Astex Announces Preclinical Data Activity; J&J’s Simponi Fails to Receive FDA Clearance. Print E-mail
By Staff and Wire Reports   
Tuesday, 27 September 2011 20:28
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 26, 2011.

Astex Pharmaceuticals, Inc. (NASDAQ: ASTX), announced that preclinical data demonstrating that AT13387, a novel non-ansamycin Heat Shock Protein 90 (HSP90) inhibitor, is active in in vitro gastrointestinal stromal tumor (GIST) models (Abstract #9407) was presented at the 2011 ECCO (European Cancer Organization) European Multidisciplinary Cancer Congress in Stockholm, Sweden.

A presentation entitled, AT13387, a Heat Shock Protein 90 Inhibitor in a Phase I Study Exhibits Potent Activity in GIST Models, Dr. John Lyons of Astex Pharmaceuticals and colleagues from Harvard`s Dana Farber Cancer Institute, demonstrated that AT13387 displayed anti-tumor activity against a panel of human GIST cell lines.

Resistance to available therapies, such as imatinib, occurs commonly in GIST tumors, and overcoming this resistance in cancer patients could represent an important therapeutic advancement.

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Johnson & Johnson (NYSE:JNJ) failed to win U.S. clearance for wider use of Simponi, a two-year-old arthritis drug.  The company said it would request a meeting with the Food and Drug Administration to discuss what would be required to gain approval for the drug as a method of curbing the progression of joint damage from the type of arthritis linked to psoriasis, New Brunswick, New Jersey-based J&J said today in a statement.

J&J, the world’s second-biggest maker of health-care products after Pfizer Inc.  (NYSE:PFE) , won FDA clearance for Simponi in 2009 to treat psoriatic arthritis, rheumatoid arthritis, and a form of spinal arthritis. The injectable drug, part of a class of anti-inflammatory drugs known as TNF blockers, had sales of $226 million last year. Simponi, also known as golimumab, competes with Amgen Inc.'s (NASDAQ:AMGN) Enbrel and Abbott Laboratories' (NYSE:ABT) Humira.

J&J also wants to market Simponi as a treatment to inhibit joint-damage progression from rheumatoid arthritis. J&J’s Janssen Biotech unit said in July that it had received a complete response letter from the FDA, asking for more information on that proposed use.



Also Tuesday:



22nd Century Group, Inc. (OTCBB: XXII)
, a company focused on smoking cessation and tobacco harm reduction products, announced today that enrollment of its X-22Phase II-B clinical trial has been successfully completed; 234 smokers have been randomized in the double-blind, active-controlled, multi-center smoking cessation study.

Acura Pharmaceuticals, Inc. (NASDAQ: ACUR), a specialty pharmaceutical company innovating abuse deterrent drugs, today announced that the company has been issued U.S. Patent No. 7,981,439 by the United States Patent and Trademark Office.

AmerisourceBergen Corporation (NYSE: ABC)
today announced that it has signed a definitive agreement to purchase TheraCom, LLC, a subsidiary of CVS Caremark Corporation (NYSE: CVS) that provides a wide range of support to pharmaceutical and biotechnology drug manufacturers including consulting and reimbursement services, for $250 million.

Biodel Inc. (Nasdaq: BIOD) today announced top-line results from a Phase 1 clinical trial of BIOD-105 and BIOD-107 at Oregon Health and Sciences University to evaluate the pharmacokinetic, pharmacodynamic and infusion site tolerability profiles of these ultra-rapid-acting formulations of recombinant human insulin, relative to Humalog®,when delivered by insulin pumps.

BioElectronics Corporation (PINKSHEETS: BIEL) (OTCQB: BIEL), the maker of inexpensive, disposable drug-free topical pain and healing devices, today announced the publication of an article in the International Wound Journal that outlines the effective use of BioElectronics Corporation Pulsed Radio Frequency Energy (PRFE) therapy to successfully treat diabetic and venous stasis ulcers.

BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development company, today announced that data from the successfully completed Phase IIb EAGLE study of BL-1020, a first in class GABA-enhanced antipsychotic for the treatment of schizophrenia, will be presented at the 3rd European Conference on Schizophrenia Research (ECSR) held in Berlin, Germany.

Biotie Therapies Corp. ("Biotie" or "Company") (NASDAQ-OMX; BTH1V) and Newron Pharmaceuticals S.p.A. ("Newron", SIX; NWRN) today announced that they have signed an agreement for Biotie to acquire Newron in a transaction valued at EUR 45 million (the "Transaction").

