Company |
Product |
Description |
Indication |
Status |
Date |
CANCER | |||||
Apotex Inc. (Toronto) |
Grastofil |
A biosimilar version of Neupogen (filgrastim, Amgen Inc.) |
Neutropenia |
FDA accepted for filing its application for Grastofil |
2/18/15 |
Bexion Pharmaceuticals Inc. (Covington, Ky.) |
Saposin C |
Active ingredient in its drug BXQ-350 |
Glioblastoma multiforme |
FDA granted orphan drug designation |
2/18/15 |
Celgene Corp. (Summit, N.J.) |
Revlimid |
Lenalidomide |
Multiple myeloma |
FDA has expanded the existing indication for Revlimid in combination with dexamethasone to include patients newly diagnosed with multiple myeloma |
2/19/15 |
Celldex Therapeutics Inc. (Hampton, N.J.) |
Rintenga |
Rindopepimut |
EGFRvIII-positive glioblastoma |
FDA granted Rintega breakthrough therapy designation |
2/24/15 |
Exelixis Inc. (South San Francisco) |
Cobimetinib |
A specific MEK inhibitor |
Unresectable or metastic melanoma |
FDA has accepted for review the new drug application (NDA) |
2/20/15 |
Ignyta Inc. (San Diego) |
Entrectinib |
Novel, orally available, selective tyrosine kinase inhibitor of the Trk family of tyrosine kinase receptors (TrkA, TrkB and TrkC), ROS1 and ALK proteins |
TrkA-positive, TrkB-positive, TrkC-positive, ROS1-positive and ALK-positive non-small-cell lung cancer |
FDA granted orphan status |
2/6/15 |
Ignyta Inc. (San Diego) |
Entrectinib |
Acts against a variety of TrkA, ROS1 and ALK-driven mouse xenograft models |
Colorectal cancer |
FDA granted orphan drug designation for entrectinib for treating TrkA-positive, TrkB-positive, TrkC-positive, ROS1-positive or ALK-positive colorectal cancer |
2/18/15 |
Nanospart Pharmaceuticals Inc. (Laguna Hills, Calif.) |
Antibody |
Antinuclear antibody conjugated liposomal doxorubicin |
Ewing's sarcoma |
Received FDA orphan drug designation for one of its lead candidates |
2/12/15 |
Oncolytics Biotech Inc. (Calgary, Alberta) |
Reolysin |
Oncolytic virus candidate |
Ovarian cancer |
FDA granted orphan drug designation |
2/12/15 |
Seattle Genetics Inc. (Bothell, Wash.) |
Adcetris |
Brentuximab vedotin; antibody-drug conjugate directed to CD30 |
Hodgkin's lymphoma |
Submitted a supplemental biologics license application to the FDA based on data from a phase III AETHERA trial of Adcetris (brentuximab vedotin) as consolidation therapy immediately following an autologous stem cell transplant in Hodgkin's lymphoma patients at high risk of relapse |
2/19/15 |
Seattle Genetics Inc. (Bothell, Wash.) |
Adcetris |
Brentuximab vedotin; antibody-drug conjugate directed to CD30 |
Hodgkin's lymphoma |
Submitted a biologics license application to the FDA based on data from the phase III AETHERA trial of Adcetris (brentuximab vedotin) as consolidation therapy immediately following an autologous stem cell transplant; data showed that Adcetris demonstrated a significant increase in progression-free survival (PFS) per independent review facility (p = 0.001), with median PFS of 43 months for patients on drug vs. 24 months for those on placebo |
2/20/15 |
Stemline Therapeutics Inc. (New York) |
SL-701 |
Immunotherapy |
Gliomas |
Gained an FDA orphan designation |
2/2/15 |
Taiho Oncology Inc. (Princeton, N.J.; subsidiary of Taiho Pharmaceutical Co. Ltd.) |
TAS-102 |
Trifluridine and tipiracil hydrochloride |
Refractory metastatic colorectal cancer |
A new drug application for TAS-102 has been accepted for review by the FDA |
2/24/15 |
Verastem Inc. (Boston) |
VS-5584 |
An inhibitor of PI3K, mTORC1 and mTORC2 |
Mesothelioma |
VS-5584 has received orphan drug designation from the FDA |
2/13/15 |
CARDIOVASCULAR | |||||
Portola Pharmaceuticals Inc. (South San Francisco) |
Andexanet alfa |
A modified human factor Xa molecule |
Serious uncontrolled bleeding events |
