FDA boosts HGSI, hammers Mela. International Stem Cell up on product launch. Anthera puts study on hold Print E-mail
By BioMedReports.com Staff   
Tuesday, 16 November 2010 19:33


Below is a look at some of the headlines for companies that made news in the healthcare sector on November 16, 2010.

Human Genome Sciences, Inc. (Nasdaq: HGSI) and GlaxoSmithKline PLC (NYSE:GSK) today received a recommendation by an FDA panel for the approval of BENLYSTA for the treatment of lupus. The committee of 15 voted 13-2 in favor of the drug despite concerns such as suicide and infection. The advisory panel's vote does not guarantee an FDA approval although the agency usually follows the advisors recommendations. If the experimental drug is ultimately approved, sales could surpass $2 billion by 2014. A decision is scheduled for December 9th and would be the first treatment available for lupus since 1958. Shares of HGSI were halted all day while the panel convened, in extended trading shares opened and traded as high as $30.10 before settling at $28.60, up $2.72 or 10.51%.

Meanwhile, shares of MELA Sciences, Inc. (NASDAQ:MELA) were hammered after an FDA staff review team sited many concerns with the companies experimental device for the diagnoses of skin cancer. The agency’s' team said the device, MelaFind, has not been studied adequately and could put patients at risk. The FDA review is suggesting a new clinical trial; something analysts said could hurt the company going forward. An FDA advisory panel is set to meet Thursday to vote whether the FDA should approve the device or not. On volume of more than 12 million shares, MELA fell $3.45, more than 54% to $2.92. Shares have been as high as $12.24 over the past year.

Shares of International Stem Cell Corporation (OTCBB:ISCO.ob) jumped more than 12% after the company announced today the commercial launch of its innovative line of topical skin care products by the company’s' wholly-owned subsidiary, Lifeline Skin Care. Containing extracts from human "parthenogenetic" stem cells (hpSC), the products were formulated by a team of ISCO’s research scientists in collaboration with cosmetic formulation experts to create an advanced scientific approach to skin care. The patent pending serums, which come in separate formulations for day and night time use, have been safety tested by highly regarded, independent laboratories, and have been shown to promote anti-aging of the skin.

On heavy volume, shares of ISCO gained 18 cents to $1.59.

Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH) shares came under pressure today after the company announced that it notified the US Food and Drug Administration that the company has placed a voluntary hold on PEARL-SC, the Phase 2b study of A-623 for the treatment of Systemic Lupus Erythematosus (lupus), due to problems found with product vials. The company was recently notified by a single clinical investigator that a number of vials of clinical product had experienced "cracking". After a preliminary inspection of selected product inventory at the site and at a product storage facility the company determined Monday evening that the single site finding was not an isolated problem. As a result of these findings, patient enrollment in the PEARL-SC study was immediately suspended and patients currently enrolled in the study will discontinue dosing while the company conducts a complete analysis of the problem. There have been no reports of patient-related side effects or problems with drug administration that could be attributed to this problem and to date; no serious adverse events (or SAEs) have been reported to the company in the PEARL-SC trial.

Shares fell to an intra-day low of $5.17 before finishing the day down 45 cents or 7.35% to $5.67.

Also Tuesday:



Amarillo Biosciences, Inc. (ABI) (OTCBB: AMAR) today announced that it has signed a supply agreement with Zydus Cadila, the fifth largest pharmaceutical company in India, with projected worldwide sales of $1 billion in fiscal year 2010 and $3 billion in 2015.

The Amergence Group (PINKSHEETS: AMNG), a company that focuses on developing, nurturing, and rapidly expanding selected emerging or disruptive companies across a wide range of industries and disciplines, announced today that its subsidiary, Altitude Organic Licensing Corporation(AO), plans to immediately target expansion into Arizona.

Aoxing Pharmaceutical (NYSE Amex: AXN) a specialty pharmaceutical company focusing on research, development, manufacturing and distribution of narcotic and pain-management products, today announced financial and operational results for the three month period ended September 30, 2010, or the first quarter of fiscal year 2011.

