Tags : European Commission

Regulatory

Biogen’s Plegridy (peginterferon beta-1a, IM) Receives EC’s Approval for Relapsing-Remitting

Shots: The approval is based on data assessing bioequivalence and AEs associated with IM administration vs SC administration of Plegridy in healthy volunteers Result: The data showed that participants receiving therapy through IM experienced fewer injection site reactions (14.4 vs 32.1 %), safety profiles were similar. The frequency of injection site reactions and AEs were […]Read More

Clinical Trials

Pfizer and BioNTech to Supply EU with up to 200M

Shots: The companies sign an agreement with the EC to supply 200M doses of BNT162b2 mRNA-based vaccine candidate against SARS-CoV-2 to EU member states, with an option to request an additional 100M doses Deliveries are anticipated to start by the end of 2020, following clinical success and regulatory authorization. The companies expect to produce ~1.3B […]Read More

Weekly Snapshot

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

Pharma

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

Regulatory

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

Regulatory

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