Bio-Pharm

"Passed FDA Inspection in One Go, Following EMA Certification"

STGen Bio Secures FDA cGMP Approval for Songdo Bio Plant

STGen Bio announced on the 14th that its Songdo Bio Plant has received current Good Manufacturing Practice (cGMP) approval from the U.S. Food and Drug Administration (FDA). The approval covers the…

Lack of evidence regarding strain theft

Hugel Wins Botulinum Toxin Lawsuit Against Medytox

Hugel has won the final ruling in the botulinum toxin-related lawsuit it faced against Medytox in the United States International Trade Commission (ITC). The ruling clears Hugel of allegations that it…

Following Previous Licensing Deals with BMS and Vertex, New Partnerships Expected

Orum Therapeutics Sets Goal of USD 70 Million by 2026

Orum Therapeutics, a biotechnology company preparing for its KOSDAQ listing, announced its goal to achieve sales of KRW 93 billion (USD 69.9 million) by 2026. In a media conference call held on the…

Aiming for Approval of Four Products, by the End of the Year

Celltrion Establishes Subsidiary in Vietnam

Celltrion has officially entered the ASEAN market by establishing a local subsidiary in Vietnam. Following the company's tradition of having its top executives spearhead entry into key markets,…

YouTube Ads Begin Nationwide on the 26th, TV and OTT Platforms to Follow Next Month

Celltrion Launches Zymfentra Media Campaign in the U.S.

Celltrion announced on the 27th that it has launched a media campaign in the U.S. for "Zymfentra," the world’s only infliximab subcutaneous (SC) formulation for treating autoimmune diseases. The…

Now present in 46 countries, with launches in 9 countries

HK inno.N's K-CAB Receives Approval in Malaysia

HK inno.N's novel drug for gastroesophageal reflux disease (GERD), K-CAB, has received marketing approval in Malaysia. HK inno.N announced on the 26th that K-CAB tablets (ingredient: Tegoprazan) were…

"Enhancing Antibody Cancer Treatment and Enabling High-Quality Protein Production"

Samsung Biologics Unveils Two New CDO Platforms

Samsung Biologics announced on the 25th that it has introduced two new Contract Development Organization (CDO) platforms at the ‘2024 Bio Process International (BPI)’ conference, a global bio…