Tags : Europe

Dexcom’s Glucose Monitoring Wearable System Receives CE Mark in the

Shots: DexCom’s G6 CGM system has obtained CE Marking across Europe for attaching on the back of the upper arm, thereby offering patients more choice when it comes to wearables. The CE marking strengthen its presence in the lucrative glucose monitoring market and boost its product portfolio The Dexcom G6 utilizes small, wearable sensor and […]Read More

Bayer Launches Eylea (aflibercept) Pre-Filled Syringe in Europe

Shots: The EMA has approved Bayer’s Eylea® (aflibercept) injection pre-filled syringe with the EC’s decision applies to all 27 EU member states as well as the UK, Iceland, Norway and Liechtenstein The P-IV ALTAIR study assessing Eylea (aflibercept) with T&E dosing regimens in patients with wet AMD, demonstrated a reduction in injection burden, i.e. up […]Read More

BioLineRx’s Motixafortide (BL-8040) Receives EC’s ODD to Treat Pancreatic Cancer

Shots: The EC has granted ODD to Motixafortide (BL-8040) for the treatment of pancreatic cancer following the positive COMP’s opinion The ODD designation is based on initial data of ongoing P-IIa COMBAT/KEYNOTE-202 study assessing the combination of BL-8040 + Keytruda (pembrolizumab) + CT in patients with m-pancreatic cancer Motixafortide is a selective inhibitor of the […]Read More

STADA Signs an Exclusive Commercialization Agreement with Alvotech for Seven

Shots: Alvotech to receive up front with subsequent milestones for the next five years. STADA to get exclusive right to commercialize seven biosimilars in all key European markets and selected markets outside Europe Alvotech will remain responsible for the development, registration and supply of the biosimilars within the EU. The collaboration will expand Alvotech’s biosimilar […]Read More

AstraZeneca Divests Rights of Seroquel and Seroquel XR to Cheplapharm

Shots: AstraZeneca to receive $178M up front and up to $61M as sales-contingent payments while it continues to manufacture and supply Seroquel and Seroquel XR to Cheplapharm during a transition period. The transaction is expected to be closed in Q4’19 The divestiture will allow AstraZeneca to focus on its main therapeutic areas by reducing its […]Read More

AstraZeneca’s Qtrilmet Receives CHMP’s Recommendation for its Approval to Treat

Shots: The CHMP’s positive opinion is based on five P-III studies assessing Forxiga (dapagliflozin) + Onglyza (saxagliptin) + Metformin vs the Forxiga + Metformin/Onglyza + Metformin/Glimepiride/Metformin in patients with inadequately controlled T2D The P-III studies results demonstrated that Qtrilmet resulted in a reduction of HbA1c and is not inferior to the combined use of insulin […]Read More

Gedeon Richter Launches Terrosa (biosimilar, teriparatide) in Europe

Shots: Richter has launched Terrosa, a biosimilar to Eli Lilly’s Forsteo approved for osteoporosis in postmenopausal women and in men at high risk of fracture and treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture Richter launched Terrosa through its affiliates in Europe following the patent […]Read More

Leo Pharma Enters into a Sub-Licensing Agreement with Bausch Health

Shots: Leo Pharma to get exclusive rights to develop & commercialize brodalumab in Australia, Brazil, Egypt, Mexico, Russia and Saudi Arabia for the treatment of moderate-to-severe psoriasis The sub-licensing agreement complements the ongoing licensing agreement b/w Leo & AstraZeneca to develop & commercialize brodalumab in Europe. Bausch Health has the rights to commercialize brodalumab through […]Read More