Drug Research
Bora secures FDA approval for CDMO services
Bora, a contract development and manufacturing organization (CDMO) that specializes in modified release (MR) and solvent production, has reported a successful FDA general inspection for its facility in Zhunan, Taiwan.
The publicly listed company recently hosted the site’s fifth successful...
Articles
Particle analysis: Growing demand with biologics
The development and introduction of new biological drug substances has been on the rise, and so have the regulatory requirements placed on these often life-saving products. At the same time, innovative analytical technologies have been developed that offer new...
Drug Research
New calcium ingredient with improved flow and compactability properties
At this year’s CPhI Worldwide, mineral producer Omya will launch its new Calcipur® DC range, which comprises seven different grades of high-purity, directly compressible and free-flowing Natural Calcium Carbonates. Thanks to improved processing properties, the ingredient is ideally suited...
Drug Research
Cancer Research UK and Hummingbird Bioscience join forces to advance novel antibody drug into clinical trials
Cancer Research UK, the world’s leading cancer charity, and Hummingbird Bioscience, an innovative systems-biology enabled biotechnology company, have announced a partnership to develop Hummingbird’s anti-HER3 antibody drug, HMBD-001, for the treatment of people with HER3 driven cancer.
Under the terms...
Drug Research
Vesselon Acquires FDA-Approved Lipid Microsphere Drug Imagent For Therapeutic Platform
Vesselon, an oncology therapeutics company, announced the acquisition of an FDA-approved drug Imagent®. Vesselon will use Imagent to create novel therapeutic complexes in four classes of cancer drugs: cytokines, oncolytic viruses, monoclonal antibodies, and nucleic acid constructs.
Vesselon incorporates Imagent...
Drug Research
FDA Approves Daiichi Sankyos TURALIO pexidartinib for the Treatment of Select Patients with TGCT a Rare and Debilitating Tumor
Daiichi Sankyo Company, Limited announced that the U.S. FDA approved TURALIO™ (pexidartinib) as the first and only treatment for adult patients with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery.
TGCT is...
Drug Research
LexaGene Approved by CDC and FDA Antibiotic Resistance Isolate Bank to Receive Samples
LexaGene Holdings, Inc, a biotechnology company that develops genetic analyzers for pathogen detection and other molecular markers, announced that it has been recognized by the Centers for Disease Control and Prevention (CDC) and the FDA Antibiotic Resistance (AR) Isolate...
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