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Daily Dose: HEB Sued, INFI On High, CTIX Makes Headlines, NVO's Sweet News


A securities fraud class action lawsuit has been filed against Hemispherx Biopharma Inc. (HEB) by Rosen Law Firm, which alleges that the company issued false and misleading information about its lead drug candidate Ampligen.

Last week, when Ampligen - the company's experimental drug for chronic fatigue syndrome, faced review before an FDA panel, the members voted 8 to 5 against recommending the drug's approval.

Specifically on the question if Ampligen's safety had been adequately assessed and characterized for the treatment of chronic fatigue syndrome, the panel members voted 9 NO, 4 YES with 1 abstention.

In the past 1 month alone, the shares have lost more than 63% and trade around $0.27.

AMAG Pharmaceuticals Inc. (AMAG) has sought expanded regulatory approval to offer its anemia drug, Feraheme, as treatment to all iron deficiency anemia patients who cannot take oral iron.

Currently Feraheme is approved by the FDA as a treatment of iron deficiency anemia only in adult patients with chronic kidney disease.

The company has submitted a supplemental new drug application to the FDA based on data from two well-controlled phase III clinical trials of more than 1,400 patients.

Once touted as a blockbuster, Feraheme, which was approved in June 2009, raked in sales of $16.48 million in the year it was approved, $59.97 million in 2010 and $52.8 million in 2011. In the nine months ended Sep.30, 2012, Feraheme sales totaled $44 million, up from $39.9 million in the comparable period last year.

Infinity Pharmaceuticals Inc. (INFI) continues to retain worldwide development and commercialization rights for its PI3K-delta, gamma program under the amended development and license agreement with Millennium: The Takeda Oncology Company and Takeda Pharmaceutical Company Ltd. that was signed on Monday.

Shares touched a new 52-week high of $34.14 in intraday trading Monday before closing at $34.08.

Aegerion Pharmaceuticals Inc. (AEGR) has won the FDA approval for its lead drug Lomitapide as an adjunct to a low-fat diet and other lipid-lowering treatments for Homozygous Familial Hypercholesterolemia.

Homozygous Familial Hypercholesterolemia, or HoFH, results in an accumulation of low-density lipoprotein, often referred to as bad cholesterol in the blood.

The drug, which will be known by the brand name Juxtapid, contains a Boxed Warning citing the risk of hepatic toxicity, and is available only through a restricted program called the Juxtapid Risk Evaluation and Mitigation Strategy, or REMS, Program.

Cellceutix Corp. (CTIX.OB) rose to an all-time high of $2.29 in intraday trading on Monday before closing 18% higher at $2.22, following the company CEO's comments about an article in New York Times, which heralds p53 drugs as the new age in cancer research.

While expressing happiness on the publication of the article titled Genetic Gamble; New Approaches to Fighting Cancer", which focuses on the key protein p53, often referred to as the "Guardian Angel Gene," and initiatives by Merck & Co., Roche Holding Ltd., and Sanofi SA, Cellceutix CEO Leo Ehrlich said he was disappointed since his company was not mentioned in the article. However, he added that the article was likely written before Cellceutix's clinical trials began.

Cellceutix's flagship p53 compound, Kevetrin, is currently in phase 1 trials at Harvard's Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center.

Here's what Ehrlich said, "It is true that Roche has had Nutlins in clinical trials for years, but has faced ongoing challenges. Our data shows that Kevetrin is non-genotoxic, meaning that it does not damage surrounding normal DNA. The New York Times may have overlooked Cellceutix and Kevetrin, but the organizations that are contacting us to host and sponsor clinical trials certainly have not."

Danish pharmaceutical company Novo Nordisk (NVO) announced Tuesday that its 'new generation' insulin product - Ryzodeg, has been approved by the Japanese Ministry of Health, Labour and Welfare for the treatment of diabetes.
In Japan, Ryzodeg will be available in FlexTouch, Novo Nordisk's latest prefilled insulin pen, which has an easy auto-injector mechanism, and in Penfill for Novo Nordisk's durable insulin pens.

On November 8, 2012, Ryzodeg along with another 'new generation' insulin product, Tresiba won the FDA panel backing for the treatment of diabetes in the U.S.

by RTTNews Staff Writer

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