Company Drug Indication Furiex Pharmaceuticals Inc. Alogliptin Type II diabetes Genentech Inc. Avastin Metastatic colorectal cancer Isis Pharmaceuticals Inc. Kynamro Homozygous familial hypercholerolemia NuPathe Inc. Zecuity Migraine Protein Sciences Corp. Flublok Influenza Salix Pharmaceuticals Ltd. Fulyzaq Noninfectious diarrhea in HIV/AIDS

Company (Location) Product Description Indication Status Date AUTOIMMUNE Vaccinex Inc. (Rochester, N.Y.) VX15/2503 A therapeutic antibody designed to target multifunctional protein semaphorin 4D Multiple sclerosis Started a Phase I trial 1/8/13 CANCER Alnylam Pharmaceuticals Inc. (Cambridge, Mass.) ALN-VSP A systemically delivered RNAi therapeutic Solid tumors Phase I data showed antitumor activity 1/31/13 Astex Pharmaceuticals Inc. (Dublin, Calif.) AT13148 A drug designed to block enzymes

Company (Location) Product Description Indication Status Date CANCER Acceleron Pharma Inc. (Cambridge, Mass.) ACE-536 A modified Type II activin receptor fusion protein Myelodysplastic syndromes Started a Phase II study 1/30/13 Active Biotech AB (Lund, Sweden) Anyara A tumor-targeting superantigen comprising a modified version of the Staphylococcal enterotoxin A fused to the Fab portion of a monoclonal antibody that recognizes the 5T4 antigen Advanced renal cell cancer Missed the primary

Company (Location) Product Description Indication Status Date AUTOIMMUNE Biogen Idec Inc. (Weston, Mass.) Peginterferon beta-1a A pegylated form of Avonex Relapsing-remitting multiple sclerosis Produced a significant reduction in annualized relapse rate and also met its secondary endpoints in a Phase III trial 1/25/13 CANCER Aeterna Zentaris Inc. (Quebec City) AEZS-108 A luteinizing hormone-release hormone-targeted cytotoxic conjugate Endometrial cancer Agreed with the FDA on an SPA for a Phase

Company (Location) Product Description Indication Status Date Allergan Inc. (Irvine, Calif.) Botox Onabotulinum-toxinA Overactive bladder FDA approved it 1/23/13 Astellas Pharma Inc. (Tokyo) Betmiga Mirabegron Overactive bladder Received European approval 1/14/13 Astellas Pharma Inc. (Tokyo) Tarceva Erlotinib Non-small-cell lung cancer FDA accepted for filing a supplemental NDA for first-line use in patients with locally advanced or metastatic disease whose tumors have epidermal growth factor

Company (Location) Product Description Indication Status Date AUTOIMMUNE Savient Pharmaceuticals Inc. (Bridgewater, N.J.) Krystexxa Pegloticase Gout European Commission granted approval 1/9/13 CANCER Del Mar Pharmaceuticals Ltd. (Vancouver, British Columbia) VAL-083 Small-molecule chemotherapeutic Glioma CHMP recommended it be designated an orphan drug 1/8/13 Emergent BioSolutions Inc. (Rockville, Md.) TRU-016 Humanized single-chain monoclonal antibody against CD37 Chronic lymphocytic leukemia

Company (Location) Product Description Indication Status Date AUTOIMMUNE Biogen Idec Inc. (Weston, Mass.) and Elan Corp. plc (Dublin, Ireland) Tysabri Natalizumab Multiple sclerosis Submitted applications to the FDA and the European Medicines Agency to expand the indication for first-line use in relapsing forms of MS that have tested negative for antibodies to the JC virus 1/17/13 Genzyme Corp. (Cambridge, Mass.) Lemtrada Alemtuzumab Relapsing multiple sclerosis FDA accepted a supplemental BLA

Antibodies containing two binding sites – bispecifics – are hot items these days generating a great deal of buzz in the industry. This is due to the fact that many of the new therapeutics now in development based on this technology hold much promise due to their synergistic effects conferred by binding two targets. Last year saw a number of lucrative deals struck in the space. At the top of the list in terms of dollar value was Amgen Inc., which paid $1.16 billion to acquire Micromet Inc., and

Pexa-Vec (JX-594), developed by San Francisco-based Jennerex Inc., is a triple cancer killer. A publication in Cancer Research confirms anti-angiogenesis is part of Pexa-Vec's mechanism of action to attack tumors. Pexa-Vec is based on Jennerex's SOLVE (Selective Oncolytic Vaccinia Engineering) platform. The modified poxvirus contains a disruption of the viral thymidine kinase (TK) gene and expresses granulocyte macrophage colony-stimulating factor (GM-CSF), an immunostimulatory cytokine. It was

NEW YORK – Last month's readout of Celgene Corp.'s successful Phase III study testing Abraxane (nab-paclitaxel) in combination with gemcitabine in pancreatic cancer is expected to change the standard of care for patients with metastatic disease, but its modest improvement in overall survival leaves plenty of room for new players in this notoriously difficult therapeutic space – assuming researchers can figure how to attack it. The incidence of pancreatic cancer is increasing – due largely to the

Financings e-Therapeutics plc raised $62.66 from a share issue that will fund it until 2017. Elcelyx Therapeutics Inc. closed a $20 million Series C financing. Imprimis Pharmaceuticals Inc. priced a public offering for gross proceeds of about $9.66 million. Jounce Therapeutics Inc. launched operations with a $47 million Series A financing. Medgenics Inc. raised $30 million for development of its Biopump protein drug implant technology. Retrophin Inc. will receive gross proceeds of about $10

"[This is] the biggest instance where the market has misinterpreted news in the 13 years I've been covering biotech. This was an incredible gift for folks who wanted to take advantage of the weakness, and a lot of folks did, obviously." – Chris Raymond, analyst, Baird Equity Research, on the Affymax Inc. announcement that partner Fresenius Medical Care North America was pausing expansion of a pilot study of patients on Omontys (peginesatide) for anemia in dialysis patients with chronic kidney

Although drugmakers will have to start tracking their payments to doctors and teaching hospitals in August under the Physician Payment Sunshine Act, the transactions will remain in the dark until late next year when the Centers for Medicare & Medicaid Services starts posting the data. With sequestration set to trigger in less than three weeks, the FDA, National Institutes of Health and other federal agencies have sent out notices to their employees, informing them that furloughs, or unpaid leave

BioWorld’s offices were closed Monday, Feb. 18 in observance of the Presidents Day holiday in the U.S. No issues were published that day.