Company*
(Country; Symbol) 		Product Description Indication Status (Date)
AUTOIMMUNE
Anthera Pharmaceuticals Inc.* A-001 Intravenous sPLA2 inhibitor To prevent acute chest syndrome in patients with sickle cell disease FDA granted orphan drug status (12/18)
Centocor Inc. (unit of Johnson & Johnson) CNTO 1275 Ustekinumab Plaque psoriasis Submitted regulatory applications in the U.S. and Europe (12/4)
CANCER
Celldex Therapeutics Inc. (BE:C4W) CDX-110 Peptide vaccine EGFRvIII-expressing glio-blastoma multiform Received orphan drug designation for CDX-110 (12/7)
Cephalon Inc. (CEPH) Treanda Bendamustine HCl Non-Hodgkin's lymphoma Company filed an NDA (12/31)
Genentech Inc. (NYSE:DNA) Avastin (FDA-approved) Bevacizumab Metastatic breast cancer FDA committee said there was not sufficient data to support an approval (12/5)
Indevus Pharmaceuticals Inc. (IDEV) Valstar (FDA-approved 1998; withdrawn 2002) Valrubicin Bladder cancer Received a non-approvable letter, related to the chemistry, manufacturing and controls supplement submitted to the NDA in May (12/20)
Millennium Pharmaceuticals Inc. (MLNM) Velcade (FDA-approved) Bortezomib Multiple myeloma Submitted an sNDA for untreated patients (12/21)
Pharmacyclics Inc. (PCYC) Xcytrin Motexafin gadolinium injection Non-small-cell lung cancer FDA said it was not approvable in combination with radiation (12/26)
CARDIOVASCULAR
Cardiome Pharma Corp. (CRME) and Astellas Pharma U.S. Inc. (BE:YPH) Kynapid Vernakalant Atrial fibrillation Federal advisers told the FDA that it should approve Kynapid (12/12)
Jerini AG (Germany; BE:GI4) Icatibant A synthetic peptidomi-metic designed to work by blocking the B2 receptor as an antagonist to the peptide hormone bradykinin Hereditary angioedema FDA accepted the NDA for priority review and issued a PDUFA date of April 26, 2008 (12/26)
Solvay Pharmaceuticals Inc. Pulzium Tedisamil sesquifumurate Atrial fibrillation Federal advisers told the FDA that it should reject Pulzium (12/12)
CENTRAL NERVOUS SYSTEM
Isis Pharmaceuticals Inc. (ISIS) ISIS 333611 A second-generation antisense drug Inherited amyotrophic lateral sclerosis Isis received orphan drug designation from the FDA (12/13)
Ista Pharmaceuticals Inc. (ISTA) Xibrom (FDA-approved) Bromfenac ophthalmic solution; topical non-steroidal anti-inflammatory drug compound Inflammation, pain and photophobia Submitted an NDA (12/21)
Jazz Pharmaceuticals Inc. (JAZZ) Luvox Fluvoxamine maleate extended-release capsules Social anxiety disorder and obsessive compulsive disorder Received an approvable letter (12/26)
Neurochem Ltd. (Switzerland; NRMX) Kiacta Eprodisate Amyloid A amyloidosis Company learned its response to the FDA approvable letter from July is complete and has been granted a Class 2 review (12/7)
Neurocrine Biosciences Inc. (NBIX) Indiplon 5-mg and 10-mg capsules of an immediate-release version Insomnia FDA delivered a second approvable letter with requests for additional clinical and preclinical studies (12/13)
Noven Pharmaceuticals Inc. (NOVN) Stavzor Valproic acid delayed-release capsules Seizures and manic episodes associated with bipolar disorder and migraine headache prevention Received tentative FDA approval (12/27)
UCB Pharma Inc.* Neupro (FDA-approved) Rotigotine; a patch designed to provide continuous drug delivery Restless leg syndrome FDA accepted for filing an sNDA (12/13)
INFECTION
Pfizer Inc. Dalbavancin HCl A once-weekly, two-dose antibiotic Complicated skin and skin structure infections Received an approvable letter for adult patients (12/26)
Tibotec Pharmaceuticals Ltd.* (Ireland) Prezista Darunavir HIV-1 Submitted an sNDA to the FDA for full approval of Prezista, as well as an expanded label for use in HIV-1 infected, treatment naive adults (12/21)
MISCELLANEOUS
AMAG Pharmaceuticals Inc. (AMAG) Ferumoxytol Intravenous iron replacement therapy Iron deficiency anemia in patients with chronic kidney disease Submitted an NDA to the FDA (12/19)
BioMarin Pharmaceutical Inc. (BMRN) Kuvan Sapropterin dihydro-chloride tablets Phenylketonuria FDA granted marketing approval (12/13)
Cypress Bioscience Inc. (CYPB) and Forest Laboratories Inc. Milnacipran A norepinephrine-serotonin-reuptake inhibitor Fibromyalgia Submitted an NDA (12/31)
DOR BioPharma Inc. (OTC BB: DORB) orBec Oral beclomethasone diproprionate Gastrointestinal graft-vs.-host disease The FDA is requiring a single, confirmatory Phase III trial following its not approvable letter (12/7)
Genzyme Corp. (GENZ) Thyrogen Thyrotropin alfa To ablate remaining thyroid issue in patients who have had their cancerous thyroids removed FDA approved a supplemental indication for Thyrogen for use in combination with radioiodine (12/17)
Insmed Inc. (INSM) Iplex (FDA-approved) Recombinant human IGF-1 and its binding protein IGFBP-3 Myotonic muscular dystrophy FDA granted orphan drug status (12/18)
Ipsen SA (France; PARIS:IPN) Dysport Injection that contains botulinum neurotoxin Type A complex as its active ingredient Cervical dystonia Submitted a BLA (12/6)
MGI Pharma Inc. (MOGN) Aquavan Fospropofol disodium injection; a sedative-hypnotic agent For patients undergoing diagnostic or therapeutic procedures FDA accepted for filing its NDA (12/17)_
Prestwick Pharmaceuticals Inc.* Xenazine Tetrabenazine; dopamine depletor that works by selectively blocking the VMAT2 transporter Chorea associated with Huntington's disease Federal advisers said that, despite the risks, the FDA should approve the treatment; the risks include the increase in parkinsonism, akathisia, depression and dysphagia (12/6)
Salix Pharmaceuticals Ltd. (SLXP) Granulated mesalamine product Ulcerative colitis Submitted an NDA (12/31)
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.

BE = Berlin Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board.