For the past 10 years The World’s Most Famous Arena has been transformed to host the most dangerous 8 seconds in sports. The top 35 professional bull riders in the world battle it out in the first PBR Major of 2016, the Monster Energy Buckoff at Madison Square Garden. Host Annamaria Stewart catches up with professional bull rider Ryan Dirteater, bullfighter Shorty Gorhman and stock contractor Jeff Robinson to learn more about the toughest sport on dirt, PBR.

PBR – Built Ford Tough Series Schedule: http://www.pbr.com/en/bfts/schedule.aspx
PBR at Madison Square Garden: www.thegarden.com

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Over the past few years the general public has become increasingly educated about the transgender community due to TV stars like Laverne Cox and Caitlyn Jenner talking openly about their experiences. Although the public is captivated by their stories, the arduous process that goes into a full transformation remains largely unknown. In this special report, host Annamaria Stewart (@AnnamariaChen) discusses the changing face of transgender surgery with world-renowned facial plastic surgeon Doctor Jeffrey Spiegel who’s specialty, facial feminization surgery, is changing the landscape for the transgender community. Join the conversation by using #transformingfaces

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Music: Infados by Kevin MacLeod is licensed under a Creative Commons Attribution license (https://creativecommons.org/licenses/…)
Source: http://incompetech.com/music/royalty-…
Artist: http://incompetech.com/

PETACH TIKVA, Israel, Nov. 23, 2015 /PRNewswire/ — Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (CFBI.TA), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory diseases, cancer, and sexual dysfunction, today announced development of its drug candidate CF102, which is currently in Phase II trials for hepatocellular carcinoma (HCC) the most common form of liver cancer, will be expanded into treatment for non-alcoholic steatohepatitis (NASH).

NASH is characterized by excess fat in the liver along with inflammation and liver damage. It resembles alcoholic liver disease; however, it occurs in people who drink little or no alcohol. If untreated, NASH can lead to cirrhosis and liver cancer. According to the National Institutes of Health, NASH affects between 2% and 5% of Americans and the prevalence of NASH has been increasing, potentially due to increasing rates of obesity and diabetes. By 2025, Deutsche Bank estimates the addressable pharmaceutical market for NASH will reach $35-40 billion in size. As of today, while there are several companies developing drugs to treat NASH that are in preclinical and clinical development, no specific U.S. Food and Drug Administration (FDA) approved treatment for NASH exists.

“Results from our recently concluded preclinical study of CF102 in liver disease revealed compelling data. Based on these findings, we’ve filed a patent for CF102 in the treatment of NASH,” stated Can-Fite CEO Dr. Pnina Fishman. “Because the prevalence of NASH continues to grow and no treatment currently exists, our data support the development of CF102 for the treatment of NASH.”

CF102 revealed its capability to improve liver pathology in a NAFLD (non-alcoholic fatty liver disease)/diabetes animal model of NASH. The data showed:

CF102 had a statistically significant reduction in NAFLD activity score compared to placebo.
CF102 reduced liver-to-body weight compared to placebo.
Representative photomicrographs of H&E-stained liver sections showed improved pathology in animals receiving CF102 vs. placebo.
CF102 decreased plasma ALT and triglycerides levels in the livers of NASH-model compared to placebo.
Liver sections from the placebo group exhibited severe micro- and macrovesicular fat deposits, hepatocellular ballooning and inflammatory cell infiltration, whereas the CF102 treated group showed a significant decrease in steatosis, ballooning and lobular inflammation compared to the placebo group.
In prior preclinical studies, CF102 has shown efficacy in the treatment of liver regeneration and function following liver surgery.

Can-Fite currently has a U.S. Investigational New Drug (IND) application active with the U.S. FDA for CF102. CF102 is currently being evaluated as a second-line treatment for HCC through a global Phase II trial. Can-Fite has received Orphan Drugs Designation for CF102 for this indication in Europe and the U.S., as well as Fast Track Status in the U.S. Data from the Phase II HCC study is expected in 2016.

JERUSALEM, Nov. 30, 2015 /PRNewswire/ — Oramed Pharmaceuticals Inc. (ORMP), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today it has signed definitive licensing and investment agreements valued at up to $50,000,000 with Hefei Tianhui Incubator of Technologies Co., Ltd. (“HTIT”) for exclusive rights to market Oramed’s oral insulin capsule, ORMD-0801, in China, Hong Kong and Macau. The agreements were signed at the Israel Knesset (Parliament).

The license agreement payments include a $3 million payment due upon execution of the agreement, $8 million in near-term payments subject to Oramed entering into certain agreements and the balance payable upon achievement of certain milestones. In addition, if all conditions are met, HTIT will pay a 10% royalty on net sales of the related commercialized products.

In addition to the contemplated payments under the license agreement, pursuant to the investment agreement, Oramed will issue to HTIT 1,155,469 restricted shares of Oramed’s common stock at a price per share of approximately $10.39 and $12 million in total, subject to customary closing conditions.

