PFE

TIVDAK® (tisotumab vedotin-tftv) Supplemental Biologics License Application Accepted for Priority Review by U.S. Food and Drug Administration for Patients with Recurrent or Metastatic Cervical Cancer

Retrieved on: 
Tuesday, January 9, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Woman, Patient, Progression-free survival, OS, Survival, ESMO, PFE, Food, Cervical cancer, Disease, PFS, Safety, Congress, Priority review, PDUFA, Pharmaceutical industry

The application has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of May 9, 2024.

Key Points: 
  • The application has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of May 9, 2024.
  • The safety profile of tisotumab vedotin-tftv in innovaTV 301 was consistent with its known safety profile as presented in the U.S. prescribing information.
  • In October 2023, results from the innovaTV 301 study were presented during the Presidential Symposium at the European Society of Medical Oncology (ESMO) Congress.
  • “The FDA acceptance of our sBLA for review is important progress toward continuing to offer an option that can extend the lives of more adults with cervical cancer.”

European Commission Approves Pfizer’s TALZENNA® in Combination with XTANDI® for Adult Patients with Metastatic Castration-Resistant Prostate Cancer

Retrieved on: 
Monday, January 8, 2024
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, European Commission, Food, HRR, Risk, Movement, Prognosis, PFE, Confidence interval, Disease, Prostate cancer, Doctor of Philosophy, Civil service commission, Cancer, University, PARP, Death, Clinical Cancer Research, University of Glasgow, ADP, Talazoparib, Patient, Safety, Medicine, Inc., Pharmaceutical industry

Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has approved TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide), for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has approved TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide), for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.
  • With this approval, TALZENNA is now the first and only PARP inhibitor licensed in the European Union for use with XTANDI for patients with mCRPC, with or without gene mutations.
  • “The European Commission’s approval of talazoparib in combination with enzalutamide offers a meaningful advancement for the treatment of patients with metastatic castration-resistant prostate cancer, the most advanced and aggressive stage of the disease.”
    “After years of fighting prostate cancer, it can be devastating for a patient to learn that their cancer has stopped responding to testosterone-lowering treatments.
  • At this stage of the disease, the prognosis is generally poor,” said Erik Briers, MS, PhD, Vice Chairman, Europa UOMO, a European advocacy movement for people with prostate cancer.

Exciting New Cures Possible from GLP-1 Diabetes, Weight-Loss Drugs

Retrieved on: 
Monday, January 8, 2024
Editorial, Diabetes, Risk, CER, Fatty liver disease, Health, Nausea, Tissue, Heart, Cancer, Inflammation, Patent, Ageing, Obesity, Crohn's disease, Liver disease, LEXX, NVO, Invention, DSM-IV codes, Parkinson's disease, Pfizer, Kidney disease, Paratriathlon, European, Disease, Alzheimer's disease, Pharmacokinetics, Bone density, Merck, Facial muscles, Human, Safety, Pharma, MRK, Addiction, SNAC, AstraZeneca, PFE, DKK, Blood, Mouth, Novo Nordisk, Vomiting, Autoimmune disease, Research, Diarrhea, Weight loss, Hanmi Pharmaceutical, Weapon, Clinical trial, Refrigeration, Chronic kidney disease, Growth, Pharmaceutical industry

NEW YORK, Jan. 8, 2024 /PRNewswire/ -- Already proven to be a revolutionary treatment for type 2 diabetes and weight loss, glucagon-like peptide-1 (GLP-1) agonists now appear to have a multitude of potential blockbuster therapeutic uses, according to recent research. Obviously, diabetes remains a primary indication, given the massive global need. However, the impact of this extraordinary molecule extends far beyond type 2 diabetes. The reach of GLP-1 drugs has widened in ways its inventors likely never imagined. Clinical trials are underway testing GLP-1 drugs to treat Alzheimer's, Parkinson's, and even drug addiction, plus there are strong indications of therapeutic efficacy in heart disease and chronic kidney disease, as well as a wide range of other conditions, including weight loss. The newfound applications of this super-drug re-enforce both the reach and impact of Lexaria Bioscience Corp. (NASDAQ: LEXX) (Profile). By supercharging GLP-1 drugs with its DehydraTECH(TM) drug-delivery formulation and processing technology, Lexaria intends to improve both delivery and efficacy of GLP-1 for diabetes and potentially a host of other maladies. With several key studies on the near-term horizon, Lexaria has positioned itself in the midst of these market opportunities alongside others changing the landscape, such as Pfizer Inc. (NYSE: PFE), Merck & Company Inc. (NYSE: MRK), AstraZeneca PLC (NASDAQ: AZN) and Novo Nordisk (NYSE: NVO).

