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- 2025-12-27 05:15:26
- Company
- Newly approved JAK inhibitor Rinvoq to apply for reimburseme
- by Eo, Yun-Ho Jun 15, 2020 06:17am
- The fourth Janus kinase (JAK) inhibitor in Korea Rinvoq is swiftly pursuing the healthcare reimbursement listing. According to the pharmaceutical industry sources, AbbVie Korea submitted the healthcare reimbursement application for Rinvoq (upadacitinib) on June 4, immediately after receiving the market approval. Considering Pfizer’s Xeljanz (tofacitinib) and Lilly’s Olumiant (baricitinib) in the same class are already listed, Rinvoq is most likely to take the pricing negotiation-exempted track by accepting the weighted average pricing for an alternative drug. The third JAK inhibitor Smyraf (peficitinib) by Astellas is also on the same track. In the setting of autoimmune disease, the interest on JAK inhibitors has been growing as a first oral option with confirmed effect equal to anti-tumor necrosis factor (anti-TNF) drugs. However, the JAK inhibitors’ impact in the market has not been too prominent as other biologics. Compared to the market leader anti-TNF drug and popular anti-interleukin drugs, JAK inhibitors’ indications are limited to rheumatoid arthritis and to some disease. It also means, JAK inhibitors have potential to grow. The first-in-class Xeljanz has expanded its indication to treat ulcerative colitis and psoriatic arthritis, and other follow-on drugs have ongoing studies to expand indication in autoimmune diseases like atopic dermatitis, Crohn’s disease and ankylosing spondylitis. When Smyraf and Rinvoq are listed for reimbursement, the competition between the two pharmaceutical companies would intensify. Rinvoq has confirmed its treatment effect in 4,443 patients with severe level of active rheumatoid arthritis through five Phase III SELECT trials (SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE and SELECT-EARLY). The result found using Rinvoq alone or with conventional synthetic DMARD (csCMARD) showed lower disease activity and improved remission rate, compared to using a placebo, methotrexate or Humira (adalimumab).
- Company
- Takeda Korea, announces massive ERP
- by An, Kyung-Jin Jun 15, 2020 06:16am
- The aftermath for the sale of the Takeda’s business division began. According to the industry on the 12th, Takeda Korea held a town hall meeting for all employees this morning, and had a time to share information related to the sale of the business division. This is a follow-up procedure following the formalization of a contract to sell 18 copyright of medicines sold in 9 countries in Asia Pacific, including Korea, Australia, Hong Kong, Macau, Malaysia, Philippines, Singapore, Taiwan, and Thailand, to Celltrion. According to an internal employee who attended the Town Hall meeting, Takeda Korea officially formulated the position that it would be inevitable to operate the ERP, without the 'employment succession' of Korean subsidiaries included in the terms of the business transfer agreement. The specific ERP-related schedule, implementation scale, and conditions have not yet been confirmed. Management announced that it would notify employees of ERP-related progress in consultation with the union. This contract includes 12 kinds of specialized medicines such as 'Nesina', 'Actos' and 'Edarbi' in charge of the Primary Care Division (PC BU), and six generic drugs such as 'Whitetuben' and Albothyl in charge of the Consumer Healthcare Division (OTC BU). It is known that there are about 70 employees belonging to the two divisions. About one-third of the 210 employees of Takeda Korea are applied to ERP. "The ERP fact was formalized at the town hall meeting this morning," said an official from the KDPU Takeda Branch. ERP notices embarrassed the internal staff. After Takeda's merger and acquisition of Shire, there were rumors that it would sell PC and OTC business division in the Asia-Pacific region to reduce debts, and similar contracts were signed in other regions of the GEM BU, where Korean subsidiaries belong, but the succession of employment to most employees was guaranteed. An official from the union said, “In other countries included in this contract, such as Australia and the Philippines, employment success has been achieved. However, Korea is the only one to carry out ERP, and it is expected that a detailed discussion will be possible from now on since the company has to notify the union 50 days before the restructuring by agreement.”
- 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.
- 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.”
- 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."
- 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
- 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."
