PFE

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.

FDA Approves Pfizer’s NGENLA™, a Long-Acting Once-Weekly Treatment for Pediatric Growth Hormone Deficiency

Retrieved on: 
Wednesday, June 28, 2023
Research, FDA, Children, Biotechnology, Health, Consumer, Pharmaceutical, Other Science, Science, GHD, Inc., EU, Pituitary gland, Growth hormone, PFE, Medicine, Puberty, OPKO Health, Patient, Standard of care, Ageing, Hybrid growth disorders, United, Regulation of tobacco by the U.S. Food and Drug Administration, Safety, NYSE, Food, Disease, Pharmaceutical industry, Birth control, Pfizer

Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK) announced today that the U.S. Food and Drug Administration (FDA) has approved NGENLA (somatrogon-ghla), a once-weekly, human growth hormone analog indicated for treatment of pediatric patients aged three years and older who have growth failure due to inadequate secretion of endogenous growth hormone.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK) announced today that the U.S. Food and Drug Administration (FDA) has approved NGENLA (somatrogon-ghla), a once-weekly, human growth hormone analog indicated for treatment of pediatric patients aged three years and older who have growth failure due to inadequate secretion of endogenous growth hormone.
  • The study met its primary endpoint of NGENLA non-inferiority compared to somatropin, as measured by annual height velocity at 12 months.
  • “The approval of NGENLA will be significant for children with growth hormone deficiency in the U.S.
  • It holds potential to reduce the treatment burden that can come with daily growth hormone injections,” said Joel Steelman, M.D., Pediatric Endocrinologist, Cook Children’s Health Care System.

FDA Accepts Pfizer’s Application for Hemophilia B Gene Therapy Fidanacogene Elaparvovec

Retrieved on: 
Tuesday, June 27, 2023
Biotechnology, Pharmaceutical, Health, Inc., Duchenne muscular dystrophy, European Medicines Agency, PFE, ABR, Haemophilia, Pfizer, FIX, Duchenne, AAV, EMA, Patient, Breakthrough, PDUFA, MAA, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, BLA, NYSE, Food, Pharmaceutical industry

Fidanacogene elaparvovec is a novel, investigational gene therapy that contains a bio-engineered adeno-associated virus (AAV) capsid (protein shell) and a high-activity variant of human coagulation Factor IX (FIX) gene.

Key Points: 
  • Fidanacogene elaparvovec is a novel, investigational gene therapy that contains a bio-engineered adeno-associated virus (AAV) capsid (protein shell) and a high-activity variant of human coagulation Factor IX (FIX) gene.
  • “Gene therapy marks a new era of scientific advancement, and if approved, we believe fidanacogene elaparvovec has the potential to transform the lives of people living with hemophilia B who are eligible for treatment.
  • Fidanacogene elaparvovec has been granted Breakthrough, Regenerative Medicines Advanced Therapy (RMAT) and orphan drug designations from the FDA.
  • Pfizer currently has three Phase 3 programs investigating gene therapy in populations where there is a high unmet need: hemophilia B, hemophilia A, and Duchenne muscular dystrophy.

Pfizer Provides Update on GLP-1-RA Clinical Development Program for Adults with Obesity and Type 2 Diabetes Mellitus

Retrieved on: 
Monday, June 26, 2023
Health, Diabetes, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Inc., Obesity, Senior, Diarrhea, PFE, American Medical Association, Vomiting, Plasma, Journal, Patient, Type 2 diabetes, Internal medicine, Nausea, Fasting, Liver, Liver failure, NYSE, Safety, Glycated hemoglobin, Human, Pharmaceutical industry, Pfizer, T2DM

Pfizer Inc. (NYSE: PFE) today announced its decision to continue to progress one oral late-stage glucagon-like peptide-1 receptor agonist (GLP-1-RA) candidate toward further clinical development for the potential treatment of adults with obesity and Type 2 diabetes mellitus (T2DM).

Key Points: 
  • Pfizer Inc. (NYSE: PFE) today announced its decision to continue to progress one oral late-stage glucagon-like peptide-1 receptor agonist (GLP-1-RA) candidate toward further clinical development for the potential treatment of adults with obesity and Type 2 diabetes mellitus (T2DM).
  • Moving forward, the company will continue advancing the clinical program for danuglipron (PF-06882961), subject to results from the ongoing Phase 2 trial, and discontinue the clinical development of lotiglipron (PF-07081532).
  • The company expects to finalize plans for the danuglipron late-stage program by the end of 2023 and also is developing a once-daily modified release version.
  • Data from these studies evaluating lotiglipron will be presented at a scientific conference or published in peer-reviewed journal(s).

FDA Approves Pfizer’s LITFULO™ (Ritlecitinib) for Adults and Adolescents With Severe Alopecia Areata

Retrieved on: 
Friday, June 23, 2023
Research, FDA, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Science, Janus, Yale School of Medicine, Inc., TEC, Diarrhea, Hepatocellular carcinoma, National Alopecia Areata Foundation, PFE, Aes, JAK3, Dermatology, ALLEGRO, Acne, Yale school, SALT, Hives, Associate, Rash, Alopecia areata, Hair, Patient, Autoimmune disease, Severity, Janus kinase 3, Headache, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, NYSE, Food, Pharmaceutical industry, Lancet, Pfizer

It is the first and only treatment approved by the FDA for adolescents (12+) with severe alopecia areata.

