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1. Scientists Describe New Genetic Subtypes of Prostate Cancer
   Two independent exome sequencing studies have identified new genetic subtypes of prostate cancer. Presenting its findings in Nature, a University of Michigan Medical School-led team identified CHD1 mutations in 8% of heavily pretreated lethal metastatic castration-resistant prostate cancers (CRPCs). Notably, CHD1 mutations were almost always found in tumors that didn’t display ETS gene family fusions. [...]
2. MSC-Secreted Factor Key to Impact of Multiple Sclerosis Cell Therapy
   Scientists have identified a factor in the conditioned medium of mesenchymal stem cell (MSCs) cultures that appears to play a key role in the therapeutic effects of MSC-based therapy in multiple sclerosis (MS). Studies by Case Western Reserve University researchers in the experimental autoimmune encephalomyelitis (EAE) mouse model of MS demonstrated that treatment using conditioned [...]
3. Marina, Girindus Ink Oligonucleotide Manufacturing, Supply Deal
   Girindus has obtained the exclusive rights to develop, supply, and commercialize certain oligonucleotide constructs using Marina Biotech’s conformationally restricted nucleotide (CRN) chemistry. In return Marina will receive royalties from the sale of CRN-based oligonucleotide reagents as well as a robust supply of cGMP material for Marina and its partners’ preclinical, clinical, and commercialization needs. CRNs [...]
4. Ventana Licenses Gen-Probe IP for Measuring ERG Protein in Prostate Cancer
   Roche’s Ventana Medical Systems co-exclusively sublicensed IP from Gen-Probe granting the firm in vitro diagnostic rights relating to the immunohistochemical measurement of ERG protein expression in prostate tissue. Ventana says the licensed IP complements its existing co-exclusive sublicense to IP covering in situ hybridization measurements of ETS gene rearrangements (including ERG gene rearrangements) in tissue. [...]
5. BioDelivery Earns $2.5M from Meda on Pricing Approval of Breakyl in First EU Country
   BioDelivery Sciences received a $2.5 million prelaunch milestone payment from Meda, triggered by the first national regulatory clearance and pricing approval for Breakyl/Onsolis (fentanyl buccal soluble film) in the EU. Breakyl is indicated for the management of breakthrough pain in opioid-tolerant adult cancer patients. BioDelivery will receive another, final $2.5 million EU-related milestone when the [...]
6. Osiris Wins Race to Market a Stem Cell Product with Canadian Go-Ahead
   Osiris Therapeutics’ adult stem cell therapy Prochymal® received approval from Health Canada for the treatment of acute graft-vs-host disease (GvHD) in children who failed to respond to steroids. The company will have to carry out certain post-launch confirmatory studies. The decision gives Osiris the distinction of being the first company to win full marketing approval [...]
7. Google Search Engine Forms Basis of Algorithm to Identify Prognostic Cancer Biomarkers
   Scientists have adapted the algorithm used by Google’s web search engine to develop a computational program that can identify panels of biomarkers for cancer prognosis. Google’s PageRank algorithm takes into account the network of hyperlinks between web documents as well as the search terms themselves to determine which pages are most relevant to a particular [...]
8. Janssen Reports Positive Phase III Data for Chronic Diabetic Peripheral Neuropathy Analgesic
   Janssen Pharmaceuticals reported Phase III results demonstrating the efficacy of Nucynta® ER (extended release tapentadol) in managing pain associated with chronic diabetic peripheral neuropathy (DPN). Janssen says the data is consistent with that of a separate study reported in 2011 in patients with DPN. Nucynta ER is a centrally acting analgesic that acts as both [...]
9. Ruga Licenses Selexagen’s RAF Kinase Program for Targeted Cancer Therapy
   Targeted cancer drug developer Ruga negotiated rights to Selexagen Therapeutics’ RAF kinase program. The firm claims the acquired technology addresses the drawbacks to BRAF inhibition as an approach to cancer therapy. Data has demonstrated that BRAF inhibition can actually induce adaptation in RAS-activated cells and promote the development of secondary skin lesions and RAS-mutated tumor [...]
10. Solvo, XenoBiotic to Provide In Vitro Transporter Services in the U.S.
    XenoBiotic Laboratories established a partnership with Hungary-based Solvo Biotechnology to offer in vitro transporter services in the U.S. Solvo will transfer its efflux and uptake transporter assays to XBL’s research facilities in New Jersey. The services will be made available to American customers through both Solvo and XBL sales channels. Through this collaboration Solvo will [...]
