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. | ||||