Company* (Symbol) | Product | Description | Indication | Status (Date) |
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CANCER |
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Aronex Pharmaceuticals (ARNX) | Atragen | Liposomal formulation of tretinoin (all trans-retinoic acid) | Acute promyelocytic leukemia | Submitted amendment to NDA for patients who need therapy with tretinoin but for whom an intravenous administration is required (7/6) | |
Cell Therapeutics Inc. (CTIC) | | Arsenic trioxide | Myelodysplastic syndromes | Granted orphan drug designation (7/18) |
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Chiron Corp. (CHIR) | Proleukin (aldesleukin) | Recombinant form of T-cell growth factor (interleukin-2) | Advance-stage kidney cancer or melanoma | Updated durable response data to labeling, reinforcing the long-term remission benefit; data demonstrated durable response of more than 10 years (7/7) |
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Maxim Pharmaceuticals (MAXM) | Maxamine | Histamine dihydrochloride; H2 receptor agonist | Stage IV malignant melanoma | Submitted NDA (7/10) |
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Matrix Pharmaceuticals Inc. (MATX) | IntraDose Injectable Gel | Biodegradable gel containing cisplatin and epinephrine (intra-tumoral injection) | Head and neck cancer | Submitted second portion of NDA (7/5) |
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NeoPharm Inc. (NEOL) | LE-AON | Liposomal encapsulated antisense oligonucleotide against c-raf-1 oncogene | Radiation-resistant tumors | Filed IND (7/20) | |
Onyx Pharmaceuticals Inc.(ONXX) and Bayer Corp. (unit of Bayer AG; Germany) | | Small-molecule ras pathway inhibitor | Cancer | Filed IND (7/18) |
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INFECTION |
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Avanir Pharmaceuticals (AMEX:AVN) and SmithKline Beecham plc (UK; NYSE:SBH) | | Docosonal 10% cream | Oral facial herpes (cold sores) | Cleared for marketing (7/26) | |
Cubist Pharmaceuticals Inc. (CBST) | Cidecin | Daptomycin for injection; lipopeptide antibiotic | Serious Gram-positive infections | FDA agreed on design of additional Phase III trials (7/27) | |
Gilead Sciences Inc. (GILD) and Fujisawa Healthcare Inc. (unit of Fujisawa Pharmaceutical Co. Ltd. [Japan]) | AmBisome | Liposomal formulation of amphotericin B for injection | Cryptococcal meningitis in HIV infected patients | FDA approved new indication (7/5) | |
Glaxo Wellcome plc (UK; NYSE:GLX) | Malarone | Atovaquone and proguanil hydro-chloride | Treatment and prevention of malaria | Cleared for marketing (7/14) | |
MISCELLANEOUS |
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Celsion Corp. (AMEX:CLN) | | Benign prostatic hyperplasia treatment system | Benign prostate hyperplasia | Granted approval to begin Phase II multicenter trial (7/24) | |
Centocor Inc. (subsidiary of Johnson & Johnson [NYSE:JNJ]) | Remicade (FDA-approved) | Infliximab; chimeric monoclonal antibody to tumor necrosis factor-alpha | Reduction of structural damage in patients with rheumatoid arthritis | FDA's Arthritis Advisory Committee voted unanimously to recommend approval (7/12) | |
Genzyme General (GENZ) and GelTex Pharmaceuticals Inc. (GELX) | Renagel tablets | Sevelamer hydrochloride; non-absorbed polymer-based compound that binds to and eliminates target substances from the intestinal tract | Reduction of serum phosphorus in hemodialysis patients with end-stage renal disease | Cleared for marketing (7/13) | |
Interneuron Pharmaceuticals Inc. (IPIC) and Eli Lilly and Co. (NYSE:LLY) | Sarafem | Fluoxetine hydrochloride dysphoric disorder | Premenstrual | Cleared for marketing (7/6) | |
Palatin Technologies (AMEX:PTN) and Mallinckrodt Inc. (NYSE:MKG) | LeuTech | Antibody-based infection imaging agent | Diagnosis of equivocal appendicitis | FDA's Medical Imaging Drugs Advisory Committee voted 8-0 to recommend the product for approval (7/10) |
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Senetek plc (SNTKY) | Invicorp IND | Combination of vasoactive intestinal peptide with 1 to 2 mg of phentolamine mesylate | Erectile dysfunction | FDA upgraded status to partial clinical hold, allowing human studies to be conducted in the U.S. with a limited duration of three months and total number of doses not exceeding three per week; New Zealand Medicines and Medical Devices Safety Authority granted full approval of product (7/3) | |
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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