Key Points: 
  • It is the first and only treatment approved by the FDA for adolescents (12+) with severe alopecia areata.
  • “LITFULO is an important treatment advancement for alopecia areata, an autoimmune disease that previously had no FDA-approved options for adolescents and limited options available for adults,” said Angela Hwang, Chief Commercial Officer, President, Global Biopharmaceuticals Business, Pfizer.
  • “With today’s approval, adolescents and adults who struggle with substantial hair loss have an opportunity to achieve significant scalp hair regrowth.”
    The FDA approval was based on results of clinical trials in alopecia areata.
  • “We believe the approval of LITFULO is a significant advancement for the treatment of alopecia areata, particularly for teens.

Pfizer Declares Third-Quarter 2023 Dividend

Retrieved on: 
Thursday, June 22, 2023
Health, General Health, Research, Pharmaceutical, Science, Biotechnology, PFE, Common stock, 339th, Inc., Pfizer, NYSE, Holding company, Pharmaceutical industry

Pfizer Inc. (NYSE: PFE) today announced that its board of directors declared a $0.41 third-quarter 2023 dividend on the company’s common stock, payable September 5, 2023, to holders of the Common Stock of record at the close of business on July 28, 2023.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) today announced that its board of directors declared a $0.41 third-quarter 2023 dividend on the company’s common stock, payable September 5, 2023, to holders of the Common Stock of record at the close of business on July 28, 2023.
  • The third-quarter 2023 cash dividend will be the 339th consecutive quarterly dividend paid by Pfizer.

Pfizer’s TALZENNA® in Combination with XTANDI® Receives U.S. FDA Approval

Retrieved on: 
Tuesday, June 20, 2023
Biotechnology, Pharmaceutical, Oncology, General Health, Health, FDA, Genetics, Clinical Trials, RAD51C, MLH1, FANCA, HRR, NBN, MRE11A, ADP, BRCA1, European Medicines Agency, PFE, RPF, NYSE, ATM, CDK12, HIV disease progression rates, Patient, Risk, Anemia, Fracture, BRCA2, MAA, PARP, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, ATR, Food, Pharmaceutical industry, Pfizer

Metastatic CRPC is a form of prostate cancer that has spread beyond the prostate gland and has progressed despite medical or surgical treatment to lower testosterone.

Key Points: 
  • Metastatic CRPC is a form of prostate cancer that has spread beyond the prostate gland and has progressed despite medical or surgical treatment to lower testosterone.
  • Therefore, new first-line treatment options are needed to reduce the risk of disease progression or death.
  • The safety of TALZENNA plus XTANDI in the TALAPRO-2 trial was generally consistent with the known safety profile of each medicine.
  • A marketing authorization application (MAA) for the TALZENNA and XTANDI combination has been accepted for review by the European Medicines Agency.

Pfizer Invites Public to View and Listen to Webcast of August 1 Conference Call with Analysts

Retrieved on: 
Tuesday, June 20, 2023
Infectious Diseases, Biotechnology, Pharmaceutical, Health, Webcast, PFE, Inc., Performance report, Pfizer, NYSE, EDT, Cryptocurrency

Pfizer Inc. (NYSE: PFE) invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 10 a.m. EDT on Tuesday, August 1, 2023.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 10 a.m. EDT on Tuesday, August 1, 2023.
  • To view and listen to the webcast and view the Performance Report, 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.
  • You can also listen to the conference call by dialing either 800-456-4352 in the United States and Canada or 785-424-1086 outside of the United States and Canada.

Spero Therapeutics Appoints Sath Shukla as President & Chief Executive Officer

Retrieved on: 
Wednesday, June 14, 2023
GSK, Interim, HBR, Penn State Board of Trustees, Culture, Infection, PFE, Pfizer, Shukla, Accounting, MDR, M.D, Spero, Interim management, MD, Patient, Rare, Treasurer, Therapy, NYSE, Management, Pharmaceutical industry, Vertex, Ankit

CAMBRIDGE, Mass., June 14, 2023 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company, focused on identifying, developing and commercializing treatments in high unmet need areas involving rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that Satyavrat “Sath” Shukla, Spero’s current Chief Financial Officer and Treasurer, will serve as Spero’s President and Chief Executive Officer (CEO), and as a member of the Board of Directors, effective August 1, 2023.

Key Points: 
  • Sath Shukla, current Spero Chief Financial Officer, will bring more than 20 years of strategic and financial leadership to the role of CEO, to be effective August 1, 2023
    Current President and Chief Executive Officer, Ankit Mahadevia, M.D to become Chairman of the Board of Directors
    CAMBRIDGE, Mass., June 14, 2023 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company, focused on identifying, developing and commercializing treatments in high unmet need areas involving rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that Satyavrat “Sath” Shukla, Spero’s current Chief Financial Officer and Treasurer, will serve as Spero’s President and Chief Executive Officer (CEO), and as a member of the Board of Directors, effective August 1, 2023.
  • Mr. Shukla will succeed Spero’s current CEO and President, Ankit Mahadevia, M.D., who will become Chairman of the Board of Directors, effective August 1, 2023.
  • “It has been an honor to lead Spero since its inception and I am thrilled to welcome Sath as our next CEO,” said Ankit Mahadevia, M.D., Chief Executive Officer of Spero Therapeutics.
  • Until this search is completed, the Board has appointed Stephen J. DiPalma as Interim CFO and Treasurer, effective August 1, 2023.