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23 Current news about the topic market approval
rss21-07-2010
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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, ...
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 ...
