Company*
(Country; Symbol)		 Product Description Indication Status (Date)
AUTOIMMUNE
Acorda Therapeutics Inc. (ACOR) Fampridine-SR A sustained-release tablet form of 4- aminopyridine Multiple sclerosis Company filed an NDA (2/2)
 
Genentech Inc. (NYSE:DNA) Raptiva Efalizumab Psoriasis FDA issued a public health advisory about three confirmed cases and possibly a fourth of the brain infection progressive multifocal leukoencephalopathy in patients using the approved drug; the EMEA recommended that marketing be suspended (2/19)
 
CANCER
 
GTx Inc. (GTXI) Toremifene 80 mg; an oral selective estrogen receptor modulator To prevent bone fractures in men with prostate cancer on androgen deprivation therapy FDA accepted for filing and review the NDA (2/18)
 
Vion Pharmaceuticals Inc. (VION) Onrigin Laromustine; formerly Cloretazine Acute myeloid leukemia Submitted an NDA (2/17)
 
CARDIOVASCULAR
 
Acusphere Inc. (ACUS) Imagify Perflubutane polymer microspheres To detect coronary artery disease Submitted an amendment to its NDA to focus on patients where the risk-to-benefit ratio of Imagify is more compelling than the broader indication that was filed originally (2/18)
 
Dyax Corp. (DYAX) Kalbitor Ecallantide; DX-88 Hereditary angioedema FDA panel voted 6-to-5 to support the drug's approval (2/4)
 
GTC Biothera-peutics Inc. (GTCB) ATryn Antithrombin III, recombinant; produced in the milk of transgenic goats To prevent perioperative and peripartum thromboembolic events in patients with hereditary antithrombin eficiency FDA granted approval for a preventive therapy (2/6)
 
CENTRAL NERVOUS SYSTEM
 
Alkermes Inc. (ALKS) and Johnson & Johnson Risperdal Consta Risperidone For adjunctive maintenance of bipolar disorder Received a complete response letter to the sNDA; the FDA asked for additional information but did not request additional studies (2/11)
 
Cipher Pharmaceuticals Inc.* (Canada) CIP-Tramadol ER Extended release formulation of tramadol Pain Received tentative approval from the FDA (2/18)
 
Genzyme Corp. (GENZ) Synvisc-One Hylan G-F 20; a single-injection viscosupplement Pain associated with osteo-arthritis of the knee FDA granted marketing approval (2/26)
 
Neuralstem Inc. (AMEX:CUR) ­ Stem cells delivered via its Human Neural Stem Cell technology Amyotrophic lateral sclerosis FDA issued a clinical hold on the first clinical trial asking for more information on product manufacturing and preclinical studies, as well as the delivery injection device and technique (2/20)
 
Nuvo Research Inc. (Canada; TSX:NRI) Pennsaid 1.5% w/w diclofenac sodium solution; topical NSAID Pain and symptoms of osteoarthritis FDA accepted its resubmission of an NDA (2/19)
 
Roxro Pharma Inc.* ROX-888 Intranasal formulation of the non-steroidal  anti-inflammatory drug ketorolac Pain FDA accepted the NDA (2/6)
 
Somaxon Pharmaceuticals Inc. (SOMX) Silenor A low-dose formulation of doxepin Insomnia Received a complete response letter from the FDA (2/27)
 
Winston Pharmaceuticals Inc. (OTC BB:WPHM) Civamide A TRPV-1 receptor  modulator Postpherpetic neuralgia Received orphan drug designation from the FDA for Civamide (2/27)
 
INFECTION
 
Theravance Inc. (THRX) Telavancin Antibiotic Complicated skin and skin structure infections and hospital-acquired pneumonia FDA issued a complete response letter asking for a risk evaluation and mitigation strategy for telavancin use in cSSSI (2/27)
 
Tibotec Inc.* Intelence Etravirine tablets; a non-nucleoside reverse transcriptase inhibitor HIV-1 Submitted an application to the FDA seeking traditional approval (2/6)
 
MISCELLANEOUS
 
Amgen Inc. (AMGN) Denosumab RANK-ligand inhibitor Post-menopausal osteoporosis and to treat and prevent bone loss in patients under-going hormone ablation therapy for prostate or breast  cancer Filed a BLA for denosumab (2/18)
 
Gilead Sciences Inc. (GILD) Aztreonam Inhalation solution Cystic fibrosis Lost its appeal of a complete response letter; FDA reiterated its position that the company needs an additional clinical study (2/19)
 
Salix Pharmaceuticals Ltd. (SLXP) Metozolv Metoclopramide; orally disintegrating tablets Gastroesophageal reflux disease Company received a complete response from the FDA indicating that a REMS is required for approval (2/27)
 
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.

AMEX = American Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSX = Toronto Stock Exchange