Astro-Med, Inc. (NASDAQ: ALOT) reports Net Sales of $18,329,000 and Net Income of $792,000, equal to 11 cents per diluted share for the Third Quarter ended October 30, 2010.

AVANIR Pharmaceuticals, Inc. (Nasdaq:AVNR) today announced that it intends to offer and sell shares of its common stock in an underwritten public offering.

Celsius Holdings, Inc. (NASDAQ: CELH), the creator and marketer of Celsius®, Your Ultimate Fitness Partner™, today announced that the company received a letter from The NASDAQ Stock Market indicating that the company is not in compliance with a NASDAQ listing rule, which requires a minimum stockholders' equity of $2.5 million for continued listing.

China Biologic Products, Inc. (Nasdaq:CBPO) one of the leading plasma-based biopharmaceutical companies in the People's Republic of China ("PRC"), operating through its indirect majority-owned subsidiaries, Shandong Taibang Biological Products Co., Ltd. ("Shandong Taibang") and Guiyang Dalin Biologic Technologies Co., Ltd. ("Dalin"), and its equity investment in Xi'an Huitian Blood Products Co., Ltd. ("Huitian"), today reported financial results for the third quarter ended September 30, 2010.

First China Pharmaceutical Group, Inc. (OTCBB: FCPG) is pleased to announce it has recently entered into agreements to distribute a full spectrum of medicinal and pharmaceutical products to five district hospitals in Yunnan Province.

Hard to Treat Diseases (PINK SHEETS:HTDS) and Slavica Bio Chem operating subsidiary are delighted to report that IBISS research group after 8 months and 5 levels of competitions passed to the semi-final level of more than 250 competitors for the annual Award "Best technological innovation in Serbia in the year 2010" announced by Serbian Ministry of Science and Technological Development.

Imagenetix, Inc. (OTC Bulletin Board:IAGX) announced today results for the three and six months ended September 30, 2010.

Medisafe 1 Technologies Corp. (OTCBB: MFTH), a developer of patented technologies that physically prevent unauthorized administration of prescription medications, announced today that the company has been invited to hold an official demonstration of its barcoded syringe locking-device at Israel's National Ministry of Health on November 29.

Nile Therapeutics, Inc. (Nasdaq:NLTX), a company focused on the development of novel therapeutics for heart failure patients, today announced that Joshua Kazam, Chief Executive Officer, will present at the Maxim Group Growth Conference on Thursday, November 18, 2010 at 10:30 a.m. EST at the Grand Hyatt Hotel in New York City, New York.

NuVim, Inc. (PINKSHEETS: NUVM) a leading provider of nutritional refrigerated and shelf stable ready to drink beverages and powder mixes announced today that United States Media Television, Inc. will produce and air 60-second commercials for the NuVim powder mix products.

Palatin Technologies, Inc. (NYSE Amex:PTN) today announced the appointment of Jeffrey D. Edelson, M.D., as Chief Medical Officer.

Radient Pharmaceuticals Corporation (RPC) (NYSE Amex: RPC) announced today it has filed a Notification of Late Filing under Rule 12b‐25 of the Securities Exchange Act of 1934, as amended, with the Securities and Exchange Commission for its Quarterly Report on Form 10-Q for the third quarter ended September 30, 2010.

RightSmile, Inc. (PINKSHEETS: RIGH) the leader in Cosmetic Laser Teeth Whitening, announces effective Wednesday, November 17th, 2010, RightSmile's trading symbol will be revised to RIGHD for a 20-day period.

Stellar Pharmaceuticals Inc. (OTCBB:SLXCF) a Canadian pharmaceutical developer and marketer of high quality, cost-effective products for select health care markets, today provided an update on of one of its lead products, Uracyst® (a sterile sodium chondroitin sulfate solution, 2%) for the treatment of interstitial cystitis/painful bladder syndrome ("IC/PBS").

Vicor Technologies, Inc. (OTCBB: VCRT), today announced the election of two new directors and re-election of an existing director to the Company's Board at the Company's annual shareholder meeting on November 4, 2010.

UV Flu Technologies, Inc. (OTCBB:UVFT) announced today that the Company is expanding its focus within the Hospitality industry to newly identified areas suffering from serious health concerns for both customers and employees alike.

"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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