- Company
- Surveillance or global standard? Dispute over SAP by MSD
- by Jun 11, 2020 06:22am
- The employees of MSD Korea are strongly opposing against the management planning to implement tightened self-assurance program (SAP) guideline. The company’s sales department is infuriated with the Korean management adhering to the global standard, regardless of the employees constantly demanding for flexible amendment. According to the pharmaceutical industry sources on June 8, MSD Korea has recently introduced the new SAP to its employees. Two key changes have been made; first, the subject for SAP would be expanded from ‘a product presentation of five or more persons’ to ‘two or more persons.’ As a result, all product presentation, except for one-on-one, would be subject for SAP. And the three-hour pre-notification of accompanying SAP agent issued to the monitored sales person would be removed. However, to minimize the disturbance, the monitored sales person would be notified via a phone call 45 minutes prior to the scheduled meeting. The new SAP guideline would come in effect from June 30. New SAP guideline announced by MSD Korea If a healthcare provider cancels meeting right before the time, despite the pre-notified SAP, prospective product presentations for the healthcare provider may get limited. The company’s sales employees are resisting the changes. Although the employees urged for more adaptable and localized guidelines, the SAP was rather strengthened and started restricting the sales activity. In other words, when a scheduled event is canceled, the damage would directly penalize the responsible sales employee. SAP is a compliance program (CP) MSD Korea enforces. Since the financial profit expenditure report system was mandated, the company implemented the CP to monitor employees complying with the business ethics code. With an external agent (‘coordinator’) accompanying to an event for healthcare provider account, the company monitors the sales employee providing appropriate venue, food and beverage and sharing appropriate conversations during product presentation. The program started off with a good objective, but it sparked a dispute between the management and employees last year. The employees reproached as the program invasively watched over employees and a third party listening to the conversation between the healthcare provider and employee during the product presentation raised an issue of invasion of privacy. Some employees received a note of warning from the management, because of what a healthcare provider said during the presentation. Regardless, the company management claims the changes in SAP is unavoidable due to the global standards. MSD Korea official explained, “SAP is applied to every small-scale meeting, consisting of two to 25 persons, convened by all global branches of MSD,” and “from the beginning, the SAP was applied to all events with two or more persons and no pre-notification. But it only got be expanded throughout APAC region from May 1.” The official added, “Monitoring a canceled event is not to penalize the employee, but to analyze the cause from different angles and to proactively seek improvements.” Summing up the management’s stance, the new changes are their effort to actually match the exceptional standard the SAP had in Korea so far to the global level of standard. The company elaborated the details internally, but the employees refuted that it was “an unacceptable explanation.” Apparently, some employees have started questioning the management’s leadership. A sales person at MSD Korea pointed out, “The company lays down unfavorable global guideline to the employees, and applies localized standard in areas the employees want the global standard to be applied.” Another sales person criticized, “The management of MSD Korea disregards the domestic situation but rather blindly accepts the order to follow the global standard. Flexibly and reasonably improving irrational guidelines is also a key role the management has to play.” The industry also shakes its head on MSD Korea’s SAP. Most of multinational pharmaceutical companies skip on SAP but reinforces CP training instead. An industry insider noted, “Even if the company follows the global guideline, flexible standard fitting to Korean environment should be used,” and “the company should also try to fathom the difficulties the employees feel on job and reflect needed changes accordingly.”
