European Medicines Agency

The EGALITY study met its primary endpoint demonstrating equivalent efficacy of Sandoz biosimilar etanercept candidate to the originator product at week 12 As a first-of-its kind, the confirmatory clinical safety and efficacy study compares originator etanercept to a biosimilar candidate … Read the full press release →

OCREVUS is the first investigational medicine seeking marketing authorisation for both relapsing and primary progressive multiple sclerosis (MS) FDA grants Priority Review Designation for OCREVUS Biologics License Application (BLA) BASEL, 29-Jun-2016 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced … Read the full press release →

Sandoz advances biosimilar portfolio with sixth major biosimilar file acceptance in less than one year Sandoz is seeking approval for all indications included in the reference product’s label Sandoz’ submission includes data from multiple clinical trials with over 800 patients … Read the full press release →

LONDON, 02-May-2016 — /EuropaWire/ — AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of a new antibiotic, CAZ AVI 2g/0.5g powder. CAZ … Read the full press release →

• A single 5g dose of idarucizumab immediately reversed the anticoagulant effect of dabigatran in all patients evaluated • Results based on analyses of high-risk patients from RE-VERSE AD™ study • Data presented at ACC 2016 Scientific Session and Expo … Read the full press release →

SUBJECT: REGULATORY LANDSCAPE FOR PHARMA MANUFACTURERS AMSTERDAM, 30-Mar-2016 — /EuropaWire/ — Christoph Krähenbühl, senior director, 3C Excellis, will be a featured speaker at Systech International’s upcoming global conference in Amsterdam titled UNIQUITY Europe, 2016, focused on serialization, global brand protection … Read the full press release →

Offers Integrated Serialization Equipment Solutions to the Global Pharma Industry BRUSSELS, 15-Mar-2016 — /EuropaWire/ — Systech International, a global leader in brand protection technologies, announces the addition of Inno4Life, an internationally recognized Original Equipment Manufacturer in Life Science equipment solutions, to its Unisolve™ partner … Read the full press release →

Requirements for industry now available on submission of clinical data for publication LONDON, 04-Mar-2016 — /EuropaWire/ — The European Medicines Agency (EMA) has published detailed guidance for pharmaceutical companies on the requirements to comply with its policy on the publication of … Read the full press release →