COVID-19 vaccine

U.S. Supreme Court to Hear Landmark NCLA Case Against Government Social Media Censorship

Retrieved on: 
Saturday, October 21, 2023

This afternoon the Court agreed to hear arguments over the Fifth Circuit’s grant of a preliminary injunction in Missouri v. Biden, a case brought on behalf of NCLA clients Drs.

Key Points: 
  • This afternoon the Court agreed to hear arguments over the Fifth Circuit’s grant of a preliminary injunction in Missouri v. Biden, a case brought on behalf of NCLA clients Drs.
  • The New Civil Liberties Alliance welcomes this opportunity to defend the First Amendment rights of our clients in the U.S. Supreme Court.
  • NCLA released the following statements:
    “We are disappointed Americans’ First Amendment rights will be vulnerable to government infringement until this case is decided.
  • The First Amendment forbids such censorship, and the Supreme Court must never allow such mischief again, if we are to keep our democracy.”

Albertsons Companies, Inc. Reports Second Quarter Fiscal 2023 Results

Retrieved on: 
Tuesday, October 17, 2023

Albertsons Companies, Inc. (NYSE: ACI) (the "Company") today reported results for the second quarter of fiscal 2023, which ended September 9, 2023.

Key Points: 
  • Albertsons Companies, Inc. (NYSE: ACI) (the "Company") today reported results for the second quarter of fiscal 2023, which ended September 9, 2023.
  • Net sales and other revenue was $18.3 billion during the 12 weeks ended September 9, 2023 ("second quarter of fiscal 2023") compared to $17.9 billion during the 12 weeks ended September 10, 2022 ("second quarter of fiscal 2022").
  • Gross margin rate decreased to 27.6% during the second quarter of fiscal 2023 compared to 27.9% during the second quarter of fiscal 2022.
  • Interest expense, net was $111.9 million during the second quarter of fiscal 2023 compared to $89.8 million during the second quarter of fiscal 2022.

Pfizer Amends U.S. Government Paxlovid Supply Agreement and Updates Full-Year 2023 Guidance

Retrieved on: 
Friday, October 13, 2023

Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.

Key Points: 
  • Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.
  • Please include “Pfizer-BioNTech COVID-19 Vaccine(2023-2024 Formula) EUA” in the first line of box #18 of the report form.
  • In addition, individuals can report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.
  • Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

Luminary Labs awarded BARDA contract to launch Project NextGen vaccine innovation prize competitions

Retrieved on: 
Friday, October 13, 2023

NEW YORK, Oct. 13, 2023 /PRNewswire/ -- Luminary Labs, a leader in accelerating innovation on behalf of the public, private, and nonprofit sectors, today announced its partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. Luminary Labs will design, promote, and administer two prize competitions in support of Project NextGen's goal to accelerate the development of COVID-19 vaccines, therapeutics, and enabling technologies.

Key Points: 
  • Luminary Labs will design, promote, and administer two prize competitions in support of Project NextGen's goal to accelerate the development of COVID-19 vaccines, therapeutics, and enabling technologies.
  • The two international prize competitions will focus on:
    Catalyzing the development of patch-based vaccine delivery technologies with an emphasis on the collection of clinical evidence with a path toward regulatory approval and commercialization.
  • The prize competition is expected to launch in 2024, with up to $50 million in prizes.
  • "We are honored to partner with BARDA to reimagine vaccine delivery technology and help our nation prepare for known and unknown threats."

Winner of 2023 ISPE Facility of the Year Awards to be Announced at Black Tie Banquet

Retrieved on: 
Thursday, October 12, 2023

LAS VEGAS, Oct. 12, 2023 /PRNewswire-PRWeb/ -- ISPE is set to unveil the recipient of the prestigious 2023 Facility of the Year Award (FOYA) Overall Winner during the upcoming FOYA Celebratory Reception and Banquet on 15 October 2023, in Las Vegas, Nevada, USA. The event will showcase the overall winner and recognize the accomplished FOYA category winners. Acceptance speeches will also be given by honorees.

