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T Cell Proliferation Assays ProImmune Ltd, a leader in epitope discovery, immunogenicity, and immune monitoring products and services, launched CFSE T cell proliferation assays for immunogenicity risk assessment. The assays form part of ProImmune’s REVEAL Immunogenicity System, a suite of tools used in the design and selection of biological drug leads at the preclinical stage. Combined with ProImmune’s unique cell-free HLA-peptide binding assays for more than 50 class II HLA alleles, thes... Read More >>
   
in vivo Pharmacodynamic Assay Trevigen offers a validated assay with higher sensitivity and pre-coated antibody plates to measure the effectiveness of PARP inhibitors in cell and tissue lysates for anticancer drug screening. In cancer drug development, a current molecular target of high interest is poly (ADP-ribose) polymerase (PARP), which is involved in DNA repair and the survival or death of cancer cells. Measuring the effectiveness of PARP inhibitors in cell and tissue lysates has been d... Read More >>
   
Proximagen Signs Deal With Upsher-Smith Proximagen Neuroscience plc, a biotechnology company focused on diseases of the central nervous system, announces that it has signed a development, license and sub-license agreement with Upsher-Smith Laboratories Inc. in relation to tonabersat, a drug compound recently acquired by Proximagen through its acquisition of Minster Pharmaceuticals plc. Under the terms of the agreement, Upsher-Smith will undertake the clinical development, regulatory filing, ... Read More >>
   
Mapping Technique Speeds Finding Specific Genes A Purdue University scientist was part of a global team that has demonstrated a specialized mapping technique that could speed work in genomic fields by quickly finding genetic associations that shape an organism's observable characteristics. Using plants from 93 different Arabidopsis thaliana populations, a team led by the Gregor Mendel Institute of Plant Biology in Austria was able to find genetic associations among multiple phenotypes, or tr... Read More >>
   
Key Protein Aids In DNA Repair Scientists have shown in multiple contexts that DNA damage over our lifetimes is a key mechanism behind the development of cancer and other age-related diseases. Not everyone gets these diseases, because the body has multiple mechanisms for repairing the damage caused to DNA by aging, the environment and other human behaviors – but the mechanisms behind certain kinds of DNA repair have not been well-understood. In a paper published today in the journal Nature... Read More >>
   
FDA Requests More Information on Certriad LONDON (AP) - AstraZeneca PLC and Abbott Laboratories said that the U.S. Food and Drug Administration has asked for more information about their Certriad cholesterol drug before approving it for sale. The companies said that FDA has sought more data in a so-called complete response letter (CRL) to their new drug application, which combines their cholesterol pills TriLipix and Crestor. Abbott's TriLipix is part of a class of drugs called fibrates tha... Read More >>
   
Food and Drug Administration NOTICES Meetings:   International Conference on Harmonisation Steering Committee and Expert Working Group ,   18848 [2010–8379] [TEXT] [PDF] Public Workshop:   Computer Methods for Cardiovascular Devices; Integration of Nonclinical and Clinical Models ,   18849 [2010–8311] [TEXT] [PDF] Small Entity Compliance Guide:   Prev... Read More >>
   
GSK Receives EMEA Approval for Duodart LONDON (AP) - Pharmaceutical company GlaxoSmithKline PLC has received European approval for Duodart, a two-in-one drug for the treatment of the symptoms of an enlarged prostate. The drug is a combination of dutasteride, currently marketed as Avodart, and tamsulosin, a generic drug marketed by Astellas Pharma as Flomax. Glaxo received backing for the drug from Germany under the European Union's decentralized approval procedure, meaning it is applicable ... Read More >>
   
FDA Says Additional Pixuvri Trial Needed, CTI Opens Drug to Expanded Access Cell Therapeutics (CTI) has decided to pursue an expanded access program for its non-Hodgkin’s lymphoma drug Pixuvri, while conducting an additional trial needed for approval. CTI plans to request a meeting with the FDA to discuss the expanded access program and design of the follow-on study. The company said it received a complete response letter from the agency citing concerns with trial data raised at a meeting of ... Read More >>
   
Pending Litigation to Delay Launch of Generic Asacol Boehringer Ingelheim’s Roxane Laboratories will postpone until at least November planned sales of its generic version of Asacol, an ulcerative colitis drug, to resolve a patent infringement suit over the drug. In a deal reached recently with Procter & Gamble Pharmaceuticals and Medeva Pharma Suisse — the brand manufacturers of Asacol (mesalamine) — Roxane agreed to delay the drug’s launch to extend the trial’s discovery phase i... Read More >>
   
