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News of Note - February 20, 2023

Updated: Feb 21


Monday, February 20, 2023


Trying something new, below you’ll find news via press release and then a section of articles (etc.) which intrigued enough to be read; occasional commentary in red..

Initial posting is likely to be AM in Europe w/ an update in the PM, and one final draft circa the US close..


Br. -john




FDA Accepts Chikungunya Vaccine License Application for Priority Review

  • VLA1553 has been assigned a Prescription Drug User Fee Act (PDUFA) review goal date at the end of August 2023

Valneva SE, a specialty vaccine company, focuses on the development and commercialization of prophylactic vaccines for infectious diseases with unmet needs. -CapIQ



Announces the appointment of the Chairman-Designate of Sandoz Board of Directors

  • Gilbert Ghostine, CEO of the Swiss multi-national fragrances business Firmenich appointed Chairman-Designate of the future Sandoz Board

  • Mr Ghostine to begin role as Sandoz Chairman following the spin-off from Novartis

Novartis AG researches, develops, manufactures, and markets healthcare products in Switzerland and internationally. -CapIQ


Meta Platforms

Testing ‘Meta Verified’ to Help Creators Establish Their Presence

  • People can purchase a monthly subscription for (USD) $11.99 on the web and (USD) $14.99 on iOS and Android

  • Testing Meta Verified, a new subscription bundle that includes account verification with impersonation protections and access to increased visibility and support

  • Want to make it easier for people, especially creators, to establish a presence so they can focus on building their communities on Instagram or Facebook

Meta Platforms, Inc. engages in the development of products that enable people to connect and share with friends and family through mobile devices, personal computers, virtual reality headsets, and wearables worldwide. -CapIQ



Announces Positive TALZENNA® and XTANDI® Combination Data from Phase 3 TALAPRO-2 Study

  • Data show 37% reduction in risk of disease progression or death in men with metastatic castration-resistant prostate cancer treated with TALZENNA plus XTANDI

  • Supplemental new drug application for TALZENNA and XTANDI combination granted U.S. FDA Priority Review

Pfizer Inc. discovers, develops, manufactures, markets, distributes, and sells biopharmaceutical products worldwide. -CapIQ


Lockheed Martin

Awarded $1.1 Billion Initial Contract to Provide Nation's First Sea-Based Hypersonic Strike Capability

  • Company will integrate weapon system onto U.S. Navy surface ships

Lockheed Martin Corporation, a security and aerospace company, engages in the research, design, development, manufacture, integration, and sustainment of technology systems, products, and services worldwide. It operates through four segments: Aeronautics, Missiles and Fire Control, Rotary and Mission Systems, and Space. -CapIQ


Pfizer & Valneva

Issue Update on Phase 3 Clinical Trial Evaluating Lyme Disease Vaccine Candidate VLA15

  • Approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator

  • The discontinuation of these participants was not due to any safety concerns with the investigational vaccine and was not prompted by a participant-reported adverse event

Significance here is time and perhaps any biotechs/ large biopharma using this group (Care Access – best I can tell given how many sites they run for the trial) for an outsized proportion of their clinical trials..


Asco-GU – Talzenna remains a wait-and-see story in prostate cancer

Moderna’s post-Covid prospects dim

Vas Narasimhan on the future of pharma, plus Moderna’s vaccine promise & a biotech presidential bid

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