| Company* (Country;Symbol) | Product | Description | Indication | Status (Date) |
| AUTOIMMUNE | ||||
| Biogen Idec Inc. (BIIB) and Elan Corp. plc (Ireland; NYSE:ELN) | Tysabri (FDA-approved) | Natalizumab | Crohn's disease | A joint FDA advisory panel gave a positive recommendation for approval (8/1) |
| CANCER | ||||
| Advanced Life Sciences Holdings Inc. (ADLS) | ALS-357 | Topical treatment that induces apoptosis | Metastatic melanoma | FDA granted orphan drug status (8/28) |
| Adventrx Pharmaceuticals Inc. (AMEX:ANX) | ANX-510 | CoFactor injection | Metastatic colorectal cancer | FDA granted fast track designation for the product (8/16) |
| Cephalon Inc. (CEPH) | Treanda | Bendamustine HCl | Chronic lymphocytic leukemia | FDA granted orphan drug designation (8/30) |
| GammaCan International Inc. (Israel; OTC BB:GCAN) | VitiGam | An intravenous IgG-based immunotherapy | Stage IIb to Stage IV meta-static melanoma | VitiGam received orphan drug designation (8/7) |
| Genentech Inc. (NYSE:DNA) | Avastin (FDA-approved) | Bevacizumab | Metastatic breast cancer | Resubmitted an sBLA seeking approval of Avastin, in combination with paclitaxel chemotherapy, for patients who have not received chemotherapy (8/24) |
| IDM Pharma Inc. (IDMI) | Junovan | Mifamurtide | Osteosarcoma | FDA issued a not-approvable letter asking for more clinical trial data (8/27) |
| Indevus Pharmaceuticals Inc. (IDEV) | Valstar (FDA-approved in 1998; withdrawn 2002) | Valrubicin | Bladder cancer | FDA issued an approvable letter; the product was taken off the market in 2002 due to impurities (8/17) |
| Innovive PharmaceuticalInc. (OTC BB:IVPH) | Tamibarotene | Oral synthetic retinoid | Acute promyelo-cytic leukemia | Company and FDA agreed on an SPA for a Phase II trial (8/3) |
| MethylGene Inc. (Canada; TSX:MYG) and Pharmion Corp. (PHRM) | MGCD0103 | Histone deacetylase inhibitor | Hodgkin's lymphoma | FDA granted orphan status (8/21) |
| CARDIOVASCULAR | ||||
| CV Therapeutics Inc. (CVTX) | Ranexa (FDA-approved) | Ranolazine extended-release tablets | Angina | FDA approved the 1,000-mg tablet (8/14) |
| Encysive Pharmaceuticals Inc. (ENCY) | Thelin | Sitaxsentan sodium | Pulmonary arterial hypertension | Filed with the FDA a request for formal dispute resolution to contest the third approvable letter for Thelin (8/7) |
| LifeCycle Pharma A/S (Denmark; CSE:LCP) and Sciele Pharma Inc. | Fenofibrate | 120-mg and 40-mg dosage strengths; it uses LifeCycles Melt-dose technology | Hyperlipidemia and hypertriglyc-eridemia | FDA approved the formulation(8/13) |
| Omrix Bio-pharmaceutical Inc. (OMRI) | Evithrom | Human thrombin product; derived from human plasma | For use in general surgery procedures to control minor bleeding | FDA approved the product (8/28) |
| The Medicines Co. (MDCO) | Angiomax (FDA-approved) | Bivalirudin | Acute coronary syndromes | Submitted an sNDA (8/7) |
| CENTRAL NERVOUS SYSTEM | ||||
| Anesiva Inc. (ANSV) | Zingo | Lidocaine product that uses a needle-free, disposable intradermal injection system that delivers 0.5 mg of powdered sterile lidocaine into the skin via compressed helium | Pain | FDA approved the product for use in hospitalized children ages 3 to 18 (8/17) |
| Janssen LP (unit of Johnson & Johnson) | Risperdal (FDA-approved) | Risperidone | Schizophrenia | FDA approved it for adolescents ages 13 to 17 (8/22) |
