Navidea Biopharmaceuticals has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for the approval to market and sale Lymphoseek Injection for sentinel lymph node (SLN) detection in patients ...
Ocera Therapeutics (Nasdaq:OCRX) today announced that it has entered into a Technology Transfer and License Agreement with the Roche Group, including the Research and Early Development arms of both Genentech and Roche, for rights to its ...
Tags: Ocera Therapeutics, Roche, Macrocyclic Template Chemistry
VBL Therapeutics has secured fast track status from the US Food and Drug Administration (FDA) for its lead oncology drug VB-111, for prolongation of survival in patients with Recurrent Glioblastoma Multiforme (rGBM). VB-111 was already ...
Collegium Pharmaceutical, a specialty pharmaceutical company, has announced that a patent has been issued by the US Patent and Trademark Office (USPTO) covering its Oxycodone DETERx formulation. Additionally, an application has been ...
The European Medicines Agency (EMA) has granted an orphan drug status to US-based clinical-stage biotechnology company GlycoMimetics' GMI-1070 (rivipansel sodium), designed to treat vaso-occlusive crisis (VOC) in patients with sickle cell ...
The European Medicines Agency (EMA) has granted an orphan drug status to US-based clinical-stage biotechnology company GlycoMimetics’ GMI-1070 (rivipansel sodium), designed to treat vaso-occlusive crisis (VOC) in patients with sickle ...
Tags: Orphan Drug, Cell Drug
Cubist Pharmaceuticals has received the US Food and Drug Administration (FDA) fast track status for its late-stage antibiotic candidate ceftolozane/tazobactam in the previously granted Qualified Infectious Disease Product (QIDP) ...
Tags: Cubist, Fast Track Status
TransTech Pharma has received FDA fast track designation for new small-molecule chemical compound TTP488, for the treatment of Alzheimer's disease. TTP488 prevents interaction of a material found in the Alzheimer's patients cells, ...
Tags: Transtech Alzheimer, FDA, Medicine
The US Patent and Trademark Office (USPTO) has granted notice of allowance (NOA) to Collegium Pharmaceutical's patent application NO.12/823,628 covering a tamper-resistant, extended-release opioid product. The patent entitled, ...
Tags: USPTO, NOA, Collegium Opioid Product
Lexicon Pharmaceuticals has won Fast Track status from the US FDA to develop LX1033, an orally-delivered small molecule drug candidate to treat diarrhea-predominant irritable bowel syndrome (IBS-d). Fast Track facilitates the development ...
Tags: Lexicon Pharmaceuticals, small molecule drug candidate
Isis Pharmaceuticals has obtained the US FDA fast track designation for ISIS-TTR to treat familial amyloid polyneuropathy (FAP). The antisense drug ISIS-TTR, a part of the Isis-GSK strategic RNA therapeutic alliance, is being developed ...
Tags: amyloid polyneuropathy candidate, Pharmaceuticals, genetic disease, drug
Ipsen and Inspiration Biopharmaceuticals have announced FDA Fast Track status to an intravenous recombinant porcine factor VIII, OBI-1, for acquired hemophilia A therapy. The drug candidate is being studied to treat acquired hemophilia A ...
Tags: FDA, fast track status, drug candidate
NewLink Genetics HyperAcute-Pancreas Immunotherapy (algenpantucel-L) has gained European orphan designation. Orphan designation provides NewLink with access to multiple incentives for drug development in EU. Incentives include decreased ...
Tags: algenpantucel-L, NewLink Genetics, HyperAcute-Pancreas Immunotherapy
The US FDA has granted fast track status to Soligenix's SGX203 for the treatment of pediatric Crohn's disease. SGX203 contains an active corticosteroid, beclomethasone 17,21-dipropionate (BDP), that targets local inflamed tissue. ...