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...
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...
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 CompanyProductIndicationEventMilestoneAblynx N.V. (Euronext:ABLX)ALX-0171Respiratory syncytial virus (RSV) infectionPh I/IIa data2Q16Acadia Pharmaceuticals Inc. (NASDAQ:ACAD)Nuplazid pimavanserinParkinson's disease psychosis (PDP)PDUFA date5/1/16Acucela Inc. (Tokyo:4589) / Otsuka Pharmaceutical Co. Ltd.EmixustatGeographic atrophy associated with dry age-related macular degeneration (AMD)Ph IIb/III data2Q16Advaxis...
07:00 , Mar 21, 2016 |  BC Week In Review  |  Clinical News

Ameluz: Phase III data

A double-blind, European Phase III trial in 281 patients with 1-3 non-aggressive BCCs of <=2 mm thickness showed that topical BF-200 ALA followed by photodynamic therapy led to complete clearance of all BCCs in 93.4%...
08:00 , Jan 11, 2016 |  BioCentury  |  Finance

Sowing season

Stephen Hansen, Associate Editor   BUYSIDE VIEW XXIV While the biotech sector's three-year rocket ride isn't likely to continue in 2016, fund managers are still anticipating a slew of high-profile milestones in the New Year. This year...