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Following Positive Results of Phase III TULIP Trial: FDA Accepts Byondis’...

The U.S. Food & Drug Administration (FDA) has accepted Byondis' submission of a Biologics License Application (BLA) for trastuzumab duocarmazine (previously known as...

HER2, Trastuzumab and the Development of Novel Antibody-drug Conjugates

In the mid-1970s, scientists discovered that certain genes, when mutated, can cause cancer.  Based on this observation they theorized that by targeting these oncogenes,...

Sutro’ STRO-002 Receives FDA Fast Track Designation for Patients with Advanced...

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for STRO-002. The investigational drug, being developed by Sutro Biopharma, is a...

Daiichi Sankyo Reaffirms Long-term Goals with Increased Investment in ADCs

With the launch of fam-trastuzumab-deruxtecan-nxki (Enhertu®), Daiichi Sankyo's first antibody-drug conjugates, coupled with a strong pipeline of innovative ADC, the company has established a...

FDA Approves Loncastuximab Tesirine in Treatment of Relapsed or Refractory Diffuse...

Diffuse large B-cell lymphoma (DLBCL), a form of non-Hodgkin lymphoma, is the most common form of blood cancer. Lymphomas occur when cells of the...

Lonza Opens News Facility for ADC Payload Manufacturing Following a Tailored...

Lonza, a specialty Contract Development and Manufacturing partner for biopharmaceutical companies, inaugurated the first of two manufacturing suites for antibody-drug conjugate (ADC) drug-linker (payload)...
Photo: Exhibition - Bird's Eye Overview. The 15th annual PEGS: The Essential Protein Engineering Summit brought more than 2,700 world-renowned experts, visionaries, and influencers from top pharma, biotech, academic, and government institutions to the Seaport World Trade Center in Boston, MA this past April 8-12, 2019, setting record-breaking attendance. Photo courtesy: CHI/PEGS

PEGS: Novel Technology to Enhance Cell Line Productivity and Expand the...

During the 16th Annual PEGS Boston Virtual Conference & Expo, which took place between August 31 – September 4, 2020, Gregory Bleck, Ph.D., Global...
Featured Image Courtesy: Byondis Biopharmaceuticals (previously Synthon Biopharmaceuticals, Nijmegen, The Netherlands.

New Phase I Study Investigates [Vic-]Trastuzumab Duocarmazine + Niraparib in HER2-Expressing...

As part of a new study focusing on advanced targeting human epidermal growth factor receptor-2 (HER2-) expressing cancers, including locally advanced or metastatic solid...

ADC Therapeutics On Track to File BLA for Loncastuximab Tesirine for...

This week Swiss-based ADC Therapeutics, a late clinical-stage oncology-focused biotechnology company pioneering the development of antibody-drug conjugates (ADCs) for patients with hematological malignancies and...
On October 16, 2019 Novocodex Biopharmaceuticals, a subsidiary of Zhejiang Medicine, and WuXi Biologics signed a strategic partnership for Phase III clinical trial production of ARX788 as well ongoing large-scale commercial production of the innovative antibody-drug conjugate.

WuXi Biologics Opens New Facility to Supports Novocodex ADC Manufacturing

Earlier this month China-based Contract Research Organization (CRO) WuXi Biologics started commercial production at the company's new Current Good Manufacturing Practice (cGMP)-approved DP3 bulk...

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