Regulatory Approval

News Regulatory Approval

• BASF to acquire CRI/Criterion’s global styrene catalysts business

  BASF announced that it has signed a purchase agreement to acquire the styrene catalysts business of CRI/Criterion, a wholly owned subsidiary of Shell based in Houston, Texas. Financial details of the transaction are not being disclosed. CRI/Criterion is a leading global manufacturer of chemical c more

• BP Agrees to Sell its Interests in Pan American Energy to Bridas Corporation

  BP announced that it has entered into an agreement to sell its interests in Pan American Energy (PAE) to Bridas Corporation. PAE is an Argentina-based oil and gas company owned by BP (60 per cent) and Bridas Corporation (40 per cent). Bridas Corporation will pay BP a total of $7.06 billion in cash more

• Univar’s acquisition of Quaron Group Benelux is ready for Closing

  Univar announced that its acquisition of the Quaron business in Belgium and the Netherlands, approved by the European Commission on July 16, 2010, will not require any further regulatory approvals. The transaction is expected to close as scheduled in the first week of January 2011. Quaron, a chemic more

White papers Regulatory Approval

• 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

• Medical grade sterilization affects synthetic polymer film properties intended for peripheral nerve repair: an in vitro study

  In vitro characterization of synthetic scaffolds in the laboratory commonly employs sterilization techniques, such as, ultraviolet light or ethanol (EtOH) soaking. These sterilization methods are not sufficient, however, to gain Regulatory approval for therapeutic use. Neglecting the effects medical more

• Gamma irradiation of electrospun poly(ε‐caprolactone) fibers affects material properties but not cell response

  Abstract Fabrication of electrospun fibrous scaffolds as future medical devices is being widely researched, with particular emphasis given to their material properties and effect on cell response and differentiation. However, the vast majority of these scaffolds are sterilized via nonmedically ap more

• Governing nanobiotechnology: lessons from agricultural biotechnology regulation

  This article uses lessons from biotechnology to help inform the design of oversight for nanobiotechnology. Those lessons suggest the following: first, oversight needs to be broadly defined, encompassing not just regulatory findings around safety and efficacy, but also public understanding and accept more

Market studies Regulatory Approval

• Romania Petrochemicals Report Q2 2011

  BMI’s latest Romania Petrochemicals Report expresses optimism about the domestic and external outlook of the industry over the medium term, particularly with continued expansion and foreign investor interest in Romanian downstream industries, specifically carmaking. However, if the recession drags o more

• Romania Petrochemicals Report Q3 2010

  The restructuring and integration of the Romanian petrochemicals industry is seen as key to its revival, according to BMI’s latest ‘Romania Petrochemicals Report’. In January 2010, Oltchim (54.8% owned by the government) agreed to acquire the Arpechim petrochemicals business from Petrom (51% owned more

• Romania Petrochemicals Report Q2 2010

  The Romanian petrochemicals industry is set to overcome the setback of the recession, with growth in both domestic and export markets from 2010 as well as the completion of a process of integration within the sector, according to BMI’s latest Romania Petrochemicals Report. BMI estimates that in 2009 more

Websites Regulatory Approval