Lilly Says New Study of Cialis Met Primary Endpoint; Hospira Issues Response on FDA Plant Inspection Print E-mail
By Staff and Wire Reports   
Monday, 18 March 2013 19:26
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 18, 2013.

Eli Lilly and Company (NYSE: LLY)
presented results at the annual European Association of Urology (EAU) Congress in Milan, Italy, of a study that showed Cialis 5 mg once daily co-administered with finasteride significantly improved scores on the International Prostate Symptom Score (IPSS), compared to placebo/finasteride, in men with lower urinary tract symptoms of benign prostatic hyperplasia (LUTS/BPH) and enlarged prostates. On a pre-specified secondary measure, Cialis/finasteride also improved erectile function scores versus placebo/finasteride in those men who had both LUTS/BPH and erectile dysfunction (ED) at baseline.

This is the first study to report co-administration of Cialis and finasteride in men with LUTS/BPH. Cialis is a phosphodiesterase type 5 inhibitor approved by the Food and Drug Administration (FDA) for the signs and symptoms of BPH and both ED and the signs and symptoms of BPH (ED+BPH). Finasteride is a type II 5alpha-reductase inhibitor (5-ARI) approved by the FDA for the treatment of BPH in men with an enlarged prostate.


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Hospira, Inc. (NYSE: HSP)
commented on the U.S. FDA re-inspection of the company's Rocky Mount, N.C., facility and the Form 483 (483) detailing the associated observations. Additional information regarding the inspection was included in Hospira's Form 8-K filing on March 5, 2013.

"Hospira has been working diligently on quality improvement and remediation efforts to reinforce our foundation and position the company for growth," said Hospira chief executive officer F. Michael Ball. "We have made good progress at Rocky Mount and believe that we have met to date the commitments that we have outlined to the FDA. While there is still work to be done, we intend to continue to work with the FDA to balance the advancement of our remediation and modernization efforts while continuing to deliver patient-critical products."

Hospira takes each observation seriously and has worked closely with its consultants to collectively analyze the 483. Hospira is encouraged that a number of the observations are related to remediation efforts currently underway or issues that had been self-identified, and are slated to be addressed in the latter part of the plant's remediation and modernization plans.

Additionally, based on the initial assessment of the 483 by Hospira and its consultants, the company continues to believe in the safety and efficacy of its products and is not anticipating any significant impact to its marketed products.

Hospira is in the process of sharing its response plan and associated corrective actions with the FDA.



Also Monday:



Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY)
, a leading RNAi therapeutics company, announced today that it has initiated dosing in its Phase I clinical trial with ALN-TTRsc, an RNAi therapeutic targeting transthyretin (TTR) for the treatment of TTR-mediated amyloidosis (ATTR). ATTR is caused by mutations in the TTR gene which cause abnormal amyloid protein deposits to accumulate in various tissues including peripheral nerves and heart, resulting in neuropathy and/or cardiomyopathy.

ALR Technologies (OTCBB: ALRT)
began the second phase of its commercial launch in the United States with the release of a detailed marketing video demonstrating the potential value to employers of improved diabetes care management including reduced healthcare costs, greater employee satisfaction and improved workplace safety.

Amarantus BioScience, Inc. (OTCQB: AMBS)
, a biotechnology company discovering and developing treatments and diagnostics for diseases associated with neurodegeneration and apoptosis centered around its patented therapeutic protein Mesencephalic Astrocyte Neurotrophic Factor (MANF), has appointed Mark Benedyk, Ph.D., to its Board of Directors.

AmbiCom Holdings, Inc. (OTCQB: ABHI)
, a leading designer and developer of wireless products for the medical and automotive industries, and a distributor of innovative healthcare products, today announced that they have received an additional $1.2 million order for their WL54-CF CompactFlash product to be used in a major company's glucose meter products.

Anavex Life Sciences Corp. (OTCQB: AVXL)
today commented on the United States Food and Drug Administration's (FDA) plan to expedite the approval of new treatments for Alzheimer's disease.

BGI-Shenzhen ("BGI"), a leading international genomics organization based in Shenzhen, China, today announced that through its wholly-owned subsidiary, Beta Acquisition Corporation, it has successfully completed the acquisition of Complete Genomics, Inc. (formerly NASDAQ: GNOM) ("Complete"), an innovative leader in accurate whole human genomic sequencing.

BioDelivery Sciences International, Inc. (NASDAQ: BDSI)
announced that it has filed its Annual Report on Form 10-K for the year ended December 31, 2012 with the U.S. Securities and Exchange Commission and, in connection therewith, is providing a review of BDSI's 2012 achievements and an update on business operations and upcoming milestones for 2013.

