Clinical Research Informer

Extension Of Innovation Partnering Office at Monash University In Collaboration With Victorian State Government To Accelerate The Life-Sciences Hub

The Pharma Data

JULY 15, 2021

Johnson & Johnson Innovation announced today the extension of the Johnson & Johnson Innovation Partnering Office at Monash University’s Clayton Campus in Melbourne (JJIPO@Monash) in collaboration with the Victorian State Government.

Life Science

Life Science Research Development Drug Delivery

World Health Assembly charts course for COVID-19 response and global health priorities

The Pharma Data

NOVEMBER 5, 2020

First, we can beat COVID-19 with science, solutions and solidarity. It reminds us why WHO’s ‘triple billion’ targets are so important, and why countries must pursue them with even more determination, collaboration and innovation. More than 47 million COVID-19 cases have now been reported to WHO, and more than 1.2

Compliance

Compliance Containment Regulation Vaccination

Microscopic innovations in women’s health

Drug Discovery World

SEPTEMBER 28, 2023

This transfer imparts immune advantages: Infants born vaginally have a greater concentration of Bacteroides, Bifidobacteria, and Lactobacillus , as well as more diverse microbial compositions in their first weeks of life compared to children born by C-section (caesarean section). The influence of these microbiomes extends to children as well.

Clinical Trials

Clinical Trials Clinical Trials Regulation Bacteria

Listen Now—The Antigen Season 3 Explores Maternal Immunization

Pfizer

NOVEMBER 14, 2022

Listen Now—The Antigen Season 3 Explores Maternal Immunization. Listen Now—The Antigen Season 3 Explores Maternal Immunization. The Antigen , Pfizer’s flagship podcast returns with a three-part mini-series spotlighting maternal immunization. Maternal Immunization. Mon, 11/14/2022 - 13:13.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

Johnson & Johnson to Acquire Momenta Pharmaceuticals, Inc., Expanding Janssen’s Leadership in Novel Treatments for Autoimmune Diseases

The Pharma Data

AUGUST 19, 2020

(Momenta), a company that discovers and develops novel therapies for immune-mediated diseases, in an all cash transaction for approximately $6.5 About Janssen’s Approach to Autoimmune Disease Janssen has pioneered breakthrough science in autoimmune diseases with five approved therapies to treat more than 30 pediatric and adult indications.

Production

Production Dermatology Development Containment

Johnson & Johnson to Acquire Momenta Pharmaceuticals, Inc., Expanding Janssen's Leadership in Novel Treatments for Autoimmune Diseases

The Pharma Data

AUGUST 19, 2020

(Momenta), a company that discovers and develops novel therapies for immune-mediated diseases, in an all cash transaction for approximately $6.5 It is now understood that multiple, diverse autoimmune diseases with high unmet medical need are linked by the same immune pathways. Learn more at www.jnj.com. Follow us at @JNJNews. .

Production

Production Dermatology Development Containment

Pfizer Receives Positive CHMP Opinion for Conversion of PAXLOVID™ Conditional Marketing Authorization to Full Marketing Authorization in the European Union

Pfizer

JANUARY 27, 2023

Pregnancy: There are no available human data on the use of nirmatrelvir during pregnancy to evaluate for a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are maternal and fetal risks associated with untreated COVID-19 in pregnancy.

Marketing

Marketing Production Drugs Licensing

Respiratory Syncytial Virus (RSV) Vaccine Candidate for the Prevention of RSV in Infants from Birth up to Six Months of Age by Active Immunization of Pregnant Women

The Pharma Data

MARCH 3, 2022

Today’s decision is a pivotal next step in our path towards potential regulatory approval for our maternal RSV vaccine candidate and is an important milestone in our efforts to help address the detrimental impact RSV disease has on infants,” said Kathrin U. Jansen, Ph.D., 4,5,6,7 In the United States alone, approximately 2.1

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

Pfizer to Provide U.S. Government with an Additional 3.7 Million Treatment Courses of PAXLOVID™ to Help Combat COVID-19

Pfizer

DECEMBER 13, 2022

Immune System Disorders: Anaphylaxis and other hypersensitivity reactions Gastrointestinal Disorders: Abdominal pain, nausea General Disorders and Administration Site Conditions: Malaise. There are maternal and fetal risks associated with untreated COVID-19 in pregnancy. Maternal Immunization Pediatrics Research Vaccines.

Drugs

Drugs Licensing Licensing Production

Pfizer Signs Agreement to Provide the European Union with PAXLOVID™

Pfizer

NOVEMBER 23, 2022

Immune System Disorders: Anaphylaxis, hypersensitivity reactions Gastrointestinal Disorders: Abdominal pain, nausea General Disorders and Administration Site Conditions: Malaise. associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Maternal Immunization, Pediatrics, Research, Vaccines.

Licensing

Licensing Licensing Drugs Manufacturing

U.S. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™

Pfizer

DECEMBER 20, 2022

Immune System Disorders: Anaphylaxis and other hypersensitivity reactions Gastrointestinal Disorders: Abdominal pain, nausea General Disorders and Administration Site Conditions: Malaise. There are maternal and fetal risks associated with untreated COVID-19 in pregnancy. About Pfizer: Breakthroughs That Change Patients’ Lives.