“China recently became the country with the largest number of diabetics in the world. Having signed these definitive license and investment agreements, our oral insulin capsule could help serve the growing population of people in China living with diabetes,” stated Oramed’s CEO Nadav Kidron. “In addition to the $50 million in milestone payments and investments, we believe the royalties on net sales throughout China will have a very significant impact on Oramed’s future revenues and earnings, upon market approval of ORMD-0801 in China.”

About Hefei

HTIT, which is partially owned by Sinopharm Group Company Limited, has state of the art insulin production facilities in Hefei, China. HTIT has a business focus which includes industrial investment and incubation services; high-tech product R&D; technology transfer and related consulting services.

HAIFA, Israel, Dec. 03, 2015 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (PSTI) (PSTI), a leading developer of placenta-based cell therapy products, today announced that it has signed a Memorandum of Understanding (MOU) for a collaboration with Fukushima Medical University, Fukushima Global Medical Science Center. The purpose of the collaboration is to develop Pluristem’s PLX-R18 cells for the treatment of Acute Radiation Syndrome (ARS), and for morbidities following radiotherapy in cancer patients.

ARS is caused by exposure to dangerously high levels of radiation, such as could occur in a nuclear catastrophe, and incorporates potentially lethal damage to the gastrointestinal tract, lung, skin and bone marrow, as well as other systems. In this new collaboration PLX-R18 cells will be studied primarily as a potential treatment for radiation-induced damage to the skin, lungs and gastrointestinal tract. The parties intend to develop preclinical models of radiation damage in these tissues, and then use them in trials. Pluristem will contribute PLX-R18 cells and scientific knowledge, while Fukushima Medical University will conduct the studies, and provide the required resources.

The collaboration will proceed alongside research supported by the U.S. National Institutes of Health (NIH), which is studying PLX-R18 as a potential treatment for the hematologic component of ARS. Insufficient blood cell production by the bone marrow, which may be caused by various reasons including ARS and cancer treatments, can be life threatening because it may lead to hemorrhage, the inability to fight infection, and anemia.

Data from a preclinical study, published in the peer-reviewed scientific journal PLOS One, suggest that PLX-R18 cells, administered intramuscularly, may be a highly effective off-the-shelf therapy for bone marrow failure following total body exposure to high doses of radiation. The work with Fukushima Medical University, Fukushima Global Medical Science Center will further evaluate the efficacy of intramuscular administration for systemic treatment of ARS.

“The researchers at Fukushima have a strong interest in cell therapies that may offer a treatment for conditions caused by exposure to ionizing radiation. We are honored to work with the thought leaders in the field at Fukushima Medical University, Fukushima Global Medical Science Center to further develop PLX-R18 for ARS-related indications,” stated Pluristem CEO Zami Aberman.

“We anticipate that our work with Fukushima Medical University, Fukushima Global Medical Science Center will help to maintain the health of those involved in decommissioning the Fukushima reactors; the decommissioning process is estimated to take about 40 years. We hope that this collaboration can advance efforts to safeguard populations around the world from illness related to radiation exposure,” concluded Mr. Aberman.

You can now experience 40 years of SNL, the longest running comedy program in U.S. history, in its first ever full-scale exhibition on 5th Avenue, just blocks from the legendary Studio 8H. Saturday Night Live: The Exhibition not only showcases the history of the iconic program, but it gives fans a behind the scenes look at the hectic week that goes into every episode, chronicling the 6-day creative process from start to finish. The interactive exhibition allows visitors to jump into SNL sets from Jeopardy, Wayne’s World, and Weekend Update while surrounded by original props and costumes from the show. Host Annamaria Stewart sits down with Creative Director Mark Lach on a full-scale recreation of Studio 8H to learn what went into creating Saturday Night Live: The Exhibition.

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www.snltheexhibition.com
Saturday Night Live: The Exhibition
417 5th Ave
New York, NY 10016

VIENNA, Va.–(BUSINESS WIRE)–

CEL-SCI Corporation (NYSE MKT: CVM) (“CEL SCI” or the “Company”) today announced that its investigational LEAPS rheumatoid arthritis vaccine candidate has been accepted for a new program of technology commercialization and niche analysis managed by Foresight Science & Technology for the U.S. National Institutes of Health (NIH). CEL-SCI’s selection into this commercialization program, including market entry strategy and launch tactics, is an extension of the Phase I Small Business Innovation Research (SBIR) grant in the amount of $225,000 awarded to CEL-SCI in July 2014 from the NIH’s National Institute of Arthritis Muscoskeletal and Skin Diseases (NIAMS).

Only a select number of SBIR recipients are additionally awarded the commercialization and launch niche analysis program, which will examine the market in depth for the LEAPS rheumatoid arthritis vaccine. This analysis will include interviews with experts and end-users, recommendations for a market entry, launch tactics and revenue projections. According to Visiongain, the world rheumatoid arthritis drug market will generate revenues of $38.5 billion in 2017.

