FRIDAY May 25, 2012 — People with inflammatory bowel disease, which includes Crohn’s disease and colitis, may be at increased risk for flare-ups when they fly or travel to high altitudes for skiing or mountain climbing, a new study suggests. This complications affected patients with either Crohn’s disease (which typically involves the small intestine) or ulcerative colitis (which typically involves the large intestine and rectum), but the risk appears to be higher in those with Crohn’s disease, the researchers found. The study included 103 patients who were seen at inflammatory bowel disease clinics in Switzerland. The 52 patients with flares…
Author: Rajeev Singla
VIB researcher Diether Lambrechts, associated with KU Leuven, has discovered a biomarker that might potentially predict which patients will benefit more from treatment with bevacizumab (Avastin). If validated, this discovery could be an important step towards personalized medicine and patient-tailored use of this important cancer drug. Diether Lambrechts (VIB – KU Leuven) said “in two large clinical studies with patients with advanced stages of pancreas and kidney cancer a variant in the DNA was discovered that identified patients who did not respond well to the prescribed course of bevacizumab. Further research in the lab showed that this variant, or biomarker,…
TRENTON, N.J. – A former research chemist with global pharmaceutical company sanofi-aventis (“sanofi”) admitted today to stealing sanofi’s trade secrets and making them available for sale through Abby Pharmatech, Inc. (“Abby”), the U.S. subsidiary of a Chinese chemicals company, U.S. Attorney Paul J. Fishman announced. Yuan Li, 29, of Somerset, N.J., a Chinese national, pleaded guilty to an Information charging her with one count of theft of trade secrets. Li entered her guilty plea before U.S. District Judge Joel A. Pisano in Trenton federal court. According to documents filed in this case and statements made in court: Sanofi is a…
Shortages of key drugs used to fight infections represent a public health emergency and can put patients at risk, according to a review published in Clinical Infectious Diseases and available online*. Frequent anti-infective shortages can substantially alter clinical care and may lead to worse outcomes for patients, particularly as the development of new anti-infectives has slowed and the prevalence of multidrug-resistant pathogens is increasing. Of the 193 medications unavailable in the U.S. at the time of the analysis, 13 percent were anti-infective drugs, the authors found, led by Marc Scheetz, PharmD, and Milena Griffith, PharmD, from Midwestern University Chicago College…
The U.S. Food and Drug Administration has completed its recommendations for three user fee programs that will help speed safe and effective drugs and lower-cost generic drug and biosimilar biological products to patients, FDA Commissioner Margaret A. Hamburg, M.D. said today. The recommendations were transmitted to Congress today by Health and Human Services Secretary Kathleen Sebelius. The programs include the fifth authorization of the Prescription Drug User Fee Act (PDUFA), and new user fee programs for human generic drugs and biosimilar biological products. Work on the proposals was concluded before the agency’s mid-January deadline. Under a user fee program, industry…
The U.S. Food and Drug Administration today approved Voraxaze (glucarpidase) to treat patients with toxic levels of methotrexate in their blood due to kidney failure. Methotrexate is a commonly used cancer chemotherapy drug normally eliminated from the body by the kidneys. However, patients receiving high doses of methotrexate may develop kidney failure. Voraxaze is an enzyme that rapidly reduces methotrexate levels by breaking the chemotherapy drug down to a form that can be eliminated from the body. Voraxaze is administered directly into a patient’s vein (intravenously). “Prolonged exposure to high levels of methotrexate can result in kidney and liver damage,…
Today, the U.S. Food and Drug Administration allowed marketing of the first test to help determine the risk for a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people using the drug Tysabri (natalizumab) to treat multiple sclerosis (MS) or Crohn’s disease (CD). The Stratify JCV Antibody ELISA test, when used with other clinical data from the patient, can help health care providers determine the risk for developing PML in MS and CD patients. The John Cunningham virus (JCV) is a common virus that many people have been exposed to at some point in their lives, and is generally…
Pharma companies are seeing the fallout from new M&A rules adopted by the Indian government. Late last year, Indian officials introduced a new deal-review process that has replaced the automatic-OK previously governing acquisitions in the pharma sector. Foreign companies looking to buy an existing drug company now must gain government approval. For the first 6 months, that meant a review by the Foreign Investment Promotion Board. After that, the Competition Commission of India will take over deal approvals. These rules were hammered out over months of debates, some of which focused on the relative merits of the FIPB and CCI as M&A…
Government policy and regulatory changes were the focus point for the pharmaceutical industry in India in the year 2011. The government actively intervened in business and sought more control in various activities from acquisition to pricing controls. While some changes were opposed others were implemented as the companies in the sector continued their business. Ranbaxy Laboratories was able to reach an agreement with the US FDA to revoke a ban on sale of drugs produced at some of its plants, in the US market. Lupin acquired I’rom Pharmaceutical Company in Japan and Sun Pharma proposed a complete takeover of the…