PF-07321332

Human medicines European public assessment report (EPAR): Paxlovid, nirmatrelvir,ritonavir, Date of authorisation: 28/01/2022, Revision: 16, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Paxlovid, nirmatrelvir,ritonavir, Date of authorisation: 28/01/2022, Revision: 16, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Paxlovid, nirmatrelvir,ritonavir, Date of authorisation: 28/01/2022, Revision: 16, Status: Authorised

Aligos Therapeutics Reports Recent Business Progress and Second Quarter 2022 Financial Results

Retrieved on: 
Thursday, August 4, 2022

SOUTH SAN FRANCISCO, Calif., Aug. 04, 2022 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today reported recent business progress and financial results for the second quarter June 30, 2022.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Aug. 04, 2022 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today reported recent business progress and financial results for the second quarter June 30, 2022.
  • In the second quarter, we continued to make strong progress in advancing our drug candidates and discovery programs, said Lawrence Blatt, PhD, MBA, CEO and Chairman of the Board at Aligos.
  • ALG-000184 (CAM-2): Enrollment of HBeAg positive subjects in 28-day and 12-week cohorts evaluating various dose levels is ongoing.
  • We plan to share data from HBeAg positive cohorts at a scientific conference in Q4 2022.

Pfizer Announces Submission of New Drug Application to the U.S. FDA for PAXLOVID™

Retrieved on: 
Thursday, June 30, 2022

(NYSE: PFE) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of PAXLOVID (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for patients who are at high risk for progression to severe illness from COVID-19.

Key Points: 
  • (NYSE: PFE) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of PAXLOVID (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for patients who are at high risk for progression to severe illness from COVID-19.
  • We look forward to working with the FDA toward full regulatory approval for PAXLOVID.
  • The NDA submission is supported by non-clinical and clinical data for PAXLOVID.
  • To date, Pfizer has shipped more than 12 million treatment courses of PAXLOVID to nearly 40 countries around the world.

Aligos Therapeutics Reports Recent Business Progress and First Quarter 2022 Financial Results

Retrieved on: 
Wednesday, May 4, 2022

SOUTH SAN FRANCISCO, Calif., May 04, 2022 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today reported recent business progress and financial results for the first quarter March 31, 2022.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., May 04, 2022 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today reported recent business progress and financial results for the first quarter March 31, 2022.
  • We plan to share top line results for 28 day and 12-week cohorts in Q2 and Q4 2022, respectively.
  • Topline results from this Phase 1 proof of concept study remain on track for release in Q3 2022.
  • Aligos expects to file a Phase 1 clinical trial application in second half of 2022.

Pfizer Initiates Phase 2/3 Study of Novel COVID-19 Oral Treatment in Pediatric Participants

Retrieved on: 
Wednesday, March 9, 2022

We are proud to expand studies of our novel COVID-19 treatment to include pediatric participants to further evaluate the safety and efficacy of this treatment in this important population.

Key Points: 
  • We are proud to expand studies of our novel COVID-19 treatment to include pediatric participants to further evaluate the safety and efficacy of this treatment in this important population.
  • The Phase 2/3 trial is an open-label, multi-center, single-arm study in approximately 140 pediatric participants under 18 years of age.
  • The safety and effectiveness of PAXLOVID have not yet been directly established in pediatric patients.
  • Pfizer is currently expanding the population of the ongoing EPIC-SR study by approximately 800 participants and expects to share results later this year.

Coronavirus-3C-like-proteinase inhibitors Drug Pipeline Market Report 2022 - ResearchAndMarkets.com

Retrieved on: 
Friday, February 4, 2022

The "Coronavirus-3C-like-proteinase inhibitors - Pipeline Insight, 2022" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Coronavirus-3C-like-proteinase inhibitors - Pipeline Insight, 2022" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This report provides comprehensive insights about 10+ companies and 10+ pipeline drugs in Coronavirus-3C-like-proteinase inhibitors pipeline landscape.
  • This segment of the report provides insights about the different Coronavirus-3C-like-proteinase inhibitors drugs segregated based on following parameters that define the scope of the report.
  • The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Coronavirus-3C-like-proteinase inhibitors drugs.

Pfizer Receives CHMP Positive Opinion for Novel COVID-19 Oral Treatment

Retrieved on: 
Thursday, January 27, 2022

During the pandemic, Pfizer will offer its oral therapy through a tiered pricing approach, pending country authorization or approval, based on the income level of each country to promote equity of access across the globe.

Key Points: 
  • During the pandemic, Pfizer will offer its oral therapy through a tiered pricing approach, pending country authorization or approval, based on the income level of each country to promote equity of access across the globe.
  • Pfizer continues to invest to support the manufacturing and distribution of PAXLOVID, including exploring potential contract manufacturing options.
  • As a result of these efforts, Pfizer has raised its production projections, with the potential ability to produce up to 120 million courses of treatment by the end of 2022.
  • PAXLOVID is not approved for any use, including for use for the treatment of COVID-19.

Pfizer Receives U.S. FDA Emergency Use Authorization for Novel COVID-19 Oral Antiviral Treatment

Retrieved on: 
Wednesday, December 22, 2021

No deaths occurred in the treatment group compared to nine deaths in the placebo group by Day 28.

Key Points: 
  • No deaths occurred in the treatment group compared to nine deaths in the placebo group by Day 28.
  • With PAXLOVID now authorized for emergency use, Pfizer stands ready to start delivery in the U.S. immediately.
  • In November 2021, Pfizer announced an agreement with the U.S. government to supply 10 million treatment courses of PAXLOVID, with delivery fulfillment expected to be completed in 2022.
  • Pfizer has submitted applications for regulatory approval or authorization to multiple regulatory agencies around the world and anticipates further regulatory decisions to follow.

Pfizer to Provide the United Kingdom an Additional 2.5 Million Treatment Courses of Investigational Oral Antiviral Candidate to Help Combat COVID-19

Retrieved on: 
Wednesday, December 22, 2021

Pfizer Inc. (NYSE: PFE) announced an additional agreement with the United Kingdom (UK) government to supply an additional 2.5 million treatment courses of its investigational candidate PAXLOVID (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), subject to local authorization.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) announced an additional agreement with the United Kingdom (UK) government to supply an additional 2.5 million treatment courses of its investigational candidate PAXLOVID (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), subject to local authorization.
  • This is in addition to the 250,000 treatment courses previously contracted by the UK Government, pending authorization and recommendation for use, bringing the full amount of treatment courses to 2.75 million.
  • We are pleased that the UK government recognizes the importance of this potential treatment option, said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.
  • Pfizer continues to invest up to approximately $1 billion to support the manufacturing and distribution of PAXLOVID, including exploring potential contract manufacturing options.

EMA Issues Advice for Potential Early Use of Pfizer’s Novel COVID-19 Oral Antiviral Candidate

Retrieved on: 
Thursday, December 16, 2021

If authorized, PAXLOVID has the potential to help save lives and reduce hospitalizations.

Key Points: 
  • If authorized, PAXLOVID has the potential to help save lives and reduce hospitalizations.
  • We look forward to working with the EMA and other regulatory agencies worldwide to bring this potential treatment to patients as quickly as possible.
  • Treatment-emergent adverse events were comparable between PAXLOVID (19%) and placebo (21%), most of which were mild in intensity.
  • Pfizer has also initiated rolling submission with the EMA for potential EU conditional marketing authorization of PAXLOVID.