Key Points: 
  • LAS VEGAS, Oct. 12, 2023 /PRNewswire-PRWeb/ -- ISPE is set to unveil the recipient of the prestigious 2023 Facility of the Year Award (FOYA) Overall Winner during the upcoming FOYA Celebratory Reception and Banquet on 15 October 2023, in Las Vegas, Nevada, USA.
  • The event will showcase the overall winner and recognize the accomplished FOYA category winners.
  • "Each of these companies and their associated projects represent manufacturing facilities of the future in pharmaceutical industry," said Tom Hartman, President and CEO of ISPE.
  • : Based in Pleasant Prairie, Wisconsin, USA, Project Tomorrow showcases Nexus Pharmaceuticals' consistent focus on meeting patient needs for the long term.

Tenacious curiosity in the lab can lead to a Nobel Prize – mRNA research exemplifies the unpredictable value of basic scientific research

Retrieved on: 
Tuesday, October 3, 2023

The 2023 Nobel Prize in physiology or medicine will go to Katalin Karikó and Drew Weissman for their discovery that modifying mRNA – a form of genetic material your body uses to produce proteins – could reduce unwanted inflammatory responses and allow it to be delivered into cells.

Key Points: 
  • The 2023 Nobel Prize in physiology or medicine will go to Katalin Karikó and Drew Weissman for their discovery that modifying mRNA – a form of genetic material your body uses to produce proteins – could reduce unwanted inflammatory responses and allow it to be delivered into cells.
  • We asked André O. Hudson, a biochemist and microbiologist at the Rochester Institute of Technology, to explain how basic research like that of this year’s Nobel Prize winners provides the foundations for science – even when its far-reaching effects won’t be felt until years later.

What is basic science?

    • Basic research, sometimes called fundamental research, is a type of investigation with the overarching goal of understanding natural phenomena like how cells work or how birds can fly.
    • Researchers sometimes conduct basic research with the hope of eventually developing a technology or drug based on that work.

What are some basic science discoveries that went on to have a big influence on medicine?

    • The 2023 Nobel Prize in physiology or medicine acknowledges basic science work done in the early 2000s.
    • Another example is the discovery of antibiotics, which was based on an unexpected observation.
    • Early discoveries start from a basic observation, asking the simple question of “How?” Only later are they parlayed into a medical technology that helps humanity.

Why does it take so long to get from curiosity-driven basic science to a new product or technology?

    • The mRNA modification discovery could be considered to be on a relatively fast track from basic science to application.
    • The importance of their discovery came to the forefront with the pandemic and the millions of lives they saved.
    • Most basic research won’t reach the market until several decades after its initial publication in a science journal.
    • Likewise, because the return on investment for basic research often isn’t clear, it can be a hard sell to support financially.

Why is basic science important?

    • For me, the most critical reason is that basic research is how we train and mentor future scientists.
    • In an academic setting, telling students “Let’s go develop an mRNA vaccine” versus “How does mRNA work in the body” influences how they approach science.
    • Almost every scientist is trained under a basic research umbrella of how to ask questions and go through the scientific method.

What is a common misconception about basic science?

    • In the short term, the worth of basic research can be hard to see.
    • But in the long term, history has shown that a lot of what we take for granted now, such as common medical equipment like X-rays, lasers and MRIs, came from basic things people discovered in the lab.
    • As long as curiosity is a part of humanity, we’re always going to be seeking answers.

TFF Pharmaceuticals Congratulates our Scientific Advisory Board Member, Drew Weissman, M.D., Ph.D., for Receiving the Nobel Prize in Physiology or Medicine for his Pioneering Work Enabling the Development of mRNA COVID-19 Vaccines

Retrieved on: 
Monday, October 2, 2023

FORT WORTH, Texas, Oct. 02, 2023 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing technology platform, would like to congratulate Drew Weissman, M.D., Ph.D., a member of the Company’s Scientific Advisory Board, for receiving the Nobel Prize in Physiology or Medicine, based on his pioneering work enabling the development of mRNA COVID-19 vaccines.

