Month: <span>June 2019</span>

Pfizer’s Zirabev (biosimilar, bevacizumab) Receives the US FDA’s Approval for

Shots: The approval is based on REFLECTIONS B7391003 study results assessing Zirabev vs reference product Avastin, in patients with advanced non-sq NSCLC The study resulted in biosimilarity data, showing clinical equivalence and no clinically meaningful differences with the reference product in patients. Additionally, Zirabev is Pfizer’s second oncology biosimilar following Trazimera (trastuzumab-qyyp) Zirabev (bevacizumab-bvzr) is […]Read More

Innovent and Eli Lilly Report NMPA’s Acceptance of NDA for

Shots: The NDA is based on two P-III studies evaluating the safety, efficacy & PK of IBI301 vs MabThera/Rituxan (rituximab) in patients with DLBCL & CD20-positive B-cell lymphoma respectively  The two P-III studies resulting in meeting its 1EPs demonstrating the bio-similarity b/w IBI301 and branded rituximab IBI301 is a biosimilar of rituximab targeting CD20 antigen […]Read More

Apple Disrupting the Healthcare with the Availability of One Drop

Shots: Apple has commenced sales of the One Drop glucose monitors which closely integrates with iPhone and the Apple Watch to bring the health app-compatible diabetes management device at its outlets The availability of One Drop |Chrome at retail outlets allows Apple to expand into healthcare by selling consumer-oriented products and integrating the data in […]Read More

Alexion’s Soliris (eculizumab) Receives FDA’s Approval for Anti-Aquaporin-4 Antibody Positive

Shots: The approval is based on P-III PREVENT study results assessing Soliris vs PBO in patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive The P-III PREVENT study results: @48wks. & @144wks. relapse free patients (98% & 96% vs 63% & 45%); relapse free patients without receiving IST @144wks. (100% vs […]Read More

GSK Amends its Development and Commercialization Agreement with Liquidia for

Shots: GSK to get rights to develop and commercialize three additional inhaled therapies utilizing Liquidia’s PRINT technology and can acquire rights to pursue additional PRINT based inhalation therapies. Liquidia to receives milestones & royalties with the initiation of P-III studies In 2012, Liquidia & GSK collaborated to develop vaccines & inhaled therapies. Later in 2015, […]Read More