NYSE:PFE

U.S. FDA Approves ABRYSVO™, Pfizer’s Vaccine for the Prevention of Respiratory Syncytial Virus (RSV) in Infants Through Active Immunization of Pregnant Individuals 32-36 Weeks of Gestational Age

Retrieved on: 
Monday, August 21, 2023
Infectious Diseases, FDA, Pharmaceutical, Health, Aurora, Inc., Pregnancy, University, Senior, Life, Hospital, Gestational age, Public, Safety, The New England Journal of Medicine, Infection, PFE, Clinical trial, Children's Hospital Colorado, University of Colorado School of Medicine, Development, Protein, RSV, Risk, Respiratory syncytial virus vaccine, Immunization, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NYSE, Food, Vaccine, Pfizer

ABRYSVO is unadjuvanted and composed of two preF proteins selected to optimize protection against RSV A and B strains and was observed to be safe and effective.

Key Points: 
  • ABRYSVO is unadjuvanted and composed of two preF proteins selected to optimize protection against RSV A and B strains and was observed to be safe and effective.
  • “We are incredibly grateful to the clinical trial participants and study investigator teams around the world, as well as our Pfizer colleagues, for their commitment to making this vaccine available.
  • These results were published in The New England Journal of Medicine in April 2023.
  • Simões, M.D., Clinical Professor, Pediatrics-Infectious Diseases, University of Colorado School of Medicine and Children’s Hospital Colorado, Aurora.

Pfizer’s ELREXFIO™ Receives U.S. FDA Accelerated Approval for Relapsed or Refractory Multiple Myeloma

Retrieved on: 
Monday, August 14, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology

Approval was based on the results of the single-arm Phase 2 MagnetisMM-3 trial, and continued approval for this indication is contingent upon verification of clinical benefit in a confirmatory trial(s).

Key Points: 
  • Approval was based on the results of the single-arm Phase 2 MagnetisMM-3 trial, and continued approval for this indication is contingent upon verification of clinical benefit in a confirmatory trial(s).
  • A confirmatory trial ( MagnetisMM-5 ) in the double-class exposed relapsed or refractory population involving 854 patients was initiated in 2022 to gather additional safety and efficacy data.
  • Unfortunately, novel therapies for triple-class-exposed multiple myeloma can be out of reach for medically underserved populations,” said Jenny Ahlstrom, Founder and Chief Executive Officer of the HealthTree Foundation for Multiple Myeloma.
  • The extensive MagnetisMM clinical development program is investigating ELREXFIO’s use across the entire spectrum of myeloma progression, from newly diagnosed multiple myeloma to RRMM.

Arvinas and Pfizer Awarded Innovation Passport Designation by the U.K. Innovative Licensing and Access Pathway Steering Group for Vepdegestrant, an Investigational PROTAC® ER degrader being developed in ER+/HER2- Breast Cancer

Retrieved on: 
Monday, July 31, 2023
Pfizer, Health care, PFE, Clinical trial, Medication, ER, Medicine, Healthcare Improvement Scotland, Wales, ARVN, Patient, National Institute for Health and Care Excellence, Innovation, Congress, Therapy, NYSE, NICE, SMC, MHRA, Breast cancer, Pharmaceutical industry, HAVEN

The Innovation Passport is the entry point for the Innovative Licensing and Access Pathway (ILAP).

Key Points: 
  • The Innovation Passport is the entry point for the Innovative Licensing and Access Pathway (ILAP).
  • The goal of ILAP is to accelerate the time to market facilitating patient access to medicines in the U.K.
  • “Arvinas is hopeful our investigational PROTAC® ER degrader, vepdegestrant, will have the potential to be an endocrine therapy backbone for ER+/HER2-breast cancer."
  • The companies also plan to submit additional data from the Phase 1b combination trial with palbociclib at a medical congress during the second half of 2023.

