FDA review sends HGSI shares reeling. Pozen receives $25 million milestone payment Print E-mail
By BioMedReports.com Staff   
Friday, 12 November 2010 19:30

Below is a look at some of the headlines for companies that made news in the healthcare sector on November 12, 2010.

Shares of Human Genome Sciences, Inc. (Nasdaq:HGSI) were under pressure today after the FDA released it review notes for the companies' lead experimental drug, Benlysta. FDA scientists raised concerns over deaths in trials for the lupus treatment being developed by Human Genome Sciences and GlaxoSmithKline. The report, cited risks including "infection, malignancy, suicidality, and overall number of deaths." 15 patiant deaths occured in study of more than 2,000 people, including two suicides. The agency questioned whether the safety record was worth the risk "in light of the marginal efficacy observed". In heavy trading, shares of HGSI fell $2.88 or 10.88% to $23.60.

Shares of POZEN Inc. (NASDAQ:POZN) moved higher today after the company announced that AstraZeneca has reported that marketing and pricing approval for VIMOVO 500/20 mg modified-release tablets, has been granted in the United Kingdom. VIMOVO is indicated for the symptomatic treatment of osteoarthritis (OA), rheumatoid arthritis (RA), and ankylosing spondylitis (AS) in patients who are at risk for developing non-steroidal anti-inflammatory drug (NSAID)-associated gastric and/or duodenal ulcers. Under the terms of its agreement with AstraZeneca, POZEN will receive a $25 million milestone payment within 20 days. As a result of the payment, the Company is confirming its 2010 year-end guidance will be net income of $21 to $23 million. Additionally, the Company's year-end cash guidance is anticipated to be $63 to $65 million. Shares of Pozen gained 9 cents to $6.71.

Also Friday:

Bacterin International Holdings, Inc. (OTC Bulletin Board:BIHI), today announced that it is scheduled to present at the upcoming 3rd annual LD MICRO conference on Thursday, December 9, 2010, at 10:30a.m.(PST) at the Luxe Sunset Bel Air, Los Angeles, California.

Scientists from Biodel Inc. (Nasdaq:BIOD) reported new findings from the company's Linjeta™, insulin glargine, "smart" basal insulin and stabilized glucagon development programs in poster presentations yesterday and today at the Tenth Annual Diabetes Technology Meeting in Bethesda, MD.

Daxor Corporation, (NYSE Amex: DXR), a medical instrumentation and biotechnology company, today announced earnings for the third quarter of 2010. The Company had net income of $0.62 per share for the current quarter versus net income of $0.62 per share for the same period in 2009.

ERT (Nasdaq:ERES), announced today that Dr. Michael J. McKelvey, the Company's President and CEO, is scheduled to present at Lazard Capital Markets' 7th Annual Healthcare Conference at 10:55 AM EST on November 16, 2010 in New York City, New York.

Hiru Corporation (PINK SHEETS:HIRU) is considering a merger with a Canada-based health products compa

Hypertension Diagnostics, Inc. (OTCBB: HDII) today announced financial results for the first quarter of fiscal year 2011 ("Q1 2011") ended September 30, 2010.

Integrated Management Information, Inc. (IMI Global) (OTCBB: INMG), a leading provider of verification and Internet solutions for the agricultural/livestock industry under the Where Food Comes From® brand, today announced a correction to its weighted average outstanding share count for the third quarter and nine-month period that lifted third quarter earnings per share to $0.01.

MedEx, Inc. (PINKSHEETS:MDXX) announced that it would be attending the largest Durable Medical Equipment conference of the year being held at the Georgia World Congress Center in Atlanta, Georgia.Management has opted to not participate as an exhibitor this year, instead choosing to focus its time and efforts meeting with a number of targeted acquisition candidates.

MMRGlobal, Inc. (OTCBB: MMRF) (www.mmrglobal.com) today announced that it has successfully revived five U.S. biotech patent applications, bringing the Company closer to its goal of patent protection for all its B-cell vaccine and anti-CD20 antibody related intellectual property acquired during the Company's reverse merger with Favrill

Neurologix, Inc. (OTC Bulletin Board:NRGX), a biotechnology company developing innovative gene therapies for the brain and central nervous system ("CNS"), today reported its financial results for the three and nine months ended September 30, 2010.

NeoStem, Inc. (NYSE Amex:NBS) an international biopharmaceutical company with product and service revenues, global research and development capabilities and operations in three distinct business units, U.S. adult stem cells, China adult stem cells, and China pharmaceuticals, today provided results of its third quarter 2010.

Nile Therapeutics, Inc. (Nasdaq:NLTX), a company focused on the development of novel therapeutics for therapeutics for cardiovascular disease, today announced its third quarter financial results for 2010.

Palatin Technologies, Inc. (NYSE Amex:PTN) will announce its first quarter, fiscal year 2011 financial results on Tuesday, November 16, 2010 before the open of the U.S. financial markets.

Regenicin, Inc. (OTC Bulletin Board:RGIN) a biotechnology company specializing in the development of regenerative cell therapies to restore the health of damaged tissues and organs, will be represented by company CEO, Randall McCoy at the 1st Annual LifeTech Investor Conference at the JW Marriott Marquis today in Miami.

Soligenix, Inc. (OTC Bulletin Board:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company, announced today its financial results for the third quarter of 2010.

Transgenomic, Inc. (OTC Bulletin Board:TBIO) today announced that it has been awarded a research and development grant totaling $1,070,453.32 from the U.S. government under HR: 3590 – Patient Protection and Affordable Care Act in immediately available funds.

Vycor Medical, Inc. (OTCBB: VYCO) a medical device company that designs, develops and markets next generation neurosurgery retraction devices, today announced the entry into a purchase agreement to acquire the assets of NovaVision, Inc., including its German subsidiary, NovaVision AG (together "NovaVision") for an aggregate purchase price of $900,000.

WuXi PharmaTech (Cayman) Inc. (NYSE:WX) today announced shareholder resolutions adopted at its annual general meeting of shareholders held in Hong Kong on November 10, 2010.

Ziegler (PINKSHEETS: ZGCO), a specialty investment banking firm serving healthcare, senior living, religion and education sectors, announced the promotion of Angelique David to the role of general counsel and corporate secretary.



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