Company |
Product |
Description |
Indication |
Status |
Date |
AUTOIMMUNE | |||||
Samsung Bioepis Co. Ltd. (joint venture between Samsung Biologics and Biogen Inc.) |
Benepali |
Biosimilar Enbrel (etancercept, Amgen Inc.) |
Rheumatoid arthritis |
Received a positive opinion from the EMA's CHMP; it is approved as SB4 in South Korea and will be branded Brenzys there |
11/23/15 |
CANCER | |||||
Aduro Biotech Inc. (Berkeley, Calif.) |
CRS-207 |
LADD-based therapeutic |
Malignant pleural mesothelioma |
EMA granted orphan drug designation |
11/24/15 |
Amgen Inc. (Thousand Oaks, Calif.) |
Kyprolis |
Carfilzomib |
Multiple myeloma |
European Commission granted marketing authorization for Kyprolis in combination with Revlimid (lenalidomide, Celgene Corp.); approved in South Korea |
11/20/15 |
Amgen Inc. (Thousand Oaks, Calif.) |
Blincyto |
Blinatumomab |
Acute lymphoblastic leukemia |
Approved in South Korea |
11/20/15 |
Amgen Inc. (Thousand Oaks, Calif.) |
Blincyto |
Blinatumomab |
Acute lymphoblastic leukemia (ALL) |
European Commission granted conditional marketing authorization for the treatment of adults with Philadelphia chromosome-negative relapsed or refractory B-precursor ALL |
11/25/15 |
Bristol-Myers Squibb Co. (New York) |
Opdivo |
Nivolumab |
Advanced renal cell carcinoma |
EMA validated a type II variation application, which seeks to extend the current indication to include the treatment of adult patients |
11/6/15 |
Celgene International Sarl (subsidiary of Celgene Corp.; Summit, N.J.) |
Vidaza |
Azacitidine for injection |
Acute myeloid leukemia |
European Commission approved it for adults 65 or older with AML who are not eligible for hematopoietic stem cell transplantation |
11/2/15 |
Essa Pharma Inc. (Vancouver, British Columbia) |
EPI-506 |
Blocks a new target on the androgen receptor |
Metastatic castration-resistant prostate cancer |
Health Canada's Health Protection Branch issued a no objection letter for the clinical trial application submission, allowing Essa to include Canadian sites in its ongoing phase I/II study |
11/6/15 |
Exelixis Inc. (South San Francisco) and Roche AG (Basel, Switzerland) |
Cotellic |
Cobimetinib |
Unresectable or metastatic melanoma |
European Commission approved Cotellic for use in combination with Roche's Zelboraf (vemurafenib) |
11/30/15 |
Ose Pharma SA (Paris) |
Tedopi |
Formerly OSE-2101 |
Advanced non-small-cell lung cancer |
Regulatory authorities in seven European countries issued a positive opinion for the firm to start its pivotal phase III trial, which will enroll 500 patients in the U.S. and Europe |
11/3/15 |
Stemline Therapeutics Inc. (New York) |
SL-401 |
Targeted therapy directed to the interleukin-3 receptor on cancer stem cells and tumor bulk |
Blastic plasmacytoid dendritic cell neoplasm |
EMA granted orphan drug designation |
11/3/15 |
CARDIOVASCULAR | |||||
Baxalta Inc. (Bannockburn, Ill.) |
Obizur |
Antihemophilic factor (recombinant), porcine sequence |
Acquired hemophilia caused by antibodies to factor VIII |
European Commission granted marketing authorization |
11/16/15 |
Swedish Orphan Biovitrum AB (Stockholm) and Biogen Inc. (Cambridge, Mass.) |
Elocta |
Recombinant factor VIII Fc fusion protein |
Hemophilia A |
European Commission approved it in all 28 EU member states, as well as Iceland, Liechtenstein and Norway |
11/25/15 |
CENTRAL NERVOUS SYSTEM | |||||
Redhill Biopharma Ltd. (Tel Aviv, Israel) and Intelgenx Corp. (Saint Laurent, Quebec) |
Rizaport |
RHB-103; oral thin film formulation of rizatriptan benzoate |
Acute migraines |
Federal Institute for Drugs and Medical Devices of Germany has given marketing authorization |
11/10/15 |
The Medicines Co. (Parsippany, N.J.) |
Ionsys |
40 mcg per dose transdermal system; active ingredient fentanyl |
Acute moderate to severe postoperative pain |
European Commission granted approval |
11/23/15 |
DIABETES | |||||
Organogenesis Inc. (Canton, Mass.) |
Apligraf |
Biotherapeutic wound-healing technology, which contains a layer of differentiated keratinocytes and a layer of fibroblasts in a collagen matrix |
Venous leg ulcers and diabetic foot ulcers |
Was approved as a transplant product in Switzerland |
11/3/15 |
INFECTION | |||||
Gilead Sciences Inc. (Foster City, Calif.) |
Genvoya |
Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg |
HIV-1 infection |
European Commission granted marketing authorization |
11/24/15 |
Protein Sciences Corp. (Meriden, Conn.) and Laboratorios Liomont SA de CV (Mexico City) |
Flublok |
Recombinant influenza vaccine |
Influenza |
Obtained approval form the Mexican regulatory agency Cofepris for adults 18 and older |
11/19/15 |
MISCELLANEOUS | |||||
Bone Therapeutics SA (Gosselies, Belgium) |
Allob |
Allogeneic bone cell therapy |
Osteogenesis imperfecta (brittle bone disease) |
Received orphan drug designation from the EMA |
11/13/15 |
Orthocell Ltd. (Perth, Australia) |
Ortho-Aci |
Regenerative cell therapy |
Articular cartilage damage within the knee joint |
Has been applied to its first patient in Singapore, following successful entry to Hong Kong earlier this year |
11/19/15 |
Radius Health Inc. (Waltham, Mass.) |
Abaloparatide |
Synthetic peptide; once-daily subcutaneous injection |
Postmenopausal osteoporosis |
Submitted a European MAA |
11/18/15 |
Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.) and Bayer AG (Leverkusen, Germany) |
Eylea |
Aflibercept |
Visual impairment due to myopic choroidal neovascularization |
Received European approval |
11/2/15 |
RESPIRATORY | |||||
Vertex Pharmaceuticals Inc. (Cambridge, Mass.) |
Kalydeco |
Ivacaftor |
Cystic fibrosis |
European Commission approved the expansion of Kalydeco to include children, ages 2 to 5, who have one of nine gating mutations in the cystic fibrosis transmembrane conductance regulator gene - – G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N and S549R – and to include people with CF ages 18 and older who have an R117H mutation |
11/19/15 |
Vertex Pharmaceuticals Inc. (Cambridge, Mass.) |
Orkambi |
Lumacaftor/ivacaftor |
Cystic fibrosis |
European Commission granted marketing authorization for Orkambi for cystic fibrosis in people age 12 and older who have two copies of the F508del mutation |
11/23/15 |
Notes BLA = Biologics license application; CHMP = Committee for Medicinal Products for Human Use; CMA = Continuous marketing application; FDA = Food and Drug Administration; IND = Investigational new drug 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. For more information about individual companies and/or products, see Thomson Reuters Cortellis. |