Company
(location)

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.