The Pharma Data

MAY 7, 2021

Any forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements.

Licensing 52

Licensing Licensing Vaccine FDA Approval 52

The Pharma Data

DECEMBER 3, 2020

Based on the positive Phase 1 results reported and the unprecedented need for COVID-19 vaccines, Clover and its partners are confident to enter late-stage clinical development for both adjuvanted vaccines. The Phase 1 clinical trial was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).

Vaccine 52

Vaccine Immune Response Virus RNA 52

The Pharma Data

OCTOBER 28, 2020

In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36 Senior Vice President and Head of Global Clinical Development at Regeneron. There was a 1.08 log10 copies/mL greater reduction with REGN-COV2 compared to placebo (combined dose groups; p=0.0003). .

Virus 40

Virus Trials Clinical Trials Production 40

The Pharma Data

DECEMBER 10, 2020

In the study, immunization with the hAd5-COVID-19 vaccine inhibited SARS-CoV-2 virus replication in 100% (10 of 10) of Rhesus macaques, with a drop in viral replication starting on the first day of vaccine administration, and undetectable viral levels as early as three to five days post-challenge in most of the animals.

Vaccine 52

Vaccine Immune Response Virus Clinical Trials 52

The Pharma Data

JANUARY 31, 2021

These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.” Similar to other enveloped RNA viruses such as HIV, RSV and Influenza, SARS-CoV-2 is also an RNA virus that has a trimeric spike (S) protein on its viral envelope.

Clinical Trials 52

Clinical Trials Vaccine Trials Virus 52

The Pharma Data

NOVEMBER 9, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. NVX-CoV2373 (SARS-CoV-2 vaccine) FDA Approval History.

Vaccine 52

Vaccine FDA Clinical Trials Immune Response 52

The Pharma Data

OCTOBER 30, 2020

About REGN-COV2 REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

Hospitals 52

Hospitals Virus Production Clinical Trials 52

Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Ayushi Jain and Khalid Mumtaz, 2022.

Metabolic Stability 52

Metabolic Stability Drugs FDA Approval Treatment 52

Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Ayushi Jain and Khalid Mumtaz, 2022.

Metabolic Stability 52

Metabolic Stability Drugs FDA Approval Treatment 52

The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” Casirivimab and imdevimab injection is not FDA approved for any use.

Hospitals 52

Hospitals Production Clinical Trials Virus 52

The Pharma Data

JANUARY 18, 2021

OKYO has been developing the chemerin molecule as a promising anti-inflammatory treatment for dry-eye disease (“DED”) licensed from researchers at On Target Therapeutics LLC. Ranibizumab and other anti-VEGF agents have had a dramatic impact on the development of therapies for these blinding disorders. LONDON and BOSTON, Jan.

Science 40

Science Virus FDA Approval Treatment 40

The Pharma Data

JULY 29, 2021

Hepatitis B virus (“HBV”) and hepatitis delta virus (“HDV”) product sales increased 8% to $237 million for the second quarter 2021 compared to the same period in 2020. Gilead presented additional lenacapavir clinical development program data at the International AIDS Society (“IAS”) 2021 Conference on HIV Science.

Science 52

Science Production Treatment FDA 52

Drug Discovery World

AUGUST 21, 2023

Diana Spencer investigates therapies in clinical development for triple-negative breast cancer and asks what future treatments might look like. TVEC is a modified herpes simplex 1 virus that includes coding sequences for the protein GM-CSF, which can stimulate the immune system.

Treatment 130

Treatment Virus Therapies Clinical Trials 130

The Pharma Data

DECEMBER 29, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron. About Regeneron Antibody Cocktail Casirivimab and imdevimab is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

Hospitals 52

Hospitals Trials Clinical Trials Production 52

The Pharma Data

OCTOBER 29, 2020

“Alopecia areata is a challenging disease that currently has no FDA-approved treatment options, making it difficult for healthcare providers to best serve the needs of these patients,” said Brett King , MD, PhD associate professor of Dermatology at Yale School of Medicine. Monitor patients for TB during Olumiant treatment.