Pfizer Announces Executive Leadership to Advance Oncology Research and Development Strategy

Retrieved on: 
Thursday, July 27, 2023
Biotechnology, Pharmaceutical, Health, Oncology, Vaccine, Inflammation, University College London Hospitals NHS Foundation Trust, University College London, Global production network, Medicine, UCL, Inc., University, GPD, Cancer Institute, PFE, Rare disease, Cancer, Joint Planning and Development Office, Royal Marsden Hospital, Pfizer, Doctor of Philosophy, Organization, Development, Acquisition, Patient, University of Pretoria, Internal medicine, Hematology, Royal Free Hospital, Immunology, Family, NYSE, Infection, Pharmaceutical industry

Pfizer Inc. (NYSE: PFE) today announced changes to its executive leadership team to further advance its aspirations to discover and develop new medicines and vaccines, with an emphasis on oncology.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) today announced changes to its executive leadership team to further advance its aspirations to discover and develop new medicines and vaccines, with an emphasis on oncology.
  • Effective today, Chris Boshoff, M.D., PhD, will join Pfizer’s Executive Leadership Team as Chief Oncology Research and Development Officer and Executive Vice President reporting to Chairman and Chief Executive Officer, Albert Bourla.
  • Under his leadership, Pfizer will continue to invest in its fight against cancer and Dr. Boshoff will be the single point of accountability for the entire oncology pipeline – from discovery to early and late-phase clinical development.
  • Mikael Dolsten, M.D., PhD, currently Chief Scientific Officer & President, Pfizer Worldwide Research, Development and Medical, will now expand his role to lead all discovery, early- and late-stage clinical development, for all non-oncology therapeutic areas as Chief Scientific Officer, President, Pfizer Research & Development.

Pfizer Announces Post-Tornado Relief Plans for Rocky Mount Community and Manufacturing Facility

Retrieved on: 
Friday, July 21, 2023
Health, Other Health, Research, Pharmaceutical, Science, Biotechnology, Inc., Rocky, Partnership, Therapy, PFE, Pfizer, Medicine, Organization, Anesthesia, Pain, Hospital, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NYSE, Food, Pharmaceutical industry

All 3,200 local Pfizer colleagues reporting to this manufacturing site are safe and accounted for after excellent implementation of the site’s long-standing evacuation plan.

Key Points: 
  • All 3,200 local Pfizer colleagues reporting to this manufacturing site are safe and accounted for after excellent implementation of the site’s long-standing evacuation plan.
  • Pfizer also announced a donation to the American Red Cross North Carolina Chapter and United Way Tar River Region to support the relief and recovery needs.
  • Pfizer is also exploring alternative manufacturing locations for production across our significant manufacturing presence in the U.S. and internationally and across the company’s partner network.
  • The site is one of 10 Pfizer manufacturing sites located in the United States.

Pfizer Announces New England Journal of Medicine Publication on Group B Streptococcus (GBS) Maternal Vaccine Candidate

Retrieved on: 
Wednesday, July 19, 2023
Biotechnology, Infectious Diseases, Health, Pharmaceutical, Clinical Trials, Vaccine, Inc., Pregnancy, Aluminium phosphate, Senior, Stillbirth, Vaccination, The New England Journal of Medicine, Fever, PFE, Aes, Antibody, Sepsis, NEJM, Mother, Șaeș, Pain, Development, Death, Streptococcus, Risk, CPS, Immunoglobulin G, GBS, Knowledge, Infant, Ageing, Safety, III, Meningitis, NYSE, Pneumonia, Disease, Pfizer

Pfizer Inc. (NYSE: PFE) today announced data from a Phase 2 study investigating its hexavalent capsular polysaccharide (CPS) conjugate Group B Streptococcus (GBS) vaccine candidate, GBS6, being developed for maternal administration to protect infants against invasive GBS disease.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) today announced data from a Phase 2 study investigating its hexavalent capsular polysaccharide (CPS) conjugate Group B Streptococcus (GBS) vaccine candidate, GBS6, being developed for maternal administration to protect infants against invasive GBS disease.
  • The results were published in The New England Journal of Medicine (NEJM) and will inform a planned Phase 3 clinical development program.
  • In both the mothers and infants, the safety profile was similar between the vaccine and placebo groups.
  • Solicited systemic events were similar among the GBS6 groups and the placebo group, with most events being mild or moderate.

Flagship Pioneering and Pfizer Partner to Accelerate Development of Innovative Medicines Targeting Unmet Needs

Retrieved on: 
Tuesday, July 18, 2023
Medicine, Partnership, PFE, Research, Science, Organization, Development, Flagship Pioneering, Patient, Panasonic Executive Partner, NYSE, Pharmaceutical industry, Flagship, Pfizer

CAMBRIDGE, Mass. and NEW YORK, July 18, 2023 /PRNewswire/ -- Flagship Pioneering, Inc. and Pfizer Inc. (NYSE: PFE) today announced the companies have partnered to create a new pipeline of innovative medicines. Under the terms of the novel agreement, Flagship and Pfizer will each invest $50M upfront to explore opportunities to develop 10 single-asset programs by leveraging Flagship's ecosystem of more than 40 human health companies and multiple biotechnology platforms. Pfizer will fund and have an option to acquire each selected development program. Flagship and its bioplatform companies will be eligible to receive up to $700M in milestones and royalties for each successfully commercialized program.

