The Pharma Data

MAY 4, 2021

Lilly is offering donations of baricitinib to the Indian government through Direct Relief while simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India during the pandemic. Ricks , Lilly chairman and CEO.

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The Pharma Data

SEPTEMBER 1, 2021

MOVe-AHEAD (MK-4482-013) ( NCT04939428 ) is a Phase 3 multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of orally administered molnupiravir compared to placebo in preventing the spread of SARS-CoV-2, the virus that causes COVID-19, within households. About Molnupiravir.

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The Pharma Data

MARCH 29, 2022

Spinner, MD, Consulting Physician Infectious Diseases and Pandemic Officer at the University Hospital Rechts der Isar and adjunct teaching professor at the Technical University of Munich, Munich, Germany, said: “Increasing COVID-19 cases, driven by the highly-transmissible BA.2 1-3 Evusheld was generally well-tolerated in the trial.

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The Pharma Data

NOVEMBER 29, 2020

Early interim data show Cytomegalovirus (CMV)-negative kidney transplant recipients vaccinated with three doses of HB-101 had reduced incidence of CMV viremia, reduced antiviral use and no CMV disease. 21 participants were vaccinated with HB-101 and 12 received placebo. NEW YORK and VIENNA, Austria, Nov.

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The Pharma Data

APRIL 15, 2022

The test can be performed in environments where the patient specimen is both collected and analyzed, such as doctor’s offices, hospitals and mobile testing sites, using an instrument about the size of a piece of carry-on luggage. In the study, the test was shown to have 91.2% The study also showed that, in a population with only 4.2%

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Codon

MAY 11, 2023

3/ A Vaccine for RSV A vaccine called Arexvy, and marketed by GlaxoSmithKline, has been approved by the FDA for adults aged 60 and older. It is used to prevent respiratory syncytial virus, or RSV, which causes about 60,000 hospitalizations in this age group each year. The vaccine was 82.6 The vaccine was 82.6

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Vaccine Engineering Licensing Licensing 52

Codon

MAY 11, 2023

3/ A Vaccine for RSV A vaccine called Arexvy, and marketed by GlaxoSmithKline, has been approved by the FDA for adults aged 60 and older. It is used to prevent respiratory syncytial virus, or RSV, which causes about 60,000 hospitalizations in this age group each year. The vaccine was 82.6 The vaccine was 82.6

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The Pharma Data

MARCH 22, 2022

Additionally, Pfizer has signed a voluntary license agreement with the Medicines Patent Pool (MPP) for its oral treatment to help expand access, pending country regulatory authorization or approval, in 95 low- and middle-income countries that account for approximately 53% of the world’s population.

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The Pharma Data

FEBRUARY 12, 2022

This trial was a Phase 2, randomized, clinical trial evaluating treatment of non-hospitalized patients with mild-to-moderate COVID-19 who were treated with the authorized dose of bebtelovimab (175 mg) alone or together with 700 mg bamlanivimab and 1,400 mg of etesevimab. About BLAZE-4.

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The Pharma Data

APRIL 16, 2021

1.429 California strain that currently accounts for 50 percent of the virus in California and over 10 percent across a number of additional states. Due to the rapidly evolving and geographically diverse nature of the SARS-CoV-2 virus, continued scientific innovation remains critical to develop additional treatments. In the U.S.,

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The Pharma Data

MAY 4, 2021

Direct Relief will allocate donations of baricitinib to low- and lower-middle-income countries (based on World Bank classification) for the treatment of hospitalized COVID-19 patients requiring supplemental oxygen, based on requests from these governments to Direct Relief. Ricks , Lilly chairman and CEO. It is approved in the U.S.

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The Pharma Data

APRIL 14, 2021

Bamlanivimab and etesevimab together and bamlanivimab alone are not authorized for use in patients: who are hospitalized due to COVID-19, OR. Treatment with bamlanivimab and etesevimab together has not been studied in patients hospitalized due to COVID-19. Some of these events required hospitalization. Adverse Events.

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The Pharma Data

JANUARY 12, 2021

Doses are being supplied for use pursuant to the FDA Emergency Use Authorization for high-risk patients with mild to moderate COVID-19 in order to reduce the risk of progression to severe COVID-19 and/or hospitalization. “Tackling the COVID-19 pandemic will require a combination of public health measures, vaccines and therapeutics.

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The Pharma Data

JULY 23, 2021

Ronapreve is a combination of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed to block infectivity of SARS-CoV-2, the virus that causes COVID-19. The US EUA is temporary and does not take the place of the formal biologics license application (BLA) submission, review and approval process.

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The Pharma Data

OCTOBER 26, 2020

Demand for our products remains robust, and production, supply and distribution of our medicines, vaccines and animal health products are moving forward with minimal disruption,” said Kenneth C. billion related to certain license and collaboration agreements, and certain other items. Non-GAAP EPS of $1.74 COVID-19 Research Highlights.

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The Pharma Data

MARCH 22, 2021

1 COVID-19-related hospitalization or death through day 29. Casirivimab and imdevimab is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed by Regeneron scientists to block infectivity of SARS-CoV-2, the virus that causes COVID-19. 1,200 mg IV. 2,400 mg IV. Patients with ?

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The Pharma Data

APRIL 6, 2021

Ongoing research for baricitinib, an oral JAK inhibitor discovered by Incyte and licensed to Lilly, in adult and pediatric AD, alopecia areata (AA), systemic lupus erythematosus (SLE), juvenile idiopathic arthritis (JIA), COVID-19 and for its approved indication for rheumatoid arthritis (RA) continues.