Therapies 52

Therapies Treatment Disease Clinical Trials 52

The Pharma Data

SEPTEMBER 1, 2020

Presentation Topic: Clinical Trials. Pregnancy outcomes in the ozanimod multiple sclerosis clinical development program. Food and Drug Administration (FDA) approved Zeposia for the treatment of adults with relapsing forms of multiple sclerosis (RMS) in March 2020. FDA-APPROVED INDICATION FOR ZEPOSIA.

Clinical Trials 52

Clinical Trials Treatment Trials Disease 52

The Pharma Data

NOVEMBER 5, 2020

FDA accepted for priority review Libtayo ® (cemiplimab-rwlc) for both advanced non-small cell lung cancer and basal cell carcinoma. FDA approved Inmazeb for Ebola ( Zaire ebolavirus). Updates from the clinical pipeline include: Dupixent ® (dupilumab). REGN-COV2 , a dual antibody therapy to SARS-CoV-2 virus.

Production 52

Production FDA FDA Approval Trials 52

The Pharma Data

DECEMBER 5, 2020

REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority. Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics.

Production 40

Production Trials Treatment Pharmaceuticals 40

The Pharma Data

DECEMBER 10, 2020

The study also will explore prevention of infection by SARS-CoV-2, the virus that causes COVID-19. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History. Secondary endpoints include prevention of severe COVID-19 in those groups. About Pfizer: Breakthroughs That Change Patients’ Lives. Source: Pfizer Inc. . Posted: December 2020.

Vaccine 52

Vaccine Trials Clinical Trials Therapies 52

Drug Discovery World

SEPTEMBER 16, 2022

Globally, the pipeline for therapies in this sector has continued to grow over the years, and in 2021, there were just under 2,500 cell and gene therapies in some stage of clinical development. . The UK stands as one of the key markets for cell and gene therapies.

Therapies 130

Therapies Clinical Trials Production Trials 130

The Pharma Data

DECEMBER 11, 2020

The study also will explore prevention of infection by SARS-CoV-2, the virus that causes COVID-19. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History. Secondary endpoints include prevention of severe COVID-19 in those groups. Source: Pfizer Inc. . Posted: December 2020. Source link.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

MARCH 4, 2021

This classification aims to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over already available therapies on a clinically significant endpoint(s).

Trials 52

Trials Treatment Therapies Clinical Trials 52

The Pharma Data

OCTOBER 26, 2020

Based on these promising findings, Transgene intends to continue the clinical development of TG4001 in a larger, controlled confirmatory study as we look to provide a better treatment option for this patient population,” added Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene. 27, 2020 06:30 UTC.

Vaccine 52

Vaccine Virus Trials Treatment 52

The Pharma Data

JULY 23, 2021

While most cases of HCC are caused by hepatitis B virus (HBV) or hepatitis C virus (HCV) infections, metabolic syndrome and nonalcoholic steatohepatitis (NASH) are rising in prevalence and expected to contribute to increased rates of HCC. To date, the Opdivo clinical development program has treated more than 35,000 patients.

Treatment 52

Treatment Trials Therapies Disease 52

The Pharma Data

DECEMBER 15, 2020

Anokion is responsible for preclinical activities and Phase I clinical development of partnered programs, and Bristol Myers Squibb will fund subsequent trials and commercial activities at clinical proof-of-concept. Patient Recruitment.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

The Pharma Data

AUGUST 22, 2021

XELJANZ has been studied in more than 50 clinical trials worldwide, including more than 20 trials in RA patients, and prescribed to over 300,000 adult patients (the majority of whom were RA patients) worldwide since 2012. FDA-APPROVED INDICATIONS. Rheumatoid Arthritis. MALIGNANCIES.

Marketing 52

Marketing Clinical Trials Treatment Therapies 52

The Pharma Data

NOVEMBER 30, 2020

“I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. Source: Moderna, Inc. . Posted: November 2020. Source link.

Vaccine 52

Vaccine FDA Clinical Trials Disease 52