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Pharma: Clinic Roundup
ALK-Abello A/S, of Horsholm, Denmark, reported a positive outcome of the first of two pivotal Phase III trials of its allergy immunotherapy tablet for the treatment of house dust mite-induced respiratory diseases, demonstrating that the treatment has a significant clinical effect in allergic rhinitis. Data from the MERIT trial showed that the immunotherapy tablet significantly reduced symptoms and medication use in patients with house dust mite-induced allergic rhinitis (p < 0.01). The outcome -
Pharma: Other News To Note
Actavis Inc., of Parsippany, N.J., and Kissei Pharmaceutical Co. Ltd., of Tokyo, said they filed lawsuits against Sandoz Inc., a unit of Basel, Switzerland-based Novartis AG, along with Hetero USA Inc., Hetero Labs Ltd. and Hetero Labs Ltd. Unit III, all part of Hyderabad, India-based Hetero Group, claiming infringement of U.S. Patent No. 5,387,603, covering Rapaflo (silodosin), a treatment for the signs and symptoms of benign prostatic hyperplasia. The lawsuit was filed in response to -
Clinic Roundup
Chemocentryx Inc., of Mountain View, Calif., completed target enrollment of 270 patients in a Phase II safety, tolerability and initial efficacy study of lead internal candidate CCX140, a CCR2 antagonist, in diabetic nephropathy. The company expects enrollment in the randomized, double-blind, placebo-controlled trial to exceed 300 when enrollment closes on or before June 30, enabling Chemocentryx to report 12-week data in approximately 200 patients in the third quarter. Full 52-week data -
Other News To Note
Amarantus Bioscience Holdings Inc., of Sunnyvale, Calif., said positive neuroprotective properties for its MANF therapeutic were reported in a preclinical study conducted at Qilu Hospital of Shandong University in Jinan, China. The findings suggested that MANF shows the potential to alleviate cell damage and inflammation in rat primary astrocytes by suppressing endoplasmic reticulum stress, indicating that MANF plays a role in astrocyte inflammation and functioning and may suggest a promising -
Flush Thrush: Bluebird's IPO At 'Beak' Value, Gets $101M
Bluebird Bio Inc.'s above-the-range initial public offering (IPO) sold about 5.9 million shares at $17 each to raise $101 million for a gene therapy strategy that deploys stem cells harvested from the patient's bone marrow, and the lead program is slated to kick off a Phase II/III trial late this year in childhood cerebral adrenoleukodystrophy (CCALD), caused by the buildup of fatty acids that damages the myelin sheath. The Cambridge, Mass.-based firm's stock (NASDAQ:BLUE) closed Wednesday at -
Turbocharged Namenda Can Repair Alzheimer's Synapses
By combining Namenda (memantine, Forest Laboratories Inc.) with nitroglycerin, researchers have developed a compound that appears capable of repairing damaged synapses in animal models of Alzheimer's disease. Such reversal of synaptic fortune might mean that the new compound, named Nitromemantine by its makers, could be developed into the first disease-modifying treatment for Alzheimer's. The drug "finally is the one that seems to protect the synapses, which is the holy grail," memantine -
Macrocure Seeks to Go Global Using Cell Therapy for Wounds
The potential value of cell therapy in wound care applications grabbed the attention of the biotech world last fall when Smith & Nephew plc, of London, picked up Fort Worth, Texas-based Healthpoint Biotherapeutics for $782 million in cash on the strength of its cell therapy product, HP802-247, in wound care. (See BioWorld Today, Nov. 29, 2012.) Macrocure, of Petach Tikva, Israel, hopes to generate similar success. The company's lead product, Curexcell, uses white blood cells obtained from the -
Transparency, Fairness Needed for the Biosimilar Playing Field
The longer timelines the FDA is proposing for biosimilar meetings and reviews add insult to the injury of expecting sponsors of the follow-on biologics (FOBs) to pay user fees up front, according to several generic drugmakers. Since biosimilars are on an abbreviated path, they should require fewer agency resources and less review time than a new reference drug, Mylan Inc. said in comments on the FDA's latest draft guidance about staff meetings with FOB sponsors. Given that fact, the drugmaker -
Stock Movers
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A&G Pharmaceutical Inc.
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A.P. Pharma Inc.
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A/F Protein Inc.
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Aarden Pharmaceuticals Inc.
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Aastrom Biosciences Inc.
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AB Enzymes GmbH
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Abbott Diabetes Care
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Abbott
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AbbVie Inc.
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Abengoa SA
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Abgenomics Corp.
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