Peregrine Pharmaceuticals Inc. (PPHM) soared 80% after the company announced that an internal review of a phase II study of Bavituximab in second-line non-small cell lung cancer supports advancing the compound into phase III development. The review was prompted by the discovery of vial coding discrepancies while preparing for an end of Phase II meeting with the FDA.
The company said it is now preparing for discussions with the FDA and worldwide regulatory agencies.
Thoratec Corp. (THOR) has received FDA approval to commence a study, dubbed REVIVE-IT, to compare the use of its HeartMate II LVAD with optimal medical management in patients with New York Heart Association Class III heart failure.
Another complementary study known as ROADMAP is currently enrolling patients, and the company expects the full cohort of 200 patients to be enrolled in the ROADMAP study by the end of 2013.
Orexigen Therapeutics Inc. (OREX) says it expects to resubmit the Contrave NDA in the second half of 2013 with potential approval in early 2014.
The company's lead obesity drug candidate - Contrave, was issued a complete response letter in January of 2011 on cardiovascular safety concerns, and was asked to conduct a cardiovascular outcomes trial for the drug before it could be approved.
Perrigo Co. (PRGO) has received FDA clearance to manufacture three new infant formula products that will be compliant with the Codex Alimentarius Commission, established by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) to set international food standards. Shares have traded in a 52-week range of $90.18 to $120.78.
Immunovaccine Inc. (IMV.V) rose more than 10% following positive results from a phase I clinical study of its cancer vaccine, DPX-Survivac, for the treatment of ovarian cancer.
Boehringer Ingelheim and Eli Lilly and Co. (LLY) reported positive top-line results from four completed phase III clinical trials for Empagliflozin, an investigational sodium glucose co-transporter-2 (SGLT-2) inhibitor being studied for treatment of patients with type 2 diabetes (T2D). The filing for regulatory review in the U.S., Europe and Japan is expected in 2013.
Acasti Pharma Inc. received approval to list its common shares on the NASDAQ Capital Market beginning on January 7, 2013 under the ticker symbol (ACST). Shares closed 25% higher at $2.70 on Monday.
XOMA Corp. (XOMA) rose over 5% to close Monday's trading at $2.89 following encouraging interim results from a phase II study that is evaluating its investigational compound Gevokizumab in moderate to severe acne vulgaris. The complete data from this trial and the results from a phase 2 proof-of-concept studies testing Gevokizumab in erosive osteoarthritis of the hand and non-infectious scleritis are expected later this year.
ARIAD Pharmaceuticals Inc. (ARIA) is collaborating with the U.K. National Cancer Research Institute for a phase 3 trial, named SPIRIT, to evaluate the impact of switching chronic myeloid leukemia patients treated with a first-line tyrosine kinase inhibitor to Ponatinib.
The National Cancer Research Institute expects to begin enrollment in the trial of 1,000 patients at approximately 172 clinical research sites in the U.K. in the second quarter of 2013.
BioTime Inc. (BTX) closed Monday's trading more than 7% higher at $3.45 following a definitive agreement with Geron Corp. (GERN) regarding stem cell assets.
Amicus Therapeutics (FOLD) said Monday that it expects 6-month results from an ongoing phase 3 Migalastat HCl monotherapy trial for fabry disease next month, and 12-month results in the second quarter of 2013.
The company plans to conduct a repeat-dose clinical study to investigate the effect of AT2220 co-administered with marketed enzyme replacement therapy for Pompe disease in the third quarter of 2013.
Soligenix Inc. (SNGX.OB) rose over 12% to close Monday's trading at $0.82 after the company announced it has been invited by the Biomedical Advanced Research and Development Authority, or BARDA, to submit a contract proposal for the development of OrbeShield as a countermeasure for the gastrointestinal effects of acute radiation syndrome.
The company intends to submit its proposal to BARDA in February 2013.
Spectrum Pharmaceuticals Inc.'s (SPPI) investigational compound for the potential treatment of hyperphosphatemia (high phosphate levels in the blood) in patients with stage 5 chronic kidney disease, RenaZorb, demonstrated positive, statistically significant data in a phase I trial in healthy volunteers.
The company is planning for phase 2 testing and is also seeking a licensing partner outside of the U.S., in particular, in Japan and other countries in Asia.
Cubist Pharmaceuticals Inc. (CBST) expects top-line data readouts from two phase III trials evaluating its investigational compound - ceftolozane/tazobactam, in the second-half of 2013.
Ceftolozane/tazobactam is being tested as a first-line intravenous therapy for the treatment of complicated intra-abdominal infections and complicated urinary tract infections caused by Gram-negative bacterial infections, including those caused by multi-drug resistant Pseudomonas aeruginosa.
BioLineRx (BLRX) announced Monday that it expects results of interim analysis of a phase II/III study of its investigational schizophrenia drug BL-1020, dubbed CLARITY, during the week beginning March 18, 2013. Shares gained as much as 10% in intraday trading before closing 2.25% higher at $2.73.
Baxter International Inc. (BAX) intends to initiate a phase II/III study of its investigational hemophilia A treatment BAX 855 in the first quarter of 2013, following positive results from a phase I trial.