Drugs

Drugs Licensing Licensing Containment

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

The Pharma Data

SEPTEMBER 15, 2020

“I am proud of the truly transformational science that our research and clinical teams are bringing to the fight against disease, as well as the unprecedented speed with which we are advancing our clinical programs in the battle against COVID-19. UPDATES ON COVID-19 DEVELOPMENT PROGRAMS. for RSV A and 18.0

Gene Therapy

Gene Therapy Vaccination Vaccine Trials

Women in Science Who Have Paved the Way Forward in Genetics

XTalks

FEBRUARY 11, 2021

Xtalks is celebrating the International Day of Women and Girls in Science with a special overview of notable female scientists who have made revolutionary contributions to the field of genetics. Daly’s interest in science began with learning about scientists through the books she read at her maternal grandparents’ home.

Genetics

Genetics DNA Genome Genomics

Safety Recommendation on Janus kinase (JAK) Inhibitors Issued in the European Union

Pfizer

OCTOBER 28, 2022

1,2,3 As the developer of tofacitinib, Pfizer is committed to advancing the science of Janus kinase inhibition and enhancing understanding of tofacitinib through robust clinical development programs in the treatment of immune-mediated inflammatory conditions. IMMUNIZATIONS. PATIENTS WITH GASTROINTESTINAL NARROWING.

Clinical Trials

Clinical Trials Clinical Trials Vaccination Vaccine

EWS/ Pfizer Provides Update on U.S. FDA Review of Abrocitinib and XELJANZ® Filings PFIZER PROVIDES UPDATE ON U.S. FDA REVIEW OF ABROCITINIB AND XELJANZ® FILINGS

The Pharma Data

JULY 21, 2021

Update immunizations in agreement with current immunization guidelines prior to initiating XELJANZ therapy. Available data with XELJANZ use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. PATIENTS WITH GASTROINTESTINAL NARROWING.

Clinical Trials

Clinical Trials Clinical Trials Development Trials

Data Published in New England Journal of Medicine Shows Pfizer’s Tofacitinib Meets Primary Endpoint in Brazilian Study in Patients Hospitalized with COVID-19 Pneumonia

The Pharma Data

JUNE 16, 2021

i,ii,iii As the developer of tofacitinib, Pfizer is committed to advancing the science of JAK inhibition and enhancing understanding of tofacitinib through robust clinical development programs in the treatment of immune-mediated inflammatory conditions. PATIENTS WITH GASTROINTESTINAL NARROWING. USE IN PREGNANCY.

Medicine

Medicine Clinical Trials Clinical Trials Trials

Pfizer and BioNTech Receive U.S. FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza

Pfizer

DECEMBER 8, 2022

A combined vaccine for influenza and COVID-19 has the potential to simplify immunization practices against two severe respiratory diseases caused by evolving viruses that require vaccine adaptation. are immunocompromised or are on a medicine that affects the immune system. About Respiratory Diseases. INDICATION. have a fever.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

Clinical Research Informer

Extension Of Innovation Partnering Office at Monash University In Collaboration With Victorian State Government To Accelerate The Life-Sciences Hub

World Health Assembly charts course for COVID-19 response and global health priorities

Trending Sources

Microscopic innovations in women’s health

Listen Now—The Antigen Season 3 Explores Maternal Immunization

Johnson & Johnson to Acquire Momenta Pharmaceuticals, Inc., Expanding Janssen’s Leadership in Novel Treatments for Autoimmune Diseases

Johnson & Johnson to Acquire Momenta Pharmaceuticals, Inc., Expanding Janssen's Leadership in Novel Treatments for Autoimmune Diseases

Pfizer Receives Positive CHMP Opinion for Conversion of PAXLOVID™ Conditional Marketing Authorization to Full Marketing Authorization in the European Union

Respiratory Syncytial Virus (RSV) Vaccine Candidate for the Prevention of RSV in Infants from Birth up to Six Months of Age by Active Immunization of Pregnant Women

Pfizer to Provide U.S. Government with an Additional 3.7 Million Treatment Courses of PAXLOVID™ to Help Combat COVID-19

Pfizer Signs Agreement to Provide the European Union with PAXLOVID™

U.S. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

Women in Science Who Have Paved the Way Forward in Genetics

Safety Recommendation on Janus kinase (JAK) Inhibitors Issued in the European Union

EWS/ Pfizer Provides Update on U.S. FDA Review of Abrocitinib and XELJANZ® Filings PFIZER PROVIDES UPDATE ON U.S. FDA REVIEW OF ABROCITINIB AND XELJANZ® FILINGS

Data Published in New England Journal of Medicine Shows Pfizer’s Tofacitinib Meets Primary Endpoint in Brazilian Study in Patients Hospitalized with COVID-19 Pneumonia

Pfizer and BioNTech Receive U.S. FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza

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