Company |
Product |
Description |
Indication |
Status |
Date |
AUTOIMMUNE | |||||
Biogen Idec Biotech India Ptvt. Ltd. (Haryana, India) |
Tecfidera |
Dimethyl fumarate |
Relapsing-remitting multiple sclerosis |
Gained approval in India |
2/17/15 |
Celsus Therapeutics plc (London) |
MRX-6 |
Cream 2% |
Mild to moderate atopic dermatitis |
Failed to demonstrate a difference in mean change from baseline to day 28 in children with mild to moderate atopic dermatitis in the phase II trial, called C012013 |
2/18/15 |
Hospira Inc. (Lake Forest, Ill.) |
Inflectra |
Infliximab; biosimilar monoclonal antibody (Remicade; Johnson & Johnson) |
Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis and plaque psoriasis |
Launched Inflectra in major European markets for the treatment of inflammatory conditions |
2/18/15 |
Hospira Inc. (Lake Forest, Ill.) |
Inflectra |
Biosimilar Remicade (infliximab, Johnson & Johnson) |
Crohn's disease and ulcerative colitis |
Patients treated with Remicade and Inflectra in Hungary showed comparable induction and maintenance of remission |
2/20/15 |
CANCER | |||||
Alethia Biotherapeutics Inc. (Montreal) |
AB-16B5 |
A fully humanized monoclonal antibody that inhibits epithelial to mesenchymal transition |
Solid tumors |
Submitted a clinical trial application with Health Canada to initiate a phase I trial |
2/18/15 |
Celgene International Sarl (subsidiary of Celgene Corp.; Summit, N.J.) |
Abraxane |
Nab-paclitaxel |
Metastatic pancreatic cancer |
Abraxane, in combination with gemcitabine, received a positive recommendation by the Scottish Medicines Consortium within the National Health Service (NHS) Scotland |
2/11/15 |
Celgene International Sarl (subsidiary of Celgene Corp.; Summit, N.J.) |
Revlimid |
Lenalidomide |
Multiple myeloma (MM) |
European Commission approved Revlimid to treat adult patients with previously untreated MM who are not eligible for transplant |
2/24/15 |
Northwest Biotherapeutics Inc. (Bethesda, Md.) |
Dcvax-L |
Dendritic cell-based vaccine |
Glioblastoma multiforme brain cancer |
Ongoing phase III trial of Dcvax-L for glioblastoma multiforme brain cancer was approved to proceed in Canada, has completed the approval processes at two sites and is under way screening patients for enrollment |
2/20/15 |
Theravectys SAS (Paris) |
Vaccine |
Candidate for a rare malignancy caused by the human T-cell lymphotropic virus type 1 |
Adult T-cell leukemia/lymphoma |
EMA has granted orphan drug designation |
2/5/15 |
Tolero Pharmaceuticals Inc. (Salt Lake City) |
Alvocidib |
A small-molecule inhibitor of cyclin-dependent kinases |
Relapsed/refractory and front-line intermediate or high-risk acute myeloid leukemia |
EMA granted orphan designation |
2/27/15 |
CARDIOVASCULAR | |||||
Prometic Life Sciences Inc. (Laval, Quebec) |
PBI-4050 |
Orally active antifibrotic candidate |
Idiopathic pulmonary fibrosis |
Was cleared by Health Canada to start a phase II trial |
2/5/15 |
CENTRAL NERVOUS SYSTEM | |||||
Arena Pharmaceuticals Inc. (San Diego) and Ildong Pharmaceutical Co. Ltd. (Seoul, South Korea) |
Belviq |
Lorcaserin HCl |
Weight management |
South Korea's Ministry of Food and Drug Safety approved Belviq |
2/4/15 |
Eisai Co. Ltd. (Tokyo) |
Zonegran |
Zonisamide; anti-epileptic drug |
Partial seizures |
The Transparency Commission of the French National Authority for Health has published advice approving of the expanded use of Zonegran for the treatment of partial seizures in adolescents and children from 6 years of age |
2/19/15 |
Zambon SpA (Milan) and Newron Pharmaceuticals SpA (Milan) |
Xadago |
Safinamide |
Idiopathic Parkinson's disease |
European Commission approved the use of Xadago |
2/27/15 |
DIABETES | |||||
Hua Medicine Ltd. (Shanghai) |
Sinogliatin |
A fourth-generation glucokinase activator |
Type 2 diabetes |
Clinical data showed it has overcome issues to provide 24-hour glucose control in diabetics with the potential to improve pancreatic beta cell function |
2/13/15 |
GASTROINTESTINAL | |||||
Infant Bacterial Therapeutics (subsidiary of Biogaia AB; Stockholm, Sweden) |
Unnamed therapy |
N/A |
