Novavax
🇺🇸United States
Moderna Withdraws FDA Application for Flu-COVID Combo Vaccine, Plans Resubmission Later This Year
• Moderna has voluntarily withdrawn its Biologics License Application (BLA) for mRNA-1083, a combination flu and COVID-19 vaccine candidate for adults 50 and older, after consultation with the FDA.
• The company plans to resubmit the application later in 2025 after obtaining vaccine efficacy data from an ongoing Phase 3 trial of its seasonal influenza vaccine candidate, mRNA-1010.
• Interim data from the mRNA-1010 Phase 3 trial is expected to be available this summer, which will inform the resubmission strategy for the combination vaccine.
FDA Overhauls COVID-19 Vaccine Approval Process, Limiting Access for Healthy Adults and Children
• The FDA has announced major changes to COVID-19 vaccine approvals, requiring placebo-controlled clinical trials for shots intended for healthy adults and children, effectively ending routine annual approvals for these groups.
• Under the new framework, COVID-19 vaccines will remain readily available through streamlined approvals only for adults 65 and older and those with health conditions that increase risk of severe COVID-19.
• The policy shift, spearheaded by FDA Commissioner Marty Makary and vaccine chief Vinay Prasad, represents a significant departure from the previous "one-size-fits-all" approach to COVID-19 vaccination recommendations.
FDA Questions Pfizer's Approach to Expand Talzenna's Indication in Prostate Cancer
• The FDA has raised concerns about Pfizer's strategy to expand Talzenna's indication to all castration-resistant prostate cancer patients, questioning the reliance on an "incompletely defined" subgroup without HRR gene mutations.
• Pfizer is seeking to broaden Talzenna's current first-line indication from only HRR-mutated castration-resistant prostate cancer to an all-comers population, representing a significant potential market expansion.
• The regulatory scrutiny highlights ongoing challenges in precision medicine approaches and biomarker-based treatment strategies in oncology drug development.
FDA Demands Additional Trial for Novavax COVID-19 Vaccine, Delaying Full Approval
• The FDA has requested an additional clinical trial for Novavax's protein-based COVID-19 vaccine (NVX-CoV2601) before granting full approval, despite promising Phase 2/3 results showing a 5.8-fold increase in neutralizing antibodies.
• Novavax's stock dropped approximately 8% following the regulatory setback, raising concerns about the company's ability to compete with established mRNA vaccines in the market.
• The timing of FDA's request coincides with HHS Secretary Robert F. Kennedy Jr.'s appointment, suggesting potential political influence in the regulatory process as Novavax negotiates the scope of the additional trial.
Takeda Spotlights Three Late-Stage Readouts as Potential "Inflection Point" Amid Vyvanse Generic Competition
• Takeda Pharmaceutical is positioning three upcoming late-stage clinical trial readouts as a strategic "inflection point" to offset revenue losses from Vyvanse's generic competition.
• The Japanese pharmaceutical giant is focusing on new product launches and pipeline advancement to maintain growth momentum, with particular emphasis on rare disease and neuroscience therapeutic areas.
• Industry analysts view Takeda's pipeline strategy as critical for the company's long-term financial stability, as it navigates the challenging transition period of losing exclusivity for one of its top-selling medications.
FDA Requests Additional Trial for Novavax COVID-19 Vaccine Before Full Approval
• The FDA has asked Novavax to conduct an additional randomized, controlled study of its COVID-19 vaccine NVX-CoV2601 before considering full approval, despite the vaccine having emergency use authorization since 2022.
• Interim results from a phase 2/3 study showed Novavax's updated XBB.1.5 variant vaccine generated 5.8 times higher neutralizing antibody levels compared to the original formulation, with a favorable safety profile.
• The FDA's request represents a significant setback for Novavax, which had expected approval based on prior conversations with regulators and had already passed its April 1 PDUFA date.
Trump's Executive Order Delays Medicare Drug Price Negotiations, Sparking Industry and Policy Debate
• President Trump signed an executive order extending the exemption period for small-molecule drugs from Medicare price negotiations by four years, a move criticized by advocacy groups as favoring pharmaceutical industry interests.
• The order aims to address what the administration calls the "pill penalty" - the current policy where small-molecule drugs (90% of medications) face negotiations after 9 years while biologics have longer exemption periods.
• The Medicare Drug Price Negotiation Program, established under the Biden administration, had already achieved price reductions of 38-79% on 10 high-cost drugs with projected savings of $6 billion if applied in 2023.
Sanofi Advances Respiratory Pipeline with Promising Amlitelimab Data in Heterogeneous Inflammatory Asthma
• Sanofi's amlitelimab demonstrated clinically meaningful efficacy in heterogeneous inflammatory asthma, showing over 70% reduction in exacerbations in patients with specific biomarkers at week 60 of the TIDE-Asthma phase 2 study.
• The company is expanding its respiratory portfolio with lunsekimig now targeting chronic rhinosinusitis and COPD alongside asthma, with phase 2 readouts anticipated in 2026.
• Itepekimab, developed in partnership with Regeneron, is broadening its clinical program beyond COPD into chronic rhinosinusitis, with phase 3 readouts in COPD expected in H2 2025.
FDA Misses Deadline for Full Approval Decision on Novavax's COVID-19 Vaccine
• The U.S. Food and Drug Administration (FDA) has missed its April 1 deadline to decide on granting full approval to Novavax's protein-based COVID-19 vaccine, which currently has Emergency Use Authorization.
• The delay comes shortly after the resignation of Peter Marks, the FDA's top vaccine regulator who played a key role in COVID-19 vaccine approvals during the pandemic.
• According to reports, FDA senior leaders have indicated that Novavax's application needs more data, making approval unlikely in the near term, though the company maintains it has responded to all information requests.
FDA Cancels Critical Flu Vaccine Advisory Meeting, Raising Production Timeline Concerns
• The FDA has unexpectedly canceled the March 13 meeting of its Vaccines and Related Biological Products Advisory Committee, which was scheduled to discuss next year's flu vaccine composition.
• The cancellation could significantly impact the six-month flu vaccine production cycle, potentially disrupting the traditional June manufacturing start date.
• Health experts and vaccine manufacturers express concern over the disruption to the established regulatory process for seasonal flu vaccine strain selection.
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