Regulatory and Drug Approvals News

NeuroMetrix, Inc. (Nasdaq: NURO) announced that it has received 510(k) clearance for its UNIVERSAL Electrodes from the U.S. Food and Drug Administration (FDA). This regulatory determination by the FDA gives NeuroMetrix clearance to market the UNIVERSAL Electrodes in the U.S. These electrodes are intended to be used with the NeuroMetrix ADVANCE(TM) NCS/EMG System for performance of nerve conduction studies.

Interrad Medical, Inc. a privately held medical device company, announced today that it has received FDA 510(k) clearance of its SecurAcath(TM) PICC with Subcutaneous Securement System. Interrad Medical has developed a completely new and innovative method for catheter securement called SecurAcath. The SecurAcath System utilizes a small anchor that deploys in the subcutaneous tissue just beneath the skin to hold an indwelling catheter securely in place.

Exelixis, Inc. (Nasdaq:EXEL) announced today that it has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration for XL888, a novel anticancer compound. XL888 is an orally available small molecule inhibitor of HSP90, which is a chaperone protein that promotes the activity and stability of a range of key regulatory proteins, including kinases.

GlaxoSmithKline announced that the United States Food and Drug Administration (FDA)continues to review the new drug application for Promacta® (eltrombopag) beyond the September 19, 2008 action date. GSK continues to work closely with the FDA towards the approval of Promacta in order to provide physicians and chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients with a novel, once-daily oral option.

Genentech, Inc. (NYSE: DNA) announced that the company has issued a Dear Healthcare Provider letter to inform potential prescribers of a case of progressive multifocal leukoencephalopathy (PML) in a 70-year old patient who had received Raptiva® (efalizumab) for more than four years for treatment of chronic plaque psoriasis. The company will work with the U.S. Food and Drug Administration (FDA) to update the prescribing information for Raptiva and determine if further action is needed.

Amgen Belgium announces the availability of Vectibix® (panitumumab), the first fully human anti-EGFR monoclonal antibody indicated as monotherapy for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer (mCRC) with non-mutated (wild-type) KRASgene after failure of fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy protocols.

The Generic Pharmaceutical Association (GPhA) today praised California Governor Arnold Schwarzenegger for signing into law legislation that will establish an electronic pedigree system in California aimed at helping to maintain the security of the drug distribution chain against counterfeit drugs.

The European Commission has published two guidelines concerning the application of Articles 8(1), (2) and (3) of Regulation (EC) No 141/2000 on orphan medicinal products.

Cardinal Health, a global provider of products and services that improve the safety and productivity of health care, today announced agreements with the U.S. Drug Enforcement Administration (DEA) and seven U.S. Attorneys' Offices that will result in reinstated licenses to distribute controlled substances from the company's Auburn, Wash., Lakeland, Fla. and Swedesboro, N.J. distribution centers.

The U.S. Food and Drug Administration today announced the awarding of 17 grants to enhance food and feed safety. These grants fund major cooperative agreements in four major areas. The FDA awarded a combined $5.2 million in these one-year grants to various state and local regulatory agencies.