Key Points: 
  • FORT WORTH, Texas, Oct. 02, 2023 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing technology platform, would like to congratulate Drew Weissman, M.D., Ph.D., a member of the Company’s Scientific Advisory Board, for receiving the Nobel Prize in Physiology or Medicine, based on his pioneering work enabling the development of mRNA COVID-19 vaccines.
  • “On behalf of our Board of Directors and all of our employees, I would like to congratulate Dr. Weissman for this extraordinary achievement,” said Harlan Weisman, M.D., Chief Executive Officer and Vice Chairman of TFF Pharmaceuticals.
  • “These discoveries laid the groundwork for the rapid development of mRNA-based COVID-19 vaccines, which proved to have an enormous impact on human health during the global pandemic.”

Pfizer and BioNTech Receive Health Canada Authorization for XBB.1.5-Adapted Monovalent COVID-19 Vaccine

Retrieved on: 
Thursday, September 28, 2023

New Omicron XBB.1.5-adapted COVID-19 vaccine is administered as a single dose for individuals 5 years of age and older, regardless of COVID-19 vaccination history.

Key Points: 
  • New Omicron XBB.1.5-adapted COVID-19 vaccine is administered as a single dose for individuals 5 years of age and older, regardless of COVID-19 vaccination history.
  • The updated vaccine will be available in Canada as a single dose for individuals 5 years of age and older, regardless of prior COVID-19 vaccination history.
  • The authorization of is based on the full body of previous clinical, non-clinical, and real-world evidence supporting the safety and efficacy of the Pfizer-BioNTech COVID-19 Vaccines.
  • “We are proud of this achievement that empowers Canadians to protect themselves against the XBB sublineages, which are currently the most dominant strains in Canada.

VBI Vaccines’ Pan-Coronavirus Vaccine Candidate, VBI-2901, Induced Broad and Durable Protective Titers Against Variants of Concern

Retrieved on: 
Wednesday, September 27, 2023

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced interim data from the Phase 1 clinical study of its multivalent pan-coronavirus vaccine candidate, VBI-2901, which expresses the ancestral COVID-19, SARS, and MERS spike antigens.

Key Points: 
  • VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced interim data from the Phase 1 clinical study of its multivalent pan-coronavirus vaccine candidate, VBI-2901, which expresses the ancestral COVID-19, SARS, and MERS spike antigens.
  • The Phase 1 clinical study enrolled 101 adults, aged 18-64 years who had received either two or three doses of a messenger RNA (mRNA) COVID-19 vaccine licensed by Health Canada, and assessed both one and two dose booster regimens of VBI-2901.
  • Based on interim data, however, peak responses were achieved with only a single 10µg dose of VBI-2901.
  • “As we’ve previously said, we endeavor to develop a vaccine with meaningful differentiation to those COVID-19 vaccines already approved – we believe these initial data are evidence of just that, demonstrating an ability to safely broaden durable, protective levels of immune responses and significantly boost neutralizing responses in participants with low baseline antibody titers,” said Jeff Baxter, VBI’s President and CEO.

NCLA Asks U.S. Supreme Court Not to Stay Injunction Against Government Social Media Censorship

Retrieved on: 
Wednesday, September 20, 2023

Surgeon General’s office from pressuring social media platforms to censor constitutionally protected speech.

Key Points: 
  • Surgeon General’s office from pressuring social media platforms to censor constitutionally protected speech.
  • On September 8, a Fifth Circuit panel upheld the most significant components of U.S. District Judge Terry Doughty’s preliminary injunction prohibiting the aforementioned officials from pressuring, coercing, or significantly encouraging social media companies to suppress constitutionally protected speech.
  • The government has failed to present a single convincing argument for staying the injunction any further.
  • The Supreme Court is unlikely to reverse the Fifth Circuit’s injunction against such abridgment of the First Amendment.