Key Points: 
  • and NEW YORK, July 18, 2023 /PRNewswire/ -- Flagship Pioneering, Inc. and Pfizer Inc. (NYSE: PFE) today announced the companies have partnered to create a new pipeline of innovative medicines.
  • Pioneering Medicines, an initiative of Flagship Pioneering, working in collaboration with Pfizer's research and development leadership, will lead the exploration process to drive rapid potential portfolio creation.
  • "Flagship and Pfizer enter into this strategic alliance driven by a shared sense of urgency to develop novel medicines that make a difference for patients," said Paul Biondi, President, Pioneering Medicines, and Executive Partner, Flagship Pioneering.
  • "This collaboration is an exciting opportunity for Pfizer to bring deep scientific expertise and apply our development and regulatory strength to Flagship's diverse portfolio of technology platforms, translating early-stage innovation to potential medicines."

Carrick Therapeutics Announces Clinical Trial Collaboration with Arvinas and Pfizer to Evaluate Samuraciclib and Vepdegestrant Combination

Retrieved on: 
Thursday, July 6, 2023
PFE, Clinical trial, CDK7, Chimera, ARVN, HR, Patient, Proteolysis, Publius Cornelius Arvina, Therapy, NYSE, ER, Pharmaceutical industry, Pfizer

DUBLIN, Ireland and BOSTON, July 06, 2023 (GLOBE NEWSWIRE) -- Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, today announced a clinical trial collaboration and supply agreement with Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE).

Key Points: 
  • DUBLIN, Ireland and BOSTON, July 06, 2023 (GLOBE NEWSWIRE) -- Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, today announced a clinical trial collaboration and supply agreement with Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE).
  • This agreement covers the execution of a Phase 1b/2 clinical trial to evaluate the novel combination of Carrick’s samuraciclib (CT7001), an oral and first-in-class inhibitor of CDK7, and Arvinas’ vepdegestrant (ARV-471), an investigational oral PROTAC® (PROteolysis TArgeting Chimera) estrogen receptor protein degrader being developed in collaboration with Pfizer, in patients who have received prior CDK4/6i, with ER+, HER2- metastatic breast cancer.
  • “We’re pleased to announce our collaboration with Arvinas and Pfizer to explore the potential of samuraciclib in combination with vepdegestrant for the treatment of advanced breast cancer,” said Tim Pearson, Chief Executive Officer of Carrick Therapeutics.
  • It is anticipated that the Phase 1b/2 trial will be initiated in the second half of 2023.

Caribou Biosciences Announces $25 Million Equity Investment from Pfizer

Retrieved on: 
Thursday, July 6, 2023
Rachel Haurwitz, CRISPR, Partnership, Multiple myeloma, PFE, Pfizer, Doctor of Philosophy, Sale, NYSE, Patient, Pharmaceutical industry, Reindeer

BERKELEY, Calif., July 06, 2023 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today announced that Pfizer Inc. (NYSE: PFE) has made a $25 million equity investment in the company. Pfizer purchased 4,690,431 of Caribou common shares at a price of $5.33 per share, pursuant to the terms of a Securities Purchase Agreement dated June 29, 2023. The purchase by Pfizer closed on June 30, 2023. In conjunction with the investment, Sriram Krishnaswami, PhD, has joined Caribou’s Scientific Advisory Board.

Key Points: 
  • -- Sriram Krishnaswami, PhD, vice president and development head, multiple myeloma, Pfizer Global Product Development, has joined Caribou’s Scientific Advisory Board --
    BERKELEY, Calif., July 06, 2023 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today announced that Pfizer Inc. (NYSE: PFE) has made a $25 million equity investment in the company.
  • Pfizer purchased 4,690,431 of Caribou common shares at a price of $5.33 per share, pursuant to the terms of a Securities Purchase Agreement dated June 29, 2023.
  • The purchase by Pfizer closed on June 30, 2023.
  • Caribou will maintain full ownership and control of its pipeline of allogeneic CAR-T and CAR-NK cell therapies.