Company*
(Country; Symbol)
Product Description Indication Status (Date)

AUTOIMMUNE
 
Roche AG (Switzerland) and Chugai Pharmaceutical Co. Ltd. (Japan) Actemra Tocilizumab; an interleukin-6 receptor-inhibiting monoclonal antibody Rheumatoid arthritis FDA issued a complete response letter and is asking for additional documentation related to the manufacturing of Actemra and certain other components (9/19)
 
Talecris Bio-therapeutics Inc.* Gamunex (FDA-approved) An intravenous immuno-globulin product Chronic inflammatory demyelinating polyneuropathy FDA approved Gamunex (9/12)
 
CANCER
 
Celator

Pharmaceuticals*

CPX-351 Cytarabine: daunorubicin

liposome injection

Acute myeloid

leukemia

FDA granted orphan drug desig-

nation (9/4)

 
ImClone Systems Inc. (IMCL) Erbitux (FDA-approved) Cetuximab Squamous cell carcinoma Submitted an sBLA to broaden use in first-line patients with recurrent and/or metastatic disease (9/3)
 
Introgen Therapeutics Inc. (INGN) Advexin Gene therapy that uses biomarker data Head and neck cancer FDA refused to accept the BLA (9/2)
 
Merck & Co. Inc. Gardasil (FDA-approved) Vaccine To prevent vaginal and vulvar cancer caused by the  human papillomavirus types 16 and 18 FDA granted approval for the expanded use of Gardasil in girls and women ages 9 to 26 (9/15)
 
Mesoblast Ltd. (Australia; ASX: MSB) ­ Allogeneic mesenchymal precursor cells for insufficient hematopoietic stem cell production For bone marrow transplantation in patients with hematologic malignancies FDA granted orphan drug designation (9/17)
 
ProStrakan Group plc (UK; LSE:PSK) Sancuso Granisetron transdermal system; a patch Chemo-induced nausea and vomiting FDA approved Sancuso (9/15)
 
CARDIOVASCULAR
 
ARCA Biopharma Inc.* Bucindolol Beta-blocker and mild vasodilator Heart failure FDA accepted an NDA (9/23)
 
Dyax Corp. (DYAX) DX-88 Ecallantide Hereditary angioedema Filed a BLA with the FDA (9/24)
 
Lung Rx Inc. (subsidiary of United Therapeutics Corp.; UTHR) Treprostinil Inhaled drug Pulmonary arterial hypertension FDA accepted for review the NDA (9/3)
 
Ortho Biotech Products LP (unit of Johnson & Johnson) Eprex Epoetin alfa Stroke FDA issued an alert showing that a German study had 16% of Eprex patients die compared with 9% of those who did not receive the drug (9/26)
 
CENTRAL NERVOUS SYSTEM
 
Alpharma Inc. (NYSE:ALO)  Embeda Morphine sulfate-extended release with sequestered naltrexone hydrochloride capsules Pain FDA accepted and designated for priority review the NDA (9/2)
 
Cephalon Inc. (CEPH) Fentora (FDA-approved) Fentanyl buccal tablet Chronic breakthrough pain FDA issued a complete response saying it would not approve an expanded indication until the company implements and demonstrates effectiveness of its risk management program (9/15)
 
Labopharm Inc. (DDSS)  DDS-04A A once-daily serotonin antagonist reuptake inhibitor Major depression Submitted and NDA under the 505(b)(2) pathway (9/22)
 
UCB SA (Belgium; BR:UCB) Keppra Levetiracetam Epilepsy FDA approved an extended-release version of Keppra to treat partial onset seizures in patients 16 years or older (9/15)
 
XenoPort Inc. (XNPT) and GlaxoSmithKline plc (UK) Solzira Extended release tablets; a gabapentin agent Restless legs syndrome Companies submitted an NDA (9/16)
 
DIABETES
 
Takeda Pharmaceutical  Co. Ltd. (Japan; FSE:TKD) Alogliptin A dipeptidyl peptidase-4 inhibitor Type II diabetes Submitted an NDA (9/25)
 
INFECTION
 
Basilea Pharmaceutica Ltd. (Switzerland; SWX:BSLN) Ceftobiprole  A first-in-class anti-MRSA broad-spectrum cephalosporin Complicated skin and skin structure infections FDA accepted for review a complete response to a not approvable letter (9/15)
 
Gilead Sciences Inc. (GILD) Aztreonam lysine Inhaled version Cystic fibrosis-related pseudomonal infections FDA wants an additional clinical study before it considers approving the product; it did not raise any significant safety concerns in a complete response letter (9/17)
 
Pfizer Inc. (NYSE:PFE) Dalbavancin A once-weekly, two-dose antibiotic Complicated skin and skin structure infections Company is withdrawing all marketing applications in the U.S. and Europe, and plans to conduct an additional Phase III trial (9/9)
 
MISCELLANEOUS
 
Enboia Pharma

Inc.* (Canada)

ENB-0040 An enzyme replacement

therapy

Hypophos-

phatasia

Received orphan drug desig-

nation from the FDA (9/19)

 
Pfizer Inc. (NYSE:PFE) Fablyn Lasofoxifene tartrate; a selective estrogen receptor modulator Osteoporosis FDA's Reproductive Health Drugs Advisory Committee voted 9 to 3, with 1 abstention, that Fablyn's benefits outweigh its risks in certain populations, but the panel could not come to a consensus on which population the drug should be used (9/8)
 
ProtAffin AG* (Austria) PA401 Recombinant human CXCL8 mutant To prevent delayed graft function after solid organ transplantation FDA gave it orphan drug status (9/5)

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.

ASX = Australian Stock Exchange; BR = Brussels Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; SWX = Swiss Stock Exchange.