EU Archives | PharmaShots

Acutus Medical’s AcQMap Contact Mapping Software Receives CE Mark Approval

April 29, 2019May 2, 2019Shiwani Sharma

Shots: The AcQMap contact mapping is a software offering physicians with multiple options to inform individualized therapy, to reconstruct atrial anatomy utilizing ultrasound [...]

Sanofi and Lexicon’s Zynquista (sotagliflozin) Receive EU’s MAA to Treat Type-1 Diabetes in Adults

April 29, 2019May 2, 2019Shiwani Sharma

Shots: The authorization is based on inTandem study consisting of three P-III trials assessing sotagliflozin (200/400 mg) vs insulin as monothx in 3000 [...]

AstraZeneca and Merck’s Lynparza (olaparib) Receive EU’s Approval as a Monotherapy to Treat Germline BRCA-Mutated HER2-Negative Advanced Breast Cancer

April 10, 2019April 24, 2019Shiwani Sharma

Shots: The approval is based on P-III OlympiAD trial assessing Lynparza (300mg, bid) vs CT (capecitabine, eribulin or vinorelbine) in 302 patients with [...]

Oncology Venture Signs an Exclusive Option Agreement to In-License Commercialization Rights for R-Pharm’s Ixempra (ixabepilone) in EU

April 5, 2019April 24, 2019Shiwani Sharma

Shots: Oncology to evaluate Ixempra (ixabepilone) in combination with DRP CDx for metastatic breast cancer in EU. Post the results of trial, Oncology [...]

Fresenius Kabi’s Idacio (adalimumab, biosimilar) Receives EU’s Marketing Approval in Rheumatology, Gastroenterology and Dermatology

April 4, 2019April 24, 2019Shiwani Sharma

Shots: The approval is based on its non-inferiority data consisting of its PK, efficacy, safety, immunogenicity data with the reference product in analytical, [...]