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ACT Comments on U.S. Appeals’ Court’s Dismissal Ruling in Case Challenging Federal Funding of Embryonic Stem Cell …

Posted: Published on August 28th, 2012

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. (ACT)(ACTC), a leader in the field of regenerative medicine, today issued a statement on the U.S. Appeals Courts ruling, upholding a lower courts dismissal of the case, Sherley v. Sebelius, 11-5241, U.S. Court of Appeals for the District of Columbia Circuit (Washington), on the permissibility of federal funding of embryonic stem cell research. This court ruling should be of considerable benefit to ACT and our embryonic stem cell-based clinical programs, commented Gary Rabin, chairman and CEO. It effectively removes major speed bumps for the National Institutes of Health (NIH) in terms of approving the several stem cell lines that we have submitted for their consideration for funding. With Fridays decisive ruling, we expect that a number of our embryonic stem cell lines will be approved for funding in coming months. Sherley v. Sebelius had sought to block the United States Health and Human Services Department and the NIH from spending federal funds for research with hESCs, contending that doing so would violate the Dickey-Wicker Amendment, a short rider attached to legislation passed in 1996. This ruling removes a great deal of the ambiguity that has hampered legislative attempts to provide an efficient mechanism … Continue reading →

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Neuralstem Completes Phase I ALS Stem Cell Trial

Posted: Published on August 28th, 2012

ROCKVILLE, Md., Aug. 27, 2012 /PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR) announced the completion of the Phase I trial of its NSI-566 spinal cord neural stem cells for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), with the eighteenth patient treated. This patient, the third to return to the trial for an additional set of injections, is also the last in the Phase I portion of the trial as it is currently designed, which is scheduled to conclude six months after this final surgery. (Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO ) "We are delighted to have completed Phase I in this groundbreaking trial, the first approved by the FDA to test neural stem cells in patients with ALS," said Karl Johe, PhD, Chairman of Neuralstem's Board of Directors and Chief Scientific Officer. "There have been many firsts in this trial, including the first lumbar intraspinal injections, the first cervical region intraspinal injections, and the first cohort of patients to receive both," said Jonathan D. Glass, MD, Director of the Emory ALS Center. "This has required incredible effort from the Emory medical and support team and I wish to express my thanks to all of them, as well as to acknowledge … Continue reading →

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AMERICA STEM CELL, INC. Initiates a Phase I/II Trial of ASC-101 in Patients with Hematologic Malignancies Undergoing …

Posted: Published on August 28th, 2012

SAN ANTONIO--(BUSINESS WIRE)-- America Stem Cell, Inc. announced today the initiation of a single-center study at The University of Texas MD Anderson Cancer Center evaluating ASC-101 in dual-umbilical cord transplantation in patients with hematologic malignancies. There is a significant unmet medical need to improve stem cell engraftment into bone marrow for patients undergoing umbilical cord transplantation, and America Stem Cell is committed to filling that need, said Dr. Linda Paradiso, Chief Development Officer at America Stem Cell. ASC-101 is a novel enzyme treatment that will potentially transform hematopoietic stem cell transplantation by accelerating patient immune system and platelet recovery, reducing opportunistic infections and other co-morbidities, and improving patient survival. Enhancing umbilical cord stem cell engraftment into bone marrow in the dual cord transplant setting will improve clinical outcomes for patients with serious, life-threatening cancers and other disorders for which hematopoietic stem cell transplant is prescribed, said, Dr. Elizabeth Shpall, MD, Medical Director, Cell Therapy Laboratory and Director, Cord Blood Bank at M.D. Anderson Cancer Center and Principal Investigator on the ASC-101 Phase I/II clinical trial. The MD Anderson study has enrolled and dosed its first patient in this Phase I/II study designed to study the safety of ASC-101 in the … Continue reading →

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Study: Roche’s T-DM1 has fewer side effects, helps women with breast cancer live longer

