News of Note - February 20, 2023
Updated: Feb 21
BULL BEAR BRES|NAHAN
Monday, February 20, 2023
11:39:17
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
*PRESS RELEASE*
VLA FP | VALN
Valneva
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
NOVN SW | NVS
Novartis
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
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
PFE
Pfizer
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
LMT
Lockheed Martin
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
PFE & VLA FP | VALN
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..
*ARTICLES, ETC.*
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