Biofrontera transfers clinical research to the U.S.

"We can be much more flexible in our strategy to expand our market presence in Europe thanks to the newly defined cost structure"

22-Feb-2024 - Biofrontera AG announces that Biofrontera AG and Biofrontera Inc. have agreed on an amendment to the existing license and supply agreement (LSA). This amendment provides that Biofrontera Inc. will take over the entire clinical development program, thus reducing the cost burden for Biofrontera ...

European Commission authorizes EU-wide marketing and distribution of Biofrontera's Ameluz

20-Dec-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-Oct-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 will ...

Positive review of the European Medicines Agency in the approval process of Biofrontera's BF-200 ALA

31-Jan-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 applicants ...

Biofrontera received official review of its drug approval dossier for BF-200 ALA

23-Dec-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 states ...

Validation of the dossier for drug approval of Biofrontera's BF-200 ALA successful

04-Oct-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 of ...

Biofrontera received manufacturing and distribution license

16-Aug-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-Dec-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 keratoses ...

Biofrontera quadruples shareholder base and increases trading volume

30-Oct-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 higher. ...

Biofrontera AG successfully places capital increase

11-Sep-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 ...