PFE

Pfizer Invites Public to View and Listen to Webcast of Pfizer Discussion at Healthcare Conference

Retrieved on: 
Tuesday, November 21, 2023
Health, Infectious Diseases, Research, Pharmaceutical, Science, Biotechnology, Webcast, EST, Pfizer, Evercore, NYSE, Conference, Inc., PFE

Pfizer Inc. (NYSE: PFE) invites investors and the general public to view and listen to a webcast of a discussion with David Denton, Chief Financial Officer, Executive Vice President, at the Evercore ISI HealthCONx Conference on Tuesday, November 28, 2023 at 10:50 a.m. EST.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) invites investors and the general public to view and listen to a webcast of a discussion with David Denton, Chief Financial Officer, Executive Vice President, at the Evercore ISI HealthCONx Conference on Tuesday, November 28, 2023 at 10:50 a.m. EST.
  • To view and listen to the webcast, visit our web site at www.pfizer.com/investors .
  • Information on accessing and registering for the webcast will be available at www.pfizer.com/investors beginning today.
  • The transcript and webcast replay of the discussion will be made available on our web site at www.pfizer.com/investors within 24 hours after the end of the live discussion and will be accessible for at least 90 days.

PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) Approved by FDA as the First and Only ADC Plus PD-1 to Treat Advanced Bladder Cancer

Retrieved on: 
Friday, December 15, 2023
Cisplatin, NYSE, PFE, Food, Platinum, Progression-free survival, Carcinoma, ADC, ESMO, Patient, PFS, Astellas Pharma, FDA, Pembrolizumab, PD-1, Survival, Death, Oncology, Pfizer, Congress, OS, Confidence interval, Pharmaceutical industry, Dietary supplement

TOKYO and NEW YORK, Dec. 15, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. (NYSE: PFE) today announced that on December 15, 2023 the U.S. Food and Drug Administration (FDA) has approved PADCEV® (enfortumab vedotin-ejfv, an antibody-drug conjugate [ADC]) with KEYTRUDA® (pembrolizumab, a PD-1 inhibitor) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC). This combination is the first approved to offer an alternative to platinum-containing chemotherapy, the current standard of care in first-line la/mUC.

Key Points: 
  • This combination is the first approved to offer an alternative to platinum-containing chemotherapy, the current standard of care in first-line la/mUC.
  • "Today's FDA approval represents a paradigm change in the treatment of advanced bladder cancer and provides hope to the thousands of Americans impacted by this aggressive disease.
  • "Despite advances in the treatment of advanced bladder cancer, there remains a need for therapies that extend patients' lives.
  • Our network is thrilled that the FDA has approved a new treatment option, and we are excited about the hope it will provide to members of the bladder cancer patient community."

Pfizer and Astellas' XTANDI® Approved by U.S. FDA in Earlier Prostate Cancer Treatment Setting

Retrieved on: 
Friday, November 17, 2023
Priority review, NYSE, Gonadotropin-releasing hormone, PFE, Food, Patient, Radiation, Astellas Pharma, FDA, Prostate cancer, TSE, New Drug Application, BCR, Pfizer, Recurrence, Fast Track, Metastasis, Pharmaceutical industry, Birth control

TOKYO and NEW YORK, Nov. 16, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. (NYSE: PFE) today announced that the companies received an approval by the U.S. Food and Drug Administration (FDA) of a supplemental New Drug Application for XTANDI® (enzalutamide), following FDA expedited development and review programs (Priority Review designation, Fast Track designation, Real-time Oncology Review), based on results from the Phase 3 EMBARK trial. With this approval, XTANDI becomes the first and only androgen receptor signaling inhibitor approved by the FDA for the treatment of patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). Patients with nmCSPC with high-risk BCR may be treated with XTANDI with or without a gonadotropin-releasing hormone (GnRH) analog therapy.

