| Company* (Country; Symbol) | Product | Description | Indication | Status (Date) |
| CANCER | ||||
| Allos Therapeutics Inc. (ALTH) | Pralatrexate | Novel antifolate | Diffuse large B-cell lymphoma | FDA granted orphan drug designation (11/25) |
| Cephalon Inc. (CEPH) | Treanda (FDA-approved) | Bendamustine hydrochloride; a purine analogue/alkylator hybrid | Non-Hodgkin's lymphoma | FDA granted approval (11/3) |
| Debiopharm Group* (Switzerland) | Trelstar (FDA-approved) | Triptorelin pamoate; luteinizing hormone-releasing hormone agonist | Locally advanced or metastatic prostate cancer | NDA for Trelstar was accepted for filing by the FDA (11/14) |
| Delcath Systems Inc. (DCTH) | Melphalan | Percutaneous hepatic perfusion system for the isolated, high-dose delivery of the anticancer agent melphalan | Cutaneous melanoma and ocular melanoma | FDA granted two orphan designations (11/18) |
| Genentech Inc. (NYSE:DNA) | Avastin (FDA-approved) | Bevacizumab | Glioblastoma | Submitted an sBLA as a therapy for people with previously treated glioblastoma (11/3) |
| Genzyme Corp. (GENZ) | Clolar (FDA-approved) | Clofarabine | Acute myeloid leukemia | Filed an sNDA to use Clolar in adult patients with AML (11/24) |
| Ortho Biotech Products LP (unit of Johnson & Johnson) andPharmaMar SA* (Spain) | Trabectedin | Derived from the sea squirt Ecteinascidia turbinata | Relapsed ovarian cancer | Submitted an NDA of trabectedin to be administered in combination with doxil (11/20) |
| CARDIOVASCULAR | ||||
| Biovitrum AB (Sweden; SSE:BVT) and Syntonix Pharmaceuticals Inc. (subsidiary of Biogen Idec Inc., BIIB) | | FIXFc compound | Hemophilia B | FDA granted orphan drug status (11/24) |
| CV Therapeutics Inc. (CVTX) | Ranexa (FDA-approved) | Ranolazine extended-release tablets | Chronic angina | FDA approved a first-line indication for Ranexa with new labeling showing it reduces arrhythmias in patients with coronary artery disease (11/6) |
| Dyax Corp. (DYAX) | DX-88 | Ecallantide | Acute attacks of hereditary angioedema | FDA accepted for filing its BLA (11/21) |
| HemaQuest Pharmaceuticals* | HQK-1001 | An oral drug | Sickle cell anemia and beta thalassemia | FDA awarded orphan drug designations (11/4) |
| Ligand Pharmaceuticals Inc. (LGND) and GlaxoSmithKline plc (UK) | Promacta | Eltrombopag | Idiopathic thrombocytopenic purpura | FDA granted accelerated approval (11/21) |
| CENTRAL NERVOUS SYSTEM | ||||
| Labopharm Inc. (Canada; DDSS) | DDS-04A | Once-daily trazodone, a serotonin-antagonist reuptake inhibitor | Major depressive disorder | FDA accepted for review the NDA (11/24) |
| Pain Therapeutics Inc. (PTIE) | Remoxy | Controlled-release formulation of oxycodone | Moderate to severe pain | In an unofficial vote, more than half of 19 federal advisers said the data were sufficient in showing that Remoxy would be less susceptible to abuse and misuse than other currently marketed therapies (11/13) |
| Vanda Pharmaceuticals Inc. (VNDA) | Iloperidone | A 5HT2/D2 antagonist | Schizophrenia | FDA accepted its resubmission of an NDA (11/20) |
| DIABETES | ||||
| Amylin Pharmaceuticals Inc. (AMLN) | Exenatide (FDA-approved) | A once-weekly formulation expected to replace twice-weekly Byetta | Diabetes | FDA rejected study data intended to show that batches made by Alkermes Inc. were equivalent to batches made at Amylin's Ohio facility; an additional study will delay plans to seek approval (11/4) |
| INFECTION | ||||
| Arpida AG (Switzerland; SWX:ARPN) | Iclaprim | A diaminopyrimidine derivative; antibiotic | Complicated skin and skin structure infections | FDA analysis of Phase III data raised significant concerns over three deaths suspected of being related to the drug; results showed Iclaprim was less effective than Zyvox, which conflicts with results released by Arpida in July 2007 and December 2006 (11/18); FDA advisers voted 17-to-2 that it failed to demonstrate safety and efficacy (11/20) |
| Basilea Pharmaceutica Ltd. (Switzerland; SWX:BSLN) | Ceftobiprole | A first-in-class anti-MRSA broad-spectrum cephalosporin | Complicated skin and skin structure infections | FDA delayed its review due to unresolved data integrity issues (11/28) |
| Pfizer Inc. | Selzentry | Maraviroc; CCR5 antagonist | CCR5-tropic HIV-1 | FDA granted full approval in treatment-experienced adult patients (11/28) |
| Targanta Therapeutics Corp. (TARG) | Oritavancin | A semisynthetic lipoglycopeptide antibiotic infections | Complicated skin and skin structure | FDA advisers voted 10-to-8 that data failed to demonstrate it was safe and effective (11/20) |
| Theravance Inc. (THRX) | Telavancin | Injectable antibiotic; a semisynthetic lipoglycopeptide antibiotic active against Gram-positive organisms | Complicated skin and skin structure infections | Federal panel supported approval, 21 to 5, despite the potential for the drug to cause birth defects and kidney problems (11/19) |
| MISCELLANEOUS | ||||
| AMAG Pharmaceuticals Inc. (AMAG) | Ferumoxytol | An intravenous form of iron | Chronic kidney disease | FDA decided to review the company's resubmitted information, setting a target action date of Dec. 30 (11/13) |
| Discovery Laboratories Inc. (DSCO) | Surfaxin | Lucinactant | To prevent respiratory distress syndrome in premature infants | FDA has accepted for review its complete response (11/10) |
| ISTA Pharmaceuticals Inc. (ISTA) | Bepreve | Bepotastine ophthalmic solution; an eye-drop treatment | Ocular itching associated with allergic conjunctivitis | Filed an NDA for Bepreve (11/14) |
| MediQuest Therapeutics Inc.* | MQX-503 | Vascana; a topical therapy | Raynaud's disease | FDA issued a complete response letter (11/3) |
| Novo Nordisk AS (Denmark; NYSE:NVO) | Norditropin (FDA-approved) | Somatropin (rDNA origin) | Short stature | FDA approved the injectable growth hormone (11/4) |
| Salix Pharmaceuticals Ltd. (SLXP) | Apriso | Mesalamine; extended-release capsules, a locally acting 5-aminosalicylic acid | Ulcerative colitis | FDA granted marketing approval for Apriso (11/3) |
| Takeda Pharmaceutical Co. Ltd. (Japan) | Febuxostat | A potent non-purine, selective inhibitor of xanthine oxidase | Hyperuricemia in patients with gout | FDA committee recommended approval (11/25) |
| XenoPort Inc. (XNPT) and GlaxoSmithKline plc (UK) | Solzira | A transported prodrug of gabapentin | Restless legs syndrome | GSK withdrew its NDA due to a data formatting issue involving one trial (11/10) |
| 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. | ||||
| NYSE = New York Stock Exchange; SWX = Swiss Stock Exchange. | ||||
