Company*
(Symbol) | Product | Description | Indication | Status
(Date) |
|
CANCER |
AEterna Laboratories Inc. (Canada; AELA; TSE:AEL) | AE-941/Neovastat | Orally bioavailable naturally occurring antiangiogenic product that blocks two regulators of angiogenesis, VEGF and MMPs | Multiple myeloma | FDA and Canadian health authorities approved the conduct of the pivotal trial, which will be conducted at 20 hospitals throughout Canada, the U.S. and Europe(12/19) |
Hemosol Inc. (Canada; TSE:HML) | Hemolink | Highly purified human-derived hemoglobin replacement product | Non-small-cell lung cancer | Company filed an IND application to begin a Phase I/II study in patients with non-small-cell lung cancer who are experiencing chemotherapy-associated anemia (12/21) |
Maxim Pharmaceuticals Inc. (MAXM) | Maxamine | Histamine dihydrochloride | Advanced metastatic melanoma | The FDA's Oncologic Drugs Advisory Committee recommended against the NDA for Maxamine as an adjuvant to interleukin-2 to treat patients who have liver metastases (12/13) |
Millennium Pharmaceuticals Inc. (MLNM) and Ilex Oncology Inc. (ILXO) | Campath | Alemtuzumab; humanized monoclonal antibody | Chronic lymphocytic leukemia | The Oncologic Advisory Committee voted 14-to-1 to recommend accelerated approval of Campath (12/15) |
OSI Pharmaceuticals Inc. (OSIP) | Unnamed compound | Small molecule developed to block tumor-induced angiogenesis; orally active potent and selective inhibitor of the vascular endothelial growth factor receptor | Cancer | Company said Pfizer Inc. has opened an IND for Phase I trials in the U.S. (12/20) |
Praecis Pharmaceuticals Inc. (PRCS) and Amgen Inc. (AMGN) | Abarelix depot-M | Gonadotropin-releasing hormone antagonist | Prostate cancer | Companies sumbitted an NDA (12/13) |
Scotia Pharmaceuticals plc (UK; LSE:SOH) | Foscan | Photodynamic therapy | Head and neck cancer | FDA is allowing the company to submit an amended NDA including 83 additional patients studied (12/6**) |
|
CARDIOVASCULAR |
Texas Biotechnology Corp. (AMEX:TXB) and SmithKline Beecham plc (NYSE:SBH) | Argatroban | Anticoagulant; synthetic direct thrombin inhibitor that blocks the activity of thrombin | Heparin-induced thrombocytopenia | Companies submitted a supplemental NDA to expand the use of Argatroban (12/21) |
The Medicines Co. (MDCO) | Angiomax | Bivalirudin; a thrombin-specific anticoagulant | Unstable angina | FDA approved the marketing of Angiomax for unstable angina in patients undergoing percutaneous transluminal coronary angioplasty (12/18) |
United Therapeutics Corp. (UTHR) | UT-15 or Uniprost | Analogue of prostacyclin | Pulmonary arterial hypertension | FDA decided UT-15 does not need to be presented to the Cardiovascular and Renal Drugs Advisory Committee (12/14) |
|
CENTRAL NERVOUS SYSTEM |
Amarin Corp. plc (UK; AMRN) | LAX-101 | Investigational compound to treat Huntington's disease | Huntington's disease | FDA cleared the IND, allowing a pivotal Phase III study to begin; it will enroll over 100 patients in the U.S., Canada and the UK (12/11) |
Celgene Corp. (CELG) | d-MPH | d-methylphenidate; chirally pure version of Ritalin | Attention deficit disorder and attention deficit hyperactivity disorder | FDA accepted for filing the NDA (12/27) |
Orphan Medical Inc. (ORPH) | Xyrem | Sodium oxybate oral solution | Narcolepsy | FDA accepted the NDA for filing (12/4) |
Praecis Pharmaceuticals Inc. (PRCS) | Apan | A drug developed with LEAP technology | Alzheimer's disease | Company submitted an IND application to initiate Phase I trials (12/29) |
|
DIABETES |
Amylin Pharmaceuticals Inc. (AMLN) | Symlin | Pramlinitide acetate; synthetic analogue of human pancreatic hormone amylin | Type I and Type II diabetes | Company submitted an NDA to market Symlin as an adjunctive therapy to insulin (12/7) |
|
INFECTION |
Aviron (AVIR) | FluMist | Intranasal vaccine | Influenza | FDA accepted for review the BLA (12/29) |
Gliead Sciences Inc. (GILD) and F. Hoffmann-La Roche Inc. | Tamiflu (FDA-approved) | Oseltamivir phosphate | Acute illness due to influenza | FDA granted marketing approval of Tamiflu in a liquid suspension for children ages 1 to 12 (12/14) |
ICN Pharmaceuticals Inc. (NYSE:ICN) and Schering-Plough Corp. (NYSE:SGP) | Rebetol (FDA-approved) | Oral formulation of ribavirin | Hepatitis C | Schering-Plough submitted a supplemental NDA to the FDA seeking approval to market Rebetol separately and used in combination with Intron A injection (12/15) |
|
MISCELLANEOUS |
Genzyme General (GENZ) | Fabrazyme | Agalsidase beta; enzyme replacement therapy | Fabry disease | FDA completed its review of the BLA and requested additional data (12/26) |
Gliatech Inc. (GLIA) | Adcon-L; Adcon-P | Gel to inhibit postsurgical scarring | Postsurgical scarring | FDA sent the company a letter questioning its methods of recording and presenting clinical trial data; it suspended review of three pre-market approval applications-two Adcon-L supplemental applications and the modular submission for Adcon-P (12/23) |
Sepracor Inc. (SEPR) and Schering-Plough Corp. (NYSE:SGP) | Desloratadine | Antihistamine, nonsedating disintegrating tablet | Seasonal allergic rhinitis and chronic idiopathic urticaria | Schering-Plough submitted NDAs for two formulations of desloratadine (12/13) |
|
Notes: |
* Privately held **Denotes the date item ran in BioWorld International |
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. |
AMEX = American Stock Exchange; CDNX = Canadian Venture Exchange; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; SSE = Swedish Stock Exchange; TSE = Toronto Stock Exchange |
BLA = Biologics License Application; NDA = New Drug Application |
ND = Not disclosed |
ASH = American Society of Hematology meeting |
