Strategies & Technologies Driving Drug Discovery to Market
eTMF System Ensures Inspection Readiness
April 9, 2013 12:17 pm | Product Releases | CommentsPharmaVigilant announced the release of I-Vault 2.7, a robust eTMF system. The system has been expanded to include the new I-Batch uploader, imbedded Redactor tool and the Report Generator.
Gilead Submits NDA for Sofosbuvir
April 9, 2013 12:00 pm | News | CommentsGilead Sciences announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of sofosbuvir, a once-daily oral nucleotide analogue for the treatment of chronic hepatitis C virus (HCV) infection.
Morning Sickness Pill Returns to US
April 9, 2013 11:47 am | News | CommentsTalk about a comeback: A treatment pulled off the market 30 years ago has won Food and Drug Administration approval again as the only drug specifically designated to treat morning sickness. That long-ago safety scare, prompted by hundreds of lawsuits claiming birth defects, proved to be a false alarm.
AstraZeneca Given 'Negative' Rating
April 8, 2013 5:10 pm | News | CommentsStandard & Poor's Ratings Service lowered its credit rating outlook on AstraZeneca PLC on Monday, citing the pharmaceutical company's declining revenue as its patents on Seroquel IR and other key drugs expire. Analyst Olaf Toelke lowered his outlook to "negative" from "stable."
Bristol-Myers Replaces Research Director
April 8, 2013 1:29 pm | by Linda A. Johnson | News | CommentsBristol-Myers Squibb Co. will replace its top researcher with a physician and former medical school professor who has worked in pharmaceutical industry research for more than two decades. Dr. Francis Cuss, 58, will become the New York-based drugmaker's executive vice president and chief scientific officer on July 1.
Lilly Thieves Claim Security Report Not Used
April 8, 2013 1:10 pm | by The Associated Press | News | CommentsA security company being sued over the theft of $60 million worth of pharmaceuticals from an Eli Lilly and Co. warehouse in Connecticut in 2010 insists there is no proof the thieves used a report it prepared detailing the building's security weaknesses. Attorneys for Tyco Integrated Systems LLC denied the allegations Thursday.
Automated ADA Test Combines Three Steps in Single Assay
April 8, 2013 12:47 pm | Product Releases | CommentsGenalyte Inc. announced the launch of its MT-ADATM anti-drug antibody (ADA) immunogenicity assay designed to run on the Maverick Detection System. This test combines screening for the presence of ADAs and the characterization of each detected ADA...
KF Coulometric Titrator for Trace Water Level Content
April 8, 2013 12:37 pm | Product Releases | CommentsJM Science announces their new AQUACOUNTER Karl Fischer Coulometric Titrator (AQ-2200S). This titrator is ideal for the trace level water content determination with its capability and upgraded performance. It will be of interest for users who have many kinds of samples to be analyzed, exchange KF reagents frequently, or after each measurement, and are eco-minded and budget-conscious.
Ex-Vivo Systems Guide for IPL Techniques
April 8, 2013 12:28 pm | Product Releases | CommentsThis new guide from Hugo-Sachs Elektronik-Harvard Apparatus GmbH, includes systems for all model species (mouse through pig), full respiratory mechanics in one system, new pig lung system for translational research and modular systems that allow custom configuration.
Valeant's Obagi Takeover Prospects Boosted
April 8, 2013 12:13 pm | by Ross Marowits, The Canadian Press | News | CommentsValeant Pharmaceuticals appears to have won its takeover battle for Obagi Medical Products after a German-based rival decided not to raise its bid for the dermatology products company. Valeant upped its offer for Obagi to US $24 per share from US $19.75 last week, after being trumped by a US $22 per share bid from Merz Pharma GmbH.
FDA Extends Cancer System Review
April 8, 2013 12:03 pm | News | CommentsDelcath Systems Inc. said today that the Food and Drug Administration will take an extra three months to review its experimental treatment for liver cancer. The company said the FDA will make a ruling on its Melblez system by Sept. 13. The FDA had asked Delcath for more information about the system, and the agency will use the additional time to review that information.
Roche, Isis Form Huntington’s Alliance
April 8, 2013 11:58 am | News | CommentsRoche and Isis Pharmaceuticals Inc. announced that they have formed an alliance to develop treatments for Huntington’s disease (HD) based on Isis’ antisense oligonucleotide (ASO) technology. This alliance combines Isis’ antisense expertise with Roche’s scientific expertise in developing neurodegenerative therapeutics.
Engineered CAR T-cells Identify Tumor-Specific Antigens
April 8, 2013 11:47 am | News | CommentsThe need to distinguish between normal cells and tumor cells is a feature that has been long sought for most types of cancer drugs. Tumor antigens, unique proteins on the surface of a tumor, are potential targets for a normal immune response against cancer.
DiaMedica Approved for Diabetes Trial in Netherlands
April 8, 2013 11:34 am | News | CommentsDiaMedica pleased to announce it has received regulatory approval to commence an anticipated 76 subject Phase 1/2 clinical trial for DM-199. The clinical trial, to be conducted in the Netherlands, is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of DM-199 in 36 healthy volunteers and in 40 Type 2 diabetes (T2D) patients.
Paragazole Excels as Breast Cancer Treatment
April 8, 2013 9:59 am | News | CommentsBreast cancers that lack estrogen receptors are more difficult to treat than ER+ cancers. New research demonstrates that an investigational drug, Paragazole, makes triple-negative breast cancer cells express estrogen receptors, and that increases the sensitivity of these cells to chemotherapy.
