Otsuka and Lundbeck Announce U.S. FDA Acceptance of New Drug Application for Aripiprazole

Excerpt U.S. FDA accepts the NDA for Otsuka and Lundbeck codevelop aripiprazole 2-month, ready-to-use, long-acting injectable, a medication administered for the treatment of schizophrenia in adults and for maintenance monotherapy treatment of bipolar I disorder in adults    Article Summary  Otsuka America Pharmaceutical, Inc., (Otsuka) and H. Lundbeck A/S (Lundbeck) announce the U.S. Food and […]

Juniper Biologics Establishes Global Headquarters in Singapore

Excerpt Juniper Biologics’ continued expansion of its global operations and established global headquarters investment will support the growth and innovation of Singapore’s pharmaceutical sector.    Article Summary  Juniper Biologics, a science-led speciality healthcare company focused on commercializing novel therapies, announced the establishment of its Global Headquarters in Singapore, from where the Company will continue the expansion […]

European Commission approves Roche’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss

Excerpt Roche’s Vabysmo Phase III data shows people with nAMD and DME who received treatments up to every four months achieved similar outcomes compared to receiving treatment every two months with aflibercept.    Article Summary  Vabysmo® (faricimab) developed by Roche was approved by the European Commission (EC) for the treatment of neovascular or ‘wet’ age-related […]

AbbVie announced positive results of clinical trials Phase 3 evaluating an NSAID treatment for active psoriatic arthritis

Excerpt AbbVie’s long-term data analyses of KEEPsAKE 1 and 2, Phase 3 trials evaluating SKYRIZI® (risankizumab, 150 mg) in adult patients with active psoriatic arthritis showed positive results and reduced symptoms over a 100 week period.   Article Summary AbbVie announced new, long-term data analyses of KEEPsAKE 1 and 2, Phase 3 trials evaluating SKYRIZI® […]

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 […]