Catalyst Pharma Reports Positive Results for CPP-115. Bristol-Myers Announces FDA Approval Of NULOJIX. Print E-mail
By Staff and Wire Reports   
Thursday, 16 June 2011 19:03
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 16, 2011.

Catalyst Pharmaceutical Partners, Inc. (NASDAQ:CPRX) announced initial positive efficacy results from an investigator sponsored study of CPP-115 in an animal model of infantile spasms (IS).

In this study, CPP-115 significantly reduced observed spasms for three times longer than vigabatrin (the active ingredient in Lundbeck's Sabril), which is currently approved for the treatment of infantile spasms.

Also, CPP-115 was more potent than vigabatrin, exhibited less side effects, and with a larger margin of safety. Catalyst anticipates that the full data will be presented at a scientific meeting and will be submitted for publication in a peer reviewed journal.

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The U.S. Food and Drug Administration (FDA) announced approval of Bristol-Myers Squibb Co. (NYSE:BMY), NULOJIX, the first selective T-cell costimulation blocker indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant, in combination with basiliximab induction, mycophenolate mofetil (MMF), and corticosteroids.

NULOJIX should only be used in patients who are EBV seropositive. Using NULOJIX for prophylaxis of organ rejection in transplanted organs other than kidney has not been established. NULOJIX will be available as 250 mg lyophilized powder.

The efficacy and safety of NULOJIX in adult de novo kidney transplant patients was studied in two 3-year, phase 3, open-label, randomized, multicenter, active-controlled studies (BENEFIT and BENEFIT-EXT).


Also Thursday:


Advanced Cell Technology, Inc. (OTCBB: ACTC), a leader in the field of regenerative medicine, announced today the enrollment of the first patients in its two Phase 1/2 clinical trials for Stargardt's Macular Dystrophy (SMD) and Dry Age-Related Macular Degeneration (Dry AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs).

American Medical Alert Corp. (NASDAQ: AMAC), a provider of healthcare communication services and advanced telehealth monitoring technologies, today announced the inception of a Medical Advisory Board and the appointment of Joseph F. Renzulli, II, MD, FACS, as Chairman of the Medical Advisory Board.

BIOLASE Technology, Inc. (NASDAQ: BLTI), the World's leading dental laser manufacturer and distributor, today announced that it reached a final settlement agreement with Koninklijke Philips Electronics N.V. (NYSE: PHG) and Discus Dental LLC, regarding the litigation that Discus brought against BIOLASE in 2010 (Discus was subsequently acquired by Philips).

Biostem U.S. Corporation (OTCQB: BOSM) (PINKSHEETS: BOSM), a leading developer of hair transplant technology using human stem cells, announced the addition of Dwight C. Brunoehler as Chief Executive Officer of the company.

China-Biotics, Inc. (NASDAQ:CHBT), a leading developer, manufacturer, and distributor of probiotics products in China, today affirmed that NASDAQ halted trading in the Company's common stock at approximately 3:35 PM EDT on Wednesday, July 15, 2011, shortly after the Company filed for an extension of time to file with the Securities and Exchange Commission its Annual Report on Form 10-K for the fiscal year ended March 31, 2011.

MedeFile International, Inc. (OTCQB: MDFI) (PINKSHEETS: MDFI), a leader in portable patient-centric electronic medical record management solutions, today announced that Kevin Hauser, Chairman, President and CEO of MedeFile, has been invited to present at the National Eagles and Angels Association's (NEAA) New York City Chapter meeting on Tuesday, June 21, 2011, at The Oak Room located in the Plaza Hotel.

MMRGlobal, Inc. (OTCBB: MMRF) ("MMR") and VisiInc PLC (FRANKFURT: VZJ) (www.deutsche-boerse.com) today announced that following the recent signing of their agreement, MMR will grant to VisiInc an exclusive license to its proprietary eHealth patent portfolio in Australia with additional rights in certain areas of Eastern Europe.

NeoStem, Inc. (NYSE Amex:NBS), an international biopharmaceutical company with product and service revenues, global research and development capabilities and operations in three distinct business units – U.S. adult stem cells, China adult stem cells, and China pharmaceuticals, and the Vatican's Pontifical Council for Culture, today announced steps forward in their partnership designed to advance adult stem cell research.

NewCardio, Inc., (OTCBB: NWCI) a cardiac diagnostic technology provider, announced today that two of its recent medical and technical submissions have been accepted for their presentations at the 33rd Annual International Conference of the IEEE Engineering in Medicine and Biology Society conference.  

OPTIMIZERx Corp. (OTCBB: OPRX) today announced Networking Technology, Inc., dba RxNT, as another powerful electronic Health record (eHr) channel to promote SampleMD free trial vouchers and co-pay support offers to help patients better afford their ePrescribed medications.

PDL BioPharma, Inc. (PDL) (NASDAQ:PDLI) today announced that it has paid the June 15, 2011, regular quarterly dividend payment of $0.15 per share to all stockholders owning shares of PDL as of June 8, 2011, the record date.

Pegasystems Inc. (NASDAQ: PEGA), the leader in Business Process Management (BPM) and software for customer centricity, today announced a new customer relationship management (CRM) offering for life sciences.

PROTEONOMIX, INC. (OTCBB: PROT), a biotechnology company focused on developing therapeutics based upon the use of human cells and their derivatives, announced today that it has engaged the services of Bedminster Financial Group, Ltd. to provide investment banking services for the Company with a view to finding joint venture partners and/or strategic investments into one or more of its subsidiaries in order to advance the scientific and commercial development of the subsidiaries and the technologies possessed by the subsidiaries.

Rosetta Genomics (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostic tests, announces that data presented at the American Society of Clinical Oncology (ASCO) 2011 showed the Company's miRview® mets2 test accurately identified the tissue of origin in Cancer of Unknown Primary (CUP) patients in a post-marketing validation study.

SCOLR Pharma, Inc. (OTC: SCLR) today announced that it has closed the sale of $1 million principal amount of its 8% Senior Secured Convertible Debentures due 2013 (the "Debentures") in an initial closing of its private offering of up to $1.75 million principal amount of Debentures.

TapImmune Inc. (OTCBB: TPIV) filed an SEC form 8-K, Regulation FD Disclosure which quietly revealed that an investigative new drug application ("IND") for a Phase I clinical trial on a set of Her2/neu breast cancer antigens that the company has the exclusive option to license after Phase I studies has been filed.

TheDirectory.com, Inc. (PINKSHEETS: EYSM) today reported record operating results for the first six months of 2011.

University General Health System, Inc. (OTCQB: UGHS) (PINKSHEETS: UGHS), a diversified, integrated, multi-specialty health care provider, today reported its audited financial results for the years ended December 31, 2010 and December 31, 2009, which were filed on Form 8-K/A with the Securities and Exchange Commission on June 14, 2011.

World Health Energy Holdings, Inc. (OTCQB: WHEN) (PINKSHEETS: WHEN), a public holding company focused on Algae tech and Algae-Biodiesel turnkey projects for the production of biodiesel and fish food for commercial fish farms, announced today that the company signed an engagement letter with Millennium Capital Resources (MCR) LLC to raise up to $100 million in working capital through non-equity financing.



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