Company
(location)

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.