@ BioWorld, Islet Sciences' subsidiary receives $2.1 million in grant funding (ISLT)

Islet Sciences, Inc. (OTCBB: ISLT) is a development-stage biotechnology company with patented technologies focused on transplantation therapy for people with insulin-dependent diabetes. The Company's transplantation technology includes methods for the culturing, isolation, maturation, and immuno-protection (microencapsulation) of islet cells. Islet Sciences’ mission includes the introduction of commercial products with applications to cell-based replacement therapy in the healthcare marketplace.

Islet Sciences was mentioned in the "Other News to Note" section of BioWorld Today, the daily biopharmaceutical news source:

"Islet Sciences Inc., of New York, said subsidiary DiaKine Therapeutics Inc. received a $2. 1 million in grant funding, comprising about $1 .83 million from the National Institutes of Health and $250,000 from the Iacocca Foundation to support its work in diabetes. Islet acquired DiaKine in a stock deal last month."

About BioWorld

BioWorld Today delivers actionable intelligence on the biotech science that drives the business, which funds the means to heal disease. With writers and editors stationed around the globe, BioWorld Today reports the breaking news -- and provides key perspective -- on hundreds of medicines in development, the companies behind those therapeutic candidates, the business development transactions that evolve the market, and the regulatory hurdles that both challenge and guard the process. Read more at BioWorld.com.

Thursday's Bio-Pharma Drug Approval And Catalyst Event List @ Seeking Alpha (VTUS)

Ventrus Biosciences (NASDAQ: VTUS) is a development stage specialty pharmaceutical company focused on the development of late-stage prescription drugs for gastrointestinal disorders, specifically hemorrhoids, anal fissures and fecal incontinence. There are approximately 12.5 million Americans suffering from hemorrhoids, 7 million from fecal incontinence and over 4 million from anal fissures.

At Seeking Alpha, contributor Scott Matusow wrote an article about catalyst trades in the biopharma sector, which "can provide big profits if traded correctly. Some traders and investors who enjoy bringing more risk into play often times will hold through the catalyst event. While this does bring a lot more risk into play, the reward from engaging in this can be a massive one."

Matusow lists a handful of biopharma companies with near-term catalyst events associated with them, and includes their drug approval dates. About Ventrus Biosciences, one of the companies listed, he writes,

"Ventrus Biosciences (VTUS) 5/2/12 pps: $9.11/ Market cap: $113.02M - Ventrus focuses on the development and commercialization of late-stage prescription drugs for gastrointestinal disorders, primarily hemorrhoidal disease, anal fissures, and fecal incontinence.

Catalyst event: Phase 3 data due by May 15th, 2012 from Phase 3 European trial of VEN 307 (diltiazem cream) for Anal fissures."

Read the full article at SeekingAlpha.com.

REGISTRATION OPEN for MD Becker Partners' 3rd Annual "Cancer Immunotherapy: A Long-Awaited Reality" Conference

Registration is now open for MD Becker Partners' 3rd annual “Cancer Immunotherapy: A Long Awaited Reality” conference event in New York.  

This unique, single-day conference event unites founding visionary researchers, clinicians, business leaders, key investors, and other stakeholders to engage in discussions, exchange information, highlight opportunities, and showcase leading companies in the field of cancer immunotherapy. It will be held on Thursday, October 4, 2012, at the New York Academy of Medicine. 

JMP Securities, Cantor Fitzgerald and Roth Capital Partners return as event sponsors. 

To register or present, and for more information, please go to the Conference Website. 

Pluristem Awarded a $3.1 Million Grant by Israeli Government (PSTI)

Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR) is a leading developer of placenta-based cell therapies. The company's patented PLX (PLacental eXpanded) cells drug delivery platform releases a cocktail of therapeutic proteins in response to a variety of local and systemic inflammatory diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an off-the-shelf product that requires no tissue matching or immune-suppression treatment prior to administration. PLX-PAD comprehensive clinical development plan has been recognized by both the EMA and FDA, targeting a sub-population of 20-million patients of Peripheral Artery Disease (PAD) market. 

The company announced that its wholly owned subsidiary, Pluristem Ltd., has been approved for a 11.8 million New Israeli Shekels (approximately $3.1 million) grant from the Office of the Chief Scientist (OCS) within the Israeli Ministry of Industry, Trade and Labor. The grant, once received, "will be used to cover R&D expenses for the period March to December 2012. According to the OCS grant terms, Pluristem Ltd. is required to pay royalties in the rate of 3% - 5% on sales of products and services derived from technology developed using this and other OCS grants until 100% of the dollar-linked grants amount plus interest are repaid. In the absence of such sales, no payment is required."

The OCS was empowered by the Law for the Encouragement of Industrial Research & Development -- 1984. It "oversees all Government sponsored support of R&D in the Israeli hi-tech and bio-tech industries. This broad-spectrum support stimulates the development of innovative state-of-the-art technologies, enhances the competitive power of the industry in the global hi-tech market, creates employment opportunities and assists in improving Israel's balance of payments."

