CONCORD, Calif.--(BUSINESS WIRE)--Feb 9, 2010 - Cerus Corporation (NASDAQ:CERS) announced today that its Phase 1 trial of red blood cells treated with the INTERCEPT Blood System met its primary endpoint, with preliminary analysis demonstrating that greater than 75 percent of treated cells continued to circulate 24 hours following transfusion. [more]
LEUVEN, Belgium, February 9/PRNewswire-FirstCall/ -- ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, vascular disease and cancer, announces today that the positive microplasmin Phase II trial results, evaluating the product's efficacy and safety in patients who require vitrectomy, have been published in the prestigious American Academy of Ophthalmology's Journal, Ophthalmology, the leading journal for the vitreoretinal community. [more]
THOUSAND OAKS, Calif., Feb. 8 /PRNewswire-FirstCall/ -- Amgen (NASDAQ: AMGN) today announced that a pivotal, Phase 3, head-to-head trial evaluating denosumab versus Zometa® (zoledronic acid) in the treatment of bone metastases in 1,901 men with advanced prostate cancer met its primary and secondary endpoints. Denosumab demonstrated superiority over Zometa for both delaying the time to the first on-study skeletal related event (SRE) (fracture, radiation to bone, surgery to bone or spinal cord compression) (hazard ratio 0.82, 95 percent CI: 0.71, 0.95), and reducing the rate of multiple SREs (hazard ratio 0.82, 95 percent CI: 0.71, 0.94). Both results were statistically significant. [more]
BETHESDA, Md.--(BUSINESS WIRE)--Feb 8, 2010 - REGENERX BIOPHARMACEUTICALS, INC. (NYSE Amex:RGN) announced today that researchers have correlated Tβ4 levels with the clinical course of patients with hepatitis B virus-related liver failure. It was reported that serum thymosin β4 levels were significantly lower in patients with chronic hepatitis B infection and that the magnitude of the reduction of thymosin β4 was closely related to the severity of the hepatic injury and to patient death. Since patients with higher Tβ4 levels survived the disease, changes in Tβ4 values could reflect outcome in some liver failure patients. [more]
ROCKVILLE, Md., Feb. 8 /PRNewswire-FirstCall/ -- Novavax, Inc. (NASDAQ: NVAX) announced today new data from a clinical study that began in May of 2009 among healthy adults 18 to 49 years of age with Novavax's trivalent seasonal influenza Virus-like Particle (VLP) vaccine. The vaccine matched the influenza strains recommended for the 2008-2009 influenza season including H1N1 A/Brisbane/59/2007, H3N2 A/Brisbane/10/2007, and B/Florida/04/2006 strains. The study enrolled 241 subjects, including 221 who were randomized to receive either VLP vaccine at 15 mcg or 60 mcg doses or a placebo and 20 subjects who received a licensed inactivated influenza vaccine (TIV). [more]
SAN DIEGO--(BUSINESS WIRE)--Feb 8, 2010 - Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, announced today additional interim safety and immunogenicity data from its therapeutic cervical cancer vaccine (VGX-3100) trial. [more]
LEXINGTON, Mass.--(BUSINESS WIRE)--Feb 8, 2010 - Synta Pharmaceuticals Corp. today announced that preclinical results presented at the “Bridging the Gap 2010” Hematologic Conference, held in Singapore City, Singapore, February 5-7, 2010, shows that STA-9090, a potent inhibitor of heat shock protein 90 (Hsp90), inhibits the Wilms' tumor 1 (WT1) protein, a key transcription factor that drives disease progression in acute myeloid leukemia (AML) as well as certain other leukemias. [more]
Geneva, Switzerland, 8 February 2010 - Addex Pharmaceuticals, the allosteric modulation company, announced today that ADX71943 has demonstrated statistically significant analgesic-like effects in three preclinical models of pain. [more]
SHELTON, Conn., Feb. 8 /PRNewswire/ -- Cara Therapeutics, Inc. today announced positive data in a Phase II proof-of-concept clinical trial of its peripherally-restricted kappa opioid agonist, CR845. The 46 patient Phase II, multi-center, double-blind, placebo-controlled study was conducted at eight hospitals in the United States and evaluated the efficacy and safety of CR845 in women following laparoscopic-assisted hysterectomy. [more]
SAN DIEGO, CA February 8, 2010 -- Inovio Biomedical Corporation (NYSE Amex: INO), a leader in DNA vaccine design, development and delivery, announced today additional interim safety and immunogenicity data from its therapeutic cervical cancer vaccine (VGX-3100) trial [more]
LEXINGTON, Mass.--(BUSINESS WIRE)--Feb 5, 2010 - AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease, today provided a safety update on Feraheme® (ferumoxytol) Injection for intravenous use. [more]