Posted: Published on August 27th, 2012

ZURICH (Reuters) - Swiss drugmaker Roche Holding AG said its "armed antibody" T-DM1 drug significantly extended the lives of women with an aggressive type of breast cancer compared to those receiving the standard drug cocktail. Breast cancer, the most common cancer among women worldwide, will afflict about 1.4 million women worldwide and more than 450,000 women will die of the disease annually, according to the World Health Organization's International Agency for Research on Cancer. Roche said its Genentech unit will soon submit a marketing application to the European Medicines Agency for trastuzumab emtansine (T-DM1) and has already applied for a license with the U.S. Food and Drug Administration. Roche said the EMILIA study of the drug had now met both primary efficacy endpoints of significant improvements in overall survival and progression-free survival, adding it will present the data at an upcoming medical meeting. Roche, the world's largest maker of cancer drugs, has been developing T-DM1 as a successor to its blockbuster Herceptin, its third-biggest seller, which could be exposed to so-called "biosimilar" generic competition in Europe from around 2015. The trial for women with breast cancer known as HER-2 positive - which makes up about a fifth of all breast … Continue reading →

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pH-sensitive liposomal cisplatin improves peritoneal carcinomatosis treatment without side-effects

Posted: Published on August 27th, 2012

Public release date: 27-Aug-2012 [ | E-mail | Share ] Contact: Andrea Teixeira Carvalho atcteixeira@gmail.com Society for Experimental Biology and Medicine Scientists at the Oswaldo Cruz Foundation and Federal University of Minas Gerais, led by Dr. Andra Teixeira-Carvalho and Dr. Mnica Cristina de Oliveira, have developed and characterized a circulating and pH-sensitive liposome containing cisplatin (SpHL-CDDP) aiming to promote the release of cisplatin near the tumor as well as decreasing toxicity. The development of analog drugs and new formulations are current strategies for increasing the effectiveness and safety of cisplatin as an anti-peritoneal carcinomatosis drug. The results, which appear in the August 2012 issue of Experimental Biology and Medicine demonstrate that the treatment of initial or disseminated Ehrlich ascitic tumor-bearing Swiss mice with SpHL-CDDP improved the antitumor efficacy and decreased renal and bone marrow toxicity of cisplatin-based therapy. "Peritoneal carcinomatosis is a serious concern in the treatment of abdominal tumors such as hepatic, gastric and gynecological tumors", says Dr. Oliveira. "The strategy of local chemotherapy is interesting due to the possibility to increase the therapeutic efficacy while minimizing systemic side-effects. SpHL-CDDP treatment was able to reduce cancer cell proliferation and increase survival, in the animal model, with no known toxicity … Continue reading →

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Tops Holding Corporation Reports Net Income of $9.5 Million in Second Quarter 2012

Posted: Published on August 27th, 2012

WILLIAMSVILLE, N.Y.--(BUSINESS WIRE)-- Tops Holding Corporation (Tops or the Company), the parent of Tops Markets, LLC, a leading supermarket retailer with 125 corporate and 5 franchise locations serving Upstate New York and Northern Pennsylvania, today reported financial results for the second quarter of fiscal 2012 (12-week period ended July 14, 2012). This was a strong quarter for Tops, with improved margins, sharply higher profitability and strong cash generation," said Frank Curci, Tops President and CEO. "We are encouraged by our current trends and expect to build on this momentum throughout the remainder of the year as we continue promotional and marketing initiatives tailored to meet the shopping needs of our customers. On July 19, 2012, the Company announced an agreement with GU Markets LLC, an affiliate of C&S Wholesale Grocers, Inc., to acquire 21 supermarkets in Upstate New York and Vermont. The transaction is expected to close during the fall of 2012, and is subject to customary closing conditions. The acquisition is expected to be fundedusingcash on hand. Mr. Curci noted, We believe this transaction is a natural strategic complement to our current footprint, and given our successful integration of the former Penn Traffic supermarkets, we are confident in our … Continue reading →

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Pharmaceutical Supply Chain in the US – Advances in RFID and ePedigree Systems to Limit Drug Counterfeits

