with MCI as selective reimbursement with higher copayment rate. The groups opposing on providing reimbursement on choline alfoscerate claim the substance’ clinical efficacy is insufficient and excessive prescription is damaging the NHI finance. Nevertheless, the clinical experts say otherwise. Currently, a treatment for dementia does not exist; pharmaceutical giants like Pfizer, MSD and Lilly have invested on the pipeline immensely, but they gave up on it in the end. Although many hopeful studies spoke of seemingly ending the fight against dementia, not one dementia drug has received the U.S. Food and Drug Administration’s (FDA) novel drug approval since 2003. Considering the situation, the best means of treatment is to protect the cognitive function as much as possible from the MCI stage, right before developing dementia, and to constantly observe the progress of dementia. Finding the sign of dementia at early stage and treating it can significantly reduce the pain and burden of the patient’s family, in which the social cost can be lessened as well. And healthcare provider’s frustration surfaces from here. The prescribers are running out of options in cognitive function related drugs as donepezil’s indication to treat vascular dementia is removed, acetyl-L-carnitine’s indications were narrowed and now choline alfoscerate reimbursement would be adjusted. These changes are contradicting the Korean government’s emphasized goal to expand state-led dementia management. When an alternative option is unavailable for the mild cognitive impairment—a crucial stage to treat dementia early, increasing the patients’ copayment rate may immediately bring down the cost. But patients would miss the window to comprehensively control dementia development due to frequent visit to hospital, which eventually would result in treating even more dementia patients. And applying differentiated copayment rate by disease type would technically cut down reimbursement more and distort the clinical scene by inputting different disease code. Choline alfoscerate may have been criticized to have insufficient clinical evidence, but it has the highest number of evidences among cognitive function enhancing drugs. And in Russia, where the drug is designated as prescription use, had positive findings in 50 patients with amnestic mild cognitive impairment. Regarding the study, the researcher states choline alfoscerate has outstanding tolerability and confirmed safety, and recommends using the drug in people with high-risk of developing Alzheimer’s disease, such as people with mild cognitive impairment, as a preventive measure. Moreover, brain disease treatments struggle to find participants for large-scale clinical trial, so evaluating the drug’s benefit tends to be extremely difficult. A high number of reimbursement claims well depicts high social demand and the reality with no other option. The health authority should be advised that adjusting reimbursement on the drug and impeding prescription due to high cost could have the patients and their families to resort to untested folk remedy with growing anxiety and ultimately spend more money in the process.
- Company
- A contract for all items with Leo/Baekje has been signed
- by Jun 11, 2020 06:22am
- A contract for exclusive sales of all items with a global pharmaceutical company and a domestic drug distributor has been concluded. On the 8th, Leo-Pharma (CEO Jung-beom Shin) and Baekje (CEO Dong Gu Kim) announced on the 9th that they have signed a distributor service contract for Leo-Pharma’s dermatology products at the headquarters of Baekje Pharmaceutical. Under this agreement, Baekje will be in charge of domestic distribution of all items for the treatment of skin diseases possessed by Leo Pharma, such as Enstilum Foam, Daivobet, Xamiol, and Protopic(0.1%, 0.03%) for three years from July. Through the signing of this contract, the two companies will announce the excellence of the product power of Leo-Pharma, a special company in skin disease treatment, and will lead the domestic drug market by enhancing competitiveness based on Baekje’s excellent local distribution network, product sales force, and real-time data management system. In particular, this agreement is noted in that it is the first distributor agreement for all products between a domestic pharmaceutical distributor and a global pharmaceutical company. Baekje expects that the domestic distribution industry will be able to grow significantly through partnerships with global companies. Currently, Baekje has an expedited delivery system that can be procured within 24 hours nationwide with an extensive distribution network consisting of 9 distribution centers and 20 branches nationwide, multiple pharmacy counterparts, and partner distributors. CEO Jung-beom Shin said, "Partnership with Baekje with excellent distribution network in Korea, rapid delivery, and real-time data management system is the best choice for both companies. We will lead the further development of treatment for domestic skin diseases such as psoriasis and atopic dermatitis through the partnership with Baekje with a deep understanding of the domestic pharmaceutical market." Dong Gu Kim, CEO of Baekje said “During the past 70 years, we have been striving to provide better medicines and services under the mission of 'Providing the medicines we need immediately'.” Also he added, "Baekje has sufficient capacity for a distributor service as well as a third-party logistics service, and it will have a greater synergistic effect in terms of cost reduction and efficiency in the future with Leo-pharma if it is provided together."