Chairman and CEO of Pluristem Zami Aberman stated,

"We are pleased Pluristem's PLX cells were recognized as an innovative state-of-the-art technology with a potential to create long term sustainable competitive advantage in the cell therapy industry. This grant will assist the company in enhancing its R&D plans and clinical trials, helping us bring the PLX product candidates to market for the treatment of millions of patients around the world." 

Read more at Yahoo Finance. 

Listing of Upcoming Meetings from FDA Live - 4/30/2012

FDALive is the World's Leading Source for FDA Broadcasting. Below is the list of upcoming meetings, current as of April 30, 2012:

Pediatric AdComm

Meeting Date: 5/7/12-5/8/12  

Agenda: On May 7, 2012, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, for Differin Lotion (adapalene), Dulera Inhalation Aerosol (mometasone furoate and formot...

 

Arthritis AdComm

Meeting Date: 5/8/12-5/8/12  

The committee will discuss supplemental biologics license application 125249, ARCALYST (rilonacept) injection, Regeneron Pharmaceuticals, Inc., for the following proposed indication: "ARCALYST (rilonacept) is an interleukin-1 blocker indicated for the prevention of gout flares during initiation o...

 

Arthritis AdComm

Meeting Date: 5/9/12-5/9/12  

The committee will discuss new drug application (NDA) 203214, tofacitinib tablets, Pfizer Inc., for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs....

Antiviral Drugs AdComm

Meeting Date: 5/10/12-5/10/12  

The committee will discuss an efficacy supplement for new drug application (NDA) 21-572, TRUVADA (emtricitabine/tenofovir disoproxil fumarate) Tablet, submitted by Gilead Sciences, Inc. The supplemental application proposes an indication for Pre-Exposure Prophylaxis (PrEP) to reduce the risk...

Endocrinologic and Metabolic Drugs AdComm

Meeting Date: 5/10/12-5/10/12  

The committee will discuss the safety and efficacy of new drug application (NDA) 22–529 (lorcaserin hydrochloride) tablets, manufactured by Arena Pharmaceuticals, Inc., as an adjunct to diet and exercise for weight management in patients with a body mass index (BMI) equal to or greater than ...

 

Gastroenterology and Urology Devices Panel of the Medical Devices AdComm

Meeting Date: 5/10/12-5/11/12  

On May 10 and 11, 2012, the committee will discuss general issues related to medical devices intended for obese patients. The committee will provide recommendations regarding trial design for clinical studies to evaluate the safety and effectiveness of weight loss devices placed either endoscopic...

 

Antiviral Drugs AdComm

Meeting Date: 5/11/12-5/11/12  

The committee will discuss new drug application (NDA) 203-100, for a fixeddose combination tablet of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate, submitted by Gilead Sciences, Inc. The application proposes an indication for the treatment of HIV-1 infection in adults who ar...

Cardiovascular and Renal Drugs AdComm

Meeting Date: 5/23/12-5/23/12  

On May 23, 2012, the Committee will discuss supplemental new drug application (sNDA) 202439/S-002 XARELTO (rivaroxaban), submitted by Janssen Pharmaceuticals, Inc. to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS) [ST elevation myocardial infarctio...

 

Peripheral and Central Nervous System Drugs AdComm

Meeting Date: 5/24/12-5/24/12  

On May 24, 2012, the committee will discuss new drug application (NDA) 202737 for tafamidis meglumine capsules, proposed trade name VYNDAQEL, submitted by FoldRx Pharmaceuticals, Inc. a subsidiary of Pfizer, Inc. The proposed indication is for the treatment of transthyretin (TTR) familial amyloid po...

Circulatory System Devices Panel of the Medical Devices AdComm

Meeting Date: 5/24/12-5/24/12  

On May 24, 2012, the committee will discuss current knowledge about the safety and effectiveness of the AMPLATZER ASO Device & Gore HELEX ASD Occluder as transcatheter Atrial Septal Defect (ASD) occluders used for the closure of secundum atrial septal defects. The AMPLATZER Septal Occluder (ASO) ...

 

Assessment of Analgesic Treatment of Chronic Pain--A Public Workshop

Meeting Date: 5/30/12-5/31/12  

The purpose of the meeting is to provide a forum to discuss the available data on the use of analgesics in the treatment of CNCP, beginning with a discussion of the underlying mechanisms of chronic pain and the epidemiology of chronic pain in the United States. Next, data on the efficacy of opioi...

 

Gastrointestinal Drugs AdComm

Meeting Date: 5/31/12-5/31/12  

The committee will discuss new drug application (NDA) 200-436, synthetic human secretin, sponsored by Repligen Corporation, proposed for use with magnetic resonance imaging (MRI) to improve pancreatic duct visualization for the detection of duct abnormalities to enhance clinical decision making i...

