Company |
Product |
Description |
Indication |
Status |
Date |
CANCER | |||||
Actinium Pharmaceuticals Inc. (New York) |
Iomab-B |
Radioimmuno-therapeutic |
It conditions acute myeloid leukemia patients for a hematopoietic stem cell transplant |
Filed an application seeking orphan drug status with the FDA |
11/24/15 |
Cellceutix Corp. (Beverly, Mass.) |
Kevetrin |
Anti-cancer drug candidate |
Retinoblastoma |
FDA granted orphan designation |
11/24/15 |
Clovis Oncology Inc. (Boulder, Colo.) |
CO-1686 |
Rociletinib |
Non-small-cell lung cancer |
FDA wants additional clinical data to evaluate the efficacy of the 500 mg and 625 mg dose groups, and it plans to focus solely on confirmed responses when reviewing the NDA |
11/17/15 |
Genentech Inc. (South San Francisco) and Exelixis Inc. (South San Francisco) |
Cotellic |
Cobimetinib |
Locally advanced or metastatic melanoma |
FDA approved it for use in combination with Roche AG's Zelboraf (vemurafenib) to treat patients carrying a BRAF V600E or V600K mutation |
12/11/15 |
Genmab A/S (Copenhagen) |
Darzalex |
Daratumumab injection; anti-CD38 antibody |
Multiple myeloma |
FDA granted accelerated approval |
11/17/15 |
Telesta Therapeutics Inc. (Pointe Claire, Quebec) |
MCNA |
Mycobacterial cell wall-nucleic acid complex |
High-risk non-muscle invasive bladder cancer |
FDA advisory panel recommended the FDA reject the BLA citing insufficient data, a too-small study and a patient population that was not clearly defined |
11/19/15 |
Triphase Accelerator Corp. (Toronto) |
Marizomib |
A protease inhibitor |
Malignant glioma |
Gained FDA orphan status |
11/20/15 |
CARDIOVASCULAR | |||||
Baxalta Inc. |
Adynovate |
Antihemophilic factor (recombinant), pegylated |
Hemophilia A |
FDA approved it |
11/17/15 |
Espero Pharmaceuticals Inc. (Jacksonville, Fla.) |
Gonitro |
Nitroglycerin powder for sublingual use |
Angina pectoris due to coronary artery disease |
FDA accepted for review its NDA |
11/5/15 |
CENTRAL NERVOUS SYSTEM | |||||
Acadia Pharmaceuticals Inc. (San Diego) |
Nuplazid |
Pimavanserin; a selective serotonin inverse agonist that targets 5-HT2A receptors |
Parkinson's disease psychosis |
FDA accepted its NDA, which has been granted priority review |
11/3/15 |
Agilis Biotherapeutics LLC (Cambridge, Mass.) |
AGIL-AS |
Gene therapy |
Angelman syndrome |
FDA granted orphan drug designation |
11/5/15 |
Braeburn Pharmaceuticals Sprl (Princeton, N.J.) and Camurus AB (Lund, Sweden) |
CAM2038 |
Weekly and monthly buprenorphine subcutaneous injection |
Opioid addiction |
FDA granted fast track status |
11/6/15 |
Collegium Pharmaceutical Inc. (Canton, Mass.) |
Xtampza ER |
Oxycodone extended-release capsules |
Pain |
FDA has granted tentative approval to the company's NDA; Xtampza ER is subject to an automatic stay of up to 30 months as a result of patent litigation filed by Stamford, Conn.-based Purdue Pharma LP |
11/10/15 |
Insys Therapeutics Inc. (Phoenix |
Nalone |
Sublingual spray |
Opioid overdose |
Gained an FDA fast track designation to treat known or suspected opioid intoxication or overdose |
11/2/15 |
Lightlake Therapeutics Inc. (New York) |
Narcan |
Naloxone hydrochloride |
Opioid overdose |
FDA approved it |
11/20/15 |
Neos Therapeutics Inc. (Dallas) |
Cotempla XR-ODT |
Orally disintegrating tablet version of methylphenidate |
Attention deficit hyperactivity |
Neos received a complete response letter |
11/12/15 |
DIABETES | |||||
Thrombogenics NV (Leuven, Belgium) |
Jetrea |
Ocriplasmin |
For inducing total posterior vitreous detachment in subjects with nonproliferative diabetic retinopathy |
FDA accepted its investigational new drug application for the phase II CIRCLE study |
11/13/15 |
INFECTION | |||||
Cellceutix Corp. (Beverly, Mass.) |
Brilacidin-OM |
An oral rinse formulation of the company's defensin-mimetic Brilacidin |
To prevent oral mucositis |
