00:47 , Jun 29, 2019 |  BioCentury  |  Finance

All eyes on new modality launches, cancer and rare disease data in 3Q19

While the typical summer lull means fewer catalysts in the third quarter, investors will be keeping a close eye on launches of new modality drugs. Of special interest to multiple buysiders is the launch of...
20:40 , Mar 22, 2019 |  BC Week In Review  |  Clinical News

Biofrontera planning applications to expand Ameluz indication

Biofrontera said it will submit regulatory applications to FDA and EMA in 3Q19 to expand the indication of Ameluz to include treatment of actinic keratoses lesions on the extremities. The decision follows Phase III data...
01:46 , Dec 30, 2016 |  BC Week In Review  |  Clinical News

Ameluz regulatory update

EMA’s CHMP recommended approval of an expanded label for Biofrontera’s Ameluz aminolevulinic acid to include treatment of superficial and/or nodular basal cell carcinoma (BCC) unsuitable for surgical treatment due to possible treatment-related morbidity and/or poor...
07:00 , Oct 24, 2016 |  BC Week In Review  |  Company News

Biofrontera sales and marketing update

Biofrontera launched Ameluz aminolevulinic acid and the BF-RhodoLED lamp in the U.S. Ameluz is approved as photodynamic therapy therapy (PDT) using the BF-RhodoLED lamp for the lesion-directed and field-directed treatment of mild to moderate actinic...
07:00 , Oct 3, 2016 |  BC Week In Review  |  Clinical News

Ameluz aminolevulinic acid: Completed Phase III enrollment

Biofrontera completed enrollment of 52 patients in an observer-blind, European Phase III trial comparing topical Ameluz plus daylight PDT vs. topical Metvix methyl aminolevulinate plus daylight PDT. Patients receive each treatment to separate areas of...
07:00 , Sep 26, 2016 |  BC Week In Review  |  Clinical News

Ameluz aminolevulinic acid regulatory update

The European Commission approved a label expansion for Biofrontera’s Ameluz aminolevulinic acid to include treatment of actinic keratosis of field cancerization. Field cancerization refers to a field or area of tissue that has cancer-associated genetic...
07:00 , Aug 1, 2016 |  BC Week In Review  |  Clinical News

Ameluz aminolevulinic acid regulatory update

EMA’s CHMP recommended expanding the label of Ameluz aminolevulinic acid from Biofrontera to include treatment of actinic keratosis of field cancerization. Field cancerization refers to a field or area of tissue that has cancer-associated genetic...
07:00 , Jul 18, 2016 |  BC Week In Review  |  Clinical News

Ameluz aminolevulinic acid: Phase III started

Biofrontera began an observer-blind, European Phase III trial to compare topical Ameluz plus daylight PDT vs. topical Metvix methyl aminolevulinate plus daylight PDT in about 50 patients. Patients will receive each treatment to separate areas...
07:00 , May 23, 2016 |  BC Week In Review  |  Clinical News

Ameluz aminolevulinic acid regulatory update

FDA approved an NDA from Biofrontera for Ameluz aminolevulinic acid as a photodynamic therapy (PDT) using the BF-RhodoLED lamp for the lesion-directed and field-directed treatment of mild to moderate actinic keratoses on the face and...
07:00 , Apr 4, 2016 |  BioCentury  |  Finance

2Q milestones

2Q milestones Company Product Indication Event Milestone Ablynx N.V. (Euronext:ABLX) ALX-0171 Respiratory syncytial virus (RSV) infection Ph I/IIa data 2Q16 Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) Nuplazid pimavanserin Parkinson's disease psychosis (PDP) PDUFA date 5/1/16 Acucela Inc....