Key Points: 
  • TOKYO and NEW YORK, Nov. 16, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. (NYSE: PFE) today announced that the companies received an approval by the U.S. Food and Drug Administration (FDA) of a supplemental New Drug Application for XTANDI® (enzalutamide), following FDA expedited development and review programs (Priority Review designation, Fast Track designation, Real-time Oncology Review), based on results from the Phase 3 EMBARK trial.
  • With this approval, XTANDI becomes the first and only androgen receptor signaling inhibitor approved by the FDA for the treatment of patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR).
  • Patients with nmCSPC with high-risk BCR may be treated with XTANDI with or without a gonadotropin-releasing hormone (GnRH) analog therapy.
  • Of men who have undergone definitive prostate cancer treatment, including radical prostatectomy, radiotherapy, or both, an estimated 20-40% will experience biochemical recurrence (BCR) within 10 years.1

Valneva to Present and Hold Investor Meetings at the Jefferies London Healthcare Conference

Retrieved on: 
Tuesday, November 7, 2023
FDA, VLA, NYSE, Food, PDUFA, Infection, Conference, Pfizer, Euronext Paris, Saint-Herblain, Webcast, Jefferies, PFE, Food and Drug Administration, Pharmaceutical industry, Valneva SE

Saint-Herblain (France), November 7, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will present and participate in 1-on-1 meetings with institutional investors at the Jefferies London Healthcare Conference, to take place November 14-16, 2023 in London, UK.

Key Points: 
  • Saint-Herblain (France), November 7, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will present and participate in 1-on-1 meetings with institutional investors at the Jefferies London Healthcare Conference, to take place November 14-16, 2023 in London, UK.
  • Chief Executive Officer Thomas Lingelbach and Chief Financial Officer Peter Bühler will host a fireside chat at 2:30pm GMT on November 14 to discuss Valneva’s commercial business and pipeline of infectious disease vaccines.
  • A replay of the webcast will be available following the live events in the “Investor” section of the Valneva website at www.valneva.com .
  • To request a meeting at the event, please contact your representative at Jefferies.

Pfizer Invites Public to View and Listen to Webcast of Pfizer Discussion at Healthcare Conference

Retrieved on: 
Thursday, November 2, 2023
Health, Infectious Diseases, Research, Pharmaceutical, Science, Biotechnology, EST, Pfizer, PFE, Inc., NYSE, Webcast, Management

Pfizer Inc. (NYSE: PFE) invites investors and the general public to view and listen to a webcast of a discussion with Aamir Malik, Chief Business Innovation Officer, Executive Vice President, at the Truist Securities BioPharma Symposium on Thursday, November 9, 2023 at 12:35 p.m. EST.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) invites investors and the general public to view and listen to a webcast of a discussion with Aamir Malik, Chief Business Innovation Officer, Executive Vice President, at the Truist Securities BioPharma Symposium on Thursday, November 9, 2023 at 12:35 p.m. EST.
  • To view and listen to the webcast, visit our web site at www.pfizer.com/investors .
  • Information on accessing and registering for the webcast will be available at www.pfizer.com/investors beginning today.
  • The transcript and webcast replay of the discussion will be made available on our web site at www.pfizer.com/investors within 24 hours after the end of the live discussion and will be accessible for at least 90 days.

Pfizer Highlights Scientific Advances from Growing Hematology Portfolio at American Society of Hematology Annual Meeting

Retrieved on: 
Thursday, November 2, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Bispecific monoclonal antibody, Science, FDA, NYSE, Food, Multiple myeloma, Haemophilia, Bone marrow, SCD, Hematology, B-cell maturation antigen, Safety, Phase 3, Sickle cell disease, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Research, Society, ASH, RRMM, Caregiver, Inc., Health equity, Abstract, PFE, Patient, BCMA, Joint Planning and Development Office, Pharmaceutical industry, Pfizer

Pfizer Inc. (NYSE: PFE) will present its latest data showcasing advances in the treatment of hemophilia, sickle cell disease, and blood cancers at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego from December 9-12.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) will present its latest data showcasing advances in the treatment of hemophilia, sickle cell disease, and blood cancers at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego from December 9-12.
  • “Pfizer has been advancing science in hematology for more than 30 years, starting with the introduction of recombinant factor replacement therapy, which became the standard of care for people living with hemophilia.
  • Fourteen abstracts focused on the treatment of SCD, including Phase 2a safety, efficacy, and pharmacodynamic data from the ongoing Phase 2/3 clinical trial study of GBT601.
  • Nineteen abstracts from our blood cancer portfolio, including six which continue to support the use of ELREXFIO, a B-cell maturation antigen (BCMA)-CD3-directed bispecific antibody immunotherapy, in patients with RRMM.

