Company (Location) Product Description Indication Status Date AUTOIMMUNE Acorda Therapeutics Inc. (Ardsley, N.Y.) rHIgM22 A remyelinating antibody Multiple sclerosis Enrollment began in the first trial 4/24/13 Arena Pharmaceuticals Inc. (San Diego) APD334 An oral drug targeting the sphingosine 1-phosphate subtype 1 receptor Autoimmune diseases Initiated dosing in a Phase I trial 4/8/13 Idera Pharmaceuticals Inc. (Cambridge, Mass.) IMO-8400 An agonist of Toll-like receptors 7, 8 and 9 Psoriasis
The typical goal of stem cell therapies is to get the mature cells they produce to take up permanent residence in patients. But there is one therapeutic area where the opposite is true: Scientists are injecting stem cells that function as temporary drug delivery vehicles for brain tumors. "Over time, the cells tend to die off," Karen Aboody told BioWorld Today. But for this particular application, that lack of staying power is a strength, not a weakness. "We really only need our cells to be
By Anette Breindl | BioWorld Today | Monday, May 13, 2013
By any measurement the U.S. biotechnology industry is the envy of the world. Perspectives on the reasons for the nation's dominance in this sector are provided by the latest Scientific American Worldview Scorecard, which for the past five years has been ranking countries on their global competitiveness in biotechnology. The 2013 edition reflects increased global competition and a growing list of countries being added to the rankings. The first Scorecard, published in 2009, analyzed 36 countries
By Peter Winter | BioWorld Insight | Monday, May 13, 2013
Company (Location) Product Description Indication Status Date AUTOIMMUNE Rigel Pharmaceuticals Inc. (South San Francisco) and AstraZeneca plc (London) Fostamatinib Oral spleen tyrosine kinase inhibitor Rheumatoid arthritis Missed the X-ray endpoint of modified Total Sharp score, but hit statistical significance in ACR20 scoring, although the Phase III still fell short of those achieved by Pfizer Inc.'s approved Xeljanz 4/8/13 CANCER Array BioPharma Inc. (Boulder, Colo.) ARRY-520 A selective KSP
Practically overnight, Affymax Inc. went from being lauded as a biotech success story and Wall Street darling to become one of the sector's biggest disappointments, and now, according to the latest 10-Q filing, the Palo Alto, Calif.-based firm might be nearing its end. Despite drastic cuts to its staff – 75 percent of employees were let go in March, and dates of separation are in the works for the remaining 25 percent, including the CEO and chief financial officer by June 15 – and restructuring
By Jennifer Boggs | BioWorld Today | Monday, May 13, 2013
Salix Pharmaceuticals Ltd., of Raleigh, N.C., reported product revenue totaling $202.6 million for the first quarter, up 18 percent over the same period in 2012. Sales of antibiotic Xifaxan (rifaximin) reached $153 million. Non-GAAP net income was $40.1 million, or 63 cents per share, falling short of consensus estimates of 68 cents per share. Salix ended the first quarter with about $960.3 million on its balance sheet. Despite the earnings miss, the firm's shares (NASDAQ:SLXP) gained $2.99
Actavis Inc., of Parsippany, N.J., on Friday confirmed that it entered early stage discussions with Warner Chilcott plc, of Dublin, Ireland, regarding a potential combination of the two companies. The big pharma said no agreement has been reached and it does not intend to issue further comments. Several weeks ago, there were reports that Valeant Pharmaceuticals International Inc., of Montreal, was in talks to acquire Actavis. On Friday, Shibani Malhotra, an analyst with RBC Capital Markets LLC
Array BioPharma Inc., a biotech known for its drug discovery engine, is expanding its capabilities, starting its first Phase III clinical trial for MEK 162. (See BioWorld Today, May 8, 2013.) As part of its partnership with Novartis AG to develop the MEK inhibitor, Array retained co-development rights, which allows it to run clinical trials to further the development of the compound. "The agreement is that Array will be entitled to run a clinical trial with 162. The spirit is that we would be
By Brian Orelli | BioWorld Insight | Monday, May 13, 2013
Acceleron Pharma Inc., of Cambridge, Mass., said preclinical research conducted by Acceleron scientists on the ACE-536 program were presented at the 12th International Symposium on Myelodysplastic Syndromes in Berlin. Acceleron presented data on the effects of its investigational protein therapeutic, ACE-536, on correcting anemia and ineffective erythropoiesis in an animal model. Amgen Inc., of Thousand Oaks, Calif., and Zhejiang Beta Pharma Co. Ltd. formed a joint venture to commercialize
