Tags : European Commission

Weekly Snapshot (Jul 06 – 10, 2020)

1. LEO Reports the US FDA’s Acceptance of BLA for Tralokinumab to Treat Adults with Moderate to Severe Atopic Dermatitis Published Date: Jul 10, 2020 | Tags: LEO, Reports, US, FDA, Acceptance, BLA, Tralokinumab, Treat, Adults, Moderate to Severe, Atopic Dermatitis 2. Philips Collaborates with BioIntelliSense to Enhance Remote Patient Monitoring Published Date:  Jul 10, […]Read More

The European Commission Signs an Agreement with Roche and Merck

Shots: The EC has signed an agreement to supply Roche’s RoActemra and Merck’s Rebif in 27 EU member states willing to buy the therapies to combat the pandemic. The agreement follows requests from EU states in May to acquire the two drugs having the potential to target COVID-19 In a discussion with EC, Roche has […]Read More

The European Commission Approves the Merger of Mylan and Upjohn

Shots: The EC has approved the Viatris merger (a merger b/w Upjohn and Mylan) under EU merger regulations but the decision is conditional on the divestment of Mylan’s certain generic therapies EC ensures that the merger does not harm competition and preserves the competitive access to certain genericized therapies for national health services and the […]Read More

Janssen’s Stelara (ustekinumab) Receives EC’s Approval for its Expanded Use

Shots: The EC approval is based on P-III UNIFI program [induction study (8wks. IV) & maintenance study (44wks., SC, q8w & q12w)] assessing Stelara vs PBO in patients with mod. to sev. active UC with inadequate response to conventional (corticosteroids, immunomodulators) or biologic (one or more TNF-alpha antagonists/vedolizumab) therapies Induction study results: Clinical response achievement […]Read More

BMS’s Triple Regimen Receives European Commission Approval for Relapse/Refractory Multiple

Shots: The approval is based on P-II ELOQUENT-3 study assessing Empliciti (elotuzumab) + pomalidomide and low-dose dexamethasone (EPd) vs pomalidomide and low-dose dexamethasone (Pd) in 117 patients with r/r MM prior treated with 2L+ therapies including lenalidomide and a proteasome inhibitor (PI) with disease progression on the last therapy The P-III ELOQUENT-3 study results: The […]Read More

Alexion’s Soliris (eculizumab) Receives European Commission’s Approval for Neuromyelitis Optica

Shots: The EC approval is based on P-III PREVENT study assessing Soliris vs PBO in patients with NMOSD who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of therapy and an undergoing extension study (ECU-NMO-302) The P-III PREVENT study results: met its 1EPs; @48wks. relapse-free patients (98% vs 63%); relapse-free patients without receiving immunosuppressive therapies […]Read More

Janssen’s Imbruvica (ibrutinib) Receives European Commission Approval for Chronic Lymphocytic

Shots: The approval is based on P-III iLLUMINATE (PCYC-1130) and P-III iNNOVATE (PCYC-1127) study assessing Imbruvica + obinutuzumab vs chlorambucil + obinutuzumab and Imbruvica + rituximab vs rituximab + PBO in patients with previously untreated CLL and r/r WM respectively Collective results: improvement in PFS with the use of ibrutinib-based therapy vs SOC providing CT […]Read More