To prevent necrotizing enterocolitis |
Obtained orphan drug designation in Europe |
2/24/15 |
Sucampo Pharmaceuticals Inc. (Bethesda, Md.) |
Amitiza |
Lubiprostone |
Chronic idiopathic constipation |
Disclosed the successful completion of the European mutual recognition procedure (MRP) for Amitiza for the treatment of chronic idiopathic constipation in select European countries, resulting in a recommendation for marketing authorization |
2/2/15 |
INFECTION | |||||
Biotime Inc. (Alameda, Calif.) |
Renevia |
Delivery matrix for a patient's own fat-derived cells |
HIV-associated lipoatrophy |
The first patient was successfully treated in a pivotal trial in Europe |
2/25/15 |
Enanta Pharmaceuticals Inc. (Watertown, Mass.) and Abbvie Inc. (North Chicago) |
Ombitasvir/paritaprevir/ritonavir |
Once-daily dosed, all-oral, ribabirin-free and interferon-free, 12-week, two direct-acting antiviral treatment |
Genotype 1 chronic hepatitis C virus infection |
Has submitted an NDA to the Japanese Ministry of Health, Labor and Welfare seeking approval |
2/13/15 |
Medigene AG (Martinsried, Germany) |
Veregen |
Sinecatechins ointment |
Genital warts |
Approved for marketing in eight additional European countries within the mutual recognition procedure, including two of the biggest EU markets, the UK and Italy |
2/23/15 |
INFLAMMATORY | |||||
Cipher Pharmaceuticals Inc. (Mississauga, Ontario) |
Beteflam Patch |
Self-adhesive medicated plaster containing 0.1% betamethasone valerate |
Inflammatory skin conditions such as chronic plaque psoriasis |
The Beteflam Patch (previously called the Betesil Patch) has been accepted for review by Health Canada |
2/13/15 |
Crystalgenomics Inc. (Seoul, South Korea) |
Acelex |
Polmacoxib; once-a-day non-sterioidal anti-inflammatory drug |
Osteoarthritis |
South Korean authorities approved it |
2/13/15 |
MISCELLANEOUS | |||||
Atyr Pharma Inc. (San Diego) |
Resolaris |
Company's first Physiocrine-based product candidate |
Facioscapulo-humeral muscular dystrophy |
European Commission granted orphan designation |
2/19/15 |
Biospecifics Technologies Corp. (Lynbrook, N.Y.) and Swedish Orphan Biovitrum AB (Stockholm) |
Xiapex |
Collagenase clostridium histolyticum |
Peyronie's disease |
Received approval from the European Commission to market Xiapex |
2/3/15 |
Biotie Therapies Corp. (Turku, Finland) |
BTT1023 |
A fully human monoclonal antibody targeting vascular adhesion protein 1 |
Primary sclerosing cholangitis |
EMA's Committee for Orphan Medicinal Products issued a positive opinion recommending orphan drug designation |
2/18/15 |
Cytori Therapeutics Inc. (San Diego) |
Cytori |
Cell therapy |
Traumatic meniscal injuries in the knee |
The first patient was enrolled and treated in a single-arm, open-label, investigator-initiated trial in patients undergoing surgery for traumatic meniscal injuries in the knee at the Orthopedic Institute of Hospital Quiron in Barcelona |
2/11/15 |
Cytori Therapeutics Inc. (San Diego) |
ECCS-50 |
Contains adipose tissue-derived stromal vascular fraction cells derived from Cytori's Celution System |
Scleroderma |
EMA's Committee for Orphan Medicinal Products issued a positive opinion toward Cytori's application for an orphan drug designation |
2/25/15 |
Kythera Biopharmaceuticals Inc. (Westlake Village, Calif.) |
ATX-101 |
Deoxycholic acid |
Submental fat |
Submitted a drug application to Australia's Therapeutic Goods Administration |
2/6/15 |
Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.) |
Eylea |
Aflibercept |
Visual impairment due to macular edema |
Was approved by the European Commission |
2/27/15 |
RESPIRATORY | |||||
Galapagos NV (Mechelen, Belgium) and Janssen Pharmaceutica NV (unit of Johnson & Johnson; Brunswick, N.J.) |
GLPG1690 |
Experimental pulmonary disease therapy |
Pulmonary disease |
Phase I data demonstrated engagement with an as-yet undisclosed target, a good safety profile and favorable drug properties; the randomized, double-blind, placebo-controlled, single-center study was conducted in 40 healthy volunteers in Belgium |
2/18/15 |
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. |