Merck and FDA to Review Sugammadex Sodium Injection; Navidea's NAV4694 β-Amyloid Imaging Agent to Be Used in Alzheimer's Studies Print E-mail
By Staff and Wire Reports   
Tuesday, 16 July 2013 18:59

Below is a look at some of the headlines for companies that made news in the healthcare sector on July 16, 2013. Merck (NYSE: MRK), known as MSD outside the United States and Canada, confirmed the U.S. FDA has cancelled Thursday's discussion of sugammadex at the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC). Sugammadex sodium injection is Merck's investigational medicine for the reversal of neuromuscular blockade (NMB) induced by rocuronium or vecuronium.

The FDA advised Merck that the agency needs additional time to assess the results of the FDA's recently completed inspection of a clinical trial site. The site was one of four sites that conducted the hypersensitivity study previously requested by the agency. Merck is engaged in discussions with the FDA to identify the steps necessary to enable the agency to complete its review.

“Merck believes that sugammadex is an important treatment option for an unmet medical need in anesthesia, and we will work with the FDA on the next steps to bring this innovation forward to patients in the United States,” said David Michelson, M.D., head of global clinical development for neuroscience, Merck Research Laboratories.

Sugammadex is marketed in 40 countries other than the U.S., and more than five million vials of sugammadex have been sold as of March 2013.

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Navidea Biopharmaceuticals, Inc. (NYSE: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced the Australian Imaging, Biomarker & Lifestyle Flagship Study of Ageing (AIBL) plans to switch to using Navidea's Fluorine-18 labeled β-amyloid imaging candidate, NAV4694, from 11C-labeled Pittsburgh Compound-B (PiB) for its comprehensive research initiative in Alzheimer's disease and Mild Cognitive Impairment. Dr. Christopher C. Rowe, MD FRACP, Director of the Department of Nuclear Medicine and Centre for PET at Austin Health, Melbourne, Australia, announced the changeover to NAV4694 at the World Wide Alzheimer's Disease Neuroimaging Initiative meeting in Boston, MA.

AIBL, a globally renowned, multi-disciplinary effort to investigate factors impacting the development of Alzheimer's disease across Australia, has previously employed the widely-recognized PiB compound in its research. PiB is the PET imaging agent prototype for β-amyloid detection, and remains an accepted benchmark standard for studies investigating Alzheimer's disease and differential diagnoses of dementia. Recently published results from a head-to-head study funded by AstraZeneca that directly compared PiB to NAV4694 demonstrated that NAV4694 displayed imaging characteristics nearly identical to those of PiB.1

“Recent updates to appropriate use criteria allow for earlier diagnosis and therapeutic intervention in the diagnosis of probable Alzheimer's disease, and we believe β-amyloid PET imaging will play an increasingly important role for clinicians investigating this disease,” said Dr. Rowe, lead author on the head-to-head study. “As the accepted benchmark β-amyloid imaging agent, PiB has an excellent performance profile, but issues around timing, logistics and costs make its routine use challenging. A β-amyloid imaging agent that is accessible and affordable and that can be reliably interpreted in a variety of clinical settings would be most pragmatic. Our studies with NAV4694 show that it mirrors the performance of PiB, and that we can therefore confidently make this changeover and begin using NAV4694 in our research.”

“The team at AIBL is recognized as a world leader in neurodegenerative disease and imaging diagnostics, and we are honored that they have selected NAV4694 as a β-amyloid standard for their research,” said Thomas H. Tulip, PhD, President and Chief Business Officer of Navidea. “We are pleased to support AIBL's work in advancing research and knowledge about the development and diagnosis of Alzheimer's disease, with the mutual goal of providing physicians with an improved diagnostic tool having outstanding performance characteristics that can aid in the diagnosis of Alzheimer's disease and other forms of neurodegenerative dementia.”


Also Tuesday:

Advaxis, Inc., (OTCQB: ADXS and ADXSD), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced the appointment of David Sidransky, MD to its Board of Directors.

CAS Medical Systems, Inc. (Nasdaq:CASM), a maker of medical devices for non-invasive patient monitoring, announced today it intends to offer, subject to market and other conditions, shares of its common stock in an underwritten public offering.

Healthcare Services Group, Inc. (Nasdaq:HCSG) reported that revenues for the three months ended June 30, 2013 increased over 2% to $273,604,000 compared to $267,108,000 for the same 2012 period.

Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today reported the issuance of U.S. Patent 8,486,395 with expiration on August 2, 2024.

Life Technologies Corporation (NASDAQ: LIFE) today announced that the company has signed  an agreement to collaborate with Merck Serono, a division of Merck KGaA, Darmstadt, Germany, for current and future companion diagnostics projects.

Masimo (NASDAQ: MASI)
announced today that it will release second quarter 2013 financial results for the period ended June 29, 2013, after the market closes on Wednesday, July 31, 2013.

NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced details today relating to its second quarter 2013 earnings announcement, which will take place on Tuesday, July 30, 2013, after the close of the market.

Nuvilex, Inc. (OTCQB: NVLX), an international biotechnology company and provider of natural products and cell and gene therapy solutions for the treatment of diseases, announces it has returned 100 million shares of its issued and outstanding common stock that had been held in escrow to the Company's treasury after completing the $1.5M cash acquisition of all of the shares of Bio Blue Bird AG ("BBB"), the former subsidiary of SG Austria Private Limited (SG Austria).

Taglich Brothers, Inc. announces that it has initiated coverage of PositiveID Corporation (OTCBB: PSID).

RadNet Inc. (Nasdaq: RDNT), a national leader in providing high-quality, cost-effective, fixed-site outpatient diagnostic imaging services through a network of 248 subsidiary-owned and/or operated outpatient imaging centers, announced its participation in a clinical trial to evaluate the biomarker effects of the investigational drug E2609, a BACE inhibitor, which is being developed for the potential disease modifying treatment of Alzheimer's disease (AD).

SIGA Technologies, Inc. (Nasdaq:SIGA) today announced it has passed another significant commercial milestone with the third delivery of its proprietary smallpox antiviral drug, Arestvyr™, to the United States Government's Strategic National Stockpile (SNS).

Titan Medical Inc. (TSX VENTURE:TMD) (OTCQX:TITXF) announced today that it has retained Raymond James & Associates, Inc. ("Raymond James") to provide financial advisory services to the Company in connection with its evaluation of strategic alternatives with a view to enhancing shareholder value.

VIVUS, Inc. (Nasdaq:VVUS)
, a pharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs in obesity and sexual health, today issued the following statement in connection with the Company's reconvened Annual Meeting of Stockholders, scheduled for July 18, 2013.

BUYINS.NET, leading provider of Regulation SHO compliance monitoring, short sale trading statistics and market integrity surveillance, has initiated coverage on Viratech Corp (OTC:VIRA) after releasing the latest short sale data through July 12, 2013.

Walgreens (NYSE: WAG) (Nasdaq: WAG)
has named Mark Lelinski as its new corporate vice president, market access.




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