Key Points: 
  • GLP-1 agonists are the hottest drugs in healthcare today, with uses targeting multibillion-dollar diabetes and obesity markets and much more.
  • Similarly, product sales for obesity drugs are forecast to reach $100 billion within a decade, and the most promising drugs at the head of the pack are GLP-1 agonists.
  • Novo Nordisk (NYSE: NVO) , the owner of Ozempic(R), Rybelsus(R), Victoza(R) and Wegovy(R), is a world leader in diabetes and GLP-1 drugs.
  • Companies that enhance efficacy and expand usage could prove to be the biggest winners in the progression of GLP-1 drugs.

Exciting New Cures Possible from GLP-1 Diabetes, Weight-Loss Drugs

Retrieved on: 
Monday, January 8, 2024
Editorial, Diabetes, Risk, CER, Fatty liver disease, Health, Nausea, Tissue, Heart, Cancer, Inflammation, Patent, Ageing, Obesity, Crohn's disease, Liver disease, LEXX, NVO, Invention, DSM-IV codes, Parkinson's disease, Pfizer, Kidney disease, Paratriathlon, European, Disease, Alzheimer's disease, Pharmacokinetics, Bone density, Merck, Facial muscles, Human, Safety, Pharma, MRK, Addiction, SNAC, AstraZeneca, PFE, DKK, Blood, Mouth, Novo Nordisk, Vomiting, Autoimmune disease, Research, Diarrhea, Weight loss, Hanmi Pharmaceutical, Weapon, Clinical trial, Refrigeration, Chronic kidney disease, Growth, Pharmaceutical industry

NEW YORK, Jan. 8, 2024 /PRNewswire/ -- Already proven to be a revolutionary treatment for type 2 diabetes and weight loss, glucagon-like peptide-1 (GLP-1) agonists now appear to have a multitude of potential blockbuster therapeutic uses, according to recent research. Obviously, diabetes remains a primary indication, given the massive global need. However, the impact of this extraordinary molecule extends far beyond type 2 diabetes. The reach of GLP-1 drugs has widened in ways its inventors likely never imagined. Clinical trials are underway testing GLP-1 drugs to treat Alzheimer's, Parkinson's, and even drug addiction, plus there are strong indications of therapeutic efficacy in heart disease and chronic kidney disease, as well as a wide range of other conditions, including weight loss. The newfound applications of this super-drug re-enforce both the reach and impact of Lexaria Bioscience Corp. (NASDAQ: LEXX) (Profile). By supercharging GLP-1 drugs with its DehydraTECH(TM) drug-delivery formulation and processing technology, Lexaria intends to improve both delivery and efficacy of GLP-1 for diabetes and potentially a host of other maladies. With several key studies on the near-term horizon, Lexaria has positioned itself in the midst of these market opportunities alongside others changing the landscape, such as Pfizer Inc. (NYSE: PFE), Merck & Company Inc. (NYSE: MRK), AstraZeneca PLC (NASDAQ: AZN) and Novo Nordisk (NYSE: NVO).

Key Points: 
  • GLP-1 agonists are the hottest drugs in healthcare today, with uses targeting multibillion-dollar diabetes and obesity markets and much more.
  • Similarly, product sales for obesity drugs are forecast to reach $100 billion within a decade, and the most promising drugs at the head of the pack are GLP-1 agonists.
  • Novo Nordisk (NYSE: NVO) , the owner of Ozempic(R), Rybelsus(R), Victoza(R) and Wegovy(R), is a world leader in diabetes and GLP-1 drugs.
  • Companies that enhance efficacy and expand usage could prove to be the biggest winners in the progression of GLP-1 drugs.