Posted: Published on August 27th, 2012

NEW YORK, Aug. 27, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue: http://www.reportlinker.com/p0922679/Pharmaceutical-Supply-Chain-in-the-US---Advances-in-RFID-and-ePedigree-Systems-to-Limit-Drug-Counterfeits.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Pharmaceutical Pharmaceutical Supply Chain in the US - Advances in RFID and ePedigree Systems to Limit Drug Counterfeits The top three wholesalers in the US, AmerisourceBergen Corporation, Cardinal Health and McKesson Corporation, accounted for 86.7% of the overall US pharmaceutical market in 2011 and combined revenue of $295.2 billion. Various supply chain models are followed across the pharmaceutical industry, such as traditional wholesaler models, limited distribution models and direct distribution models. Pharmaceutical companies are now focusing on supply chains as a value-adding process rather than viewing them as a money drain, which was the scenario in the past. Managing a supply chain is a complicated task, as there are a number of issues that can affect performance and disrupt product and information flow. Counterfeits have emerged as the greatest threat to the smooth functioning of the supply chain in the US. The recent case of fake Avastin entering the legitimate supply chain has raised concerns over administrative abilities, and the Food and Drug Administration (FDA) has taken numerous steps to track and trace counterfeits. The state of California has implemented … Continue reading →

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Drug testing on way for jobseekers

Posted: Published on August 27th, 2012

Paula Bennett Social Development Minister Paula Bennett announced today pre-employment drug testing would take effect from next July and beneficiaries with work expectations would face sanctions if they refused to apply for drug-tested jobs. Around 40 percent of the jobs listed with Work and Income require drug tests and the policy will apply only to those with a work expectation attached to their benefit and only for available work opportunities requiring drug tests. Currently an unemployment beneficiary can decline to apply for an available drug-tested job, because they won't pass the test, without consequence. Work and Income have announced they will reimburse employers for test failures but beneficiaries who fail a test will have the cost of the drug test deducted from their benefit. "Where people fail a drug test or refuse to apply for a drug tested job, they must agree to stop using drugs or their benefit will be cut by 50 percent. They will be given 30 days to allow any drugs they have taken to leave their system. "Where they fail a test or refuse a second time, they will have their benefit suspended until they agree that they will provide a 'clean' drug test within … Continue reading →

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Beneficiary drug testing plans unveiled

Posted: Published on August 27th, 2012

Experts will carry out "robust clinical assessments" to determine whether beneficiaries are recreational drug users or are drug addicts, under Government plans to screen job seekers. The Government today released details of its plans to drug test beneficiaries ahead of legislation being introduced to Parliament next month. The changes would come into effect next July. Social Development Minister Paula Bennett said about 40 per cent of the jobs listed at Work and Income required drug testing. "It's reasonable for employers to expect people to be drug free." Bennett said beneficiaries would face sanctions if they refused to apply for drug-tested jobs. Under the current system an unemployment beneficiary can decline without penalty to apply for an available drug-tested job because they won't pass the test. "Recreational drug use is simply not an acceptable excuse for avoiding available work. Thousands of working New Zealanders are in jobs requiring they be clean of drugs; it's reasonable to expect someone looking for work to do the same." Drug testing only applied to those with a work expectation attached to their benefit and only for jobs requiring drug tests. Those who failed tests would be given a warning and reasonable period of time to … Continue reading →

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Call for clot-buster drugs on ambulances

Posted: Published on August 27th, 2012

PARAMEDICS should carry clot-busting drugs to counteract life-threatening treatment delays for rural patients suffering serious heart attacks, experts say. MonashHeart emeritus director of cardiology Richard Harper said the drugs were important for rural Victorians who were a long distance from major hospitals and needed urgent treatment. Professor Harper said three-quarters of Victorians had access to hospitals that provided around-the-clock emergency angioplasty and stenting to re-open blocked arteries. But rural Victorians were a long way from such treatment, putting them at increased risk of death or long-term disability. Advertisement Professor Harper said Victoria should follow the lead of other states, including Queensland and New South Wales, where paramedics were trained to administer clot-busting drugs to rural and regional patients who faced delays accessing the preferred treatment in hospital. In such cases, he said, paramedics took an electrocardiogram to confirm the patient was experiencing the most serious type of heart attack in which the coronary artery was completely blocked, known as an ST-segment elevation myocardial infarction (STEMI) They then administered the drugs en route to hospital, greatly improving outcomes for patients. The Heart Foundation, which backed the call, said about 10,000 Australians died each year from a STEMI heart attack. An audit … Continue reading →

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