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Sepsis Patients May Need Bigger Immune Response
Through the indirect targeting of toll-like receptors via their co-receptor, researchers have boosted the immune response to infection, and helped animals with experimentally induced sepsis fight off the bacteria that set off the septic response. Given that one effect of sepsis is massive hyperinflammation, the notion of helping sepsis patients by boosting their innate immune response might seem counterintuitive at best, or like the punch line of a bad mother-in-law joke, at worst. But the -
'JAK'ing Up Myelofibrosis; Sanofi's Phase III Data Solid
As sales of Incyte Corp.'s approved JAK inhibitor Jakafi (ruxolitinib) begin to pick up steam, a competing myelofibrosis candidate from Sanofi SA moved a step closer to market. The Paris-based big pharma, which gained rights to JAK drug SAR302503 in its 2010 buyout of TargeGen Inc., reported solid top-line data from the Phase III study dubbed JAKARTA, showing that both dose groups of the drug hit the primary endpoint of reducing spleen volume. The study was conducted under a special protocol -
Oncos Targets Solid Tumors With Oncolytic Virus Approach
Taking an inventive route to drug development, Oncos Therapeutics Ltd. has its roots in a type of compassionate use program that was started in 2007 at the international comprehensive cancer center, Docrates, in Helsinki, Finland. The Advanced Therapy Access Program for experimental treatments with the company's oncolytic viruses was made possible through European Union (EU) regulation EC/1394/2007, designed to improve safe access by patients across the EU to gene therapy, somatic cell therapy -
Pharma: Other News To Note
Bristol-Myers Squibb Co., of New York, said it has notified the New York Stock Exchange (NYSE) of its intention to voluntarily delist its $2 convertible preferred stock from the NYSE, a decision driven by the low number of shares outstanding, low daily trading volume, listing fees and compliance administration costs. Mylan Inc., of Pittsburgh, said its subsidiary Mylan Pharmaceuticals Inc. has shipped Fenofibrate Tablets, 48 mg and 145 mg. Mylan Pharmaceuticals received final approval from -
Appointments and Advancements
Aeterna Zentaris Inc., of Quebec City, added Marcel Aubut, David A. Dodd, José P. Dorais, Carolyn Egbert, Juergen Ernst, Pierre Lapalme and Gérald Limoges to its board. AltheRx Pharmaceuticals Inc., of Exton, Pa., named Jim Bennethum CEO, appointed Charles E. Becker board chairman and named Jeffrey O'Donnell and Anthony Zook to its new board of directors. BG Medicine Inc., of Waltham, Mass., appointed Paul Sohmer president and CEO. Biota Pharmaceuticals Inc., of Rockville, Md., added Anne -
Pharma: Clinic Roundup
UCB SA, of Brussels, Belgium, said data from a double-blind, placebo-controlled study found that Neupro (rotigotine transdermal system) reduced total nocturnal systolic blood pressure (NSBP) elevations associated with periodic limb movements during sleep (PLMS) and total PLMS in patients with idiopathic moderate to severe restless legs syndrome (RLS)/Willis-Ekbom disease. The data were presented at the annual meeting of the American Society of Hypertension. Results showed that rotigotine -
Clinic Roundup
Cellular Biomedicine Group Inc., of Palo Alto, Calif., achieved 50 percent enrollment of the total projected enrollment required for its Phase I trial to evaluate the safety and preliminary efficacy of human adipose-derived mesenchymal progenitor cells therapy for knee osteoarthritis. No severe adverse effects have been reported so far. Cytos Biotechnology AG, of Zurich, Switzerland, and Singapore's Agency for Science, Technology and Research (A*STAR) said the first healthy volunteer has been -
Stimuvax Ekes Out OS Benefit in NSCLC Subgroup
Oncothyreon Inc.'s detailed results for its cancer immunotherapy product L-BLP25 (formerly Stimuvax), reported at the meeting of the American Society of Clinical Oncology Annual Meeting in Chicago, failed to comfort nervous investors. Having previously missed its primary endpoint of overall survival (OS) in non-small-cell lung cancer, the company said that median OS was 25.6 months compared to 22.3 months for the placebo group, with a "p" value of 0.123. A post hoc analysis in a subgroup of 806 -
Clinic Roundup
Amgen Inc., of Thousand Oaks, Calif., reported findings from analyses of Vectibix (panitumumab) in combination with Folfox, an oxaliplatin-based chemotherapy regimen, as first-line treatment in metastatic colorectal cancer (mCRC). The analyses included the description of new predictive biomarkers of clinical response to Vectibix, activating mutations in KRAS (beyond exon 2) and in NRAS, collectively referred to as RAS. The RAS biomarkers were identified in a predefined retrospective subset -
MedImmune: Phase III Begins, IMTC Poised as Cancer Key
MedImmune Inc., part of AstraZeneca plc, started the first patient in its Phase III hairy-cell leukemia (HCL) trial with its first-in-class antibody-drug conjugate moxetumomab pasudotox (MP), a CD22 immunotoxin made up of an anti-CD22 antibody fused to a toxin. The molecule binds to CD22, gets internalized and processed, and then releases the toxin payload to blast the tumor. MP looked promising in Phase I, with a manageable safety profile, which led London-based AstraZeneca to make the -