Pfizer and BioNTech Announce Positive Topline Data for mRNA-based Combination Vaccine Program Against Influenza and COVID-19

Retrieved on: 
Thursday, October 26, 2023
Urinary tract infection, FDA, NYSE, Food, BioNTech, Vaccine, SARS-CoV-2, FAAM, GMT, MD, Doctor of Philosophy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Influenza, Senior, Pfizer, Vaccination, Clinical trial, COVID-19, Risk, Viral, Head, BNTX, Safety, PFE, Immunization, Patient

In the clinical trial, the vaccine candidates were compared to a licensed influenza vaccine and the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine given at the same visit.

Key Points: 
  • In the clinical trial, the vaccine candidates were compared to a licensed influenza vaccine and the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine given at the same visit.
  • The data from the trial showed that the companies' lead formulations demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains.
  • “We are encouraged by these early results in our Phase 1/2 study of our combination vaccine candidates against influenza and COVID-19.
  • Pfizer and BioNTech previously announced that their mRNA-based combination vaccine candidate for influenza and COVID-19 received Fast Track Designation from the U.S. Food and Drug Administration (FDA).

Pfizer and BioNTech Announce Positive Topline Data for mRNA-based Combination Vaccine Program Against Influenza and COVID-19

Retrieved on: 
Thursday, October 26, 2023
COVID-19, Research, Infectious Diseases, Clinical Trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Other Science, Urinary tract infection, FDA, NYSE, Food, BioNTech, Vaccine, SARS-CoV-2, FAAM, GMT, MD, Doctor of Philosophy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Influenza, Senior, Pfizer, Vaccination, Inc., Clinical trial, Risk, Viral, Head, BNTX, Safety, PFE, Immunization, Patient

In the clinical trial, the vaccine candidates were compared to a licensed influenza vaccine and the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine given at the same visit.

Key Points: 
  • In the clinical trial, the vaccine candidates were compared to a licensed influenza vaccine and the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine given at the same visit.
  • The data from the trial showed that the companies' lead formulations demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains.
  • “We are encouraged by these early results in our Phase 1/2 study of our combination vaccine candidates against influenza and COVID-19.
  • Pfizer and BioNTech previously announced that their mRNA-based combination vaccine candidate for influenza and COVID-19 received Fast Track Designation from the U.S. Food and Drug Administration (FDA).

FDA Approves PENBRAYA™, the First and Only Vaccine for the Prevention of the Five Most Common Serogroups Causing Meningococcal Disease in Adolescents

Retrieved on: 
Friday, October 20, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Survivor, NYSE, Upstate University Hospital, Food, Meningococcal disease, Vaccine, Mortality, MD, Infection, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Development, Senior, CDC, Inc., Attenuated vaccine, IMD, Head, ACIP, Safety, PFE, Patient, Hospital, Death, Pfizer

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved PENBRAYA™ (meningococcal groups A, B, C, W and Y vaccine), the first and only pentavalent vaccine that provides coverage against the most common serogroups causing meningococcal disease in adolescents and young adults 10 through 25 years of age.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved PENBRAYA™ (meningococcal groups A, B, C, W and Y vaccine), the first and only pentavalent vaccine that provides coverage against the most common serogroups causing meningococcal disease in adolescents and young adults 10 through 25 years of age.
  • “Today marks an important step forward in the prevention of meningococcal disease in the U.S.
  • The Phase 3 trial (NCT04440163) evaluated more than 2,400 patients from the U.S. and Europe.
  • The CDC Advisory Committee on Immunization Practices (ACIP) will meet on October 25, 2023, to discuss recommendations for the appropriate use of PENBRAYA in adolescents and young adults.

Update Regarding Pfizer’s Statement on COMIRNATY-Related Write-Offs

Retrieved on: 
Monday, October 16, 2023
Risk, COVID-19, NYSE, BNTX, BioNTech, PFE, Pharmaceutical industry, Pfizer

According to Pfizer, the write-offs do not address Pfizer-BioNTech COVID-19 Vaccine doses adapted to the XBB.1.5 variant, which has been approved and is being marketed in key geographies.

Key Points: 
  • According to Pfizer, the write-offs do not address Pfizer-BioNTech COVID-19 Vaccine doses adapted to the XBB.1.5 variant, which has been approved and is being marketed in key geographies.
  • BioNTech is evaluating the potential impact of Pfizer’s write-offs and other charges related to COMIRNATY on the Company’s financial results.
  • Any such write-offs will reduce the revenues the Company would report for 2023.
  • BioNTech expects to release its financial report for the third quarter of 2023 on November 6, 2023.