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The Pharma Data

OCTOBER 29, 2020

Baricitinib, an oral JAK1/JAK2 inhibitor discovered by Incyte, is developed by Lilly under license from Incyte. SERIOUS INFECTIONS: Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. VACCINATIONS : Avoid use of live vaccines with Olumiant.

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The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021.

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The Pharma Data

JANUARY 26, 2021

“The death toll from COVID-19 continues to rise around the world and hospitalizations, particularly in the U.S., These data further support our belief that bamlanivimab and etesevimab together have the potential to be an important treatment that significantly reduces hospitalizations and death in high-risk COVID-19 patients.

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Drug Discovery World

SEPTEMBER 16, 2022

“In particular these SMEs wanted affordable workspace; better provision of wet laboratory and clean room space in London, available at higher specification but not necessarily at great scale; universities and hospitals to make their equipment and facilities more usefully available; and more endeavour to grow skills and talent,” Patel said. .

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The Pharma Data

MARCH 11, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced real-world evidence demonstrating dramatically lower incidence rates of COVID-19 disease in individuals fully vaccinated with the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2), underscoring the observed substantial public health impact of Israel’s nationwide immunization program.

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The Pharma Data

NOVEMBER 20, 2020

Casirivimab and imdevimab are not authorized for use in patients who are hospitalized or require oxygen therapy due to COVID-19, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19. . “The Yancopoulos, M.D.,

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Agency IQ

FEBRUARY 2, 2024

The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

NOVEMBER 3, 2023

Although this guidance document is mostly focused on chemistry, manufacturing and control (CMC) information, it clarifies that LBPs are considered biologics, and will thus need to utilize the Biologics License Application (BLA) pathway. What’s next? AgencyIQ is planning a deeper dive into these recent actions by the FDA.

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The Pharma Data

SEPTEMBER 7, 2021

Bristol Myers Squibb has a global exclusive license to develop, manufacture and commercialize the Rockefeller University’s novel monoclonal antibody (“mAb”) duo treatment that neutralizes the SARS-CoV-2 virus for therapy or prevention of COVID-19. We are encouraged that more than 85% of our employees in the U.S. All of our U.S.

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The Pharma Data

NOVEMBER 21, 2020

Casirivimab and imdevimab are not authorized for use in patients who are hospitalized or require oxygen therapy due to COVID-19, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19. . Yancopoulos , M.D.,

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The Pharma Data

NOVEMBER 9, 2020

TScan Therapeutics announced the signing of a research license and option agreement with QIAGEN to develop T cell-based laboratory tests for detecting prior exposure to the novel coronavirus, SARS-CoV-2, using discoveries from TScan’s high-throughput TCR/Target discovery platform. Testing Therapies, Antivirals and Vaccines.

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The Pharma Data

NOVEMBER 30, 2020

(Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis.

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Vaccine FDA Clinical Trials Disease 52

The Pharma Data

JANUARY 24, 2021

Gritstone Oncology , based in Emeryville, California, announced that it is advancing development of its own second-generation vaccine against COVID-19. Innovation Pharmaceuticals received the greenlight from the FDA to initiate a Phase II trial of Brilacidin in hospitalized COVID-19 patients. Read on to see. COVID-19-Related.

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The Pharma Data

NOVEMBER 9, 2020

Bamlanivimab is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. Patients treated with bamlanivimab showed reduced viral load and rates of symptoms and hospitalization.

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PLOS: DNA Science

SEPTEMBER 7, 2023

Now, college tuition includes a fee to license an e-textbook for a limited time. Trace a rare blood type in a family on General Hospital ? Each edition brought new fonts, design elements, and palettes, to make the new version appear different, because some topics – mitosis, Mendel, DNA – don’t change.

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DNA Science Therapies Licensing 84

The Pharma Data

DECEMBER 20, 2020

CureVac announced it has enrolled the first volunteer in the pivotal Phase IIb/III trial of its own mRNA vaccine candidate, CVnCoV against COVID-19. The technology used for the CureVac vaccine is similar to that utilized by Pfizer-BioNTech and Moderna. Russia’s Sputnik V COVID-19 vaccine demonstrated 91.4%

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Vaccine Trials Small Molecule Therapies 52

The Pharma Data

APRIL 27, 2021

at CER driven by growth drivers Dupixent ® and Vaccines. Vaccines up 5.3%, driven by PPH franchise and demand for influenza vaccines in southern hemisphere. Vaccines delivered growth in its core segments. Polio/Pertussis/Hib vaccines (incl. Influenza vaccines (incl. Meningitis/Pneumo vaccines (incl.

Vaccine 52

Vaccine Production FDA FDA Approval 52

The Pharma Data

MARCH 4, 2021

” Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. SERIOUS INFECTIONS: Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Viral Reactivation – Viral reactivation, including cases of herpes virus reactivation (e.g.,

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Trials Therapies Treatment Clinical Trials 52

The Pharma Data

OCTOBER 15, 2020

The award honors McHutchison’s work in developing life-changing and curative therapies for patients with the hepatitis C virus. Floyd co-founded Elion Oncology which licensed PCS6422 to Processa. Meissa Vaccines – William Daly was named CBO and Keith H. BeyondSpring – BeyondSpring Inc.

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The Pharma Data

MARCH 11, 2021

These results are consistent with those seen in other data sets from BLAZE-1: in the previous Phase 3 cohort, bamlanivimab 2800 mg with etesevimab 2800 mg reduced the risk of hospitalizations and deaths by 70 percent and in the Phase 2 cohort, bamlanivimab alone reduced the risk of hospitalizations and ER visits by approximately 70 percent.

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