Other News To Note
AnaptysBio Inc., of San Diego, disclosed a contract award from the U.S. government for the development of highly thermostable anti-ricin antibodies for biodefense applications. Under the terms of AnaptysBio's contract with the Science and Technology Corp., AnaptysBio will be responsible for delivering anti-ricin antibodies to the Edgewood Chemical and Biological Center, an agency of the U.S. Army. The contract is funded by the Defense Threat Reduction Agency, and follows successful completion -
Some Biotechs Provide Troll Bait, Others are Troll Prey
Like the troll of yore demanding his pound of goat flesh as the toll for using his bridge, patent trolls are threatening to swallow up biotech start-ups – just as they have other businesses that strayed too close to the vague boundary lines of their intellectual property. So far, patent trolls, also known as patent licensing companies, haven't gotten too gruff with drug- and devicemakers, but it looks like that could change, Jeff Grainger, managing partner of the Foundry LLC, a medical device -
RuiYi, Genor Blaze Trail in China with JV for Rheumatoid Arthritis
TAIPEI, Taiwan – In what is likely one of the first attempts by a foreign biopharma to complete the full range of clinical trials in China for a new biologic, leading to regulatory and market approval by Chinese drug approval authorities, therapeutic antibodies specialist RuiYi Inc., of La Jolla, Calif., and Shanghai, entered a collaboration agreement with Genor BioPharma Co. Ltd., of Shanghai, to develop its anti-IL-6 monoclonal antibody RYI-008 for rheumatoid arthritis (RA). The deal -
Ambit Cuts Price, Ups Shares; $65M IPO to Fund Quizartinib
Despite losing a potentially lucrative FLT3 inhibitor partnership with Astellas Pharma Inc. barely two months ago, Ambit Biosciences Corp. forged ahead with its initial public offering (IPO). The San Diego-based biotech priced about 8.1 million shares at $8 apiece for gross proceeds of about $65 million. The pricing came in lower than Ambit had hoped – it set a $13 to $15 price range earlier this month – but the firm increased the number of shares offered to make up the difference. Proceeds -
Pharma: Other News To Note
Bayer AG, of Leverkusen, Germany, signed an agreement to acquire the shares of Steigerwald Arzneimittelwerk GmbH, of Darmstadt, Germany, a privately held pharmaceutical company specializing in pharmacy-only herbal medicines. Steigerwald's product portfolio includes Iberogast for the treatment of functional gastrointestinal disorders and Laif for the treatment of mild to moderate depression. Financial details were not disclosed, but Steigerwald generated 2012 sales of €61.3 million (US$79 -
Stock Movers
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Other News To Note
Common stock in Fibrocell Science Inc., of Exton, Pa., has been approved for listing on the NYSE Market, to commence trading on May 17, under the ticker symbol FCSC. The FDA approved Tarceva (erlotinib) tablets for first-line treatment of metastatic non-small-cell lung cancer characterized by tumors with epidermal growth factor receptor-activating mutations. The product is marketed by Genentech Inc., a member of the Basel, Switzerland-based Roche Group, and Astellas Pharma Inc., of Tokyo. In -
Pharma: Other News To Note
Merck Serono SA, of Rockland, Mass., a division of Merck KGaA, of Darmstadt, Germany, and Quintiles Inc., of Research Triangle Park, N.C., signed a new, five-year clinical development agreement. Under the agreement, Quintiles will direct clinical trial planning and execution of trials guided by Merck Serono's strategy. Quintiles will also contribute to Merck Serono's future trial design process. The two companies will share decision-making responsibility for the Merck Serono portfolio. Mylan -
NIH Research Flat Lining over Budget Numbers
The pulse of the National Institutes of Health (NIH) could weaken without a healthy injection of money to fund future innovations and the scientists who form the core of biomedical research. "This is a perilous moment" for both the NIH and the future of innovative research, NIH Director Francis Collins told a Senate Appropriations subcommittee Wednesday as he pushed for more funding for the agency. NIH has lost 22 percent of its purchasing power over the past decade, and the number of grants it -
Success Reported in Cloning Human Embryonic Stem Cells
Embryonic stem cells have been the subject of so many political fights that it's easy to forget they have also faced formidable scientific obstacles. But they have. Human eggs, it turns out, are far more fragile than those of most other mammals – including those of other primates. And so, methods that have been used to clone mammals from Dolly the sheep to Snuppy, the cloned dog that was South Korean stem cell scientist Woo-Suk Hwang's only non-fraudulent claim to fame, have failed to produce
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