FDA granted orphan designation to andexanet alfa for reversing the anticoagulant effect of direct or indirect factor Xa inhibitors in patients experiencing serious uncontrolled bleeding events or who require urgent or emergency surgery |
2/27/15 |
CENTRAL NERVOUS SYSTEM | |||||
Biodelivery Sciences International Inc. and Endo Pharmaceuticals Inc. (subsidiary of Endo International plc) |
Belbuca |
Buprenorphine HCl buccal film |
Severe pain |
FDA accepted a new drug application |
2/24/15 |
Collegium Pharmaceutical Inc. (Canton, Mass.) |
Xtampza ER |
Oxycodone extended-release capsules |
Chronic pain |
FDA accepted for filing its new drug application for Xtampza ER |
2/18/15 |
Inspiron Delivery Technologies LLC (Valley Cottage, N.Y.) |
Morphabond ER |
An extended-release, abuse deterrent formulation of morphine that uses IDT's patent-protected technology |
Pain |
FDA accepted the new drug application for Morphabond ER to manage pain severe enough to require daily, round-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate |
2/11/15 |
DIABETES | |||||
Genentech Inc. (unit of Roche AG; Basel, Switzerland) |
Lucentis |
Ranibizumab injection; a vascular endothelial growht factor inhibitor |
Diabetic retinopathy in diabetic macular edema |
FDA approved it at 0.3 mg |
2/10/15 |
INFECTION | |||||
Actavis plc (Dublin) |
Avycaz |
Ceftazidime/avibactam |
Complicated intra-abdominal infections and complicated urinary tract infections |
FDA approved it |
2/27/15 |
Merlion Pharmaceuticals Pte. Ltd. (Singapore) |
Finafloxacin |
Otic suspension |
Acute otitis externa caused by Pseudomonas aeruginosa and Staphylococcus aureus |
FDA approved it |
2/12/15 |
MISCELLANEOUS | |||||
Cytori Therapeutics Inc. (San Diego) |
ECCS-50 |
Cell-based therapy |
Hand manifestations of scleroderma |
Received FDA approval to expand the number of U.S. trial sites in its 80-patient pivotal trial of ECCS-50 from 12 to 20 centers |
2/27/15 |
Otonomy Inc. (San Diego) |
Auripro |
A sustained-exposure formulation of the antibiotic ciprofloxacin |
Middle ear effusion after tympanostomy tube placement surgery |
Submitted a new drug application |
2/27/15 |
Phosphate Therapeutics Ltd. (London) |
PT20 |
Phosphate binder |
Hyperphospha-taemia related to dialysis-dependent chronic kidney disease |
Completely enrolled the first pivotal trial |
2/27/15 |
Repros Therapeutics Inc. (The Woodlands, Texas) |
Androxal |
Enclomiphene |
Secondary hypogonadism |
Submitted a new drug application to the FDA for Androxal for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function |
2/3/15 |
Sprout Pharmaceuticals Inc. (Raleigh, N.C.) |
Flibanserin |
Once-daily nonhormonal pill |
Hypoactive sexual desire disorder |
Resubmitted a new drug application to the FDA |
2/18/15 |
Synageva Biopharma Corp. (Lexington, Mass.) |
Kanuma |
Sebelipase alfa |
Lysosomal acid lipase deficiency |
FDA has accepted for review its biologics license application |
2/24/15 |
Targazyme Inc. (San Diego) |
TZ101 |
Enzyme-based treatment comprised of a recombinant enzyme, α-1,3 fucosyltransferase VI, plus its substrate, GDP-fucose |
Graft-vs.-host disease |
Received orphan drug designation |
2/12/15 |
RESPIRATORY | |||||
Advanced Inhalation Therapies Ltd. (Rehovot, Israel) |
AIT-CF |
High-dose formulation of nitric oxide |
Cystic fibrosis |
Received FDA orphan drug designation |
2/10/15 |
Celtaxsys Inc. (Atlanta) |
CTX-4430 |
Once-daily, oral leukotriene A4 hydrolase inhibitor |
Cystic fibrosis |
FDA granted orphan drug designation |
2/4/15 |
Prometic Life Sciences Inc. (Laval, Quebec) |
PBI-4050 |
Orally active antifibrotic lead drug candidate |
Idiopathic pulmonary fibrosis |
FDA orphan drug designation status was granted |
2/18/15 |
|
Notes 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. For more information about individual companies and/or products, see Thomson Reuters Cortellis. | |||||
