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Products FDA

UHPLC-MS for high resolution applications

Is your current HPLC system limiting you? Do you want more sensitivity and confidence in your data than with UV detection? This offer is for you! more

Software FDA

Merck Millipore Introduces Unique Lab Water E-Solution: Millitrack® Compliance

This unique fully-embedded water purification system software has been developed especially for the pharmaceutical, biotech and contract labs more

Videos FDA

Merck Millipore Introduces Unique Lab Water E-Solution: Millitrack® Compliance

Millitrack® Compliance is a unique e-solution designed to enable regulatory compliance for lab water purification system users. Millitrack® Compliance has been designed specifically for the pharmaceutical, biotech and contract labs that follow GxP regulations (GLP, GCP, or cGMP - U.S. Food and Drug more

News FDA

• New study finds digoxin safe despite recent reports

  A study published in the European Heart Journal found no evidence that digoxin increases mortality in patients with atrial fibrillation (AF), the opposite of results just published by another group in the same journal analyzing the same data. Older patients with AF also often have heart failure, and more

• Higher mercury levels in humans associated with increased risk for diabetes

  A new study found that higher levels of mercury exposure in young adults increased their risks for type 2 diabetes later in life by 65 percent. The study, led by Indiana University School of Public Health-Bloomington epidemiologist Ka He, is the first to establish the link between mercury and diabet more

• FDA approves Kineret for the treatment of NOMID

  Sobi announced that the US Food and Drug Administration (FDA) has approved Kineret® (anakinra) for the treatment of children and adults with neonatal-onset multisystem inflammatory disease (NOMID). Kineret® is the FDA-approved therapy for NOMID, the most severe form of cryopyrin associated periodic more

White papers FDA

• Predictor(TM) hERG Fluorescence Polarization Assay Kit performed on the PHERAstar/PHERAstar Plus
  

  The potential for cardiotoxic side-effects continues to challenge the development of small molecule based therapies. These intolerable side-effects are often precipitated by drug-induced long QT syndrome (LQT), which is often linked to blocking the human ether-a-go-go related gene (hERG) potassium channel. Although patch-clamp electrophysiology remains the gold standard for determining the interaction of compounds with the function of the hERG channel, radioligand displacement assays have proven to be a cost-effective initial alternative assay for hERG channel liability at early stages of compound development. more

• Wyeth 'learns and confirms' in India
  

  Aparna Singh (AS), Program Manager with Frost & Sullivan's Chemical Materials and Foods team caught up with Dr. Michael Kolb (Dr. MK) at Frost & Sullivan's Opportunities in Lifescience Molecules: Global Partnership Summit 2006. This annual summit was held at Goa (India) from 21st -23rd May, 2006. more

• Outsourcing in Pharmaceutical Industry

  Pharmaceutical industry is constantly undergoing a change. In the past pharmaceuticals had a different strategy, companies use to build all the products internally and confine access to information or resources to third parties. The past situation is changing; in-house resources are getting exhausted with a very thin product pipeline and in addition many drugs are going off patent by 2008 hampering company sales and competitiveness. It takes $800 million and 20 years for... more

Publications FDA

• Development of everolimus, a novel oral mTOR inhibitor, across a spectrum of diseases

  Everolimus is a potent, oral inhibitor of the mammalian target of rapamycin (mTOR) that has been investigated in multiple clinical development programs since 1996. A unique collaboration between academic and pharmaceutical experts fostered research that progressed rapidly, with simultaneous indica more

• Tumor treating fields: a new frontier in cancer therapy

  Tumor treating fields (TTFields) is a noninvasive, regional antimitotic treatment modality that has been approved for the treatment of recurrent glioblastoma by the U.S. FDA and has a CE mark in Europe. TTFields therapy delivers low‐intensity (1–3 V/cm), intermediate‐frequency (100–300 kHz), alter more

• Fixed-dose combination of phentermine–topiramate for the treatment of obesity

  The aim of this article is to focus on the fixed-dose combination of phentermine and topiramate, a new antiobesity drug recently approved by the US FDA. The mechanisms of weight loss for each drug in monotherapy is described, followed by the rationale for its use as a combination therapy and a compr more

Market studies FDA

• Puerto Rico Pharmaceuticals and Healthcare Report Q2 2012

  BMI View: Puerto Rico is struggling to retain its reputation as a pharmaceutical manufacturing hub, with a number of plants found to be in breach of regulations and standards over recent years. Additionally, the flagging economy is expected to push skilled staff to emigrate, leaving fewer candidates more

• Thailand Pharmaceuticals and Healthcare Report Q2 2012

  BMI View: Thailand is a moderately attractive pharmaceutical market for multinationals. On the positive side, rewards are potentially considerable, given the country’s epidemiological profile and the growing population numbers. However, the government’s stance on compulsory licences and regulatory a more

• FDA Approves Erivedge (Vismodegib) for Metastatic or Locally Advanced Basal Cell Carcinoma

  Introduction GlobalData, the industry analysis specialist, has released its new report, “FDA Approves Erivedge (Vismodegib) for Metastatic or Locally Advanced Basal Cell Carcinoma”. The report is an essential source of information on the approval of Erivedge by the US FDA. The report also provides more

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