“As we advance the clinical development program for our LEAPS rheumatoid arthritis vaccine, we are very pleased that the NIH has recognized the potential market value of this product. We believe the commercialization and program niche analysis will be of value to CEL-SCI as we apply for a Phase II SBIR grant to continue to support our efforts of bringing LEAPS into human clinical trials,” stated Daniel Zimmerman, Ph.D., Senior Vice President Research and Development, Cellular Immunology.

ROCKVILLE, Md., Nov. 05, 2015 (GLOBE NEWSWIRE) — Rexahn Pharmaceuticals, Inc. (RNN), a clinical stage biopharmaceutical company developing next generation therapeutics for the treatment of cancer, announced today that interim clinical data from an ongoing Phase IIa study of its novel anti-cancer drug candidate, Archexin®, will be presented on Friday, November 6, 2015 at the 14th International Kidney Cancer Symposium in Miami, Florida.

“We are excited to present interim data from the ongoing Phase IIa clinical trial showing that Archexin, in combination with everolimus (Afinitor®), appears to be safe and well tolerated at the doses tested to date. We have also noted early evidence of clinical activity at low doses in patients with metastatic kidney cancer,” commented Peter D. Suzdak, Chief Executive Officer. “We look forward to completing the randomized, open-label, 2-arm dose expansion study of Archexin in combination with everolimus versus everolimus alone in order to further evaluate Archexin in metastatic renal cell carcinoma.”

CAESAREA, Israel, Nov. 11, 2015 /PRNewswire/ — LabStyle Innovations Corp. (DRIO), developer of the Dario™ Diabetes Management Solution, announced today that it has signed an exclusive distribution agreement with one of India’s leading pharmaceutical and medical device networks, Centaur Pharmaceuticals Pvt. Ltd. As one of India’s top ranked healthcare companies, Centaur’s network includes a sales force of 1,000 covering 250,000 doctors and 250,000 retailers.

“We are proud to partner with Centaur, a company that leads the market in bringing improvements and innovation to the health system in India. They are the perfect partner to bring the Dario™ blood glucose monitoring system to the market in India to help the millions of people with diabetes to self-manage and improve their health,” said LabStyle Innovations’ President and Chief Executive Officer Erez Raphael.

According to the International Diabetes Federation (IDF) diabetes is growing to epidemic proportions in India, with over 66.8 million people diagnosed. The prevalence of diabetes in the general population is 8.6%, with some regions reported to have up to 20% prevalence.

“Diabetes is the fastest growing epidemic across the region. In India it is a very challenging disease due to our large infrastructure and resource constraints. According to the IDF there is limited availability of much needed self-management education. The Dario Diabetes Management Solution is the perfect tool for the diabetes community in India. For the first time, Dario will enable self-management and education through digital and remote monitoring,” said Mr. S D Sawant, Chairman and Managing Director of Centaur. “We are enthusiastic about bringing the cutting-edge Dario™ platform to the Indian market to assist and improve the health and the quality of care.”

PETACH TIKVA, Israel, Sept. 17, 2015 /PRNewswire/ — Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (CFBI.TA), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, today announced the U.S. Food and Drug Administration (FDA) has granted the Company’s drug candidate CF102 Fast Track designation as a second line treatment for hepatocellular carcinoma (HCC), the most common form of liver cancer. CF102 had already received the FDA’s Orphan Drug designation.

Can-Fite is currently conducting a Phase II study for this indication in the U.S., Europe and Israel. The randomized, double blind, placebo controlled study is expected to complete enrollment by the end of the first half of 2016 in 78 patients with Child-Pugh Class B cirrhosis who failed the only FDA approved drug on the market, Nexavar® (sorafenib). Patients are treated twice daily with 25 mg of oral CF102, which has been found to be the most efficacious dose in Can-Fite’s earlier Phase I/II study resulting in the longest overall survival time, with excellent safety results.

Fast Track, aimed at getting important new drugs that meet an unmet need to patients earlier, is expected to expedite the development of CF102. Drugs that receive Fast Track designation benefit from more frequent meetings and communications with the FDA to review the drug’s development plan to support approval. It also allows the Company to submit parts of the New Drug Application (NDA) on a rolling basis for review as data becomes available. Since the Fast Track Program started, from March 1998 through June 30, 2015 a total of 318 Fast Track applications have been received by the FDA. The FDA has granted 202 of them, and denied 110, with 6 more pending.

“We are very pleased that the FDA recognizes the potential for CF102 to treat HCC patients who have tried, and not been responsive to Nexavar, the only FDA approved drug currently on the market for this indication,” stated Can-Fite CEO Dr. Pnina Fishman. “We consider Fast Track designation to be a major catalyst for our CF102 development program and we believe it could shorten our time to market for CF102, thereby making a considerable difference for patients.”

According to Global Industry Analysts, the global market for liver cancer drugs is projected to exceed $2 billion in 2015. Nexavar® annual sales, as reported by Bayer, were €773 million in 2014.