 

Circulatory System Devices Panel of the Medical Devices AdComm

Meeting Date: 6/13/12-6/13/12  

On June 13, 2012, the committee will discuss, make recommendations and vote on information related to the premarket approval application for the Edwards SAPIEN Transcatheter Heart Valve sponsored by Edwards Lifesciences. The Edwards SAPIEN Transcatheter Heart Valve is indicated for use in patient...

Oncologic Drugs AdComm

Meeting Date: 6/20/12-6/20/12  

On June 20, 2012, during the morning session, the committee will discuss new drug application (NDA) 203213, with the established name semuloparin sodium injection, application submitted by sanofi-aventis U.S. LLC. The proposed indication (use) for this product is for the prophylaxis of venous thr...

General and Plastic Surgery Devices Panel of the Medical Devices AdComm

Meeting Date: 6/21/12-6/21/12  

On June 21, 2012, the committee will discuss, make recommendations, and vote on information related to the premarket approval application, sponsored by Dune Medical Devices, Inc., for the MarginProbe System, that utilizes electromagnetic waves to characterize human tissue in real time and provide...

Read more at http://www.fdalive.com/index.cfm 

  

37th Annual Health Care Conference May 7 - 9, 2012 at the InterContinental Boston

The 37th Annual Health Care Conference will take place May 7 - 9, 2012 at the InterContinental Boston. The conference is hosted by Deutsche Bank Securities.

Senior executives from over 150 of the health care industry's most prestigious public and private companies will make presentations with updates on their businesses.

The health care industry will be broadly represented from the product and services side, including:

• Biotechnology
• Health Care Facilities
• Health Care Technology & Distribution
• Managed Care 
• Medical Supplies & Devices
• Life Science Tools & Diagnostics
• Pharmaceuticals/Major
• Pharmaceuticals/Specialty

Each public company will host a 35 minutes presentation and will be available for one-on-one and group meetings throughout the conference. Private companies will be available for one-on-one and group meetings only. 

Agenda highlights include special keynote speakers and thoughtleader workshop series.

Location:

InterContinental Boston

510 Atlantic Avenue

Boston, MA 02210

tel. +1(617)747-1000      

fax. +1(617)217-5190

For more information, go to http://conferences.db.com/americas/healthcare12/

TONIX Pharmaceuticals to Present at Three Investor Conferences in May $TNXP

Tonix Pharmaceuticals Holding Corp. (OTCBB:TNXP) (“TONIX”), a specialty pharmaceutical company developing therapies for challenging disorders of the central nervous system (“CNS”), will be presenting at the following three conferences during the month of May:

• New York Biotechnology Association (“NYBA”) 21^st Annual Meeting, Corporate Showcase
  May 2, 2012 at 2:00 PM (EDT) in New York City

• Wall Street 1-2-1 Conference
  May 9, 2012 in Orlando, Florida (meetings throughout day)

• Security Research Association (“SRA”) Spring Growth Conference
  May 15, 2012 at 2:00 PM (PDT, tentative scheduled time) in San Francisco

TONIX’s management team will provide an overview of the company and discuss the clinical development of its lead product candidates in development for the treatment of fibromyalgia and post-traumatic stress disorder and TONIX’s business strategy. Management’s presentations at the NYBA Corporate Showcase and SRA Conference will be webcast live and can be accessed through the company’s website using the following link:

http://ir.stockpr.com/tonixpharma/presentations

Members of the investment community who are interested in meeting with management during these conferences are encouraged to call Sharon Weinstein at 212-564-4700 to schedule a meeting.

ABOUT TONIX

TONIX Pharmaceuticals is developing new therapies for challenging disorders of the central nervous system. The Company targets conditions characterized by significant unmet medical need, inadequate existing treatment options, and high dissatisfaction among both patients and physicians. TONIX reformulates approved pharmaceutical active ingredients to design products with optimal safety, efficacy and predictability. Its most advanced product candidates, TNX-102 for FM and TNX-105 for PTSD, are novel dosage formulation of cyclobenzaprine, the active ingredient in two U.S. FDA-approved muscle relaxants. To learn more about the Company and its pipeline of treatments for CNS conditions, please visit www.tonixpharma.com.

Rodman & Renshaw on Celgene Corp: CELG Misses 1Q EPS, But The Thesis Remains Intact (CELG)

Celgene Corporation (NASDAQ:CELG), headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation.  

Rodman & Renshaw has released a company update on Celgene Corp, assigning it an "Outperform" rating with Moderate Risk and a target price of $102. 

Analyst Michael G. King, Jr. writes that "despite the disappointing 1Q results, we maintain our Market Outperform rating and our YE2012 Price Target of $102. We continue to view CELG as our top-large cap pick in the large-cap biotechnology space. We remain bullish on the company’s products and management’s ability to execute. Despite the shortfall, we believe fundamentals remain intact, and would be buyers on weakness. In addition, the Celgene story is replete with milestones for the remainder of 2012. Based on our DCF valuation (utilizing an 11.5% discount rate), we derived a valuation of $102 leading to our price target. Using our standardized CAGR valuation model we arrived at a valuation $110."

Read the full report here.