BioMed Realty Trust, Inc. (NYSE: BMR)
today announced that its board of directors has declared a first quarter 2013 dividend of $0.235 per share of common stock, The dividend is equivalent to an annualized dividend of $0.94 per common share.

Bio-Rad Laboratories, Inc. (NYSE: BIO)
and (NYSE: BIO.B), a multinational manufacturer and distributor of life science research and clinical diagnostics products, announced today the filing of its annual report on Form 10-K for the year ended December 31, 2012.

Celsion Corporation (NASDAQ: CLSN)
, a leading oncology drug development company, today announced financial results for the year ended December 31, 2012, and provided an update on its clinical trials of ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin.

Connectyx Technologies Holdings Group, Inc. (OTC Pink: CTYX)
, www.connectyx.com, a Healthcare Business Process Outsourcing (BPO) company with personal healthcare product offerings, announced today that LogicMark, the manufacturer of Guardian Alert, Freedom Alert and Life Sentry Personal Emergency Response Systems (P.E.R.S.), will be offering exclusively to its national dealer network a private label version of Fonemed Nurse Assist Powered by MedFlash.

Cytomedix, Inc. (OTCQX: CMXI)
, a leading developer of biologically active regenerative therapies, today reported financial results for the three and twelve months ended December 31, 2012.

Immunotech Laboratories, Inc. (PINKSHEETS: IMMB)
today announced the company has begun discussions with a professional medical consulting group to start the process for Pre-IND (Investigational New Drug) application in the USA.

MiMedx Group, Inc.  (OTCBB: MDXG)
, an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that MiMedx management has received a number of inquiries regarding trading activity in its shares late last week and the resultant drop in the trading price for the Company's common stock.

MMRGlobal, Inc. (OTCQB: MMRF)
Chairman and CEO Robert H. Lorsch, returning from the 2013 HIMSS Conference in New Orleans, March 3-7, said that patents and patients are clearly the stars of health IT going into Stage 2 of Meaningful Use.

Northwest Biotherapeutics (NASDAQ: NWBO)
, a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that it has been issued a key U.S. patent (#8389278) covering novel processes for manufacturing human dendritic cells.

Omeros Corporation (NASDAQ: OMER)
, a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products targeting inflammation, coagulopathies and disorders of the central nervous system, today announced financial results for the fourth quarter and year ended December 31, 2012.

OncoSec Medical Inc. (OTCBB: ONCS)
, a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumor cancers, announced Dr. Adil Daud, chair of OncoSec's Melanoma Advisory Board, will present at the HemOnc Today Melanoma and Cutaneous Malignancies Meeting at the Hilton New York Hotel on Friday, March 22 at 2:25 PM ET.

OrganovoHoldings, Inc. (OTCQX: ONVO)
("Organovo"), a three-dimensional biology company focused on delivering breakthrough 3D bioprinting technology, has reported on its financial results for the year ended December 31, 2012.

Patient Safety Technologies, Inc. (OTCBB:PSTX, OTCQB:PSTX)
today announced results for its fourth quarter and fiscal year ended December 31st, 2012.

Pernix Therapeutics Holdings, Inc. (NASDAQ: PTX)
, a specialty pharmaceutical company, today announced financial results for the fourth quarter and year ended December 31, 2012.

Quest Diagnostics (NYSE: DGX)
, the world's leading provider of diagnostic information services, today announced the availability of the first clinical test panel for aiding the diagnosis of suspected dementia due to treatable forms of cognitive impairment.

Santarus, Inc. (NASDAQ: SNTS)
today announced that results from its CORE II clinical study, one of two of the company’s pivotal Phase III clinical studies with UCERIS™ (budesonide) extended release tablets in patients with ulcerative colitis, have been published online in the peer-reviewed journal Gut.

Stevia First Corp. (OTCQB: STVF)
, an early-stage agribusiness based in California's Central Valley growing region and focused on the industrial scale production of stevia, the all-natural zero-calorie sweetener that is rapidly transforming the food and beverage industry, is pleased to announce that the USDA's IR-4 Program has committed support for stevia trials of the herbicide "clethodim," an important herbicide used in conventional agriculture throughout the United States.

ULURU Inc. (OTCQB: ULUR)
today provided a business update and outlook for the balance of 2013.

Verenium Corporation (Nasdaq: VRNM)
, a leading industrial biotechnology company focused on the development and commercialization of high-performance enzymes,today announced that it will release fourth quarter and year end 2012 financial results on Wednesday, March 27, 2013 after market close.

WPCS International Incorporated (NASDAQ: WPCS)
, a leader in design-build engineering services for communications infrastructure, today announced financial results for the fiscal year 2013 third quarter ended January 31, 2013.



"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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