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

Retrieved on: 
Tuesday, January 2, 2024
Biotechnology, Pharmaceutical, Health, PST, PFE, Webcast, Conference, Inc., Pfizer

Pfizer Inc. (NYSE: PFE) invites investors and the general public to listen to a webcast of a discussion with Albert Bourla, Chairman and Chief Executive Officer, at the 42nd Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024 at 3:00 p.m. PST.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) invites investors and the general public to listen to a webcast of a discussion with Albert Bourla, Chairman and Chief Executive Officer, at the 42nd Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024 at 3:00 p.m. PST.
  • To 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.

Update: Annual Changes to the Nasdaq-100® Index

Retrieved on: 
Tuesday, December 12, 2023
TTWO, PFE, NDAQ, Acquisition, Seagen, Take-Two Interactive, Pfizer

NEW YORK, Dec. 12, 2023 (GLOBE NEWSWIRE) -- Nasdaq (Nasdaq: NDAQ) today announced an update to the annual reconstitution of the Nasdaq-100 Index® (Nasdaq: NDX).

Key Points: 
  • NEW YORK, Dec. 12, 2023 (GLOBE NEWSWIRE) -- Nasdaq (Nasdaq: NDAQ) today announced an update to the annual reconstitution of the Nasdaq-100 Index® (Nasdaq: NDX).
  • Per the announcement by Pfizer Inc. (NYSE: PFE), the pending acquisition of Seagen, Inc. (Nasdaq: SGEN) is expected to close on December 14, 2023.
  • The other constituent changes from the initial announcement by Nasdaq on Friday, December 8, 2023, will remain the same.
  • For information about the company being added to the Nasdaq-100 Index® per this update, please visit the company website: Take-Two Interactive Software, Inc. – https://www.take2games.com/ .

Arvinas to Host Conference Call and Webcast to Discuss Vepdegestrant (ARV-471) Data Presented at 2023 San Antonio Breast Cancer Symposium and Plans to Expand Vepdegestrant Development Program

Retrieved on: 
Wednesday, December 6, 2023
PFE, Webcast, ARVN, Pfizer

NEW HAVEN, Conn., Dec. 05, 2023 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced that a conference call and webcast will be held with executives from Arvinas and Pfizer Inc. (NYSE: PFE) to discuss vepdegestrant (ARV-471) data presented at the 2023 San Antonio Breast Cancer Symposium (SABCS) as well as plans to expand the vepdegestrant development program.

Key Points: 
  • NEW HAVEN, Conn., Dec. 05, 2023 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced that a conference call and webcast will be held with executives from Arvinas and Pfizer Inc. (NYSE: PFE) to discuss vepdegestrant (ARV-471) data presented at the 2023 San Antonio Breast Cancer Symposium (SABCS) as well as plans to expand the vepdegestrant development program.
  • Arvinas will host a conference call and webcast on Wednesday, December 6 at 7:30 a.m.
  • Participants are invited to listen by going to the Events and Presentation section under the Investors page on the Arvinas website at www.arvinas.com .
  • A replay of the webcast will be archived on the Arvinas website following the presentation.

Arvinas and Pfizer Announce Interim Data from Phase 1b Trial of Vepdegestrant in Combination with Palbociclib (IBRANCE®) and Plans to Expand Vepdegestrant Development Program

Retrieved on: 
Tuesday, December 5, 2023
CBR, Patient, Febrile neutropenia, ESR1, Breast Cancer Research, HER2, Neoplasm, Infection, Breast cancer, Fulvestrant, PFE, Colorectal cancer, Cyclin-dependent kinase 4, Chimera, Neutropenia, Melanoma, Sarah Cannon Research Institute, DNA, Incidence, Research, CDK4, ARVN, Abstract, FIH, Proteolysis, Face, Webcast, CDK, Safety, PFS, Circulating tumor DNA, Pharmaceutical industry

NEW HAVEN, Conn. and NEW YORK, Dec. 05, 2023 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today announced clinical data for vepdegestrant (ARV-471), a novel oral PROteolysis TArgeting Chimera (PROTAC®) estrogen receptor (ER) degrader, in combination with palbociclib (IBRANCE®). Interim results from the Phase 1b combination cohort demonstrate encouraging clinical activity in heavily pre-treated patients with a median of four lines of therapy across disease settings with locally advanced or metastatic ER positive/human epidermal growth factor 2 (HER2) negative (ER+/HER2-) breast cancer. These data will be presented in a spotlight presentation at the 2023 San Antonio Breast Cancer Symposium (SABCS).

