Company |
Product |
Description |
Indication |
Status |
Date |
AUTOIMMUNE | |||||
Genzyme Corp. (Cambridge, Mass.) |
Lemtrada |
Alemtuzumab |
Multiple sclerosis |
FDA accepted the resubmission of its supplemental BLA |
6/2/14 |
CANCER | |||||
Agios Pharmaceuticals Inc. (Cambridge, Mass.) |
AG-221 |
An oral IDH2 mutant inhibitor |
Acute myelogenous leukemia |
FDA granted orphan drug designation |
6/17/14 |
Critical Outcome Technologies Inc. (London, Ontario) |
COTI-2 |
Has a p53-dependent mechanism of action |
Ovarian cancer |
FDA granted orphan drug designation |
6/18/14 |
Dara Biosciences Inc. (Raleigh, N.C.) |
KRN5500 |
An intravenous, non-opioid, non-narcotic spicamycin derivative |
Multiple myeloma |
FDA granted orphan drug designation |
6/17/14 |
Immunomedics Inc. (Morris Plains, N.J.) |
IMMU-132 |
Antibody-drug conjugate |
Pancreatic cancer |
Achieved a second orphan drug designation from the FDA |
6/10/14 |
Mirati Therapeutics Inc. (San Diego) |
Mocetinostat |
Spectrum selective histone deacetylase inhibitor |
Myelodysplastic syndrome |
Granted FDA orphan drug status |
6/18/14 |
Momenta Pharmaceuticals Inc. (Cambridge, Mass.) |
Necuparanib |
A heparan sulfate mimetic |
Pancreatic cancer |
Received orphan drug designation from the FDA |
6/6/14 |
Navidea Biopharmaceuticals Inc. (Dublin, Ohio) |
Lymphoseek |
Technetium 99m tilmanocept injection |
Squamous cell carcinoma |
FDA approved an additional indication for radioactive imaging agent Lymphoseek injection to help determine the spread of squamous cell carcinoma into sentinel lymph nodes in the body's head and neck region |
6/16/14 |
Pharmacyclics Inc. (Sunnyvale, Calif.) |
Imbruvica |
Ibrutinib |
Chronic lymphocytic leukemia |
FDA accepted its supplemental NDA |
6/10/14 |
CARDIOVASCULAR | |||||
Acella Pharmaceuticals LLC (Atlanta) |
Tranexamic Acid |
1,000 mg/10mL injection |
Hemophilia |
Received approval of an abbreviated NDA, which was determined to be bioequivalent to the reference listed drug, Cyklokapron (tranexamic acid; Pharmacia & Upjohn Inc.) |
6/10/14 |
Biogen Idec Inc. (Cambridge, Mass.) |
Eloctate |
Antihemophilic factor (recombinant), Fc fusion protein |
Hemophilia A |
Received FDA approval |
6/10/14 |
Chemocentryx Inc. (Mountain View, Calif.) |
CCX168 |
An oral inhibitor that targets the receptor for the complement protein known as C5a |
Antineutrophil cytoplasmic autoantibodies-associated vasculitides |
FDA granted orphan drug designation |
6/4/14 |
Symplmed Pharmaceuticals LLC (Cincinnati) |
Prestalia |
A single-pill, fixed-dose combination on long-acting angiotensin-converting enzyme inhibitor perindopril arginine and calcium channel blocker amlodipine besylate |
Hypertension |
FDA accepted for review the NDA |
6/18/14 |
CENTRAL NERVOUS SYSTEM | |||||
Alexion Pharmaceuticals Inc. (Cheshire, Mass.) |
Soliris |
Terminal complement inhibitor eculizumab |
Myasthenia gravis |
Gained FDA orphan drug status |
6/18/14 |
Biodelivery Sciences International Inc. (Raleigh, N.C.) |
Bunavail |
Buprenorphine and naloxone buccal film |
Opioid dependence |
FDA approved its NDA for maintenance treatment of opioid dependence as part of a complete treatment plan to include counseling and psychosocial support |
6/10/14 |
Insys Therapeutics Inc. (Phoenix) |
ND |
Pharmaceutical cannabidiol (CBD) |
Lennox-Gastaut syndrome |
FDA granted orphan drug designation |
6/26/14 |
Omeros Corp. (Seattle) |
Omidria |
Phenylephrine and ketorolac injection; formerly OMS302 |
To reduce postoperative pain and pupil constriction |
FDA approved it to maintain pupil size during cataract surgery or intraocular lens replacement by preventing intraoperative pupil constriction, or miosis, and to reduce postoperative pain. |
6/3/14 |
Orexigen Therapeutics Inc. (San Diego) |
Contrave |
Naltrexone/bupropion |
Obesity |
FDA pushed back the PDUFA data by three months to Sept. 11, indicating the extension will provide extra time to reach agreement on the postmarketing obligation related to an ongoing cardiovascular outcomes trial |
6/12/14 |
Cubist Pharmaceuticals Inc. (Lexington, Mass.) |
CXA-201 |
Gram-negative antibiotic ceftolozane/tazobactam |
Complicated urinary tract infections and complicated intra-abdominal infections |
FDA accepted for review its NDA |
6/23/14 |
Cubist Pharmaceuticals Inc. (Lexington, Mass.) |
Sivextro (tedizolid phosphate) |
Oxazolidinone antibiotic |
Acute bacterial skin and skin structure infections |
FDA approved it |
6/24/14 |
DIABETES | |||||
Mannkind Corp. (Valencia, Calif.) |
Afrezza |
Insulin human (rDNA origin) |
Type 1 and type 2 diabetes |
Gained FDA approval as a rapid-acting inhaled insulin for administration at the beginning of each meal, or within 20 minutes of starting a meal |
6/30/14 |
MISCELLANEOUS | |||||
Edison Pharmaceuticals Inc. (Mountain View, Calif.) |
EPI-743 |
Vatiquinone |
Leigh syndrome |
Gained FDA orphan drug status |
6/10/14 |
Effrx Pharmaceuticals SA (Zurich, Switzerland) |
EX404 |
Metformin-based candidate |
Pediatric polycystic ovary syndrome |
FDA granted an orphan drug designation |
6/11/14 |
Makindus Inc. (Doylestown, Pa.) |
MI-100 |
Therapy for juvenile macular degeneration |
Stargardt's disease |
Received orphan drug designation from the FDA |
6/11/14 |
Rockwell Medical Inc. (Wixom, Mich.) |
Calcitriol |
Active Vitamin D injection |
Low-cost generic active vitamin D drug |
FDA approved its supplemental ANDA |
6/24/14 |
|
Notes 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. Public biotech company stock symbols can be found in the stock report located on the last two pages of this issue. The date indicated refers to the BioWorld Today issue in which the news item can be found. | |||||
