Summary: FDA approved Amgen Inc's Bkemv as the first interchangeable biosimilar to AstraZeneca's Soliris for rare diseases like PNH and aHUS. The monoclonal antibody works by binding to the complement C5 protein, preventing the breakdown of red blood cells. Bkemv has a Boxed Warning for meningococcal infections and is available through a restricted program.
Full articleSummary: Amgen received FDA approval for Bkemv as the first interchangeable biosimilar to AstraZeneca's Soliris, aiming for a launch no later than March 2025. The biosimilar is highly similar to Soliris and will treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
Full articleSummary: Pfizer and AstraZeneca have ambitious growth plans focused on developing new blockbuster medicines and expanding their revenue, with AstraZeneca's plan to outperform Pfizer due to its emphasis on core pipeline execution over extensive business development activities. AstraZeneca aims to reach $80 billion in revenue by 2030, while Pfizer aims for at least $103.5 billion.
Full articleSummary: Pfizer and AstraZeneca, two leading drugmakers, have ambitious growth plans involving significant investment in research and development to drive revenue growth. AstraZeneca's strategic roadmap appears more focused and less dependent on extensive business development activities compared to Pfizer. Based on their future goals, AstraZeneca's stock is likely to outperform Pfizer's.
Full articleSummary: The FDA approved Amgen's Bkemv as the first interchangeable biosimilar to AstraZeneca's rare disease drug Soliris for the treatment of PNH and aHUS, with a boxed warning for meningococcal infections. Soliris has been a top-selling product for AstraZeneca.
Full articleSummary: The FDA approved Amgen's Bkemv as the first biosimilar to AstraZeneca's Soliris for rare blood disorders, with a black-box warning on serious infections. Amgen's drug met main goal in late-stage study, comparable to Soliris. Bkemv is approved for two rare blood disorders - paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
Full articleSummary: Pharmaceutical regulators approved Amgen's biosimilar Bkemv as a treatment for rare diseases, including paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, previously treated by Soliris developed by AstraZeneca-owned Alexion Pharmaceuticals.
Full articleSummary: The U.S. FDA approved Amgen's biosimilar Bkemv, the first competitor to AstraZeneca's Soliris for rare blood disorders, with a black-box warning about serious bacterial infections.
Full articleSummary: Pharmaceutical companies Pfizer, AstraZeneca, and Moderna faced patent trials for cancer drug and COVID vaccine rights. AstraZeneca owes Pfizer $107.5 million for patent infringement on lung cancer drug Tagrisso. Moderna wins patent dispute with Pfizer-BioNTech over COVID-19 vaccine.
Full articleSummary: AstraZeneca aims to deliver $80 billion in total revenue by 2030 with new growth from 20 new medicines, Bristol Myers Squibb's FDA decision date for Opdivo moved forward, GSK's success with new asthma treatment in Phase 3 trials.
Full articleSummary: Amgen and AstraZeneca announced the results of the phase 2a COURSE trial evaluating Tezspire in people with moderate to very severe COPD, showing reduction in COPD exacerbations with tezepelumab use, particularly in patients with baseline eosinophil counts =150 cells/µL and =300 cells/µL. Tezspire targets and blocks TSLP, a key cytokine associated with airway inflammation.
Full articleSummary: AstraZeneca ordered to pay $107.5m to Pfizer for patent infringement related to Tagrisso, AstraZeneca confident in its IP position, Pfizer wins patent dispute against AstraZeneca. Moderna wins key patent dispute against Pfizer and BioNTech in Europe.
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