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
Dendreon Corporation has sold its immunotherapy manufacturing facility (IMF) in Morris Plains, New Jersey, US, to Novartis Pharmaceuticals for $43m. In early 2012, Dendreon had decided to bring down Provenge production at the facility as ...
Tags: Novartis, Dendreon immunotherapy, manufacturing facility, Medicine
AMC Health will offer an array of telemonitoring services for clinical trial of lisinopril, which will be conducted by Transparency Life Sciences (TLS). US FDA has granted Investigational New Drug (IND) status to Lisinopril, which allows ...
Tags: AMC Health, Telemonitoring Services, clinical trial, Medicine
The US FDA has approved Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for Quinine Sulfate Capsules USP, 324mg, the generic equivalent to Mutual Pharmaceutical's Qualaquin. Mylan has commenced shipping the generic ...
Tags: FDA, Capsules Anda, Mylan Pharmaceutical, Medicine
Abbott has received US Food and Drug Administration clearance for its new testosterone test, ARCHITECT 2nd generation testosterone assay. The testosterone assay is expected to help physicians to accurately measure the wide range of ...
Tags: FDA, testosterone test, clinical technology
Aptus Endosystems, a developer of endovascular aneurysm repair (EVAR) technology, has completed $25m series BB equity financing. Aptus will use the finance to expand commercialization of its HeliFX Aortic Securement system in the US and ...
Tags: Aptus Endosystems, endovascular aneurysm repair technology
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
Janssen Research & Development has submitted a New Drug Application (NDA) to the US FDA seeking approval for a fixed-dose therapy combining canagliflozin and immediate release metformin to treat patients with type 2 diabetes. ...
The US FDA has granted orphan drug designation to Milo Biotechnology's AAV1-FS344 to treat Becker and Duchenne muscular dystrophy. AAV1-FS344 is myostatin inhibitor delivered through gene therapy to increase muscle strength in patients. ...
Tags: FDA, orphan drug designation, US
Supplier of packaging solutions for food, tobacco, and consumer products Shiner International announced that it received a notification letter from The NASDAQ Stock Market informing the Company of its decision to delist the Company from the ...
Tags: Shiner International, NASDAQ, packaging solutions, notification letter
Horizon Pharma has commercially launched Rayos (prednisone) delayed release tablets in the US. Rayos is used to treat rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma ...
Tags: Horizon Pharma, Rayos, rheumatoid arthritis
The US FDA has approved Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for generic Atacand HCT tablets to treat hypertension. Candesartan Cilexetil and Hydrochlorothiazide Tablets in 16/12.5mg, 32/12.5mg and 32/25mg ...
Tags: US FDA, hypertension medication, ANDA, hypertension
Threshold Pharmaceutical has received orphan drug designation for TH-302, a cancer drug, from the US FDA. Threshold is presently testing TH-302 along with a commonly used chemotherapeutic agent, doxorubicin, in a late-stage trial to treat ...
Volcano, a manufacturer of precision guided therapy tools, has entered into an agreement to buy US-based Crux Biomedical for $36m in cash. Crux Biomedical's product includes the Crux VCF system, an inferior vena cava (IVC) filter, which ...
Tags: precision guided therapy tools, buy.Crux Biomedical, Crux VCF system
Biopharmaceutical company Zalicus has received the US FDA approval for its supplemental new drug application (sNDA) for the 32 mg dose strength of Exalgo(hydromorphone HCl) Extended-Release Tablets (CII). Exalgo is used to treat moderate ...
Tags: Exalgo Extended-Release Tablets, around-the-clock opioid analgesia