FDA granted fast track designation |
11/30/15 |
Destiny Pharma Ltd. (Brighton, UK) |
XF-73 |
Exeporfinium chloride; a synthetic drug with antibacterial activity |
Multi-antibiotic-resistant strain, methicillin-resistant Staphylococcus aureus |
FDA granted qualified infectious disease product designation |
11/12/15 |
Emergent Biosolutions Inc. (Gaithersburg, Md.) |
Biothrax |
Anthrax vaccine |
Preventing disease following suspected or confirmed exposure to Bacillus anthracis |
Approved in a new indication |
11/25/15 |
Gilead Sciences Inc. (Foster City, Calif.) |
Genvoya |
Once-daily single-tablet tenofovir alafenamide-based regimen |
HIV |
FDA approved it for adults and pediatric patients 12 years and older |
11/6/15 |
Gilead Sciences Inc. (Foster City, Calif.) |
Harvoni |
Ledipasvir/sofosbuvir |
Hepatitis C virus and HIV |
FDA approved additional indications for use in patients with genotype 4, 5 and 6 chronic HCV infection and in patients co-infected with HIV |
11/16/15 |
Paratek Pharmaceuticals Inc. (Boston) |
Omadacycline |
Once-daily oral and intravenous formulations |
Acute bacterial skin and skin structure infections |
FDA granted fast track designation |
11/6/15 |
MISCELLANEOUS | |||||
Amag Pharmaceuticals Inc. (Waltham, Mass.) |
Makena |
Hydroxy-progesterone caproate injection |
To reduce the risk of preterm birth |
Received a complete response letter from the FDA, requesting additional information |
11/20/15 |
Amgen Inc. (Thousand Oaks, Calif.) |
Etelcalcetide |
Formerly AMG 416 |
Secondary hyperparathyroidsm in chronic kidney disease |
FDA accepted for review its NDA |
11/9/15 |
Applied Genetic Technologies Corp. (Gainesville, Fla.) |
Gene therapy product |
Gene therapy |
Achromatopsia |
FDA granted orphan drug designation |
11/24/15 |
Armagen Inc. (Calabasas, Calif.) |
AGT-181 |
Enzyme replacement therapy |
Hurler syndrome |
FDA granted rare pediatric disease designation |
11/6/15 |
Bone Therapeutics SA (Gosselies, Belgium) |
Allob |
Allogeneic bone cell therapy |
Osteogenesis imperfecta (brittle bone disease) |
Received orphan drug designation from the FDA |
11/13/15 |
CTI Biopharma Corp. (Seattle) |
Pacritinib |
Oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R |
Myelofibrosis |
Initiated a rolling new drug application to the FDA |
11/24/15 |
Cumberland Pharmaceuticals Inc. (Nashville, Tenn.) |
Caldolor |
Ibuprofen |
Pain and reduction of fever |
FDA approved it |
11/24/15 |
Genkyotex SA (Geneva) |
GKT 137831 |
NOX1 and 4 inhibitor |
Fibrotic disorders |
Was granted orphan drug designation by the FDA and EMA |
11/12/15 |
Green Cross Corp. (Yongin, South Korea) |
IVIG-SN |
Human normal immunoglobulin G for intravenous administration |
Primary immunodeficiency diseases |
Submitted a biologics license application to the FDA |
11/25/15 |
Lipocine Inc. (Salt Lake City) |
LPCN 1021 |
Twice-a-day, oral testosterone replacement therapy candidate |
Hypogonadism |
FDA has accepted its NDA |
11/2/15 |
Lysogene SAS (Paris) |
LYS-SAF-302 |
Has the potential to replace the defective gene in the cells |
Sanfilippo type A (mucopolysaccharidosis type IIIA) |
FDA granted orphan designation and rare pediatric disease designation |
11/25/15 |
Repros Therapeutics Inc. (The Woodlands, Texas) |
Enclomiphene |
Formerly Androxal |
Secondary hypogonadism |
FDA canceled an advisory committee meeting with a panel from its Division of Bone, Reproductive and Urologic Products scheduled to review the NDA, due to questions that arose late in the review regarding the bioanalytical method validation that could affect interpretability of certain pivotal study data |
11/2/15 |
RESPIRATORY | |||||
Arch Biopartners Inc. (Toronto) |
AB569 |
A nebulized solution |
Pseudomonas aeruginosa pulmonary infections in cystic fibrosis |
FDA granted orphan drug designation |
11/16/15 |
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. |