J&J Pushed Risperdal for Kids Without Approval; Rexahn Secures Approval in Europe to Conduct a First-in-Human Trial Print E-mail
By Staff and Wire Reports   
Wednesday, 18 January 2012 19:29
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 18, 2012.

Officials of Johnson & Johnson's (NYSE:JNJ) Janssen unit pushed salespeople in Texas to “flood clinics with Risperdal stuff” as part of a 2004 campaign to increase prescriptions for the anti-psychotic drug written for children and adolescents, according to an internal memo put into evidence today in state court in Austin, Texas. The U.S. Food and Drug Administration didn’t approve Risperdal for any pediatric use until 2006.

A J&J’s unit marketed its Risperdal drug in 2004 to doctors working with troubled children even though regulators hadn’t approved the drug for those patients, company records show.

Texas officials contend New Brunswick, New Jersey-based J&J, the world’s largest health-care products company, defrauded the state Medicaid program by promoting Risperdal for uses not approved by U.S. regulators, including for children with psychiatric disorders. The state joined a lawsuit filed by a whistle-blower, Allen Jones, a former Pennsylvania health-care fraud investigator.

Lawyers for Texas Attorney General Greg Abbott are asking jurors to award the state at least $579 million from J&J and Janssen in damages over the companies’ marketing program for the anti-psychotic medicine.

Shane Scott, a former Janssen sales manager in Texas, testified he got a memo from his superiors in the summer of 2004 calling for a push to market Risperdal to treat attention- deficit syndrome in kids at the beginning of a new school year.

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Rexahn Pharmaceuticals, Inc. (NYSE: RNN) announced tht it has secured Hungarian Regulatory Authority and Ethics Committee approval for Rexahn's initial Clinical Trial Application. This allows Rexahn to initiate an exploratory first-in-human Phase I clinical trial of RX-3117, a small molecule antimetabolite for the treatment of solid tumors.

“Preclinical studies demonstrate RX-3117 to have exciting anti-cancer properties, and we look forward to moving this compound into clinical development,” said Rick Soni, President and COO of Rexahn. “We will continue to develop RX-3117, which has potential therapeutic applications in a broad range of cancers, including colon, lung and pancreatic cancer.”


Also Wednesday:


Agilent Technologies Inc. (NYSE:A) today announced that on Jan. 17, 2012, its board of directors approved the initiation of quarterly cash dividends to its shareholders and declared the first cash dividend in the company’s history.

AMRI (NASDAQ: AMRI) announced today that the Medicines and Healthcare Regulatory Agency (MHRA) of the UK government has issued a Good Manufacturing Practice (GMP) certificate for AMRI's manufacturing facility in Holywell, Wales, UK, following an inspection in October 2011.

Cambridge Heart, Inc. (OTCBB: CAMH), a developer of non-invasive diagnostic tests for cardiac disease, today announced that on January 17, 2012 it completed an initial closing of a private placement to new and current institutional and individual accredited investors.

CDEX Inc. (OTCBB: CEXI), a leading developer of chemical detection products using patented technologies for use in healthcare, safety and security markets, to showcase the ID2 Meth Scanner, Pocket ID2 illicit drug detector and the ValiMed™ G4 (VG4) multi-component medication and narcotic detection system at the American Correctional Association (ACA) - 2012 Winter Conference.

Celldex Therapeutics, Inc. (Nasdaq: CLDX) today announced that it will host a research and development day for the investment community on Monday, January 23, 2012 at 8:30 am Eastern Time.

Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that the European Medicines Agency (EMA) has approved its manufacturing plant in Framingham, Mass., for the production of Fabrazyme® (agalsidase beta).

Given Imaging (NASDAQ: GIVN) today announced that the company will host conference calls on Wednesday, February 15, 2012 to discuss fourth quarter and full-year 2011 financial results.

Hadasit Bio-Holdings Ltd. (TASE: HDST, OTC: HADSY) a publicly traded portfolio of biotech companies, all based on intellectual property developed and owned by Hadassah University Hospital, Israel's foremost medical research center, today announced the completion of an investment round totaling $1.4 million for Thrombotech Ltd. at a pre-investment valuation of $5 million.

Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible robotics and the developer of robotic technology for accurate 3D control of catheter movement, today announced it will showcase its Magellan™ Robotic System at the Leipzig Interventional Course (LINC), from January 25-28, at the Trade Fair Leipzig, Hall 4, in Leipzig, Germany.

MedPro Safety Products, Inc. (OTCBB: MPSP)
, a leading developer of transformational technologies that enable safer medication delivery and blood collection, will participate in two leading drug delivery industry conferences in the coming weeks.

PROLOR Biotech, Inc. (NYSE Amex: PBTH) today announced positive top-line results from a post-Phase II clinical study of its long-acting CTP-modified version of human growth hormone (hGH-CTP) in growth hormone deficient adults.

Provectus Pharmaceuticals, Inc. (OTCBB: PVCT)
, a development-stage oncology and dermatology biopharmaceutical company, has received guidance from the U.S. Food and Drug Administration ("FDA") to submit its Phase 3 protocol for review, either via standard review or a request for Special Protocol Assessment (“SPA”).

Soligenix, Inc. (OTCBB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today results from long-term stability studies of its proprietary DNI (dominant negative inhibitor) anthrax rPA (recombinant protective antigen) subunit protein vaccine, known as SGX204.

Stellar Biotechnologies, Inc. ("Stellar") (TSX VENTURE: KLH) (PINKSHEETS: SBOTF) is pleased to announce that it has retained TheBiotechPanel, Inc. (www.thebiotechpanel.com), a Florida-based company specializing in financial and investor relations and communications focused on Europe, to provide the Company with investor relations services.

Tianyin Pharmaceutical Co., Inc. (NYSE Amex: TPI), a pharmaceutical company that specializes in patented biopharmaceutical medicine, modernized traditional Chinese medicine (mTCM), branded generics and active pharmaceutical ingredients (API) announced the Company has received the Good Manufacturing Practice (GMP) certification for its 250-ton Jiangchuan Macrolide Facility (JCM) designated as "CHUAN M0799" valid through the period of December 31, 2011 until December 31, 2015.



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