The influential Framingham Heart Study, a joint project of Boston University and the National Institutes of Health, will lose $4 million effective August 1 as a result of the sequester. That amounts to 40 percent of its funding from the National Heart, Lung and Blood Institute, a division of the NIH. Begun in 1948, The study has identified major common risk factors and characteristics that contribute to cardiovascular disease by following disease development in three generations of participants. The long-term study also provided detailed information on the impact of risk factors on disease development, including blood pressure, blood triglyceride and cholesterol levels, age, gender, obesity, and psychosocial issues. Study administrators plan to lay off 19 staff from clinical and administrative areas and to reduce the number of clinic exams and lab operations. Basic research will also be curtailed.

A paper published in The Lancet medical journal in 2007 on the use of Novartis’s drug valsartan for the treatment of high blood pressure will be retracted. The pending retraction follows the announcement from Jikei University School of Medicine that a committee investigating the validity of the study data indicated that a former employee might have manipulated data. An interim report by the committee said part of the blood pressure data in The Lancet paper differed from data in the medical records of subjects in the trial. Guest professor and former Novartis employee Seibu Mochizuki, the paper’s author, led the research designed to determine if valsartan could reduce the incidence of cerebral stroke and cardiac angina in addition to lowering blood pressure.

GE Healthcare sent its customers an urgent medical device recall notice covering seven of its magnetic resonance imaging machines. During the ongoing investigation into a death from a collapsed machine last month, the company determined that bolts securing the machine’s camera to a support structure were loose, thereby stressing the support mechanism and causing the camera to fall and crush the patient. GE Healthcare is asking all facilities operating any of the seven nuclear medicine systems to discontinue operations until it completes an inspection of each machine and has expanded the list of machines that should cease operations because of the similarities in design of the support structure across many product lines.

India’s Intellectual Property Appellate Board revoked the patent on GlaxoSmithKline’s breast cancer drug Tykerb, stating that the new salt form of the original lapatinib is merely an incremental improvement over the original dihydrochloride salt form of the active pharmaceutical ingredient. Fresenius Kabi Oncology filed the patent challenges against both the original and new salt form of lapatinib, stating that evidence GlaxoSmithKline submitted for the patents should be rejected as prior art. Fresenius Kabi Oncology manufactures both active pharmaceutical ingredients and finished dosage forms India. Lapatinib is formulated as a dihydrochloride salt and Tykerb is formulated as a ditosylate salt, a form that absorbs less water and therefore has greater stability.

Halozyme Therapeutics will discontinue a mid-stage study of its combination therapy for the treatment of hereditary angioedema, a disease that causes episodes of swelling in multiple body parts including the hands, feet, face and airway. The Center for Biologics Evaluation and Research expressed concern about unexpected immune reactions in a number of patients, including the presence and concentration of antibodies reactive to a component of the combination therapy, recombinant human hyaluronidase. Hyaluronidase is a key component of the extracelluar matrix that forms the body’s tissues. The combination therapy includes the U.S. Food and Drug Administration-approved C1-esterase inhibitor from development partner ViroPharma.

Nova Diabetes Care recalled as many as 62 million glucose test strips sold individually as Nova Max Blood Glucose Test Strips or as part of its Nova Max Plus glucose meter kits. The U.S. Food and Drug Administration posted on their website that 21 lots of strips are under recall. The strips may report a false, abnormally high blood glucose result that could lead to an insulin dosing error, potentially causing serious health risks that require immediate medical attention. “It is important that patients using these test strips discontinue their use immediately,” said Alberto Gutierrez, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health. The recalled test strips were distributed in the United States, Canada, Chile, Peru, Argentina, Dominican Republic, Jamaica, Puerto Rico, United Kingdom, Germany, Belgium, Finland, Congo, and Saudi Arabia.

Pacira Pharmaceuticals’ experimental drug designed to eliminate pain associated with thoracotomy procedures failed a late-stage trial assessing safety and efficacy as a nerve blocker. The drug, bupivacaine in a liposome suspension formulation for injection between the ribs, did not reduce cumulative pain scores over 72 hours in trial patients. A total of 180 patients participated in the study and an analysis is underway to understand why some patients had a very high placebo response. Ongoing studies for use of the experimental drug in femoral nerve block for total knee arthroplasty will continue, said the company, since the FDA previously indicated that one single pivotal trial meeting its primary endpoint would be sufficient to gain approval for the nerve block indication.