Omeros Says FDA Has Agreed to Pediatric Study Plan for OMS302; Geron Data from Myelofibrosis IST to be Presented at ASH Oral Session Print E-mail
By Staff and Wire Reports   
Tuesday, 15 October 2013 19:03
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 15, 2013.

Omeros Corporation (NASDAQ: OMER) announced that the U.S. FDA confirmed its agreement with the Pediatric Study Plan (PSP) proposed by Omeros to study the use of OMS302 in pediatric patients undergoing primary cataract extraction. The FDA also issued a Written Request consistent with the PSP, which means that successful completion of the PSP would make OMS302 eligible for an additional six months of marketing exclusivity in the U.S. Added to standard irrigation solution used during ophthalmological procedures, OMS302 is Omeros' proprietary PharmacoSurgery^® product designed to maintain intraoperative mydriasis (pupil dilation), prevent surgically induced miosis (pupil constriction), and reduce postoperative pain resulting from cataract and other lens replacement surgery.

As announced in July, the European Medicines Agency approved Omeros' Pediatric Investigation Plan to study the use of OMS302 in pediatric patients, which is expected to lead to additional marketing exclusivity in Europe. Omeros has OMS302 marketing applications under review in the U.S. and Europe with anticipated market launch in 2014. Results of the pediatric studies are expected to be available during the post marketing period.


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In November 2012, Dr. Ayalew Tefferi at Mayo Clinic initiated an investigator-sponsored trial to evaluate the safety and efficacy of imetelstat in patients with myelofibrosis, and to determine an appropriate dose and schedule for further evaluation (the "Myelofibrosis IST").

Geron Corporation (NASDAQ: GERN)
has been informed by Dr. Tefferi that his abstract on preliminary data from the ongoing Myelofibrosis IST has been selected by the American Society of Hematology (ASH) Program Committee for presentation in an Oral Session at the 55th ASH Annual Meeting and Exposition in New Orleans, LA. The presentation is scheduled to occur during the Myeloproliferative Syndromes: Clinical: Novel Therapeutic Strategies session on Monday, December 9, 2013 at 4:45 p.m. local time.



Also Tuesday:



Aberdeen Group, a Harte-Hanks Company (NYSE: HHS), today announced the publication of four new research reports by Nick Castellina, Senior Research Analyst for its Business Planning and Execution research practice.

ARRAYit Corporation (OTCQB: ARYC)
is pleased to announce a non brokered financing with selected accredited investors at 30 cents with 50% warrant coverage at $0.45. Closing to be 10/18/13.

AtheroNova Inc. (OTCBB: AHRO)
, a biotech company focused on the research and development of compounds to safely regress atherosclerotic plaque and improve lipid profiles in humans, today announced that Erik SG Stroes, MD, Chair and Professor at the Department of Vascular Medicine at the Academic Medical Center (AMC), Amsterdam has joined the Company as a member of the Clinical Advisory Board.

BIOLASE, Inc. (NASDAQ: BIOL)
, the world's leading manufacturer and distributor of dental lasers, and a pioneer in laser surgery in other medical specialties, and Auris Surgical Robotics, Inc. ("Auris"), the developer of a robotic microsurgical system designed specifically for ophthalmic surgery, announced jointly today that they have signed a letter of commitment to develop a new product for ophthalmologists.

Can-Fite BioPharma Ltd. (TASE: CFBI), (OTCQB: CANFY)
, a biotechnology company developing a pipeline of small molecule drugs that address inflammatory and cancer diseases, announced today that Can-Fite's CF101 was selected as one of the "Top Autoimmune/Anti-Inflammatory Disease Projects to Watch" by Elsevier Business Intelligence, the publisher of In Vivo and The Pink Sheet, and a global leader in the field of healthcare industry information.

CEL-SCI Corporation (NYSE MKT: CVM)
today announced that it has signed a co-development and profit sharing agreement with Ergomed Clinical Research Ltd. for CEL-SCI’s investigational immunotherapy drug Multikine (“Leucocyte Interleukin Inj.”) in HIV/HPV co-infected women with cervical dysplasia.  

In a pain care skills training for military healthcare providers, technicians, policy makers and program managers in Portsmouth, Virginia, Competitive Technologies, Inc., (OTCQX: CTTC) was selected as one of the pain care training providers to our Nation's military personnel. CTI's flagship 510-K cleared and CE-marked medical device, Calmare® was highlighted as a promising pain management device of choice.

Cryo-Cell International, Inc. (OTCQB:CCEL)
, the world's first private cord blood bank to separate and store stem cells in 1992, today announced results for the fiscal third quarter ended August 31, 2013.

Cutera, Inc. (Nasdaq:CUTR)
, a leading provider of laser and other energy-based aesthetic systems for practitioners worldwide, will announce results for the third quarter ended September 30, 2013 on Monday, November 4, 2013, after market close.

eRAD, a subsidiary of RadNet, Inc. (Nasdaq:RDNT)
, a leading provider of standards-based, web-centric radiology image and data management solutions, announced today that Reno Diagnostic Centers (RDC) has implemented eRAD's teleradiology platform as part of its growth strategy.

Fusion-io (NYSE: FIO)
today announced ioControl Server Performance Extension (SPX), a new suite of ioControl hybrid storage solutions that amplify Fusion ioMemory server flash performance with intelligent server caching.

OXiGENE, Inc. (Nasdaq:OXGN)
, a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, announced that data from a preclinical study of ZYBRESTAT® (fosbretabulin tromethamine/combretastatin A-4 phosphate or CA4P) demonstrating antitumor activity in a model of pancreatic neuroendocrine tumors (PNETs) will be presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, being held in the Hynes Convention Center, Boston, MA, October 19-23, 2013.

OxySure Systems, Inc. (OTCQB: OXYS)
, a medical technology company that has pioneered an FDA-approved solution to produce medically pure oxygen from dry, inert powders for emergency and short duration use, today announced the launch of OxySure Commercial Finance(SM) , a service that allows OxySure customers to easily and conveniently lease OxySure's suite of medical devices and products, including the OxySure Model 615, Automated External Defibrillators (AEDs), and other medical equipment, supplies and accessories.

Portola Pharmaceuticals, Inc. (Nasdaq:PTLA
) announced today that Morgan Stanley & Co. LLC and Credit Suisse Securities (USA) LLC, the joint book-running managers in the Company's recent public sale of 9,686,171 shares of common stock, are releasing a lock-up restriction with respect to 95,962 shares of the Company's common stock held by a director of the Company.

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA)
today announced the Empowered Genome Community, which is a first-of-its-kind initiative to help people who have had their genomes sequenced share, explore, and interpret their data with researchers and each other.

Vycor Medical, Inc. (OTCBB: VYCO)
announced today its wholly-owned NovaVision subsidiary plans to launch a new "direct to the patient" saccadic eye training program to be marketed as NeuroEyeCoach™.



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