Key Points: 
  • These data will be presented in a spotlight presentation at the 2023 San Antonio Breast Cancer Symposium (SABCS).
  • The results from this trial evaluating vepdegestrant in combination with palbociclib help advance our goals of benefitting patients with ER+/HER2- breast cancer.
  • “Collectively, the data presented this year at SABCS for vepdegestrant, especially in combination with palbociclib, show the potential of this investigational innovative therapeutic option.
  • A conference call and webcast will be held with executives from Arvinas and Pfizer to discuss the data presented at SABCS.

Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial for Lyme Disease Vaccine Candidate, VLA15

Retrieved on: 
Monday, December 4, 2023
DSMB, Food, Șaeș, Euronext Paris, BLA, Data monitoring committee, Marketing, PFE, FDA, EMA, MAA, Lyme disease, Disease, Research, Biologics license application, European Medicines Agency, VLA, Safety, Development, Senior, Vaccine

Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial for Lyme Disease Vaccine Candidate, VLA15

Key Points: 
  • Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial for Lyme Disease Vaccine Candidate, VLA15
    9,437* participants enrolled at sites across the U.S., Europe and Canada in areas where Lyme disease is endemic
    Pfizer aims to submit regulatory filings in the U.S. and Europe in 2026
    New York, NY, and Saint-Herblain (France), December 4, 2023 – Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced that they have completed recruitment for the Phase 3 trial Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) for Lyme disease vaccine candidate VLA15.
  • The trial builds on previous positive Phase 1 and 2 trial results and includes both adult and pediatric participants, with the aim to confirm the efficacy, safety, lot consistency, and immunogenicity of VLA15.
  • “We are pleased that the Phase 3 trial recruitment is complete.
  • Pfizer and Valneva entered into a collaboration agreement in April 2020 to co-develop VLA15, with updates to the terms within this agreement made in June 2022.3,4

Arvinas and Pfizer Announce Updated Vepdegestrant (ARV-471) Data to be Presented at the 2023 San Antonio Breast Cancer Symposium

Retrieved on: 
Tuesday, November 28, 2023
HER2, Breast cancer, PFE, Chimera, Clinical trial, ARVN, Abstract, ID, Proteolysis, Patient, PROTAC, Birth control

NEW HAVEN, Conn. and NEW YORK, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today announced that updated clinical trial data for vepdegestrant (ARV-471) will be presented at the 2023 San Antonio Breast Cancer Symposium (SABCS). Vepdegestrant is a novel oral PROteolysis TArgeting Chimera (PROTAC®) estrogen receptor (ER) degrader currently being investigated for the potential treatment of patients with locally advanced or metastatic estrogen receptor (ER) positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. Arvinas and Pfizer are collaborating to develop and commercialize vepdegestrant.

Key Points: 
  • -- Six abstracts have been accepted for presentation, including updated data on vepdegestrant alone and in combination with palbociclib (IBRANCE®) --
    NEW HAVEN, Conn. and NEW YORK, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today announced that updated clinical trial data for vepdegestrant (ARV-471) will be presented at the 2023 San Antonio Breast Cancer Symposium (SABCS).
  • Arvinas and Pfizer are collaborating to develop and commercialize vepdegestrant.
  • Data from the Phase 1b study assessing vepdegestrant in combination with palbociclib (IBRANCE®) will be presented in a spotlight session on December 7, 2023.
  • An update on the Phase 2 vepdegestrant monotherapy (VERITAC) study will be presented in a poster presentation alongside four other posters during the symposium held from December 5-9, 2023, in San Antonio, Texas.