AbGenomics International, a biopharmaceutical company, has obtained FDA agreement on Its Phase 2 clinical trial plans of the novel autoimmune therapeutic candidate, AbGn-168H. The current Phase 2 AbGn-168H trial will be a multicenter, ...
Tags: FDA approval, psoriatic, clinical trial, pharmaceutical product
The US Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) of Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company for Tradjenta (linagliptin) tablets for use as add-on therapy to insulin. ...
Tags: FDA, sNDA, pharmaceutical product, clinical development
CZ BioMed has signed a worldwide licensing agreement with South Texas Technology Management (STTM) on behalf of The University of Texas Health Science Center San Antonio and The University of Texas System Board of Regents for exclusive use ...
Apexigen, a biopharmaceutical company, has announced the filing of investigational new drug (IND) application for APX001, also known as SSS07, by its partner 3SBio [SSRX] of Shenyang, China. With the IND approval, APX001/SSS07 will be ...
Tags: IND approval, clinical trials, autoimmune diseases, inflammatory diseases
Lorus Therapeutics has received first Japanese patent for its small molecule anticancer drug LOR-253 that will provide Lorus with exclusive rights to LOR-253 in Japan until 2023. The patent will provide protection for LOR-253 composition ...
The US Food and Drug Administration (FDA) has granted final approval to Mylan Pharmaceuticals' abbreviated new drug application (ANDA) of Modafinil tablets USP,100 mg and 200 mg. Modafinil USP,100 mg and 200 mg tablets are generic ...
Qualitest Pharmaceuticals, a generic pharmaceutical company, has won the US Food and Drug Administration (FDA) approval for abbreviated new drug application (ANDA) for Levetiracetam extended-release tablets, 500mg and 750mg. The ...
The European Patent Office has granted patent No.1,793,809 to SCOLR Pharma's oral modified release ibuprofen formulation. The oral modified release ibuprofen formulation is based on the company's CDT controlled delivery technology ...
Astellas Pharma and Medivation have announced the submission of marketing authorization application (MAA) to the European Medicines Agency (EMA) for enzalutamide to treat metastatic castration-resistant prostate cancer in men who have ...
Tags: enzalutamide, metastatic castration-resistant prostate cancer
AcelRx Pharmaceuticals has received a US patent which provides intellectual property protection for sufentanil NanoTab based products through late 2030. The patent entitled, Small-Volume Oral Transmucosal Dosage Forms, describes a method ...
Tags: US patent, clinical technology, pharmaceutical product
The Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has recommended Orphan Drug Designation (ODD) for Erytech Pharma's investigational product Enhoxy. The drug, which is used to treat sickle cell ...
Tags: orphan drug designation, Erytech product, debilitating disease
The US Food and Drug Administration (FDA) has approved Genentech's Perjeta (pertuzumab) for the treatment of HER2-positive metastatic breast cancer (mBC), in combination with Herceptin (trastuzumab) and docetaxel chemotherapy. The ...
Tags: FDA approval, breast cancer, clinical study, pharmaceutical product
Mylan Pharmaceuticals, the Canadian subsidiary of Mylan, has gained Health Canada approval for Mylan-Bosentan Tablets, 62.5mg and 125mg. The generic version of Actelion's Tracleer is indicated for pulmonary arterial hypertension. Mylan ...
Tags: mylan-bosentan tablet, approval, pharmaceutical product
Lupin Pharmaceuticals has received FDA approval for Suprax (Cefixime) capsules 400mg and will initiate the shipment of the product shortly. The approval will expand Lupin's range of Suprax dosage forms available to treat the approved ...
CytRx Corporation has received a patent covering for its tumour-targeting linker platform technology and pharmaceutical compositions from the European Patent Office (EPO). The company also revealed aldoxorubucin as the new generic ...
Tags: Patent, pharmaceutical technology, pharmaceutical product