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23 Current news about the topic market approval

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Pantec Biosolutions Closes CHF 20 Million Financing

21-07-2010

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 ...

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Pevion Biotech and CEVEC Pharmaceuticals Sign Exclusive License Option Agreement

28-05-2010

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 ...

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

27-05-2010

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 ...

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MediGene AG Reports Financial Results for the 2009 Fiscal Year

EBITDA loss EUR 18.8 million

30-03-2010

MediGene AG reported its results for the fiscal year 2009, and gave an outlook for the fiscal year 2010. According to the forecast, MediGene reduced the loss on an EBITDA basis in 2009, from approximately 25 million euros to approximately 19 million euros, with unchanged revenue of ...

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Modernisation of Richter-Helm BioLogics’ Small-Scale GMP-Production Facility in Hannover completed

25-09-2009

Richter-Helm BioLogics GmbH & Co. KG completed the modernisation of it´s GMP-production facility in Hannover in September 2009. Hence GMP-production capacity in a scale of 300L fermentation volume and corresponding down-stream capacity for the production of recombinant proteins, plasmid DNA ...

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FDA Grants Orphan Drug Designation for MediGene's Drug Candidate EndoTAG(TM)-1

Orphan drug designation ensures market exclusivity for a period of seven years following market approval

25-05-2009

MediGene AG has obtained orphan drug designation from the US regulatory authority FDA (US Food and Drug Administration) for paclitaxel, the active ingredient in MediGene's drug candidate EndoTAG(TM)-1 for the indication pancreatic cancer. Orphan drug designation for EndoTAG(TM)-1 in this ...

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MorphoSys Appoints New Head of Preclinical Development

MorphoSys Further Strengthens its Proprietary Development Team

24-02-2009

MorphoSys AG announced the appointment of a new Head of Pre-clinical Development & Project Management. Dr. Ulrich Moebius joins MorphoSys from Medigene AG. For the last nine years, he held the position of Head of Pre-clinical Development, where he was responsible for the company's ...

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Great opportunities for developers of biosimilars

Between 2009 and 2019 blockbuster biopharmaceuticals with a total value of over 50 billion $US will lose patent protection.

05-12-2008

Biopharmaceuticals or biologicals are drugs synthesized by “recombinant DNA technology”, a gene technological process developed in the mid seventies. In contrast to classic low-molecular drugs like Aspirin®, for example, which can be produced by way of chemical synthesis due to their simple ...

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DxS launches cancer mutation kit for K-RAS in Australia

New diagnostic assists clinicians in selecting appropriate cancer therapy for patients

03-07-2008

DxS has announced the launch of its K-RAS cancer mutation detection kit in Australia. This follows the kit meeting the compliance standards of Australia's Therapeutic Goods Administration (TGA). DxS' TheraScreen® K-RAS kit allows clinicians to screen patients for mutations in the K-RAS gene, ...

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Intercell AG to acquire Iomai Corporation to expand late stage product pipeline and strengthen leadership in vaccine innovation

14-05-2008

Intercell AG and Iomai Corporation announced that they have entered into a definitive agreement pursuant to which Intercell will acquire Iomai for USD 6.60 per share representing a fully diluted equity value of approximately USD 189 million (EUR 122 million). The transaction has been ...

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