Biotechnology Healthcare - September/October 2008 - (Page 10)

DRUG TRACK SELECTED FDA BIOLOGIC DRUG AND TEST APPROVALS, JUNE–JULY 2008 Action date New indication June 20, 2008 bortezomib (Velcade) Molecular test marketing clearance July 31, 2008 Pathwork Tissue of Origin Pathwork Diagnostics Used for hard-to-identify tumors; determines Microarray type of cancer cells present in malignant tumors technology Millenium/Takeda First-line treatment of multiple myeloma IV injection Drug or test name (Trade name) Sponsor Indication Dosage form SELECTED FDA ACTIONS, JUNE–JULY 2008 Manufacturer Drug name (Trade name) Type of drug Indication Notes New drug application Hemispherx Biopharma poly I:poly C12U Toll-like receptor (Ampligen) therapy Chronic fatigue syndrome Accepted July 8, 2008 Biologics license application Introgen Ad5CMV-p53 (Advexin) Gene therapy Recurrent, refractory head and neck cancer Filed June 30, 2008; FDA did not accept Orphan drug designation Clinuvel Denials or delays Eurand EUR-1008 (Zentase) Enzyme replacement therapy Exocrine pancreatic insufficiency Received approvable letter June 18, 2008 afamelanotide Melanotan peptide Erythropoietic porphyrias (severe skin sensitivity to sunlight) Granted July 28, 2008 Sources: FDA, manufacturers’ package inserts and news releases, U.S. Securities and Exchange Commission filings phase 3 trial of tasimelteon, a novel melatonin agonist, show significant improvements in sleep among adults with chronic primary insomnia. Vanda Pharmaceuticals also is evaluating tasimelteon as a potential treatment of circadian rhythm sleep disorders. Novo Nordisk ended its phase 3 trial evaluating coagulation factor VIIa (NovoSeven) as a therapy for bleeding in the brain after a “futility analysis” predicted a low likelihood of positive outcomes. While Insmed waits for development of a regulatory pathway for follow-on biologics, it forges ahead with development of INS-19, a version of Amgen’s filgrastim (Neupogen). Insmed reported that in a small trial, INS-19 showed bioequivalence to filgrastim. Did you hear? An FDA advisory panel expressed concerns about the risk of malig- nancy and serious infections, but nonetheless voted 7–5 to recommend that etanercept be approved for use in children with moderate to severe psoriasis. The panel expressed the same concerns about ustekinumab but voted unanimously to recommend approval. Another FDA advisory panel gave a 10–1 endorsement to tocilizumab for treatment of RA. The FDA is not bound by its panels’ advice, but usually follows it. Amgen’s anemia drugs should not be used until a patient’s hemoglobin drops to 10 g/dL, according to new, stricter safety labeling ordered by the FDA. Biogen Idec says two more patients taking its powerful MS therapy natalizumab (Tysabri) have contracted progressive multifocal leukoencephalopathy. Genentech has advised physicians not to use bevacizumab (Avastin) in combi- nation with sunitinib (Sutent), citing a higher risk of anemia. After publication of a study that reported hypersensitivity reactions in patients with HIV, the FDA has urged physicians to test for a certain genetic variation before administering abacavir (Ziagen). Monogram Biosciences and Invitrogen have introduced two new tests to diagnose HER2-positive breast cancer. Big pharma is scaling back clinical research in the United Kingdom, pointing to what it sees as the National Institute for Health and Clinical Excellence’s hostility toward high-tech, high-priced therapies. Recent NICE decisions mean the National Health Service won’t pay for bevacizumab and erbitux (Cetuximab) to treat certain cancers. NICE did approve adalimumab (Humira) for treatment of plaque psoriasis. 10 BIOTECHNOLOGY HEALTHCARE · SEPTEMBER/OCTOBER 2008

Table of Contents Feed for the Digital Edition of Biotechnology Healthcare - September/October 2008

Biotechnology Healthcare - September/October 2008 Openers Editorial/David B. Nash, MD, MBA Contents At a Glance: Multiple Sclerosis Drug Track Personalized Medicine Healthcare Reform’s Effects on Biologic Access Breast Cancer Status Testing: A Crapshoot With Deadly Odds Trends, Issues, and Perspectives In the Management of MS So High-Tech, Yet So Simple The Evolution of Ascertaining the Value Proposition Specialty Pharmacy Employer to Employer Health Plan Confidential Trends

Biotechnology Healthcare - September/October 2008

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