- Company
- Ildong Idience’s Venadaparib IND approved in China
- by Kim, Jin-Gu Dec 13, 2021 05:56am
- On the 10th, Ildong Holding’s new drug development subsidiary Idience announced that its IND(Investigational New Drug) application for ‘Venadaparib (IDX-1197)’ for gastric cancer patients was approved by China’s National Medical Products Administration. Venadaparib, a PARP (ADP-ribose polymerase) inhibitor, is a new targeted therapy c
- Company
- GC Pharma, stopped discussing consignment of Janssen vaccine
- by Kim, Jin-Gu Dec 13, 2021 05:56am
- GC Pharma announced on the 9th that it will suspend discussions on Janssen's consignment production of the COVID-19 vaccine. GC Pharma said it has suspended discussions with Johnson & Johnson on consignment production of vaccines as of today (9th). It has been about four months since GC Pharma announced in August that it will produce Janss
- Company
- PH3s of Daewoong’s SGLT-2i antidiabetic near completion
- by Kim, Jin-Gu Dec 10, 2021 05:53am
- 1i Clinical trials for the new antidiabetic SGLT-2 inhibitor ‘Enavogliflozin’ in development by Daewoong Pharmaceutical are gaining speed. One of the three Phase III clinical trials is already complete, and the remaining two are also nearing their final stages after completing patient recruitment. With such progress, the industry expect
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- ₩150 bil export of Celltrion’s Regkirona on track to
- by Kim, Jin-Gu Dec 10, 2021 05:51am
- Export of Celltrion’s COVID-19 antibody treatment ‘Regkirona (regdanvimab)’ is now fully on track. On the 9th, Celltrion Healthcare announced that it had completed shipping 150,000 vials of the initial load of Regkirona for 9 countries in Europe. Celltrion Healthcare has been discussing exporting Regkirona with 70 countries. In addi
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- Signifor Lar discontinued in the lacking acromegaly Tx mkt
- by Eo, Yun-Ho Dec 9, 2021 05:59am
- A considerable blow is expected in the already lacking acromegaly treatment market with the discontinuation of one of its very few available options. According to industry sources, the domestic supply of the acromegaly treatment ‘Signifor LAR (pasireotide)’ has been discontinued. The decision was made as Novartis sold the rights to Sign
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- Hanmi’s poziotinib enters final phase for commercialization
- by Kim, Jin-Gu Dec 8, 2021 06:00am
- ‘Poziotinib,’ a drug licensed out by Hanmi Pharmaceuticals, is entering its last phase for authorization in the US. The variables that remain to approval are the US FDA’s interpretation of the clinical trial results and the on-site investigations on the company’s production and manufacturing facilities. If these progress as planned, H
- Company
- Hanmi's lung cancer drug Poziotinib has been applied for NDA
- by Kim, Jin-Gu Dec 8, 2021 06:00am
- The U.S. FDA marketing approval process for Poziotinib, a new lung cancer drug developed by Hanmi Pharmaceutical, has begun. Hanmi Pharmaceutical's partner Spectrum announced on the 6th (local time) that it has submitted an NDA to the U.S. Food and Drug Administration (FDA). This indication is NSCLC with local progression and metastatic H
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- The kit for precocious puberty in Korea has been stopped
- by Moon, sung-ho Dec 8, 2021 06:00am
- The increase in the number of precocious puberty patients in Korea is unusual. As the number of patients, which was 80,000 in 2015, exceeded 130,000 in 2020, there are opinions that it should now be recognized as a social problem. In response, some in the medical community and clinical sites predict that the number of precocious puberty patie
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- Dire need for a rational pricing system for new drugs
- by Nho, Byung Chul Dec 7, 2021 05:57am
- Improving the drug pricing system through social consensus has been proposed as a prerequisite for the government to achieve the 60 trillion won export and 300,000 job creation in the biohealth industry as one of its 3 new growth engine industries. In addition to the primary purpose of fostering the biopharmaceutical industry to create
- Company
- Moderna tackles the Omicron variant with booster shots
- by Dec 7, 2021 05:57am
- ” We are developing three vaccine strategies to rapidly respond to the much-concerned Omicron variant. We plan to soon release a booster shot that is most appropriate for the Omicron variant.” Randall N. Hyer, senior vice president of Global Medical Affairs at Moderna, replied so to an inquiry about the company’s plans on responding to