MARIETTA, Ga., Feb. 5 /PRNewswire-FirstCall/ -- Solvay Pharmaceuticals, Inc. announced today that Phase IIIb data published in the January issue of Clinical Therapeutics confirm that CREON (pancrelipase) Delayed-Release Capsules significantly improves a key measure of fat absorption in children aged 7-11 years who have exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF), EPI is a condition resulting from a deficiency in the production and/or secretion of pancreatic enzymes that are necessary to digest nutrients in food. [more]
ALAMEDA, Calif.--(BUSINESS WIRE)--Feb 5, 2010 - BioTime, Inc. today reported recently-released results from an independent study evaluating the use of Hextend in hemodynamically unstable trauma patients. Hextend (6% Hetastarch in Lactated Electrolyte Injection) is BioTime's commercially-available blood plasma volume expander used to treat hypovolemia (low blood volume). [more]
NOVATO, Calif., Feb. 4 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. today announced an update on the Phase I/II trial for BMN 110 or N-acetylgalactosamine 6-sulfatase (GALNS), intended for the treatment of the lysosomal storage disorder Mucopolysaccharidosis Type IVA (MPS IVA), or Morquio A Syndrome. Preliminary clinical data from the first 24 weeks of the study (12 weeks at 0.1mg/kg and 12 weeks at 1.0 mg/kg) have been evaluated, and BioMarin plans to announce top-line results for the full 36-week study after completion of dosing at 2.0 mg/kg in the second quarter of 2010. [more]
SAN ANTONIO, Feb. 4 /PRNewswire-USNewswire/ -- Tanezumab, a humanized monoclonal antibody that targets nerve-growth factor, reduced pain in three common pain conditions, according to the results from three phase two studies presented today in a single poster at the American Academy of Pain Medicine's 26th Annual Meeting. [more]
CARMIEL, Israel, Feb. 4 /PRNewswire-FirstCall/ -- Protalix Biotherapeutics, Inc. today announced that data from its pivotal Phase III trial of taliglucerase alfa in patients with Gaucher disease will be presented at the Annual Meeting of the Lysosomal Disease Network: WORLD Symposium 2010, February 10-12, 2010 in Miami, Florida. [more]
SAN ANTONIO, Feb. 4 /PRNewswire-USNewswire/ -- Findings from a retrospective analysis of a three-week treatment program for chronic pain revealed African Americans experienced worse outcomes compared to a matched group of Caucasians. The research was presented today at the American Academy of Pain Medicine's 26th Annual Meeting in San Antonio. [more]
CAMBRIDGE, Mass., Feb. 3 /PRNewswire-FirstCall/ -- Shire plc , the global specialty biopharmaceutical company, today announced that data from one of three Phase III clinical trials for velaglucerase alfa, the company's enzyme replacement therapy (ERT) in development for the treatment of Type 1 Gaucher disease, will be presented at the Lysosomal Disease Network (LDN) World Symposium, February 10-12, 2010 in Miami, Florida. In addition to two oral presentations and two poster presentations on Gaucher disease, the company will present findings from a re-analysis of disease stage progression in Globoid Cell Leukodystrophy (GLD). Dr. Michael West from Dalhousie University in Halifax, Canada will also present head-to-head REPLAGAL ® 0.2 mg/kg and Fabrazyme 1.0 mg data, sponsored by the Canadian Fabry Disease Initiative (CFDI). [more]
INDIANAPOLIS, Feb. 3 /PRNewswire-FirstCall/ -- In a new study, 60 mg of Cymbalta® (duloxetine HCl) taken once daily significantly reduced chronic low back pain, as measured by the Brief Pain Inventory (BPI) average pain rating, compared with placebo.(1) The data were presented today at the annual meeting of the American Academy of Pain Medicine (AAPM) in San Antonio, Texas. [more]
TORONTO, Feb. 3 /CNW/ - An extended release generic nifedipine product (Mylan-Nifedipine extended release 60 mg formerly Gen-Nifedipine extended release 60mg, Genpharm ULC) is not bioequivalent to the Canadian originator product, Adalat(R) XL(R)(1), according to the results of a study recently published in the International Journal of Clinical Pharmacology and Therapeutics.( [more]
Mergers & Acquisitions, Partnerships, & Collaborations 2010 – Review and Outlook
This PharmaLive Special Report analyzes the healthcare industry’s M&As of 2009, providing a comprehensive listing of companies’ M&A activity and detailing the top 20 deals within each of the Pharmaceutical, Biotechnology, Specialty, and Medical Device sectors, and previews potential M&A activity within the healthcare arena for 2010.
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