Company* (Symbol)

Product

Description

Indication

Status (Date)

CANCER

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)

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)

Maxim Pharmaceuticals (MAXM)

Maxamine

Histamine dihydrochloride; H2 receptor agonist

Stage IV malignant melanoma

Submitted NDA (7/10)

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)

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)

INFECTION

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

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)

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:

* Privately held.

Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market.

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