- Company
- The first APDS drug 'Joenja' gets orphan drug status in KOR
- by Eo, Yun-Ho Jun 13, 2024 05:48am
- A rare disease treatment 'Joenja' has received orphan drug designation in South Korea. The Ministry of Food and Drug Safety (MFDS) states this through the report on the designation of Orphan Drugs. Joenja (leniolisib), developed by the Dutch company Pharming group, is the first treatment for activated phosphoinositide 3-kinase delta synd
- Company
- A growing trend of SC injections heats up competition
- by Son, Hyung-Min Jun 13, 2024 05:48am
- Pharmaceutical and biotech companies in Korea and worldwide focus on developing formulation modifications for anticancer agents. Following 'Tecentriq (atezolizumab)' SC (subcutaneous injection obtaining marketing authorization from the European Medicines Agency (EMA) in January, the R&D of 'Opdivo (nivolumab)' and 'Rybrevant (amivantamab)' is
- Company
- ‘Verify safety when using botulinum toxin for hair loss'
- by Nho, Byung Chul Jun 12, 2024 05:45am
- The market for hair loss treatment is growing day by day as hair loss, once considered a typical condition of middle-aged men, has become a general condition across all genders and ages. In particular, the market is being segmented across a wide age range and various lifestyles, and new treatments that complement the limitations of existin
- Company
- Autotelic Bio signs licensing agreement with Chinoin
- by Nho, Byung Chul Jun 12, 2024 05:45am
- Autotelic Bio announced on the 7th that it has signed an exclusive license and supply agreement with Chinoin Productos Farmaceuticos in Mexico to distribute ATB-101, a novel combination drug for the treatment of hypertension and diabetes. ATB-101 is a fixed-dose combination product comprising&160;of the hypertension drug ‘olmesartan’
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- Failed reimb negotiations for Lorviqua, was it for the best?
- by Eo, Yun-Ho Jun 12, 2024 05:45am
- After a long wait, the result was still a ‘no go.’ A solution does exist, but hesitation seems to be holding them back. The insurance reimbursement expansion for the 3rd-generation ALK anticancer drug Lorviqua to first-line therapy has become unclear again. Negotiations between Pfizer Korea and the National Health Insurance Service o
- Company
- Boryung wins the Pomalyst patent challenge for the 2nd time
- by Kim, Jin-Gu Jun 11, 2024 03:25pm
- Boryung won the second attempt to avoid the substance patent of ‘Pomalyst (pomalidomide),‘ a treatment for multiple myeloma. Despite winning the infringement trial for the same patent in 2021, Boryung had not released generic versions. It seems that Boryung changed the method of generic development and rechallenged the patent. The an
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- GC's Sanfilippo syndrome drug receives fast-track status
- by Son, Hyung-Min Jun 11, 2024 05:47am
- GC Biopharma announced on Tuesday that the U.S. FDA has granted Fast Track Designation for GC1130A, a treatment for Sanfilippo syndrome type A (MPS IIIA) that it has been co-developing with Novel Pharma. The fast-track designation follows the FDA's clearance of the Phase I investigational new drug (IND) application for GC1130A last month
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- 'Novel drugs·CDMO competitiveness↑'
- by Son, Hyung-Min Jun 10, 2024 05:41am
- Major biotech companies in Korea participated in the BIO International Convention (BIO USA 2024) and introduced their in-house competitiveness. Over 50 Korea-based companies attended the BIO USA 2024, held between June 3-6 in San Diego, United States. They sought opportunities to expand partnerships along with discussions for technology tr
- Company
- Chronic kidney disease drug ‘Kerendia’ can be prescribed
- by Eo, Yun-Ho Jun 10, 2024 05:41am
- ‘Kerendia,’ a treatment for chronic kidney disease, is now available for prescription after receiving approval for insurance reimbursement. According to industry sources, Bayer’s Kerendia (finerenone) has passed the drug committee (DC) of Big 5 tertiary general hospitals, including Seoul National University, Seoul Asan Hospital, and
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- Pharma company MRs illegally work for CSOs on the sideline
- by Lee, Seok-Jun Jun 10, 2024 05:41am
- Contract Sales Organizations (CSOs) are trending in the pharmaceutical industry. In the case of small and medium-sized pharmaceutical companies, the companies have been opting to use CSOs rather than their own sales departments, to the extent that their departments are disappearing with the expansion of CSO business. The smaller the com
