|J&J and Pfizer Halt Alzheimer’s Drug Studies; ViroPharma Receives FDA Approval of Cinryze®|
|By Staff and Wire Reports|
|Monday, 06 August 2012 18:56|
Johnson & Johnson (NYSE:JNJ) said it would halt studies of its Alzheimer’s drug bapineuzumab after the drug failed to meet the company’s goals. J&J subsidiary Janssen Alzheimer Immunotherapy has been developing the drug with Pfizer (PFE). Shares of both companies were down between 1% and 2%. Eli Lilly (NYSE:LLY), which is also developing an Alzheimer’s drug, was down 2.1%.
“While we are disappointed in the results of the two bapineuzumab IV studies, particularly in light of the urgent need for new advancements in Alzheimer’s disease, we believe that targeting and clearing beta amyloid remains a promising path to potential clinical benefits for people suffering from this disease,” said Husseini K. Manji, M.D., Global Therapeutic Area Head for Neuroscience, Janssen Research & Development, LLC.
The companies had already halted one of the studies a couple of weeks ago, but had agreed to continue other studies of the drug.
ViroPharma Incorporated (Nasdaq: VPHM) announced the U.S. FDA has approved the supplement to the Cinryze Biologics License Application (BLA) for industrial scale manufacturing changes. As previously announced, the company expects completion of labeling for previously produced vials to take approximately six weeks before entering into the trade.
The company also announced that it expects to release its financial results for the second quarter of 2012 on Thursday, August 9, 2012 before the open of the U.S. financial markets.
The company will host a conference call and live audio webcast at 9:00 a.m. Eastern Time on the same day. During the conference call, ViroPharma management will discuss the 2012 second quarter financial results and other business.
"We believe the approval of our supplement for industrial scale manufacturing now enables us to ensure Cinryze is available to any patient who chooses prophylaxis against their attacks of hereditary angioedema," stated Dan Soland, ViroPharma's chief operating officer.
Continued Soland, "With the addition of the industrial scale process to our current production, we believe we now have the means to ensure the market is fully served and build adequate safety stock levels. We also believe we have flexibility to increase our production even further through additional shifts should the need arise."
AeroGrow International, Inc. (PINKSHEETS: AERO) ("AeroGrow" or the "Company"), makers of the AeroGarden® line of indoor gardening products, will host a conference call on Friday, August 10, 2012, to review operational results for the quarter ended June 30, 2012.
BioLargo, Inc. (OTCBB: BLGO) announced today that former Smith & Nephew Vice President of Innovation (and Vice President at Smith & Nephew Wound Management) Tanya Rhodes has joined the BioLargo management team as a senior strategy advisor.
Bion Environmental Technologies, Inc. (OTC BB/QB: BNET) announced today that it was notified that its Canadian patent application 2503166 entitled "Low Oxygen Biologically Mediated Nutrient Removal" has been approved.
Saladax Biomedical, Inc., a privately held company developing and commercializing novel diagnostic assays to achieve the promise of personalized medicine for new and existing therapeutics, announced today the company has expanded its existing relationship with Bristol-Myers Squibb Company (NYSE: BMY) by entering into a Master Early Development Collaboration Agreement, which may include multiple feasibility studies and companion diagnostic development projects.
Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today announced that it would hold a conference call to discuss second quarter 2012 results at 11:00 a.m. ET on Tuesday, August 14, 2012.
CompuMed, Inc. (PINKSHEETS: CMPD) (www.compumed.net), a medical informatics and telemedicine services company, has secured a contract extension to provide its signature CardioGram™ electrocardiogram (ECG) remote interpretation system and over-read services for the Oklahoma Department of Corrections (OKDOC).
Cytomedix, Inc. (OTCBB: CMXI) (OTCQB: CMXI) (the "Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies for wound and tissue repair, today announced that the Centers for Medicare & Medicaid Services ("CMS") has issued a final National Coverage Determination ("NCD") for autologous blood-derived products for chronic non-healing wounds.
CytoSorbents Corporation (OTCBB: CTSO), a pioneer in the use of blood purification to treat life-threatening illnesses such as sepsis, trauma, burn injury, lung injury and pancreatitis, announced that the Defense Advanced Research Projects Agency, or DARPA, has awarded the Company a technology development contract worth up to $3.8 million as part of its Dialysis-Like Therapeutics (DLT) program to treat sepsis, pending satisfactory achievement of key milestones.
EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that Mark B. Knudson, Ph.D., President and Chief Executive Officer, is scheduled to present at the 32nd Annual Canaccord Genuity Growth Conference on Wednesday, August 15, 2012 at 8:30 pm Eastern Time, at the InterContinental Hotel, Boston, MA.
Luminex Corporation (NASDAQ: LMNX) announced today that Public Health Wales is using Luminex's CE marked xTAG Gastrointestinal Pathogen Panel (GPP) for outbreak investigation activities during Olympic and Paralympic training and events taking place in Wales.
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 the Company has raised over $4.9 million through the exercise of Callable Warrants issued in conjunction with the October 2010 Private Placement.
MMRGlobal, Inc. (OTCBB: MMRF) ("MMR") today called attention to the annual National Physicians Survey showing that fax remains the predominant form of communication for 63% of healthcare providers. MMRGlobal owns numerous worldwide patents encompassing hundreds of claims for the use of fax in Health IT.
Neogen Corporation (Nasdaq: NEOG) has developed the quickest and easiest test to definitively detect Listeria.
NeoGenomics, Inc. (NASDAQ: OTCBB: NGNM), a leading provider of cancer-focused genetic testing services, announced today that it has validated and launched the first molecular assay for clinical use in the United States that detects mutations in the SF3B1 gene (splicing factor 3b, subunit 1).
Response Biomedical Corp. (TSX:RBM) (OTCBB:RPBIF) will release its second quarter financial results for the period ending June 30, 2012 after markets close on Tuesday, August 7, 2012.