- Company
- HPV vaccine Gardasil9 eligible age to extend up to 45
- by Eo, Yun-Ho Jun 10, 2020 06:12am
- The vaccination eligible age for the human papillomavirus (HPV) vaccine Gardasil9 would be extended in Korea as well. Pharmaceutical industry sources reported, MSD has submitted an indication extension application to Ministry of Food and Drug Safety (MFDS) to vaccinate both female and male in age 27 to 45. The approval may be cleared in this year at earliest. Gardasil9 covers the most number of HPV types, in which it added five more types of HPV (Type 31, 33, 45, 52, 58) from the original Gardasil (Type 6, 11, 16, 18). In Korea, the vaccine is used in female and male aged from nine to 26 to prevent HPV-related cervical cancer, vulva cancer, vaginal cancer and anal cancer. The indication to vaccinate people aged from 27 to 45 was approved in the U.S. two years ago. In a clinical study on 3,200 women aged from 27 to 45, Gardasil9 demonstrated 88 percent prevention effect in HPV-induced cervical cancer. The study also confirmed the vaccine’s effect on male user as well. Meanwhile, the number of patients with cervical cancer is surging in Korea. Health Insurance Review and Assessment Service (HIRA) explained, the number of patients with cervical cancer in 2015 was at 54,603. But the figure soared by 15% in 2019 with 63,051 patients. In the same span of time, the number of patients in 20s and 30s skyrocketed by 47%. The cervical cancer patient size in the age group of 40s and 50s was also increased by 7 percent.
- Company
- Medtronic Korea joined the KDPU
- by An, Kyung-Jin Jun 10, 2020 06:09am
- A union was established in Medtronic Korea, an Irish medical device company. According to the industry on the 9th, Medtronic Korea recently launched an in-house union and joined the new branch of the Korea democratic Pharmaceutical Unions. The union was founded on May 28th. The union sent official letters to the company to formalize the establishment of the union, and began to work in earnest. Medtronic Korea is a 100% subsidiary of Medtronic International Technologies, a global healthcare company headquartered in Ireland. It has entered more than 150 countries around the world and earns more than $30 billion in annual sales. The Korean corporation was established in June 2000 for the purpose of importing and selling medical products such as medical devices, trade, and brokerage. Recently, it has focused on four business areas: Cardiac and Vascular Group, Diabetes Group, Minimally Invasive Therapies Group, and Restorative Therapies Group. The reason for the sudden establishment of a union in Medtronic Korea, which had not even had a labor-management council for 20 years in Korea, is the spread of employment anxiety. Medtronic Korea was rumored to be restructuring at a Japanese corporation last year, and the sudden change of CEO Heo Joon, who had worked at a Korean corporation for about six years, began to create anxiety about the reduction of manpower among employees. After February, Global performance has deteriorated due to the worldwide spread of COVID-19, and it is confirmed that the internal agitation increased due to the freezing of wages and the guidelines for holding the promotion at the head office. As of the 9th, Medtronic Korea union secured 55 members. A little over 10% of the total number of employees. As of the 9th, Medtronic Korea union secured 55 members. A little over 10% of the total number of employees. The union executive has the aspiration to increase the number of union members and represent the opinions of employees by actively proposing the need for unions. Chief of Korea democratic Pharmaceutical Unions of Medtronic Korea, Kwang-sun Bae, said that due to changes in the company's management policy, the work load of employees is increasing and Work and Life Balance is gradually deteriorating. Also, he added that it was time for the union to come and speak for the opinions of the employees, and we want to change the negative perception of unions and establish an in-house atmosphere that guarantees employment security. The KDPU is a union of pharmaceutical companies that was launched in 2012 under the Federation of Korean Chemical Workers’ Union. At that time, 8 companies including ▲Novartis Korea ▲Takeda Pharmaceuticals ▲Sanofi-Pasteur ▲AstraZeneca Korea ▲Pfizer Korea ▲Zuellig Pharma ▲BMS Korea ▲Janssen Korea participated as founding members. Afterwards, ▲Baxter Korea ▲Merck Korea ▲Ferring ▲Allergan Korea ▲Fresenius Kabi Korea ▲Novonordisk Pharmaceuticals ▲Fresenius Medical Care ▲Abbvie Korea ▲Kolon Pharmaceutical ▲Astellas Korea ▲MSD Korea ▲Mundipharma ▲Galderma ▲Zuelligpharma Solutions Service ▲Korea Lundbeck ▲Zanovex Korea joined and increased to 25 branches, ▲Pfizer Korea ▲Janssen Korea ▲Novonordisk ▲AstraZeneca ▲Merck Korea ▲Novartis Korea, including Sanofi-Pasteur, have withdrawn. With the joining of Medtronic Korea, the number of branches increased to 18.
