Monthly Archives: May 2012

Cell Therapeutics’ Pixuvri® Approved in European Union as Monotherapy to Treat Adult Patients with Multiply Relapsed …

Posted: Published on May 12th, 2012

SEATTLE, May 10, 2012 /PRNewswire/ -- Cell Therapeutics, Inc.("CTI") (CTIC) today announced that it has received conditional marketing authorization from the European Commission ("EC") for Pixuvri (pixantrone) as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas ("NHL"). Pixuvri is the first approved treatment in the European Union ("EU") in this patient setting. (Photo: http://photos.prnewswire.com/prnh/20120510/SF05192) The decision allows CTI to market Pixuvri in the 27 Member States of the EU as well as in Iceland, Liechtenstein and Norway. CTI expects to make Pixuvri immediately available in the EU, initially through a named patient program. CTI plans to market and commercialize Pixuvri with its own sales force in the EU starting in the 2nd half of 2012. "Pixuvri is a welcome addition in our efforts to control disease progression in these late-stage aggressive NHL patients as it has demonstrated a significant benefit compared to standard treatments used at this stage of disease. By addressing this unmet need, Pixuvri adds an important treatment option for patients," said Norbert Schmitz, M.D., Ph.D., Head of the Department of Hematology, Askelepios Klinik St. Georg in Hamburg, Germany. "The EC's decision for Pixuvri is an important milestone for adult … Continue reading →

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Cell Therapeutics' Pixuvri® Approved in European Union as Monotherapy to Treat Adult Patients with Multiply Relapsed …

Posted: Published on May 12th, 2012

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New England Journal of Medicine Reports on Three Phase III REVLIMID® (lenalidomide) Trials in Patients with Newly …

Posted: Published on May 12th, 2012

BOUDRY, Switzerland--(BUSINESS WIRE)-- Celgene International Srl, a subsidiary of Celgene Corporation (NASDAQ: CELG - News), today announced that results from three phase III studies evaluating the use of continuous REVLIMID (lenalidomide) treatment in newly diagnosed multiple myeloma (MM) patients or maintenance treatment with lenalidomide following autologous stem cell transplant were published online in the May 10, 2012 edition of the New England Journal of Medicine. All three publications highlight the expanding body of clinical evidence supporting lenalidomide treatment in these areas. Continuous Lenalidomide Therapy (non-transplant eligible population): The first article highlights a Celgene-sponsored study of continuous lenalidomide treatment in elderly patients newly diagnosed with multiple myeloma. Continuous Lenalidomide Treatment for Newly Diagnosed Multiple Myeloma (MM-015) This double-blind, phase III, multicenter, randomized study conducted by Celgene compared melphalanprednisonelenalidomide induction followed by lenalidomide maintenance (MPR-R), with melphalanprednisonelenalidomide (MPR), or melphalanprednisone (MP) followed by placebo in 459 patients aged 65 years with newly-diagnosed myeloma who were not eligible for autologous stem-cell transplant. http://www.nejm.org/doi/full/10.1056/NEJMoa1112704 Post-transplant maintenance The two additional articles published in the edition highlighted cooperative group studies that evaluated the use of lenalidomide maintenance following autologous stem cell transplant (ASCT). In each of the studies, one funded by the National Cancer Institute and … Continue reading →

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Opexa Therapeutics Reports First Quarter 2012 Financial Results and Provides Corporate Update

