Shots:Health Canada has granted NOC for Yesafili (vial & PFS presentations, 2 mg/0.05 mL), a biosimilar to Eylea (aflibercept), anticipated launch on Jul 04, 2025Approval was supported by the P-III (INSIGHT) study in Diabetic Macular Edema(DME), which showed no clinically meaningful differences from EYLEA in PK, safety, efficacy, or immunogenicity.YESAFILI is a…
Shots:Biocon Biologics & Regeneron have entered into a settlement & license agreement, allowing the US launch of Yesafili, an interchangeable biosimilar version of Eylea (aflibercept) by H2’26Yesafili’s FDA approval was supported by analytical, nonclinical & clinical data incl. P-III (INSIGHT) trial assessing Yesafili vs Eylea in DME pts, confirming its similarity in PK,…
Shots:Subsequent to our last year’s series titled “Top Performing Drugs of 2021”, PharmaShots presents a list of 12 high revenue-generating drugsWith the ongoing pandemic playing an instrumental role in reshaping the life science industry now and then, it becomes increasingly onerous for the pharmaceutical industry to keep up with the growing global demands…
In an interview with PharmaShots, Sree Vadlamudi, Vice president, Head of Business Development EU and RoW at Iktos, shared his views on the role of AI in shaping the pharma & biotech industry.Shots:Sree spoke about the drug development process and how AI is contributing to gaining the productivity and changing the scenario in the…
In an interview with PharmaShots, John Meduri, Chief Strategy Officer at Accelerate Diagnostics shared his views on antimicrobial resistance and discuss the epidemiology of AMR cases in the US and worldwide. He also shared his views on Accelerate Pheno system and PhenoTest BC kit.Shots:Antibiotic resistance occurs when bacteria develop the ability to defeat…
In an interview with PharmaShots, Chris Arendt, Head of the Oncology Therapeutic Area Unit at Takeda shared his views on the new data of Alunbrig in the P-III ALTA-1L study for the Treatment of ALK+ mNSCLCShots:The P-III ALTA-1L study evaluates Alunbrig vs Crizotinib in patients with ALK+ mNSCLC who have not received prior treatment with an ALK inhibitorThe results showed…
In an interview with PharmaShots, Lloyd Miller, MD, Ph.D., Vice President, Immunodermatology Disease Area Leader at Janssen shares his views on the data presented at EADV 2021 about patients who switch to Tremfya (guselkumab) from Humira (adalimumab) in P-III VOYAGE 1 & 2 trials for PsO & also highlighting the P-III DISCOVER-1 & 2 trial for PsAShots:The P-III VOYAGE 1 &…
In an interview with PharmaShots, Laurent Debussche, Global Head of Molecular Oncology Research Therapeutic Area at Sanofi shares insight on the SERDs data being presented at ASCO 2021 and highlight the need for this type of innovation for ER+ breast cancerShots:Sanofi has presented the data from P-I AMEERA-1 study evaluating amcenestrant in combination with palbociclib &…
In an interview with PharmaShots, Monica Mann, Head of Global Medical, Multiple Sclerosis at Biogen shares her views on the Plegridy and how it works on MS patients. She also shed light on the approval of the therapy in the US and EU.Shots:The approval of Plegridy (IM) by the EC and the US FDA is based on…
In an interview with PharmaShots, Douglas E. Williams, Ph.D., President and Chief Executive Officer of Codiak BioSciences shares insights on the potential of engineered exosomes and the data presented at SITC 2020.Shots:Codiak demonstrated the potential of engineered exosomes - extracellular vesicles that act like the body's FedEx delivery trucks to carry messengers between cells -…

