Pfizer
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FDA Approves Updated Covid-19 Vaccines to Address Now Circulating Variants
The FDA said the updated messenger RNA vaccines from Pfizer/BioNTech and Moderna will protect against the omicron subvariants now prevalent in circulation. Left out of the FDA decision is Novavax, whose protein-based vaccine is still under regulatory review.
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Pfizer Expands to Multiple Myeloma With FDA Approval for New Antibody Drug
Oncology is already a big piece of Pfizer’s drug lineup. The portfolio is expanding to multiple myeloma with FDA approval of Elrexfio, a bispecific antibody that targets the cancer protein BCMA.
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Payer’s Place: Dawn Maroney
Dawn Maroney, President, Markets of Alignment Health and CEO of Alignment Health Plan, to discuss how they are using technology to provide better service and care to consumers.
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GSK Patent Suit Aims to Halt Pfizer’s RSV Vaccine for Adults, But Not Infants
GSK claims that Pfizer’s FDA-approved vaccine for respiratory syncytial virus infringes on four patents protecting its own approved vaccine, Arexvy. The patent suit comes with the RSV season approaching.
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Pfizer, Flagship Team Up in $100M R&D Pact: 10 New Drugs for Unmet Needs
Pfizer and Flagship Pioneering are partnering in a drug research alliance leveraging the capabilities of the more than 40 biotech startups in the venture capital firm’s portfolio. The new partners aim to develop drugs for unmet needs, including those in broad patient populations.
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Pfizer Growth Hormone Drug Measures Up at FDA With O.K. for Weekly Dosing
Ngenla, a hormone drug from partners Pfizer and Opko Health, is now FDA approved for treating children with growth hormone deficiency. The once-weekly injectable biologic will compete against an Ascendis Pharma product that won its FDA approval in 2021.
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FDA Approval of Pfizer Alopecia Drug Brings New Competition to Eli Lilly Med
Pfizer’s Litfulo is the first treatment approved for treating adolescents with severe alopecia areata. The drug’s approval also covers adults, were it will compete against Eli Lilly’s Olumiant.
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Pfizer’s RSV Vaccine Wins FDA Approval on Heels of Regulatory Nod for GSK
Pfizer’s Abrysvo is now approved for preventing illness caused by respiratory syncytial virus, or RSV, in adults 60 and older. The regulatory decision comes weeks after GSK won approval for its RSV vaccine, Arexvy.
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Pfizer Hemophilia Drug Reduces Bleeding in Key Study; Regulatory Filings Are Planned
Marstacimab, a Pfizer drug for both hemophilia A and B, met the main goal of a Phase 3 study and the company now plans to discuss the data with regulators. The Pfizer drug could beat to the market a Novo Nordisk drug that addresses the same novel target.
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FDA Nod Makes Pfizer’s Paxlovid the First Approved Oral Covid-19 Antiviral Drug
Paxlovid, a Pfizer antiviral awarded FDA emergency authorization in 2021 for treating Covid-19, is now approved for treating adults. Results from a pivotal clinical trial showed that Paxlovid led to an 86% reduction in Covid-19-related hospitalization or death from any cause compared to a placebo.
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Applying Remote Patient Monitoring to Surgery Prep and Recovery, Oncology and Women’s Health
Join us to learn about the latest trends in remote monitoring and how to extend its benefits beyond chronic conditions to more patients – all while using fewer staff resources.
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The Public Health Emergency Is Expiring, So What Is the Future of Covid-19 Vaccines?
The FDA will decide this summer which strains the next Covid-19 vaccines should address. But companies are also taking a longer view, developing shots for the future that offer different features than the current ones and potentially broader protection against a wider range of pathogens.
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FDA’s Covid-19 Changes Set Stage for the Vaccines to Emulate Seasonal Flu Shots
Older adults and immunocompromised people may now get a second Covid-19 booster shot, according to amendments to the FDA authorizations of the mRNA vaccines. Further changes will be discussed at an advisory committee meeting planned for June.
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Pfizer’s Migraine Drug Approval Triggers $475M Payment to Royalty Pharma
Royalty Pharma’s milestone payment from the approval of Pfizer migraine drug Zavzpret stems from financing deals struck with the therapy’s previous developer, Biohaven Pharmaceuticals. Royalty Pharma is also in line to receive royalty payments going beyond the next decade.
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Pfizer’s Seagen Acquisition Brings It Full Circle in a Hot Area of Cancer Drug R&D
Pfizer is no stranger to antibody drug conjugate cancer therapies, but it hasn’t been commercially successful with them. The pharma giant’s agreement to acquire Seagen for $43 billion will thrust it to the forefront of the ADC drug class, which has become a hot space for research and regulatory activity in recent years.
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Pfizer RSV Vaccine Hits Trial Goal for Infants; Year-End FDA Filing Planned
Pfizer’s respiratory syncytial virus vaccine candidate infants has clinical data showing it helped prevent severe infections in infants. It’s a maternal vaccine that produces antibodies in the mother that confer temporary protection to a baby.
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FDA authorizes updated Covid-19 boosters to protect against omicron this fall, winter
The FDA has authorized mRNA Covid-19 booster shots designed to protect against the original strain of the novel coronavirus, as well as the two omicron subvariants that are currently driving U.S. caseloads. An advisory committee to the CDC is scheduled to discuss these vaccines and vote on their recommended use on Thursday.
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Payer’s Place: Dr. Anil Singh
Dr. Anil Singh shares his insights into the strategies employed by the organization to identify the most effective digital solutions for their members.
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Discover the Next-Gen Platform for Integrated Collaborative Care
Beyond EHRs and digital front doors, reducing the gaps in patient care journeys.
