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19 Current news of Biofrontera
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European Commission authorizes EU-wide marketing and distribution of Biofrontera's Ameluz
20-12-2011
Biofrontera was informed by the European Commission that its product Ameluz® (in development called BF-200 ALA) was approved for distribution throughout the entire EU, Norway, Island and Liechtenstein. Already in October had the responsible "European Medicines Agency" recommended the approval ...
The EMA recommends approval of Biofrontera's BF-200 ALA
26-10-2011
The European Medicines Agency (EMA) issued a favourable opinion on Biofrontera's marketing approval application for its new medicinal product BF-200 ALA for the treatment of actinic keratosis. There was no recommendation for a restriction or temporal limitation of the approval. The product ...
Positive review of the European Medicines Agency in the approval process of Biofrontera's BF-200 ALA
31-01-2011
Biofrontera has received a positive interim report of the responsible committee of the European Medicines Agency (EMA) in the ongoing centralized approval process of BF-200 ALA for the treatment of actinic keratosis.The "Committee for Medicinal Products for Human Use (CHMP)" provides ...
Biofrontera received official review of its drug approval dossier for BF-200 ALA
23-12-2010
Biofrontera announces that the European Medical Agency (EMA) has sent the official summaries and preliminary questions of the reviewers (rapporteurs) about the approval dossier of its leading drug candidate BF-200 ALA for actinic keratosis. The reviews will now be distributed to all member ...
Validation of the dossier for drug approval of Biofrontera's BF-200 ALA successful
04-10-2010
Biofrontera AG announced that the European Medical Agency EMA has confirmed the successful validation of the drug approval dossier for BF-200 ALA. With this, the first phase of the approval process has been passed and the completeness, conformity with legal requirements, and technical quality ...
Biofrontera received manufacturing and distribution license
16-08-2010
Biofrontera AG announces, that its subsidiary Biofrontera Pharma GmbH received the permission to import pharmaceutical products, clear them for European sales and distribute them. The responsible district government has inspected the Company, assessing all requirements for granting the ...
Biofrontera: Phase III data of BF-200 ALA demonstrate superiority against Metvix
07-12-2009
Biofrontera announced that the company has today been informed about preliminary results of the final pivotal phase III trial with its leading drug candidate BF-200 ALA. The results show with high statistical significance that 78% of the patients were totally cleared from all actinic ...
Biofrontera quadruples shareholder base and increases trading volume
30-10-2009
Biofrontera announced that its shareholder base has grown four-fold to about 1200 shareholders since the beginning of the year. At the same time the liquidity of the stock has greatly increased. Compared to the last months of the preceding year the recent daily trading was 10 to 20 times ...
Biofrontera AG successfully places capital increase
11-09-2009
Biofrontera AG announces that the subscription of shares in the anticipated capital increase was closed. According to the current assessment the subscription of 1.2 million shares at a share price of € 1.50 is documented. The successful completion of the capital increase represents another ...
Clinical study with BioFrontera's BF-derm1 shows efficacy in severe chronic urticaria
29-07-2009
Biofrontera AG announced that it has received the results of an adaptive phase II study with BF-derm1 in chronic urticaria patients who cannot be sufficiently treated with current medication. The study has demonstrated very good efficacy and safety for the orally available BF-derm1 ...
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