Company (Location) Product Description Indication Status Date AUTOIMMUNE Genzyme Corp. (Cambridge, Mass.) Aubagio Teriflunomide; once-daily Multiple sclerosis Was approved in Argentina in a 14 mg formulation for patients with relapsing forms 4/9/13 CANCER Celgene Corp. (Summit, N.J.) Revlimid Lenalidomide Transfusion-dependent anemia CHMP adopted a positive opinion for Revlimid 4/29/13 Curis Inc. (Lexington, Mass.) Erivedge Vismodegib Symptomatic metastatic basal cell carcinoma CHMP recommended
Company (Location) Product Description Indication Status Date CANCER CytRx Corp. (Los Angeles) Aldoxorubicin Tumor-targeting doxorubicin conjugate (formerly INNO-206) Soft tissue sarcomas Reached an agreement with the FDA for an SPA for a global Phase III 4/24/13 CARDIOVASCULAR Amarin Corp. plc (Bedminster, N.J., and Dublin, Ireland) Vascepa Icosapent ethyl capsules High triglycerides FDA accepted its supplemental NDA for use as an adjunct to diet 4/24/13 Santarus Inc. (San Diego) and Pharming
Financings Arrowhead Research Corp. completed a $36 million private offering to advance its pipeline. Cardio3 BioSciences closed a $25 million investment round to fund an ongoing European Phase III trial of its stem cell therapy for ischemic heart failure. Galapagos NV raised $70.7 million in an over-subscribed private placing. Idera Pharmaceuticals Inc. closed a $16.5 million underwritten public offering. Isis Pharmaceuticals Inc. priced a public offering seeking to raise $171 million. Lumena
"It's very clear that we need certain types of data in animal models before we move into the clinic, and then in Phase I or Phase Ib see evidence of proof of concept in a pre-selected patient population. If we don't see that, we cannot bring such a drug into Phase III and just see what happens. Patients don't benefit from this type of approach." – Carlo Toniatti, head of research at the Institute for Applied Cancer Science and the Center for Co-Clinical Trials at the University of Texas MD
LONDON – Creabilis SA reported positive Phase IIb results for its topical TrkA kinase inhibitor CT327 in the relief of chronic pruritus (itch) caused by psoriasis, paving the way for a Phase III study designed to gain approval for treating itch in any dermatological disease. "We are delighted by the outcome," said Eliot Forster, CEO. "In addition to some benefits in terms of the underlying disease, CT327 showed a highly significant impact on itch, which in psoriasis and other dermatological
By Nuala Moran | BioWorld Today | Monday, May 13, 2013
In a footnote to its recent 10-Q filing, Pfizer Inc. shared results of a March meeting with the FDA to discuss a June 2011 complete response letter (CRL) for Remoxy (oxycodone) saying that it may not continue development, and if so, it would not have a response to the CRL before mid-2015. Partners Durect Corp. and Pain Therapeutics Inc. both took major hits on Friday as a result: Durect (NASDAQ:DRRX) plummeted 54 cents, or 34 percent, to close at $1.05. Pain Therapeutics (NASDAQ:PTIE) fell $2
By Catherine Shaffer | BioWorld Today | Monday, May 13, 2013
Discovery Laboratories Inc., of Warrington, Pa., said it priced a $14.25 million public offering of 9.5 million shares of common stock at $1.50, an 8.5 percent discount to Thursday's closing price. Net proceeds of about $13.2 million will be used primarily to support the commercial introduction of Surfaxin, its surfactant product approved last year for respiratory distress syndrome in premature infants, and the Afectair aerosol-conducting airway connector for infants, as well as for general
Company Drug Indication BioAlliance Pharma SA Sitavig Recurring herpes labialis Sucampo Pharmaceuticals Inc. Amitiza Opioid-induced constipation Tris Pharma Inc. Karbinal ER Seasonal and perennial allergic rhinitis
Thai Trial Analysis Shows Antibody Competition Follow-up analyses of the RV144 trial of Sanofi SA's ALVAC HIV and VaxGen Inc.'s AIDSVAX B/E HIV vaccine by a team from Duke University has provided evidence that the competition of two different types of antibodies may have lowered the efficacy of the vaccine. The RV144 trial was the first trial to provide any protection against HIV, but at a risk reduction of about 30 percent; that protection was not enough to justify going into large-scale
Company (Location) Product Description Indication Status Date AUTOIMMUNE Acorda Therapeutics Inc. (Ardsley, N.Y.) rHIgM22 A remyelinating antibody Multiple sclerosis Enrollment began in the first trial 4/24/13 Arena Pharmaceuticals Inc. (San Diego) APD334 An oral drug targeting the sphingosine 1-phosphate subtype 1 receptor Autoimmune diseases Initiated dosing in a Phase I trial 4/8/13 Idera Pharmaceuticals Inc. (Cambridge, Mass.) IMO-8400 An agonist of Toll-like receptors 7, 8 and 9 Psoriasis