Topic regulatory approval

News regulatory approval

• Merck KGaA Sells Théramex To Teva for EUR 265 million

  Merck KGaA announced that it will sell Théramex, its Monaco-based pharmaceutical company specialized in women’s health and gynecology, to Teva. Merck and Teva have signed an agreement whereby Teva will acquire all Théramex operations including 100% of the shares of Théramex S.A.M of Monaco and Théra more

• QIAGEN and Abbott Enter Into Agreement on Molecular Tests for HIV, HCV and HPV

  QIAGEN and Abbott announced that they have entered into an agreement that significantly strengthens both companies’ testing menus for automated in-vitro diagnostic applications in the United States and Canada. Financial terms were not disclosed. Under the terms of the agreements, QIAGEN will receiv more

• Galapagos starts Phase II clinical trial in rheumatoid arthritis patients

  Galapagos NV announced that it has started a Phase II clinical study for the Company's flagship program GLPG0259, a novel drug being developed for rheumatoid arthritis (RA). In this clinical trial, the safety and efficacy of this novel candidate drug will be tested in RA patients. Galapagos plans more

White papers regulatory approval

• Clinical Biomarkers: Novel Tools for Pharmacodynamic Applications
  

  Biomarkers are currently changing the way we diagnose and treat diseases. Today pharmacodynamic biomarkers are widely used in the industry elaborating optimal dosing of new drugs and predictive biomarkers have an enormous potential for companion diagnostics more

• Characterizing Biotherapeutics with HPLC
  

  As demonstrated here, there are a broad range of HPLC applications used in development, production, validation and release of protein therapeutics for human use. Some of the applications mentioned above are mandatory when submitting a new biopharmaceutical to approval at the regulatory agencies. The introduction of the first so-called biosimilars in Europe further increased the demand for highly efficient analysis methods. The continuous development of new stationary phases for the common modes of biochromatography, such as size exclusion, ion exchange and hydrophilic interaction chromatography support biochemists in increasing lab productivity and establishing high-throughput HPLC analysis not only for small molecules but also for large biopolymers more

• Outsourcing R&D Innovation takes on New Meaning
  

  Innovative drugs are the lifeblood of pharmaceutical companies, but the cost of developing them is rising to unsustainable levels. Pharma executives are already saying that as the economy falters, they foresee bleak prospects and mergers unless their companies get more innovative drugs into their pipelines. The clock is ticking on the race to increase productivity, as key patents worth a projected $30 billion in revenue will expire between 2010 and 2013, opening the floodgates to competition from generics, according to Barbara Ryan, an analyst at Deutsche Bank. This imperative is propelling increased outsourcing of R&D operations as companies trim overcapacity. more

Publications regulatory approval

• Determination of Chinese hamster ovary cell line stability and recombinant antibody expression during long‐term culture

  Abstract Chinese hamster ovary (CHO) cell lines are frequently used as hosts for the production of recombinant therapeutics, such as monoclonal antibodies, due to their ability to perform correct post‐translational modifications. A potential issue when utilizing CHO cells for therapeutic protein more

• Pharmaceuticals, Vol. 5, Pages 353-368: On the Regulatory Approval Pathway of Biosimilar Products

  Biosimilars (or follow-on biologics) are a new class of medicine which enters the market subsequent to a previously approved version. They have demonstrated similarity to innovator biologic products in terms of quality, safety, and efficacy. The EMA has taken the lead in the regulatory approval fram more

• Pharmaceuticals, Vol. 5, Pages 353-368: On the Regulatory Approval Pathway of Biosimilar Products

  Biosimilars (or follow-on biologics) are a new class of medicine which enters the market subsequent to a previously approved version. They have demonstrated similarity to innovator biologic products in terms of quality, safety, and efficacy. The EMA has taken the lead in the regulatory approval fram more

Market studies regulatory approval

• Type 2 Diabetes - Global Drug Forecasts and Treatment Analysis to 2020

  Introduction GlobalData, the industry analysis specialist, has released its new report, “Type 2 Diabetes - Global Drug Forecasts and Treatment Analysis to 2020”. The report is an essential source of information and analysis on the global type 2 diabetes therapeutics market. The report provides comp more

• Ovarian Cancer Therapeutics - Global Drug Forecasts and Treatment Analysis 2020

  Introduction GlobalData, the industry analysis specialist, has released its new report, “Ovarian Cancer Therapeutics - Global Drug Forecasts and Treatment Analysis 2020”. The report is an essential source of information and analysis on the global ovarian cancer therapeutics market. The report provi more

• Lebanon Pharmaceuticals and Healthcare Report Q2 2012

  BMI View: Continued improvement in Lebanon's intellectual property (IP) and pharmaceutical regulatory environment reinforces BMI's view that the country will begin to attract investment in a similar fashion to Jordan. Better quality control over pharmaceuticals will help multinational drugmakers via more

Websites regulatory approval