Company* (Symbol) | Product | Description | Indication | Status (Date) |
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CANCER |
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Akorn Inc. (AKRN) | AK-1003 | Photodynamic drug targeted to large feeder vessels | Age-related macular degeneration | Submitted IND (6/30) |
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Ligand Pharmaceuticals Inc. (LGND) | Targretin Gel | Bexarotene 1%; topical therapy based on synthetic retinoid that selectively activates retinoid X receptors | Cutaneous lesions in patients with early-stage cutaneous T-cell lymphoma | Received approvable letter (6/12); cleared for marketing (6/29) |
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Millennium & Ilex Partners LP (joint venture of Millennium Pharmaceuticals Inc. [MLNM] and Ilex Oncology Inc. [ILXO]) and Schering AG (Germany) | Campath | Alemtuzumab; humanized monoclonal antibody that specifically targets and binds to CD52 cell surface antigen on lymphocytes | B-cell lymphocytic leukemia | Received a complete response letter for BLA delineating deficiencies; companies plan to respond rapidly (6/26) |
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CARDIOVASCULAR |
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Aventis Behring LLC (unit of Aventis SA [France; NYSE:AVE]) | Helixate FS | Recombinant, non-plasma-derived factor VIII product | Hemophilia A | Cleared for marketing (6/29) |
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Bayer Corp. (unit of Bayer AG; Germany) | Kogenate FS Antihemo-philiac Factor | Recombinant factor VIII formulated with sucrose | Hemophilia A | Cleared for marketing (6/28) |
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Genentech Inc. (NYSE:DNA) | TNKase | Tenecteplase; second-generation, single-bolus recombinant plasminogen activator with greater specificity to fibrin than Genentech's first-generation tissue-plasminogen activator (Activase) | Acute myocardial infarction | Cleared for marketing (6/2) |
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Texas Biotechnology Corp. (AMEX:TXB) and SmithKline Beecham plc (NYSE:SBH) | (Formerly Novastan) | Argatroban; synthetic small molecule derived from arginine; acts as a direct inhibitor of thrombin | Prevention or treatment of thrombosis associated with heparin-induced thrombocytopenia | Cleared for marketing (6/30) |
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CENTRAL NERVOUS SYSTEM |
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Cima Labs Inc. (CIMA) and AstraZeneca plc (UK; NYSE: AZN) | | Fast-dissolving formulation of the Zomig (zolmitriptan) anti-migraine medication | Migraine | AstraZeneca filed NDA (6/5) |
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Elan Corp. plc (Ireland; NYSE:ELN) | Ziconotide | Intrathecally delivered N-type neuronal calcium channel blocker | Severe pain | Received approvable letter (6/28) |
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Ligand Pharmaceuticals Inc. (LGND) and Elan Corp. plc (Ireland; NYSE: ELN) | Morphelan | Once-daily, modified-release, oral dosage form of morphine | Management of pain in oncology and HIV patients | Elan filed NDA for the product, to be marketed by Ligand (6/8) |
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Novartis Pharmaceuticals Corp. (unit of: Novartis AG [Switzerland; NYSE: NVS]) | Zelmac | Tegaserod; targets 5-H4 serotonin receptors in the gastrointestinal tract | Abdominal pain or discomfort and constipation in women with irritable bowel syndrome | FDA's Gastrointestinal Drugs Advisory Committee recommended approval (6/26) |
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INFECTION |
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Abbott Laboratories (NYSE:ABT) | ABT-378/r | Lopinavir/ritonavir; HIV protease inhibitor | HIV infection and AIDS | Submitted NDA based on ongoing Phase II/III trials (6/1) |
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Access Pharmaceuticals Inc. (AMEX:AKC) | OraDisc | Polymer disc formulation of amlexanox that adheres to the disease site and slowly erodes, releasing the drug | Canker sores | FDA cleared Phase III trial following successful initial irritation study (6/26) |
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Avanir Pharmaceuticals (AMEX:AVN) | | Docosonal 10% cream | Oral-facial herpes (cold sores) | Received approvable letter for over-the-counter product (6/1) |
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Gilead Sciences Inc. (GILD) and Hoffmann-La Roche Inc. (Switzerland) | Tamiflu (FDA-approved) | Oseltamivir phosphate; oral neuraminidase inhibitor | Acute illness due to influenza in children 1 year old and older | Submitted application for new indication (6/16) |
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Hemispherx Biophamra Inc. (AMEX:HEB) | Ampligen | Double-stranded synthetic RNA compound poly I: poly C12U | HIV patients with multidrug resistance | Received FDA approval to conduct Phase II/III trial (6/26) |
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Palatin Technologies Inc. (AMEX: PTN) and Mallinckrodt Inc. (NYSE:MKG) | LeuTech | Antibody-based infection imaging agent | Diagnosis of equivocal appendicitis | FDA scheduled advisory panel meeting for 7/10 (6/5) |
