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- Read more about FDA clears icometrix’ image quantification software
The health tech company icometrix obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for their image quantification software. Outside the US, the software is already extensively used and offered via MSmetrix.
- Read more about Glucose changes a traditional Chinese medicine into powerful anticancer medicine
More than 20 years ago, a billboard in China piqued the interest of a chemical biologist. It endorsed an extract from the plant known as the "thunder god vine" as an immunosuppressant. A brief review of published research revealed that the extract's key ingredient, the small molecule triptolide, had been identified 20 years before that billboard ad, and it could stop cells from multiplying.
- Read more about Indoor dust with antibacterial components could lead to antibiotic resistance
Antibiotic-resistant bacteria, known as superbugs, pose a major public health threat. Some officials have even warned of a post-antibiotic, and sicker, era. To better understand the problem, researchers have been piecing together its contributing factors.
- Read more about Neutron crystallography aids in drug design
Neutron crystallography is an important complementary technique to X-ray crystallography since it provides details of the hydrogen atom and proton positions in biological molecules. Furthermore, as neutrons are a non-destructive probe, the resulting structures are free from radiation damage even at room temperature.
- Read more about Evoke Pharma present Positive Non-Clinical Pre-NDA Meeting with FDA for Gimoti
Evoke Pharma, Inc. announced that it has completed a pre New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding its lead product candidate, Gimoti™, its patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women. The focus of this pre-NDA meeting with the FDA was the content of the regulatory, chemistry, manufacturing, and control (CMC), and non-clinical sections of the Company's planned 505(b)(2) NDA for Gimoti.
- Read more about FDA Accepts sBLA, Assigns Priority Review and Grants Breakthrough Therapy Designation to Merck’s KEYTRUDA
Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1, with a PDUFA, or target action, date of Dec. 24, 2016. Additionally, the FDA granted Breakthrough Therapy Designation for this indication. Merck has also submitted a Marketing Authorization Application to the European Medicines Agency for this indication.
- Read more about Lysozyme can be new marker for Alzheimer's disease
New research suggests that Alzheimer's disease may trigger increased expression of an enzyme called lysozyme, which attempts to counteract amyloid build-up in the brain.
- Read more about Matinas BioPharma's MAT2203 Granted QIDP and Fast Track Designations by U.S. FDA
Matinas BioPharma Holdings, Inc. announced that the U.S. Food and Drug Administration (FDA) has designated the Company’s lead drug candidate, MAT2203, as a Qualified Infectious Disease Product (QIDP) with Fast Track status for prophylactic treatment of invasive fungal infections due to immunosuppressive therapy.
- Read more about Soligenix got New Composition of Matter Patent for Dusquetide Analogs
Soligenix, Inc. announced that the United States (US) Patent Office granted the patent entitled “Peptides for Treating and Preventing Immune-Related Disorders, Including Treating and Preventing Infection by Modulating Innate Immunity.” The newly issued patent claims composition of matter of analogs of dusquetide (research name: SGX94), the Company’s lead development compound. Dusquetide recently demonstrated positive preliminary results in a Phase 2 clinical trial for the treatment of oral mucositis in head and neck cancer patients. The recently issued patent broadens the protection around dusquetide and provides further protection for the underlying innate defense regulator (IDR) technology platform. Similar claims have been granted and/or are being pursued in jurisdictions worldwide.
- Read more about Alvogen introduce first generic equivalent of Copaxone in Europe
Alvogen announced the launch of RemurelTM (glatiramer acetate), the first generic equivalent of CopaxoneTM in Central and Eastern Europe. The product will be marketed as a once daily subcutaneous 20 mg prefilled syringe under the brand name RemurelTM and will be launched throughout all Central and Eastern European countries from September 2016 onwards.

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