Ambit Biosciences and Teva Pharmaceutical Industries have announced the FDA clearance of CEP-32496, a novel BRAF (V600E) kinase inhibitor. The preclinical findings also demonstrate that CEP-32496 possesses potent and sustained anti-tumor ...
Tags: Ambit, Teva, FDA clearance
The FDA has granted fast track designation for Achillion Pharmaceuticals' ACH-3102 as part of an interferon-free regimen for the treatment of chronic hepatitis C (HCV). ACH-3102 is a pan-genotypic second-generation NS5A inhibitor ...
Tags: FDA Fast Track Designation, chronic hepatitis C, pharmaceutical product
Carl Zeiss Meditec, the medical technology specialist that is majority-owned by the German optics giant Carl Zeiss, has reported a strong set of data for the first six months of its current financial year – thanks in part to ...
Tags: Meditec, Boost, German firm
Argal plans to exhibit a number of its new pumps at Achema, which takes place in Frankfurt, Germany, from 18 to 22 June. These include the ASTRA range of AODD pumps, which is manufactured with port sizes starting from ¼ in up to 2 ...
Tags: market view, pump
Oramed, a wholly owned Israeli subsidiary of Oramed Pharmaceuticals, has received government grant of NIS2m (approximately $540,000) in Israel. The funds will be used to support R&D and clinical studies on the company's oral insulin ...
Tags: Oramed Pharmaceuticals, Medicine
The US Food and Drug Administration (FDA) has approved Novartis Afinitor (everolimus) to treat patients with non-cancerous kidney tumors associated with tuberous sclerosis complex (TSC). The approval was based on the Phase III ...
Dynavax Technologies has submitted a US Biologics License Application (BLA) to the FDA for HEPLISAV, an investigational adult hepatitis B vaccine. In Phase III trials, HEPLISAV demonstrated higher and earlier protection with fewer ...
BOTOX Cosmetic (onabotulinumtoxinA) Celebrates 10-Year Anniversary of U.S. Food and Drug Administration Approval. BOTOX Cosmetic is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe ...
Tags: BOTOX Cosmetic, 10-year anniversary, FDA, frown lines, glabellar lines
SK Biopharmaceuticals, a South Korean pharmaceutical company, has received orphan drug designation status for carisbamate for the management of patients with infantile spasms (IS). Carisbamate has previously been shown to have ...
REGENX BioSciences has received FDA orphan drug designation for treatment of familial hypercholesterolemia (HoFH) using NAV rAAV8 vectors. The REGENX program consists of a NAV rAAV8 vector expressing a normal copy of the human ...
Tags: orphan drug designation, familial hypercholesterolemia, clinical study
EpiCept has received fast track designation for AmiKet (amitriptyline 4%, ketamine 2% cream) from the US Food and Drug Administration (FDA). AmiKet is indicated for the treatment of neuropathic pain associated with ...
Tags: FDA, fast track designation, treatment of neuropathic pain
Sanofi and Regeneron Pharmaceuticals have received FDA priority review for the biologics license application (BLA) of ZALTRAP (aflibercept) as a treatment for metastatic colorectal cancer (mCRC). The filing was based on the Phase III ...
Watson Pharmaceuticals has confirmed favorable US District Court for the District of Delaware ruling in generic Sanctura XR (trospium chloride extended-release capsules) patent suit. The Court has ruled that the asserted claims of US ...
Tags: treatment of overactive bladder, pharmaceutical product
The US Food and Drug Administration (FDA) has approved Novo Nordisk's Levemir (insulin detemir [rDNA origin] injection) for a pregnancy Category B classification. The approval indicates that Levemir, when used in pregnant women with ...
Tags: FDA approval, lable update, Levemir, clinical study
Davis-Standard (Pawcatuck, CT) is showing a newly developed mid-range controller called the DS-eVUE at NPE2012 (Orlando, FL; April 1-5). Features include a solid-state hard drive, a 15-inch (381mm) wide-screen HMI (human machine interface); ...
Tags: market view, Extruder