Tags : European Commission
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
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
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
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
Shots: EC has released Takeda from the obligation to divest SHP647 & its associated rights. Takeda will discontinue the clinical study of SHP647 and will provide an opportunity to the participants to access in a PTA study In 2018, EC approved its proposed acquisition of Shire with a condition. To avoid overlap in IBD b/w […]Read More
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
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
Shots: The approval is based on P-III KEYNOTE-426 study assessing Keytruda (200mg) + Inlyta (5mg) vs Sunitinib (50mg) in 861 patients in a ratio (1:1) with advanced RCC regardless of PD-L1 tumor expression and IMDC risk group The P-III KEYNOTE-426 study results: improvement in OS, 47% reduction in risk of death, m-PFS (15.1 vs 11.0 […]Read More
Shots: The approval is based on P-III IMpassion130 study assessing Tecentriq + nab-paclitaxel vs PBO + nab-paclitaxel in 902 patients in ratio (1:1) with unresectable locally advanced or metastatic TNBC treated with no prior CT for disease P-III IMpassion130 study results: reduction the risk of disease worsening or death by 38%; mPFS (7.5 mos. vs […]Read More
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
