Market Approval

News Market Approval

• Pantec Biosolutions Closes CHF 20 Million Financing

  Pantec Biosolutions AG announced the closing of a CHF 20 million investment achieved by two financing rounds. The StemCell Holding AG, an Austrian investment company in the life sciences sector, acted as lead investor. No further terms were disclosed. The investment strengthens Pantec’s financial p more

• Pevion Biotech and CEVEC Pharmaceuticals Sign Exclusive License Option Agreement

  Pharmaceuticals announced the signing of an exclusive license option agreement with Pevion Biotech. The agreement enables Pevion Biotech to exclusively use CEVEC’s transient CAP-T™ cell expression technology to manufacture and commercialize a protein antigen for vaccination against a widespread huma more

• t2cure First Company to Have Quality of Cellular Therapeutic Certified by European Medicines Agency

  t2cure GmbH announced that the quality of its lead product t2c001 has been certified by the European Medicines Agency. t2c001 is the first product ever to obtain a certificate under the EMA regulations for Advanced Therapy Medicinal Products (ATMPs). It is a somatic cell therapy product derived fro more

Publications Market Approval

• Environmental change challenges decision-making during post-market environmental monitoring of transgenic crops

  The ability to decide what kind of environmental changes observed during post-market environmental monitoring of genetically modified (GM) crops represent environmental harm is an essential part of most legal frameworks regulating the commercial release of GM crops into the environment. Among others more

• Additional safety risk to exceptionally approved drugs in Europe?

  “What is already known about the subject” box What is already known about the subject ▪ Safety profile of new drugs is not well known at time of market approval and serious safety issues are regularly identified for marketed drugs. ▪ Drugs intended to meet an unmet medical need can be ap more

• DuraHeart™ magnetically levitated centrifugal left ventricular assist system for advanced heart failure patients

  The implantable left ventricular assist system (LVAS) using pulsatile pump technology has become an established therapeutic option for advanced heart failure patients. However, there have been technological limitations in some older designs, including a high incidence of infection and mechanical fai more

Market studies Market Approval

• Cardiac Assist Devices Market to 2017 - Increasing Uptake of Ventricular Assist Devices and Total Artificial Heart to Drive Growth

  GBI Research’s report, “Cardiac Assist Devices Market to 2017 - Increasing Uptake of Ventricular Assist Devices and Total Artificial Heart to Drive Growth” provides key data, information and analysis on the global cardiac assist devices market. The report provides market landscape, competitive lands more

• Ophthalmic Imaging Systems Inc. (OISI) - Financial and Strategic SWOT Analysis Review

  Ophthalmic Imaging Systems Inc. (Ophthalmic Imaging) is a division of MediVision Medical Imaging Ltd. It is engaged in the design, development, production and marketing of digital imaging system solutions of both fluorescein and indocyanine green to the ophthalmic angiography markets. The company’s more

Websites Market Approval