Celltrion Healthcare acquires Celltrion USA

Excerpt Celltrion Healthcare announced that it has decided to acquire a 100% stake in Celltrion USA in New Jersey for 18 billion won.   Article Summary Celltrion Healthcare has officially begun preparing to directly market its drugs in the US by acquiring Celltrion USA from Celltrion. Celltrion Healthcare and Celltrion believe the acquisition will help […]

Enhertu approved in the US as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer

Excerpt Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. Article Summary AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2-low (IHC […]

Samsung Bioepis’ Humira biosimilar approved both in high and low concentration in US

Excerpt The U.S. Food and Drug Administration (FDA) has approved a high concentration formulation biosimilar from Samsung Bioepis Co. Hadlima, which references Humira (adalimumab) from AbbVie. Article Summary Samsung Bioepis Co. high concentration (100 mg/mL) formulation biosimilar, Hadlima has been approved by The U.S. Food and Drug Administration (FDA). Hadrima is indicated for the treatment […]

Sanofi and Innovent Biologics enter strategic collaboration to accelerate development of oncology medicines and expand presence in China

Excerpt Sanofi and Innovent Biologics collaborate to accelerate the development and access of oncology medicines for cancer patients in China.  Article Summary Sanofi and Innovent Biologics announced a collaboration to bring innovative medicines to patients in China with difficult-to-treat cancers. Innovent is a leading biopharmaceutical company with strong clinical development capabilities and a broad commercial […]

WuXi Biologics Plans to Build a Comprehensive CRDMO Center in Singapore

Excerpt A cutting-edge, fully integrated CRDMO center of WuXi Biologics will be developed in Singapore, including a large-scale drug substance and drug product manufacturing facility. Article Summary With a 10-year investment plan worth USD$1.4 billion (S$2 billion), WuXi Biologics, a global leader in Contract Research, Development and Manufacturing (CRDMO), will expand its research, development, and […]

Samsung Biologics signs 426 billion won land purchase deal to build 2nd campus

Excerpt CDMO Samsung Biologics has signed a land purchase agreement with the Incheon Free Economic Zone (IFEZ) to create its second Bio Campus.  Article Summary Samsung Biologics signed a land purchase contract worth 426 billion won ($323 million) to build a second campus inside a free economic zone west of Seoul.  The deal signed between […]

LOTTE BIOLOGICS Signs MoU with MilliporeSigma for Strategic Partnership

Excerpt Lotte Group has named MilliporeSigma as its preferred bioprocess vendor to support its burgeoning US-based CDMO business. Article Summary LOTTE BIOLOGICS, new biologics business of LOTTE group, signed a Memorandum of Understanding (MoU) with MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, a leading science and technology company, outlining […]

Lonza to Establish Large-Scale, Commercial Drug Product Fill & Finish Facility in Stein (CH)

Excerpt Lonza to build a new large-scale, commercial drug product fill and finish facility to support customers across the entire product life cycle in Stein.  Article Summary Lonza, a global development and manufacturing partner to the pharma, biotech and nutrition industries, announced plans to construct a large-scale commercial drug product fill and finish facility in […]

Pre-filled syringe

WuXi Biologics Launches First Commercial Drug Product Facility for Pre-Filled Syringes

Excerpt WuXi Biologics launched the GMP operation of its new drug product facility DP5 located in Wuxi, China. Article Summary Wuxi Biologics, a global CRDMO service company, recently opened its DP5 facility in Wuxi, China. The facility is the ninth active facility in WuXi Biologics’ global network.   A continuous and steady isolator filling system […]

Newsletter Biologics

Prestige Biopharma announces International Non-proprietary Name for PBP1510

Excerpt Prestige Biopharma Limited, announced that its first-in-class antibody PBP1510 has acquired an International Nonproprietary Name (INN) of ‘Ulenistamab’ and was placed on the INN Recommended List by the World Health Organization (WHO). Article Summary Prestige Biopharma Limited first-in-class antibody has acquired an International Nonproprietary Name (INN) of ‘Ulenistamab’. INN-Ulenistamab, which is also known as […]

MVC Covid-19

Medigen applies for Australian vaccine approval

Excerpt Medigen Vaccine Biologics Corp (高端疫苗) has applied to the Australian medicines regulator for provisional approval of its COVID-19 vaccine. Article Summary Medigen Vaccine Biologics Corp applied to Australian medicines regulator for provisional approval of the COVID-19 vaccine and has delivered the necessary documents to the Australian Therapeutic Goods Administration (TGA), but did not say […]

ILIAS Biologics signed a collaborative research agreement with JW Pharmaceutical

Excerpt JW Pharmaceutical had signed a joint research contract with bioventure ILIAS Biologics to develop a targeted exosome treatment equipped with a new low molecular weight anticancer drug. Article Summary ILIAS Biologics and JW Pharmaceutical signed a collaborative research agreement to develop an exosome-based small molecular anti-cancer treatment together.    This agreement was announced after […]