FDA Approves Mylan’s Drug Applications Mylan Inc. Monday announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Bupropion Hydrochloride Extended-Release Tablets USP, (SR), 100 mg, 150 mg and 200 mg, the generic version of GlaxoSmithKline’s antidepressant Wellbutrin SR. Pittsburgh Business Times Read More >>
   
New Class of Brain-Protecting Drugs Emerging Researchers have identified a compound that mimics one of the brain's own growth factors and can protect brain cells against damage in several animal models of neurological disease. 7,8-dihydroxyflavone is a member of the flavonoid family of chemicals, which are abundant in fruits and vegetables. The compound's selective effects suggest that it could be the founder of a new class of brain-protecting drugs. The results were published online this w... Read More >>
   
Statins May Slow Progression Of Multiple Sclerosis, New Study Finds A UCSF-led study examining the impact of statins on the progression of multiple sclerosis found a lower incidence of new brain lesions in patients taking the cholesterol-lowering drug in the early stages of the disease as compared to a placebo. Study participants received an 80 milligram daily dose of atorvastatin, marketed by Pfizer Inc. as Lipitor. Although the study was small with only 81 participants and its prima... Read More >>
   
AllTranz Developing Multi-Use Transdermal Patch   AllTranz, Lexington, Ky., is focused on the development of transdermal treatments for pain and other neurological disorders. The lead product in the company pipeline is a synthetic non-psychoactive cannabinoid delivered via gel. The initial indication is for the treatment of osteoarthritis. AllTranz also plans to develop a second generation of this product for the treatment of alcoholism. The gel product for arthritis pain is scheduled for a... Read More >>
   
Novozymes Partnering With ProMetic Life Sciences Inc.Drug Discovery & Development - April 01, 2010 Novozymes (Copenahgen, Denmark) and ProMetic Life Sciences Inc. (Montreal) announced that they have entered into a strategic alliance regarding proprietary albumin purification technology based upon a synthetic-ligand affinity adsorbent developed by ProMetic’s UK subsidiary, ProMetic BioSciences Ltd. The purification technology has been designed for the rapid and cost-effective development... Read More >>
   
U.S. Food & Drug Administration (FDA) New and Generic Drug Approvals Calan (verapamil hydrochloride) Tablets, Pfizer, Incorporated, Labeling Revision Calan (verapamil hydrochloride) Injection, Pfizer, Incorporated, Labeling Revision Calan (verapamil hydrochloride) Injection, Pfizer, Incorporated, Labeling Revision Covera HS (verapamil hydrochloride) Extended-Release Tablets, Pfizer, Incorporated, Labeling Revision Doral (quazepam) Tablets, Questcor Pharma., In... Read More >>
   

News & Events

  • GSK Receives EMEA Approval for Duodart LONDON (AP) - Pharmaceutical company GlaxoSmithKline... Read more>>
  • FDA Approves Mylan’s Drug Applications Mylan Inc. Monday announced that its subsidiary Mylan Ph... Read more>>
  • Novozymes Partnering With ProMetic Life Sciences Inc.Drug Discovery & Development - April 0... Read more>>
  • U.S. Food & Drug Administration (FDA) New and Generic Drug Approvals Calan (verapamil h... Read more>>
  • New Class of Brain-Protecting Drugs Emerging Researchers have identified a compound that mim... Read more>>
  • Food and Drug Administration NOTICES Meetings:   Internationa... Read more>>
  • Key Protein Aids In DNA Repair Scientists have shown in multiple contexts that DNA damage ov... Read more>>
  • Pending Litigation to Delay Launch of Generic Asacol Boehringer Ingelheim’s Roxane Laboratori... Read more>>
  • Proximagen Signs Deal With Upsher-Smith Proximagen Neuroscience plc, a biotechnology company... Read more>>
  • Statins May Slow Progression Of Multiple Sclerosis, New Study Finds A UCSF-led study exa... Read more>>
  • FDA Requests More Information on Certriad LONDON (AP) - AstraZeneca PLC and Abbott Laborator... Read more>>
  • FDA Says Additional Pixuvri Trial Needed, CTI Opens Drug to Expanded Access Cell Therapeutics... Read more>>