11. Affymetrix Launches Circulating Tumor Cell Platform in Deal with ScreenCell
    Affymetrix signed a worldwide distribution agreement for ScreenCell’s isolation devices and dilution buffers for the collection of circulating tumor cells (CTCs) in peripheral blood. The QuantiGene® ViewRNA CTC platform, which consists of ScreenCell’s products and Affymetrix’ QuantiGene ViewRNA Assays, is now available from Affymetrix. The arrangement makes Affymetrix the exclusive distributor of ScreenCell products used [...]
12. Alga Provides Feasible Mass Production System for Subunit Malaria Vaccine Candidate
    An algal system for manufacturing recombinant proteins has provided scientists with the means to generate a malaria-blocking vaccine candidate based on two native unglycosylated Plasmodium falciparum surface proteins, Pfs25 and Pfs28. The University of California, San Diego researchers produced the two P. falciparum proteins in the chloroplasts of the widely used model alga Chlamydomonas reinhardtii, [...]
13. Agilent Acquires Cancer In Vitro Diagnostic Firm Dako for $2.2B in Cash
    Agilent is buying Danish cancer in vitro diagnostics firm Dako for $2.2 billion in cash on a debt-free basis. Agilent says the acquisition is the largest in its history, and will complement its existing life science business and boost its presence in the clinical diagnostics market. “In the rapidly growing diagnostics market, Dako’s products and [...]
14. Aveo, Astellas Report Positive Data from Phase III Comparative Tivozanib Trial in RCC
    Aveo Oncology and partner Astellas Pharma Europe reported positive data from the pivotal Phase III study Viro-1, comparing the once-daily oral tyrosine kinase inhibitor candidate tivozanib with sorafenib in 517 patients with advanced renal cell carcinoma (RCC). Astellas says it plans to submit a marketing authorization application for tivozanib to the European authorities during the [...]
15. Evotec Becomes First European CRO to Offer Agilent’s RapidFire Screening Tool
    Evotec is adding Agilent Technologies’ RapidFire mass spectrometry analysis capabilities to its high-throughput screening facilities in Hamburg. RapidFire is an in-line solid-phase extraction technology. It enables ultrafast, direct analysis of native compounds for a variety of biochemical assays including routine ADME and lead discovery applications across a range of therapeutic areas. Evotec reports that it [...]
16. Pfizer’s Torisel Misses Endpoints in Renal Cell Carcinoma Trial Testing Second-Line Setting
    Pfizer’s drug candidate for advanced renal cell carcinoma (RCC), Torisel, failed to meet the primary endpoint of progression-free survival in the Phase III Intorsect study. The trial compared Torisel and Nexavar in patients whose disease had progressed on or after treatment with the company’s approved drug Sutent. Although PFS was numerically higher in patients treated [...]
17. Lonza, Avalanche Partner on Baculovirus-Based AAV Manufacturing Platform
    Biologics manufacturer Lonza and ocular gene therapy specialist Avalanche Biotechnologies established a global manufacturing collaboration to aid in the latter’s gene therapy programs. Avalanche’s lead wet age-related macular degeneration (wet-AMD) gene therapy candidate AVA-101 started in early clinical trials at the end of 2011. The partnership will focus on the process development and scale-up of [...]
18. IntelligentMDx Wins CE Mark for Group B Strep Assay on Abbott m2000 Instrument
    IntelligentMDx received a CE Mark for its qualitative Group B Streptococcus (GBS) in vitro diagnostic, IMDx GBS, for use on the Abbott m2000™ system. The assay is used to screen for Group B Streptococcus infection in at-risk pregnant women and women in labor. The real-time PCR test can be carried out on either direct swabs [...]
19. Admescope to Provide PlexPress Multiplex CYP Gene Expression Analysis Technology
    CRO Admescope will offer PlexPress’ TRAC (transcript analysis with the aid of affinity capture) platform for high-throughput gene expression analysis as part of its in vitro drug interaction and preclinical ADME-Tox services. Finland-based Admescope will initially offer Plexpress’ multiplex cytochrome P450 (CYP) assays. The firm says the service will meet FDA’s recent draft recommendations that [...]
20. Six Suitors Join Bristol-Myers in Considering a Bid for Amylin
    After turning down an unsolicited bid from Bristol-Myers Squibb (BMS) in February, Amylin Pharmaceuticals is preparing to weigh offers from BMS and up to six other potential suitors. Citing unnamed “people familiar with the matter,” Bloomberg News reported that BMS has joined AstraZeneca, Merck & Co., Pfizer, Roche, Sanofi, and Takeda in signing confidentiality agreements [...]