Posted: Published on May 12th, 2012

THE WOODLANDS, Texas--(BUSINESS WIRE)-- Opexa Therapeutics, Inc. (NASDAQ:OPXA - News), a company developing Tovaxin, a novel T-cell therapy for multiple sclerosis (MS), today reported financial results for the quarter ended March 31, 2012 and provided an update on recent corporate developments. Corporate development highlights include: We are progressing favorably in the planning and preparations for a clinical trial in Secondary Progressive MS patients, commented Neil K. Warma, President and Chief Executive Officer of Opexa. The clinical trial protocol was submitted to the FDA for final review and we received no additional comments from them. This is a key milestone for us, providing us with the necessary regulatory positioning to advance with the trial preparations and discussions with potential trial sites. Operationally, we believe we remain on track to initiate the trial in the coming months as the team continues to work diligently to finalize preparations. In order to initiate the trial, we will need to secure additional financing, either through a potential partnership or additional capital raise, and this continues to be an important focus for us. The meeting we recently held with clinical trial investigators at the annual American Academy of Neurology conference was well attended and included some … Continue reading →

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Stem cell shield may protect body from chemotherapy side effects

Posted: Published on May 12th, 2012

A new study suggests stem cells may be able to act as a shield to protect the body from the harmful side effects of chemotherapy, the BBC News reported. As chemotherapy drugs attempt to kill cancer drugs, they can also affect the bone marrow and other healthy tissues. In a new study, however, researchers from the Fred Hutchinson Cancer Research Center in Seattle were able to use genetically modified stem cells to protect the bone marrow. The bone marrow is very susceptible to chemotherapy, and in response to the treatment, produces less blood cells. This leaves the body more prone to infection and fatigue. Stem cell shielding appeared to stave off some of these negative side effects. Researchers took bone marrow from patients with brain cancer and isolated the stem cells. They infected the cells with a virus which carried a gene to protect the cells against a chemotherapy drug, and then re-implanted the cells into the patients. "We found that patients were able to tolerate the chemotherapy better, and without negative side effects, after transplantation of the gene-modified stem cells than patients in previous studies who received the same type of chemotherapy without a transplant of gene-modified stem cells, … Continue reading →

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Bone Drug Risks Grow Over Time

Posted: Published on May 12th, 2012

The U.S. Food and Drug Administration says doctors need to reassess which women are likely to benefit from popular bone-building drugs, given the lack of evidence showing that taking them for the long term really helps and the possibility that they put some women at risk for rare but serious side effects. In a report published in the New England Journal of Medicine on Wednesday, the U.S. Food and Drug Administration raised concerns about the potential for some serious side effects in women taking bone-building drugs called bisphosphonates, specifically Fosamax, Actonel and Reclast. The published findings are not new. In 2011, the agency voiced concerns that taking the drugs long-term may actually make bones weaker and increase the risk of rare but serious side effects such as atypical fractures of the thigh bone, esophageal cancer and osteonecrosis of the jaw, a rare but painful condition in which the jaw bone crumbles. To investigate, the FDA reviewed data from women who had taken the drugs for six to 10 years. In Wednesday's report, the agency repeated its 2011 conclusions: Women without osteoporosis seem to get few to no benefits to their bones from taking the drugs beyond five years. In light … Continue reading →

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Alliance Boots wholesale supply chain gets performance boost with Manhattan Associates' Integrated Planning Solutions

Posted: Published on May 12th, 2012

Leading supply chain solutions provider, Manhattan Associates, Inc. (NASDAQ: MANH), announced that Alliance Boots plc, a leading international pharmacy-led health and beauty Group formed following the recent merger between Alliance UniChem Plc and Boots Group Plc, has implemented the Demand Forecasting and Replenishment components of Manhattan Associates' Integrated Planning Solutions, and achieved a remarkable return on investment (ROI) from the project. The near-complete roll-out of the solutions forms the technological cornerstone of a pan-European project to streamline the supply chain processes of Alliance Boots' wholesale division. Two years ago, Alliance Boots' wholesale division decided to re-design its European logistics function, with the replacement of the division's proprietary replenishment system representing a central aspect of the project. The choice of solution was crucial as it had to be deployed in most of the European countries encompassed by Alliance Boots, and integrate rapidly to all the company's suppliers. The Alliance Boots wholesale network, including 'associates', operates in 14 countries with more than 380 warehouses serving over 125,000 pharmacies, hospitals and health centres. Following Alliance Boots' decision to choose Manhattan Associates in September 2004, the European deployment of the solutions was planned meticulously by a core team of local project managers from across … Continue reading →