The trial, dubbed PROLONG-ATE, will be initiated in the United States with more than 100 previously treated adult patients with severe hemophilia A to assess the efficacy, safety and pharmacokinetics of BAX 855 for prophylaxis and on-demand treatment of bleeding.
Shares of Sirona Biochem Corp. (SBM.V) rose more than 11% Monday after the company announced that its skin lightening compounds, TFC-849 and TFC-723, were proven to be safe in an industry standard genotoxicity study. The genotoxicity test measures DNA degradation, which can be evidence of potential mutagenicity or carcinogenicity.
Therapeutic Solutions International Inc. (TSOI.OB) on Monday received regulatory approval to market its Migran-X(R) device for migraine prevention into the Brazilian market. The company noted that entering the large Brazilian market is the first step in its anticipated expansion across South America.
Talon Therapeutics (TLON.OB) is reviewing strategic alternatives that may lead to a possible transaction, including the merger, business combination, or sale of the company. Goldman Sachs has been engaged as financial advisor. Shares closed over 19% higher at $0.62.
iCAD Inc. (ICAD) on Monday received FDA approval for its next generation mammography computer-aided detection platform - PowerLook Advanced Mammography Platform with Digital CAD for Philips' MicroDose Full-Field Digital Mammography System. The FDA approval provides radiologists with expanded access to next generation CAD platform, says the company.
BioMarin Pharmaceutical Inc. (BMRN) has acquired Zacharon Pharmaceuticals, a private biotechnology company based in San Diego focused on developing small molecules targeting pathways of glycan and glycolipid metabolism.
Under the terms of the stock purchase agreement, BioMarin paid $10 million upfront for 100 percent of Zacharon's share capital and may make potential additional payments for clinical, regulatory and commercial milestones.
The acquisition of Zacharon is expected to further expand BioMarin's glycobiology expertise and support its lysosomal storage disease drug development efforts.
Israeli biopharmaceutical company RedHill Biopharma Ltd. (RDHL) has been issued a new U.S. patent for its investigational compound - RHB-104, designed for the treatment of Crohn's disease which is an inflammatory disease of the gastrointestinal system, that expires no earlier than 2029.
The company plans to commence patient recruitment in an initial phase III study of RHB-104 in subjects with moderately to severely active Crohn's disease in Q2, 2013.
Shares of Oramed Pharmaceuticals Inc. (ORMP.OB) rose more than 18% to $0.39 on Monday after the company announced it has filed an Investigational New Drug application with the FDA to begin a phase II trial of its orally ingested insulin candidate, ORMD-0801.
The IND application was filed with the FDA on December 31, 2012. If Oramed does not receive comments from the FDA on the IND application within 30 days from filing, the company intends to immediately commence the trial to evaluate the safety, tolerability and efficacy of its oral insulin capsule on type 2 diabetic volunteers.
Repros Therapeutics Inc. (RPRX) announced that its 1 year DEXA study, which evaluates the effects of Androxal on bone mineral density, is fully enrolled 3 months ahead of schedule, ensuring the submission of the Androxal NDA by mid-2014.
Ron Bentsur, CEO of Keryx Biopharmaceuticals Inc. (KERX) will make a presentation on Thursday, January 10th, at 9:00 AM Pacific Standard Time at the 31st Annual J.P. Morgan Healthcare Conference, being held January 7-10, 2013, in San Francisco, CA.
The company's Japanese partner, Japan Tobacco Inc. on Monday filed its New Drug Application with the Japanese Ministry of Health, Labor and Welfare for marketing approval of ferric citrate in Japan for the treatment of hyperphosphatemia in patients with chronic kidney disease. Keryx will receive a non-refundable payment of $7 million for the achievement of the NDA filing milestone.
The company awaits top-line results from its U.S. long-term phase 3 study of Zerenex (ferric citrate) in dialysis patients.
Intercept Pharmaceuticals Inc. (ICPT) has initiated a phase 2 clinical trial of obeticholic acid in adult nonalcoholic steatohepatitis, or NASH, patients in Japan. The trial, which is being conducted by Intercept's partner Dainippon Sumitomo Pharma, in Japan is expected to be completed in the first half of 2016. The U.S.-based phase 2b NASH trial has completed enrollment, and results from this trial are expected in late 2014.
In a move that will expand its geographical presence in Europe and secure its long-term presence in the region, DaVita HealthCare Partners Inc. (DVA) has acquired nine dialysis centers from Fresenius Medical Care - with four of the clinics located in Portugal and five clinics in Poland.
Cellceutix Corp. (CTIX.OB) closed Monday's trading 10% higher at $2.04 after the company announced that a phase 1b study of its flagship anti-cancer compound Kevetrin in patients with acute myelogenous leukemia is scheduled to begin during the first half of 2013.
Covidien (COV) on Monday announced that its Tri-Staple technology platform has achieved more than $1 billion in product sales since launching in mid-2010. Tri-Staple technology platform for endoscopic surgical stapling is the first-of-its-kind technology that enables surgeons to use staplers in a broader range of tissue thicknesses than ever before.
by RTT Staff Writer
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