Company (Location) |
Product |
Description |
Indication |
Status (Date)# |
CANCER | ||||
Advaxis Inc. (Princton, N.J.) |
ADXS-HPV |
An immunotherapy that is designed to target cells expressing the HPV gene E7 |
Cervical cancer |
Phase II data of ADXS-HPV, with or without cisplatin, in Indian women, showed no serious adverse events (12/19) |
Celsion Corp. (Lawrenceville, N.J.) |
ThermoDox |
A heat-activated liposomal encapsulation of doxorubicin |
Hepatocellular carcinoma |
The European Medicines Agency confirmed that the company's Phase III trial is acceptable as a basis for submission of an MAA (12/20) |
Genentech Inc. (San Francisco; unit of the Roche Group) |
Avastin |
Bevacizumab |
Metastatic breast cancer |
Health Canada revoked approval following the FDA's decision to withdraw approval after confirmatory studies failed to support improvement seen in the original pivotal trial (12/1) |
Roche AG (Basel, Switzerland) |
Zelboraf |
Vemurafenib |
Metastatic melanoma |
The CHMP recommended approval as a monotherapy for adults with BRAF V600 mutation-positive unresectable or metastatic melanoma (12/19) |
Roche AG (Basel, Switzerland) |
Vismodegib |
A Hedgehog inhibitor |
Advanced basal cell carcinoma |
Submitted an MAA (12/27) |
CARDIOVASCULAR | ||||
InterMune Inc. (Brisbane, Calif.) |
Esbriet |
Pirfenidone |
Idiopathic pulmonary fibrosis |
The private Institute for Quality and Efficiency in Health Care in Germany determined that there is no additional benefit to Esbriet; InterMune said it will challenge the assessment (12/19) |
CENTRAL NERVOUS SYSTEM | ||||
Biotie Therapies Oyj (Turku, Finland) |
Nalmefene |
An opioid receptor antagonist |
Alcohol dependence |
The EMA accepted for review the MAA (12/27) |
DIABETES | ||||
Novartis AG (Basel, Switzerland) |
Lucentis |
VEGF-inhibiting ophthalmic drug; ranibizumab |
Diabetic macular edema |
UK authorities recommended against the drug after concluding it did not provide a true reflection of the cost-effectiveness compared to the current standard of care, laser photocoagulation (12/1) |
INFECTION | ||||
Gilead Sciences Inc. (Foster City, Calif.) |
Quad |
Elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate |
HIV |
EMA validated and will review its MAA (12/22) |
MediGene AG (Martinsried, Germany) |
Veregen |
Ointment |
Genital warts |
Regulators of 17 additional European countries accepted MAAs for Veregen, which is already marketed in Austria, Germany and the U.S., and is approved in Spain (12/13) |
Optimer Pharmaceuticals Inc. (San Diego) |
Dificlir |
Fidaxomicin tablets |
Clostridium difficile infection |
European Commission granted marketing authorization (12/13) |
MISCELLANEOUS | ||||
AMAG Pharmaceuticals Inc. (Lexington, Mass.) and Takeda Canada Inc. (Mississauga, Ontario) |
Feraheme |
Ferumoxytol injection |
Iron deficiency anemia in patients with chronic kidney disease |
Health Canada granted marketing approval (12/13) |
Clinuvel Pharmaceuticals Ltd. (Melbourne, Australia) |
Scenesse |
Afamelanotide |
Erythropoietic protoporphyria |
Phase III data showed it met the primary endpoint; company plans to complete a European regulatory filing (12/21) |
|
Notes: CHMP = Committee for Medicinal Products for Human Use; EMA = European Medicines Agency; MAA = Marketing authorization application; MRP = Mutual Recognition Procedure. 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. | ||||