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Shearwater Polymers Inc.* and F. Hoffmann-La Roche Ltd. (Switzerland) | Pegasys | Peginterferon alfa-2a; once-weekly injection of pegylated version of interferon alfa-2a | Chronic hepatitis C in non-cirrhotic and cirrhotic patients with compensated liver disease | Filed NDA (6/5) |
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MISCELLANEOUS |
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Bioject Medical Technologies Inc. (BJCT) | Cool.click | Needle-free device that delivers Saizen (recombinant pediatric growth hormone) through the skin in a fine mist in less than a second | Treatment of growth hormone deficiency in children | Cleared for marketing (6/26) |
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Genentech Inc., Tanox Inc. (TNOX) and Novartis Pharmaceuticals Corp. (unit of Novartis AG [Switzerland; NYSE:NVS]) | | Recombinant humanized monoclonal antibody to immunoglobulin E | Asthma and allergy | Submitted BLA (6/5) |
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Genzyme General (GENZ) | Fabrazyme | Agalsidase beta; enzyme replacement therapy | Fabry disease | Filed BLA (6/23) |
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Immunex Corp. (IMNX) and American Home Products Corp. (NYSE:AHP) | Enbrel (FDA-approved) | Etanercept; recombinant, soluble T75 tumor necrosis factor receptor (TNFr) linked to the Fc portion of human IgGi | Reduction of signs and symptoms and delay of structural damage in patients with moderately to severely active rheumatoid arthritis | Label expanded to include new indication (6/6) |
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Interneuron Pharmaceuticals Inc. (IPIC) and Madaus AG (Germany) | | Trospium chloride | Urinary incontinence | After meeting with the FDA to discuss existing European efficacy and safety data, Interneuron said it plans to initiate clinical trials later this year (6/6) |
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Lifecore Biomedical Inc. (LCBM) | Intergel Adhesion Prevention Solution | Combines hyaluranon and iron to create ferric hyaluranon | Reduction of post-surgical adhesion formation after certain pelvic abdominal procedures | Filed amendment to PMA in response to decision of General and Plastic Surgery Advisory Panel's decision not to recommend approval (6/5) |
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Millennium Pharmaceuticals Inc. (MLNM) and Genentech Inc. (DNA) | LDP-02 | Humanized monoclonal antibody against alpha-4 beta-7, an integrin on inflammatory cells that causes the cells to adhere to the gastrointestinal tract | Ulcerative colitis | Submitted IND to begin Phase II trials (6/12) |
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Novo Nordisk A/S (Denmark; NYSE:NVO) | Liquid Norditropin | Premixed liquid formulation of recombinant somatropin and pen device for delivery | Growth hormone deficiency in children | Cleared for marketing (6/21) |
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Organogenesis Inc. (AMEX:ORG) and Novartis Pharmaceuticals Corp. (unit of Novartis AG [Switzerland; NYSE:NVS]) | Apligraf (FDA-approved) | Living human skin equivalent, composed of living human keratinocytes and fibroblasts | Diabetic foot ulcers | FDA approved additional indication (6/20) |
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Oxford GlycoSciences plc (UK; LSE:OGS) | OGT 918 | Oral capsule formulation of a glucosyltransferase inhibitor | Gaucher disease | Granted fast-track status (6/20) |
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Serono Inc. (Switzerland; SWX:SEO) | Gonal-F (FDA-approved) | Follitropin alfa for injection; recombinant follicle-stimulating hormone | Female infertility | New dosage approved (6/5) |
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Serono Inc. (Switzerland; SWX:SEO) | Gonal-F (FDA-approved) | Follitropin alfa for injection; recombinant follicle-stimulating hormone | Male infertility | New indication approved (6/2) |
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Transkaryotic Therapies Inc. (TKTX) | Replagel | Agalsidase alfa; enzyme | Fabry disease replacement therapy | Submitted BLA (6/16) |
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Notes: |
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* Privately held. |
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Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. |
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AMEX = American Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; SBI=Stockholm Borsinformation; SSE = Swedish Stock Exchange; TSE = Toronto Stock Exchange |
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ND = Not disclosed. |
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BLA = Biologics License Application |
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IND = Investigational New Drug Application |
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NDA = New Drug Application |
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PMA = Pre-market Approval Application |