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Drug charges bring Nobriga 4 months in jail

Posted: Published on May 12th, 2012

LIHUE A repeat drug offender got a harsher sentence on two cases Thursday in 5th Circuit Court. Chief Judge Randal Valenciano said there were two felony charges and that it would be a harsher sentence, but that they would be carried out concurrently. Lacilee Napua Nobriga was sentenced to 120 days of jail in addition to time served. She must also take part in chemical dependency assessments and other programs that are determined appropriate. Nobriga, 26, of Anahola, was arrested on Nov. 14 for third-degree promotion of a detrimental drug, third-degree promotion of a dangerous drug, drug paraphernalia, and resisting an order to stop. She was also being sentenced in another case of drug paraphernalia, promotion of a controlled substance, and first-degree contraband. Second Deputy Prosecuting Attorney Samuel Jajich said Nobriga has a minimal prior record and is remorseful, but that she has not performed well in court ordered programs. He recommended the 120 days sentence with probation and drug rehabilitation. She pleaded no contest to third-degree promotion of a dangerous drug on Jan. 26. She could have been sentenced for up to 20 years with an extended sentence on two or more felony charges. The state agreed to drop … Continue reading →

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Predicting Success Rates for Epilepsy Drugs

Posted: Published on May 12th, 2012

50% of Patients Seizure-Free After Trying First Anti-Seizure Drug By Salynn Boyles WebMD Health News Reviewed by Laura J. Martin, MD May 9, 2012 -- Half of all epilepsy patients who are initially started on one anti-seizure drug remain seizure-free for at least a year, a new study confirms. Among patients followed for as long as 26 years, initial response to drug treatments strongly predicted future seizure control. Yet less than 1% of patients who failed to respond to three anti-seizure drug regimens achieved adequate seizure control on subsequent drug treatments even though some were treated with as many as nine different drugs or drug combinations. The findings make it clear that epilepsy patients who are candidates for surgery or other non-drug treatments should be considered for these procedures earlier rather than later, says neurologist Patricia E. Penovich, MD, of the University of Minnesota and the Minnesota Epilepsy Group in St. Paul. "These patients don't have to wait until they have failed five or six different drug regimens," she tells WebMD. "If their seizures are not controlled by the first few medications it is reasonable to consider surgery." Roughly 2.7 million Americans have epilepsy, and about 1 in 10 people … Continue reading →

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Commercializing Pancreatic Cancer Drugs: The Faster Route to Consider Your Options and Position of Others

Posted: Published on May 12th, 2012

NEW YORK, May 10, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue: http://www.reportlinker.com/p0849622/Commercializing-Pancreatic-Cancer-Drugs-The-Faster-Route-to-Consider-Your-Options-and-Position-of-Others.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_and_Medication This report will excel your competitive awareness and decrease your decision making time in managing pancreatic cancer drug development. Find out whether you are number one, two or further down the ladder in this highly competitive market. Locate the right drugs to benchmark against and see were others may have succeeded or failed before you. This report comprises defined and up to date development strategies for 247 pancreatic cancer drugs within the portfolio of 158 companies world-wide, from Ceased to Marketed. The report extensively analyses their 197 identified drug targets, organized into 163 drug target strategies, and assesses them in pancreatic cancer. BioSeeker has applied its unique drug assessment methodology to stratify the pancreatic cancer drug pipeline and discern the level of competition in fine detail. Major Findings from this report: * The identified competitive landscape of pancreatic cancer drugs is split between the half which have unique drug target strategies and the other half which have head-to-head target competing drugs in 37 different clusters. The latter has a competing ratio which is more than two times higher than … Continue reading →

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Monthly Archives: May 2012

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