The Bedford Report examines the outlook for companies in the Biotechnology Industry and provides equity research on Neoprobe Corporation (NYSE Amex: NEOP) and XOMA Ltd. (NASDAQ: XOMA).

China Botanic Pharmaceutical Inc. (NYSE AMEX: CBP) ("China Botanic" or the "Company"), a developer, manufacturer and distributor of botanical products, bio-pharmaceuticals and traditional Chinese medicines ("TCM") in China, today announced that on September 17, 2011, the Company hosted the National Marine and Terrestrial Symposium on Research and Development of Polysaccharide, Peptide and Natural Innovative Drugs (the "Symposium") in Harbin, China.

Codexis, Inc. (Nasdaq: CDXS) and Raizen Energia S.A. today announced the signing of a joint development agreement to develop an improved first generation ethanol process with enhanced performance economics. Raizen is Brazil's largest sugar and ethanol producer.

Cord Blood America, Inc. (OTC Bulletin Board: CBAI), the umbilical cord blood stem cell preservation company focused on bringing the life saving potential of stem cells to families nationwide and internationally, today updated shareholders on the progress of Biocordcell Argentina S.A. (BioCells, Inc.), which is 50.1 percent owned by Cord Blood America.

Given Imaging Ltd. (NASDAQ: GIVN) today announced that a special meeting of shareholders has been scheduled for November 15, 2011 to approve the extension and amendment of an existing Registration Rights Agreement between the Company and its affiliated shareholders, Discount Investment Corporation, Elron Electronic Industries Ltd. (Elron) and RDC Rafael Development Corporation, which collectively own approximately 46.7% of the Company's ordinary shares.

Medtronic, Inc. (NYSE: MDT) today announced the start of the Engager™ European Pivotal Trial to pursue CE (Conformité Européenne) Mark for the Engager Transcatheter Aortic Valve Implantation System in patients suffering from severe aortic stenosis.

MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostics company in the field of personalized medicine, confirmed today that it continues to make progress on partnering of its technology and companion diagnostics tests with pharmaceutical companies.

Neogen Corporation (Nasdaq: NEOG) announced today that its revenues for the first quarter of FY 2012, which ended Aug. 31, increased 6.5% to $45,697,000, from the previous year's first quarter revenues of $42,923,000.

NeoStem, Inc. (NYSE Amex: NBS), an international biopharmaceutical company with a focus on cell-based therapeutic development, today announced a change in the scheduling of its previously announced presentation at the 6th Annual JMP Securities Healthcare Conference.

Oramed Pharmaceuticals Inc. (OTC BB: ORMP), a developer of oral delivery systems, announced that EnteraBio Ltd. recently reported successful Phase 1 clinical trial results.

PLX Technology, Inc. (NASDAQ: PLXT), the leader in high-speed connectivity solutions for the enterprise and the home, today announced the inclusion of four more unique PCI Express (PCIe) Gen2 devices on the PCI Special Interest Group's (PCI-SIG) PCI Express 2.0 Integrators List, fully passing all key rigorous compliance testing required by leading global OEMs, assuring designer confidence in interoperability, quality and reliability.

Radient Pharmaceuticals Corporation (OTCQX: RXPC) (PINKSHEETS: RXPC), a developer and marketer of In Vitro Diagnostic (IVD) cancer tests, today announced it has signed a Collaboration Agreement with the Colon Cancer Coalition, which operates Get Your Rear in Gear, a series of events nationwide aimed at encouraging individual health advocacy.

Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of biopharmaceutical products in China, today announced that Tangshan Yian Biological Engineering Co., Ltd., its wholly owned subsidiary, received the production license for its developed inactivated animal rabies vaccine RabEnd from China's Ministry of Agriculture (MOA).

TheDirectory.com, Inc. (PINKSHEETS: SEEK) today announced it will report earnings and financial statements for the quarter and nine month period ended August 31, 2011 after the market closes on Thursday, September 29th, 2011.

Tianyin Pharmaceutical Co., Inc. (NYSE Amex: TPI), a pharmaceutical company that specializes in patented biopharmaceutical, modernized traditional Chinese medicine, branded generics and other pharmaceuticals, announced the financial results for the Fiscal Year 2011.

Wound Management Technologies, Inc., (OTCQB: WNDM | WNDM.PK) a leader in advanced wound care solutions, today announced that its President, Deborah Hutchinson will be presenting at AdvaMed 2011: The MedTech Conference.



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