Company |
Product |
Description |
Indication |
Status |
Date |
CANCER | |||||
Bioalliance Pharma SA (Paris) |
Livatag |
Doxorubicin Transdrug |
Advanced hepatocellular carcinoma |
European independent board of experts in charge of the safety profile of the Relive phase III trial unanimously recommended continuing the study without modification |
4/15/14 |
Cytrx Corp. (Los Angeles) |
Aldoxorubicin |
Combines doxorubicin with a linker-molecule that binds specifically to albumin |
Advanced soft tissue sarcomas |
Received orphan medicinal product designation from the European Commission |
4/1/14 |
Erytech Pharma SA (Lyon, France) |
Graspa/Ery-asp |
An enzyme formulation of L-asparaginase |
Acute myeloid leukemia |
Was granted orphan drug designation by the FDA |
4/3/14 |
E-Therapeutics plc (Oxford, UK) |
ETS2101 |
Dexanabinol |
Solid tumors |
The UK phase Ia trial showed it was well tolerated at all six dose escalations with no serious diverse events |
4/1/14 |
CARDIOVASCULAR | |||||
Aegerion Pharmaceuticals Inc. (Cambridge, Mass.) |
Lomitapide |
Adjunct treatment |
Homozygous familial hyperchol-erolemia |
Patient enrollment was initiated in Japan in a phase III trial |
4/10/14 |
Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.) and Sanofi SA (Paris) |
Alirocumab |
A monoclonal antibody targeting PCSK9 |
High cholesterol |
The first phase II study in Japanese patients met its primary endpoint |
4/2/14 |
CENTRAL NERVOUS SYSTEM | |||||
Coronado Biosciences Inc. (Burlington, Mass.) |
CNDO-201 |
Trichuris suis ova |
Autism spectrum disorder |
Launched in Jerusalem a randomized, double-blind, placebo-controlled, study of 60 patients ages 6 to 17 |
4/11/14 |
Intelgenx Corp. (St. Laurent, Quebec) and Redhill Biopharma Ltd. (Tel-Aviv, Israel) |
Versafilm |
Oral thin film formulation of rizatriptan |
Migraine |
Initiated a comparative bioavailability clinical study comparing Versafilm to the European reference drug |
4/29/14 |
Salix Pharmaceuticals Ltd. (Raleigh, N.C.) and Progenics Pharmaceuticals Inc. (Tarrytown, N.Y.) |
Relistor |
Methylnaltrexone bromide subcutaneous injection |
Opioid-induced constipation in chronic noncancer pain |
Submission to the EMA has been accepted for review |
4/23/14 |
INFECTION | |||||
Chongqing Zhifei Biological Products Co. Ltd. (Hong Kong) |
AC-Hib vaccine |
Vaccine against group A and C meningococcus and haemophilus influenzae type B |
Infectious diseases |
The CFDA gave the green light to Chongqing to launch its joint vaccine against group A and C meningococcus and haemophilus influenzae type B |
4/17/14 |
INFLAMMATORY | |||||
Glenmark Pharmaceuticals Ltd. (Mumbai, India) |
GRC 27864 |
Targets microsomal prostaglandin E synthase-1 |
Chronic inflammatory diseases and pain management |
Plans to begin phase I testing in the UK |
4/4/14 |
MISCELLANEOUS | |||||
Alexion Pharmaceuticals Inc. (Cheshire, Conn.) |
Soliris |
Eculizumab; a terminal complement inhibitor |
To prevent graft rejection following solid organ transplantation |
European Commission has granted an orphan drug designation |
4/24/14 |
Alnylam Pharmaceuticals Inc. (Cambridge, Mass.) |
ALN-TTRsc |
RNAi drug |
Transthyretin-mediated amyloidosis |
EMA's Committee for Orphan Medicinal Products adopted a positive opinion |
4/3/14 |
Apricus Biosciences Inc. (San Diego) |
Vitaros |
Topical version of vasodilator alprostadil |
Erectile dysfunction |
Approved in Luxembourg; approved in Spain |
4/4/14; 4/25/14 |
Hospira Inc. (Lake Forest, Ill.) |
Retacrit/Silapo |
Epoetin zeta; biosimilar |
Renal anemia |
European data showed it appeared to be as safe as other epoetin alfa products |
4/29/14 |
Keryx Biopharmaceuticals Inc. (New York) |
Zerenex |
Ferric citrate coordination complex |
Hyperphos-phatemia in patients with chronic kidney disease |
EMA determined that the firm's MAA is valid |
4/3/14 |
Thrombogenics NV (Leuven, Belgium) |
Jetrea |
Ocriplasmin |
Vitreomacular traction |
Was approved in Malaysia |
4/18/14 |
|
Notes BLA = Biologics license application; CHMP = European Committee for Medicinal Products for Human Use; CMA = Continuous marketing application; EMA = European Medicines Agency; FDA = Food and Drug Administration; IND = Investigational new drug application; MAA = Marketing authorization 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. | |||||