| Jazz Pharmaceuticals Inc. (JAZZ) and Solvay Pharmaceuticals Inc. | Luvox CR | Fluvoxamine maleate extended-release capsules | Obsessive compulsive disorder and social anxiety disorder | FDA accepted for review the submission of the complete response to an approvable letter (8/3) |
| Neurocrine Biosciences Inc. (NBIX) | Indiplon | 5-mg and 10-mg capsules of an immediate-release version | Insomnia | FDA accepted its resubmitted NDA (8/22) |
| Pozen Inc. (POZN) | Trexima | Combination of 85 mg of sumatriptan with 500 mg of naproxen sodium | Migraine | Pozen received a second approvable letter from the FDA; the agency is concerned over a preclinical genotoxicity study (8/2) |
| INFECTION | ||||
| Lux Biosciences Inc.* | LX211 | A next-generation calcineurin inhibitor | Uveitis | FDA granted fast-track designation (8/7) |
| Monogram Biosciences Inc. (MGRM) | Trofile | Diagnostic; co-receptor tropism assay | HIV | Monogram launched the product, which must be used with Pfizer Inc.'s Selzentry (maraviroc) tablets for HIV; it received FDA approval recently (8/6) |
| MISCELLANEOUS | ||||
| Abraxis BioScience Inc. (ABBI) | Oxytocin | A new dose injection | To initiate or improve uterine contractions in labor-related issues | Received FDA approval of the sNDA on a new dose of Oxytocin injection (8/7) |
| Adolor Corp. (ADLR) | Entereg | A peripherally acting muopioid receptor antago-nist; alvimopan | Postoperative ileus | FDA accepted the complete response to an approvable letter (8/28) |
| Axcan Pharma Inc. (Canada; AXCA) | Ultrase (FDA-approved) | Pancrelipase capsules | Exocrine pancreatic insufficiency | Submitted a complete NDA (8/2) |
| Auxilium Pharmaceuticals Inc. (AUXL) | Xiaflex | Clostridial collagenase for injection | Dupuytren's contracture | Was cleared from the FDA to resume its Phase III trials for Xiaflex (8/16) |
| Indevus Pharmaceuticals Inc. (IDEV) | Sanctura XR (FDA-approved) | Trospium chloride extended-release capsules | Overactive bladder | FDA approved Sanctura XR (8/6) |
| Indevus Pharmaceuticals Inc. (IDEV) | Nebido | An injectable three-month formulation of testerone undecanoate | Primary and secondary hypogonadism | Filed with the FDA seeking approval (8/28) |
| Oragenics Inc. (AMEX:ONI) | SMaRT Replacement Therapy | Topical treatment based on a genetically modified strain of Streptococcus mutans | To prevent dental cavities | FDA placed a clinical hold on a proposed Phase Ib safety study (8/13) |
| Regeneron Pharmaceuticals Inc. (REGN) | Rilonacept | Interleukin-1 Trap | Cryopyrin-associated periodic syndromes | FDA accepted for filing and granted priority review status to the BLA (8/8) |
| Tercica Inc. (TRCA) and Ipsen SA (France; PARIS:IPN) | Somatuline Depot | A somatostatin analog packaged as a pre-filled syringe | Acromegaly | FDA approved the product (8/31) |
| Tikvah Therapeutics Inc.* | Sodium phenylbutyrate | A histone deacetylase inhibitor | Spinal muscular dystrophy | FDA granted orphan drug status (8/20) |
| Notes: | ||||
| * Privately held. BLA = Biologics license application; CMA = Continuous marketing application; FDA = Food and Drug Administration; IND = Investigational new drug application; NDA = New drug application; PDUFA = Prescription Drug User Fee Act; SPA = Special protocol assessment. Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market.AMEX = American Stock Exchange; CSE = Copenhagen Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSX = Toronto Stock Exchange | ||||
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